Part I Overview Information

Department of Health and Human Services

Participating Organizations
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/)

Components of Participating Organizations
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), (http://www.cdc.gov/nccdphp/)

Title: Health Promotion and Disease Prevention Research Centers: Special Interest Project Competitive Supplements

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
Supplement to Program Announcement 04003, which was released on March 27, 2003.

Request For Applications (RFA) Number: RFA-DP-04-003 (Supplements)

Catalog of Federal Domestic Assistance Number(s)
93.135

Key Dates
Release Date: May 13, 2005
Letters of Intent Receipt Date: May 26, 2005
Application Receipt Date: June 15, 2005
Peer Review Date(s): Week of July 11, 2005
Earliest Anticipated Start Date: August 31, 2005
Expiration Date: June 16, 2005
Due Dates for E.O. 12372
Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

This RFA will provide supplemental funding to Prevention Research Centers, to design, test, and disseminate effective prevention research strategies in the areas of epilepsy, cancer, cardiovascular health, and nutrition and physical activity.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

 Section II. Award Information
   1. Mechanism(s) of Support
   2. Funds Available

 Section III. Eligibility Information
   1. Eligible Applicants
     A. Eligible Institutions
     B. Eligible Individuals
   2. Cost Sharing or Matching
   3. Other - Special Eligibility Criteria

 Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Receipt, Review and Anticipated Start Dates
       1. Letter of Intent
     B. Sending an Application to the CDC
     C. Application Processing
   4. Intergovernmental Review
   5. Funding Restrictions
   6. Other Submission Requirements

 Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

 Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
       1. Principal Investigator Rights and Responsibilities
       2. NCCDPHP Responsibilities
       3. Collaborative Responsibilities
       4. Arbitration Process
   3. Reporting

 Section VII. Agency Contact(s)
   1. Scientific/Research Contact(s)
   2. Peer Review Contact(s)
   3. Financial/Grants Management Contact(s)

 Section VIII. Other Information - Required Federal Citations

 Section IX. Special Interest Project Descriptions

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

The purpose of the Prevention Research Centers (PRC) program's Special Interest Projects (SIPs) is to support supplemental projects in health promotion and disease prevention research that: (1) focus on the major causes of death and disability, (2) improve public health practice within communities, and (3) cultivate effective state and local public health programs. One of the major focuses of this supplemental funding program is to design, test, and disseminate effective prevention research strategies.

This program addresses the department-wide initiative, Steps to a HealthierUS , which advances the HealthierUS goal of helping Americans live longer, better and healthier lives by focusing on the importance of prevention. This funding opportunity supports the following Steps focus areas: Physical Activity and Fitness, Nutrition and Overweight, Cancer, and Diabetes. This program also focuses on areas addressed by “Healthy People 2010” including Access to Quality Health Services, Disability and Secondary Conditions, Educational and Community-Based Programs, and Health Communications.

Measurable outcomes of this funding opportunity are in alignment with the following performance goal for the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP): To support prevention research to develop sustainable and transferable community-based behavioral interventions.

1. Research Objectives

Nature of the Research Opportunity

This RFA builds upon the infrastructure of the Prevention Research Centers (PRC) program and solicits applications in the form of cooperative agreements to support supplemental health promotion and disease prevention research projects that focus on the major causes of death and disability, improve public health practice within communities, and cultivate effective state and local public health programs. Special Interest Projects (SIPs) provide supplemental funding to the PRCs to design, test, and disseminate effective prevention research strategies in the areas of epilepsy, cancer, cardiovascular health, and nutrition and physical activity.

Background

Many chronic diseases, injuries, and some infectious diseases are caused by behavioral and environmental factors that can be changed. Prevention research is critical to helping people change risk factors in their lives and their communities. The gaps between research findings and their translation into public health programs, practice, and policy must be eliminated so that new knowledge is effectively applied in states and communities throughout the country. As the US population ages and health care costs increase, prevention becomes even more critical to the national health care agenda.

The Prevention Research Centers program is a national network of 33 academic-based research centers that are committed to community-based participatory research and to the translation of research into programs and policies. The consortium of academic, public health, and community partners engages in community-based prevention research, research translation, and education to address the leading causes of death and disability. The combined research portfolio for the 33 centers includes nearly 500 projects. CDC supports infrastructure and various research projects guided by community committees. The partnerships and expertise each center builds strengthens its competitiveness for funding by additional federal agencies and private foundations.

Since 1993, the PRCs have coordinated Special Interest Projects funded by many divisions throughout CDC as well as other agencies of the Department of Health and Human Services. Often these projects build on the expertise a PRC develops from its core projects. Typically, SIPs are funded for a minimum of one year and $100,000; however, there are many SIPs that are multi-year endeavors to which several million dollars are dedicated.

Scientific Knowledge to be achieved through this Funding Opportunity

This RFA is expected to fund research that will expand our knowledge and understanding in the areas of epilepsy, cancer, cardiovascular health, nutrition and physical activity, and reproductive health. Individual project descriptions are contained in Section IX. Special Interest Project Descriptions of this announcement. SIP descriptions are grouped by the following topical areas:

Epilepsy and Stroke Special Interest Projects 1-3
Cancer Special Interest Projects 4-7
Cardiovascular Health Special Interest Projects 8-11
Nutrition and Physical Activity Special Interest Projects 12-18

Experimental Approach and Research Objectives

The research objectives of the SIPs are in alignment with the performance goal for the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP): To support prevention research to develop sustainable and transferable community-based behavioral interventions. The experimental approach and research objectives for each SIP are detailed in the individual project descriptions contained in Section IX. Special Interest Project Descriptions of this announcement.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the CDC (U48) cooperative award mechanisms. The applicant will be solely responsible for planning, directing, and executing the proposed project. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NCCDPHP staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative and National Policy Requirements, "Cooperative Agreement Terms and Conditions of Award".

This funding opportunity uses the just-in-time budget concepts. It requires the summary budget information provided in the application package, including the budget justification and support, written in the form, format, and level of detail as specified in the budget guidelines. You may access the latest version of the budget guidelines at: http://www.cdc.gov/od/pgo/funding/budgetguide2004.htm.

This RFA is a one-time solicitation.

2. Funds Available

The NCCDPHP expects to award $4,325,000 in FY05 to fund approximately 18 cooperative agreements ranging in total costs from $150,000 to $600,000 in response to this funding opportunity. Because t he nature and scope of the proposed research will vary by SIP, and from application to application, it is anticipated that the size and duration of each award will vary. In previous years, the amount of funding per SIP has, on average, ranged from $100,000 to $1,250,000.

The anticipated start date for each SIP is September 30, 2005. Performance periods will vary by SIP (see individual SIP description for details regarding performance periods). Following is a list of the SIP numbers, titles, and funding amounts:

1-2005: Validation of Questions about Epilepsy to be used in Population Health Interview Surveys ($200,000)

2-2005: Use of Computer Multimedia Technology to Develop a Theory-Driven, Interactive Chronic Disease Self-management Program for Epilepsy ($200,000)

3-2005: Examination of Post-stroke Rehabilitation Referral and Enrollment Rates ($150,000)

4-2005: A Community-based Health Promotion Program using Barbers as Peer Educators to Convey Cancer Early Detection Information ($150,000)

5-2005: Use of a Community-based Intervention to Increase Utilization of Colorectal Cancer Screening Among African American Women and Men in Urban Areas ($400,000)

6-2005: Intervening on the Social Determinants of Cancer Health Disparities ($300,000)

7-2005: Determinants of Patient Dropout from Cancer Treatment and Follow-up ($600,000)

8-2005: Network for Cardiovascular Health Intervention Research and Translation–Coordinating Center ($175,000)

9-2005: Network for Cardiovascular Health Intervention Research and Translation Network–Collaborating Center ($250,000)

10-2005: Cardiovascular Disease (CVD) Curriculum Modules for American Indian and Alaska Native Youth ($200,000)

11-2005: Adapting a Cardiovascular Health Promotion School-based Nutrition Intervention for Obesity Prevention and Control ($200,000)

12-2005: Adapting Evidence-based Strategies for Public Health Practice to the Developing World: Applying the Community Guide Physical Activity Recommendations in Brazil ($300,000)

13-2005: Increasing Physical Activity Among Adults in Racially/Ethnically Diverse Communities in the United States ($250,000)

14-2005: Improving the Validity of Questionnaires for U.S. Physical Activity Surveillance using Technology Integration ($200,000)

15-2005: Development of a “ready to use” Plan to Evaluate Readily or Commercially Available Nutrition and Physical Activity Program in New School Settings ($150,000)

16-2005: Evaluate the Effectiveness of a Readily Available Nutrition and Physical Activity Health Program to Prevent Overweight in the Preschool Setting ($150,000)

17-2005: Development and Testing of a Parent-focused Intervention to Reduce Children's Television Viewing ($250,000)

18-2005: Intervention Component to Reduce Television Viewing for Incorporation into an Evidence-based Multi-component School-based Nutrition and Physical Activity Intervention ($200,000)

Although the financial plans of the NCCDPHP provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Only applicants who have applied for and have been selected as Prevention Research Centers under CDC Program Announcement 04-003 are eligible to compete for the Special Interest Project (SIP) supplemental funding. Competition is limited to Prevention Research Centers funded under PA 04-003 because they are uniquely positioned to perform, oversee, and coordinate community-based participatory research that promotes the field of prevention research due to their established relationships with community partners.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs.

Note: Title 2 of the United States Code section 1611 states that an organization described in section 501 (c)(4) pf the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

2. Cost Sharing or Matching
Matching funds are not required for this program.

3. Other-Special Eligibility Criteria
Applicants may request a funding amount greater than the award ceiling listed for the SIP.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at PHS 398 Grant Application in an interactive format. Applicants must use the currently approved version of the PHS 398. If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700, Email: PGOTIM@cdc.gov.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The number of this funding opportunity, title, and SIP number must be typed on line 2 of the face page of the application form.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: May 26, 2005
Application Receipt Date: June 15, 2005
Peer Review Date: Week of July 11, 2005
Earliest Anticipated Start Date: August 31, 2005

Explanation of Deadlines: All requested information must be received in the CDC Procurement and Grants Office by 4:00 p.m. Eastern Time on the deadline date.

If you submit your LOI or application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If CDC receives your submission after closing due to: (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will be given the opportunity to submit documentation of the carrier's guarantee. If the documentation verifies a carrier problem, CDC will consider the submission as having been received by the deadline.

This announcement is the definitive guide on LOI and application content, submission address, and deadlines. It supersedes information provided in the application instructions. If your application does not meet the deadline above, it will not be eligible for review and will be discarded. You will be notified that you did not meet the submission requirements.

CDC will not notify you of receipt of your submission. If you have a question about the receipt of your LOI or application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: (770)488-2700. Before calling, please wait two to three days after the submission deadline. This will allow time for submissions to be processed and logged.

3.A.1. Letter of Intent

CDC requests that prospective applicants send a Letter of Intent (LOI). Although an LOI is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCCDPHP staff to estimate the potential reviewer workload and plan the review. Prospective applicants will be asked to submit their LOI electronically through the PRC website: http://www.cdc.gov/prc.

Prospective applicants are asked to submit a LOI that includes the following information:

Although a LOI is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review. The LOI should be sent by the date listed at the beginning of this funding announcement to:

N. Jean Smith
Prevention Research Centers Program
National Center for Chronic Disease Prevention and Health Promotion
4770 Buford Highway, MS K-45
Atlanta, GA 30341
Telephone: (770) 488-5588
FAX: (770) 488-5486
Email: JNSmith@cdc.gov

3.B. Sending an Application to the CDC

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and two signed photocopies in one package to:

Technical Information Management –PA 04003A
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA 30341

At the time of submission, three additional copies of the complete application, including the appendix material, must be sent to:

N. Jean Smith
Prevention Research Centers Program
National Center for Chronic Disease Prevention and Health Promotion
4770 Buford Highway, MS K-45
Atlanta, GA 30341
Telephone: (770) 488-5588
FAX: (770) 488-5486
Email:JNSmith@cdc.gov

FedEX Address:
N. Jean Smith
Koger Center/Rhodes Building
3005 Chamblee Tucker Road, Room 4182
Atlanta, GA 30341

For further assistance contact the CDC Procurement and Grants Office, Technical Information Management Section: Telephone (770)488-2700, Email pgotim@cdc.gov.

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the Procurement and Grants Office (PGO) and responsiveness by the NCCDPHP. Incomplete and non-responsive applications will not be reviewed.

4. Intergovernmental Review
Executive Order 12372 does not apply to this program.

5. Funding Restrictions

Restrictions, which must be taken into account while writing your budget, are as follows:

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.

6. Other Submission Requirements

A PRC may apply for multiple Special Interest Projects; however, a separate application must be submitted for each SIP. The application must clearly indicate which SIP you are applying for. Only one application per Special Interest Project will be accepted from each PRC.

This announcement requires the summary budget information provided in the application package, including the budget justification and support, written in the form, format, and level of detail as specified in the budget guidelines. You may access the latest version of the budget guidelines by accessing the following web site: http://www.cdc.gov/od/pgo/funding/budgetguide2004.htm.

Projects that involve the collection of information from ten or more individuals and funded by cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.

The goals of CDC-supported research are to advance the understanding of biological systems, improve the control and prevention of disease and injury, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by PGO and responsiveness by the NCCDPHP. Incomplete and/or non-responsive applications will not be reviewed.

If the application is not responsive to the RFA, NCCDPHP staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate CDC review cycle.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate external peer review group convened by the NCCDPHP in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Scored applications will receive a second level of review by the NCCDPHP Secondary Review Committee. The review process will follow the policy requirements as stated in the GPD 2.04 (http://198.102.218.46/doc/gpd204.doc).

The following criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

Individual SIP Project Preferences: Does the applicant adequately address the preferences detailed in the Special Interest Project they are applying for? See Section IX. Special Interest Project Descriptions of this announcement for specific details.

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: Federa l regulations (45 CFR Part 46) require that applications and proposals involving human subjects must be evaluated and reference to the risk to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: Does the application adequately address the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research? This includes: (1) the proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) the proposed justification when representation is limited or absent; (3) a statement as to whether the design of the study is adequate to measure differences when warranted; and (4) a statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

3. Anticipated Announcement and Award Dates
CDC expects to announce awards on or about August 31, 2005.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will receive a written critique called a Summary Statement. If the application is under consideration for funding, CDC may request "just-in-time" information from the applicant. For details, applicants may refer to the DHHS Awarding Agency Grants Administration Manual, Chapter 2.04.104B Grant and Cooperative Agreement Funding.

Those applications under consideration for funding will receive a call or email from the Grants Management Specialist (GMS) of the Procurements and Grants Office (PGO) for additional information.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The notice of award signed by the Grants Management Officer (GMO) is the authorizing document. This document will be mailed and/or emailed to the recipient fiscal officer identified in the application.

Selection of the application for award is not an authorization to begin performance. Any cost incurred before receipt of the NoA is at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.

The Notice of Award will be mailed and/or emailed to the institutional business official identified in the application.

2. Administrative and National Policy Requirements

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about policy requirements. For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. The following additional requirements can be found in Section VIII. Other Information of this document or on the CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement ( CDC U48 ), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NCCDPHP programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NCCDPHP purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NCCDPHP as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

The rights and responsibilities of the Principal Investigator are delineated in each special interest project description contained in Section IX. Special Interest Project Descriptions of this announcement.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and CDC policies.

2.A.2. NCCDPHP Responsibilities

A NCCDPHP Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described in each of the special interest project descriptions contained in Section IX of this announcement. Each SIP has specific requirements and applicants should refer to Section IX. Special Interest Project Descriptions of this announcement for details.

Additionally, an agency program official or the NCCDPHP program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Each SIP has specific collaborative responsibilities. Please refer to the specific SIP descriptions in Section IX. Special Interest Projects Descriptions of this announcement for details.

2.A.4. Arbitration Process
Not applicable

3. Reporting

CDC a ward recipients will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement. These reports must contain the following elements:

a. Current Budget Period Activities Objectives
b. Current Budget Period Financial Progress
c. New Budget Period Program Proposed Activity Objectives
d. Budget
e. Additional Requested Information
f. Measures of Effectiveness

In addition, award recipients must submit a financial status report, no later than 90 days after the end of the budget period. Award recipients will also be required to file final financial and performance reports, no later than 90 days after the end of the project period. These reports must be mailed to the Grants Management Specialist listed in the "Agency Contacts" section of this announcement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. General Questions:
Technical Information Management Section
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
Telephone: 770-488-2700
Email: PGOTIM@cdc.gov

2. Scientific/Research Contacts:

Eduardo Simoes
Director, CDC Prevention Research Centers Program
National Center for Chronic Disease Prevention and Health Promotion
4770 Buford Highway, MS K-45
Atlanta, GA 30341
Telephone: (770) 488-5395
FAX: (770) 488-5486
Email: ESimoes@cdc.gov

3. Peer Review Contacts:

Scientific Review Administrator
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
4770 Buford Highway, MS K-92
Atlanta, GA 30341
Telephone: (770) 488-8390
FAX: (770) 488-8046
Email: OER@cdc.gov

4. Financial or Grants Management Contacts:

Lucy Picciolo
Grants Management Specialist
CDC Procurement and Grants Office
2920 Brandywine Road, Room 3000
Atlanta, GA 30341
Telephone: (770) 488-2683
FAX: (770) 488-2777
Email: LPicciolo@cdc.gov

Section VIII. Other Information

Required Federal Citations

The following list contains full descriptions of Program Announcement Additional Requirements.

AR-1
Human Subjects Requirements
If the proposed project involves research on human subjects, the applicant must comply with the Department of Health and Human Services (DHHS) Regulations (Title 45 Code of Federal Regulations Part 46) regarding the protection of human research subjects. All awardees of CDC grants and cooperative agreements and their performance sites engaged in human subjects research must file an assurance of compliance with the Regulations and have continuing reviews of the research protocol by appropriate institutional review boards.

In order to obtain a Federalwide Assurance (FWA) of Protection for Human Subjects, the applicant must complete an on-line application at the Office for Human Research Protections (OHRP) website or write to the OHRP for an application. OHRP will verify that the Signatory Official and the Human Subjects Protections Administrator have completed the OHRP Assurance Training/Education Module before approving the FWA. Existing Multiple Project Assurances (MPAs), Cooperative Project Assurances (CPAs), and Single Project Assurances (SPAs) remain in full effect until they expire or until December 31, 2003, whichever comes first.

To obtain a FWA contact the OHRP at: http://www.hhs.gov/ohrp/assurances/assurances_index.html

OR

If your organization is not Internet-active, please obtain an application by writing to:

Office for Human Research Protections (OHRP)
U.S. Department of Health and Human Services
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852

Note: In addition to other applicable committees, Indian Health Service (IHS) institutional review committees must also review the project if any component of IHS will be involved with or will support the research. If any American Indian community is involved, its tribal government must also approve the applicable portion of that project.

AR-2
Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research
It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

AR-4
HIV/AIDS Confidentiality Provisions
Recipients must have confidentiality and security provisions to protect data collected through HIV/AIDS surveillance, including copies of local data release policies; employee training in confidentiality provisions; State laws, rules, or regulations pertaining to the protection or release of surveillance information; and physical security of hard copies and electronic files containing confidential surveillance information.

Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.

Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.

AR-5
HIV Program Review Panel Requirements
Compliance with Content of AIDS-Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992) is required.

To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.

If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application. Before funds are used to develop educational materials, determine whether suitable materials already exist in the CDC National AIDS Clearinghouse.

AR-6
Patient Care
Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.

AR-8
Public Health System Reporting Requirements
This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:

A. A copy of the face page of the application (SF 424).
B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:

A description of the population to be served.
A summary of the services to be provided.
A description of the coordination plans with the appropriate state and/or local health agencies.

If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.

AR-9
Paperwork Reduction Act Requirements
Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).

AR-10
Smoke-Free Workplace Requirements
CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.

AR-11
Healthy People 2010
CDC is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a national activity to reduce morbidity and mortality and improve the quality of life. For the conference copy of "Healthy People 2010," visit the internet site: http://www.health.gov/healthypeople.

AR-12
Lobbying Restrictions
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition no part of CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of CDC funds should give close attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

AR-14
Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

Capability Assessment
It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.

AR-16
Security Clearance Requirement
All individuals who will be performing work under a grant or cooperative agreement in a CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardee employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at CDC must undergo a security clearance process.

AR-21
Small, Minority, And Women-owned Business
It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:

Place small, minority, women-owned business firms on bidders mailing lists.
Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.

AR-22
Research Integrity
The signature of the institution official on the face page of the application submitted under this Program Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 50, Subpart A, entitled "Responsibility of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science."

The regulation places several requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity's (ORI) Assurance Program. For examples:

Section 50.103(a) of the regulation states: "Each institution that applies for or receives assistance under the Act for any project or program which involves the conduct of biomedical or behavioral research must have an assurance satisfactory to the Secretary (DHHS) that the applicant: (1) Has established an administrative process, that meets the requirements of this subpart, for reviewing, investigating, and reporting allegations of misconduct in science in connection with PHS-sponsored biomedical and behavioral research conducted at the applicant institution or sponsored by the applicant; and (2) Will comply with its own administrative process and the requirements of this Subpart."

Section 50.103(b) of the regulation states that: "an applicant or recipient institution shall make an annual submission to the [ORI] as follows: (1) The institution's assurance shall be submitted to the [ORI], on a form prescribed by the Secretary,...and updated annually thereafter...(2) An institution shall submit, along with its annual assurance, such aggregate information on allegations, inquiries, and investigations as the Secretary may prescribe."

An additional policy is added in the year 2000 that "requires research institutions to provide training in the responsible conduct of research to all staff engaged in research or research training with PHS funds.

AR-24
Health Insurance Portability and Accountability Act Requirements
Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions. The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency. CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

AR-25
Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the CDC data sharing agreement will be released as follows:

a. In a timely manner.
b. Completely, and as accurately as possible.
c. To facilitate the broader community.
d. Developed in accordance with CDC policy on Releasing and Sharing Data.

April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), where applicable, The Office of Management and Budget Circular A110, (2000) revised 2003, http://www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) http://straylight.law.cornell.edu/uscode/html/uscode05/usc_sec_05_00000552---a000-.html.

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide CDC with appropriate documentation on the reliability of the data.  Applications submitted without the required Plan may be ineligible for award.  Award will be made when reviewing officials have approved an acceptable Plan.  The successful applicant and the Program Manager will determine the documentation format.  CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality. 

Authority and Regulations
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Public Health Service Act, Section 1706, 42 U.S.C. 300u-5, as amended; Section 2(d), Public Law 98-551. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Section IX. Special Interest Project Descriptions

SIP 1-2005

Project Title: Validation of Questions about Epilepsy to be Used in Population Health Interview Surveys

Project Description: Consistent with CDC's priority to assess the public health burden of epilepsy, funds will be made available to support a project to validate a set of five survey questions developed to help determine epilepsy prevalence and severity in general populations. High priority will be placed on approaches that validate these questions among representative populations of persons with and without epilepsy. It is expected that the recipient will determine the sensitivity and predictive values of this set of questions, using accepted diagnostic reference standards, e.g. diagnostic information derived from clinical care provider records or data. To achieve these objectives, collaboration with other health care organizations or agencies is encouraged.

Questions regarding epilepsy prevalence have been included in health-related interview surveys of selected states since 1998 (Kobau R et al. Health-Related Quality of Life Among Persons With Epilepsy--Texas, 1998. MMWR 2001; 50(02):24-26, 35; Kobau R et al. Prevalence of epilepsy and health status of adults with epilepsy in Georgia and Tennessee: Behavioral Risk Factor Surveillance System, 2002. Epilepsy & Behavior 2004; 5:358-366). From this experience, a set of five questions have been developed. The first is a screening question:

The remaining are follow-up questions for those answering affirmatively:

As an optional supplement to the Behavioral Risk Factor Surveillance System and other population-based health interview surveys, it is expected that this set of questions may constitute an important tool for monitoring epilepsy prevalence in populations, may help to describe its severity and consequences, and describe the use of specialty care.

These questions have undergone cognitive testing through the Behavioral Surveillance Branch, National Center for Chronic Disease Prevention and Health Promotion; however, they have not been validated by a thorough study of their sensitivity, specificity, and positive and negative predictive values. Thus, there is a need for such an assessment of their validity.

Project Activities:

The main objective of this project is to assess the validity of the set of five epilepsy-related survey questions described above. A copy of the CDC epilepsy questions, including response options, will be made available to applicants.

Preference will be given to applicants who provide evidence of the following:

1) Documentation of how they will create and coordinate an interdisciplinary team to design and implement the proposed project, which at a minimum should include epidemiologic and clinical collaborators;

2) Description of how they will use prior validity study experiences and apply those to the current project. Approaches may vary and should include such items as use of medical record reviews, administrative data, and interviews;

3) Documentation of access to a representative population of persons with and without epilepsy for whom clinical diagnostic data are available to be used as a reference standard;

4) Detailed project plan, providing evidence of the project's feasibility and statistical soundness, that addresses diagnostic sensitivity, specificity, and positive and negative predictive values with sample(s) of adequate size;

5) Project objectives that are specific, measurable, and time-framed for a two-year project period;

6) Identification of any anticipated barriers to conducting the project and plans to address them;

7) Documentation of how they will apply for and obtain approvals from relevant institutional review boards, including provision of examples of past successes and any anticipated barriers and plans to address them;

8) Detailed plans of how they will synthesize and report project findings in peer-reviewed journals and at national meetings.

Project Proposal Length and Supporting Material: Proposal narratives are limited to 25 pages. Supporting materials included in the appendices should not exceed 40 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $200,000/yr. will be available to fund one Prevention Research Center for the first year of a two-year funding period; up to $250,000/year may be available for the second year. Funding may vary and is subject to change.

Research Status: It is expected that this project will be exempt research. CDC staff will not serve as investigators on these projects, but will provide technical assistance on both the study design and analysis of data. As applicable, applications should provide a Multiple Project Assurance or a Federal-wide Assurance registration number for each performance site included in the project.

SIP 2-2005

Project Title: Use of computer multimedia technology to develop a theory-driven, interactive chronic disease self-management program for epilepsy

Project Description: Consistent with CDC's priority to improve care for persons with epilepsy, funds will be made available to support intervention research on the use of computer technology and chronic disease self-management strategies to improve health and psychosocial outcomes in adolescents or adults with epilepsy. High priority will be placed on approaches that incorporate an interdisciplinary team that can develop a computer-based, theory-driven self-management program (Bensley et al. 2004) that addresses treatment management, seizure management, and life management of epilepsy (Buelow 2001). It is expected that the Prevention Research Centers will build on their effective relationships with various partners to develop and test their intervention.

Living Well with Epilepsy I and II, the national conferences on public health and epilepsy in 1997 and 2003, identified self-management in epilepsy as a priority area for CDC program activities. Models of behavior change have been developed to promote the adoption of self-management strategies in chronic illness, such as those developed for persons living with arthritis, cancer, and asthma (IOM, 2001). Insufficient evidence exists, however, in relation to the effectiveness of self-management programs in epilepsy. Many people with epilepsy do not know how to monitor and self-regulate behaviors that affect seizure susceptibility such as medication adherence, sleep, exposure to environmental stimuli, excessive use of drugs and alcohol, and stress reduction. Most psycho-educational approaches that have been developed over the past decade have focused on improving knowledge and coping skills, yet many of these programs have not been tested in diverse populations, in longitudinal studies, nor have they gained widespread acceptance in the clinical community. Recently funded CDC-research has indicated that the lack of transportation to attend a group-based self-management program is a barrier for people with epilepsy who typically cannot drive.

Computer-based multimedia programs have been developed to help patients monitor and change behavior related to alcohol use, cigarette use, asthma self-management, diet, and HIV prevention (Bensley et al. 2004; Gerbert et al. 2004). The development of a computer-based multimedia self-management program with response-dependent persuasive communication may be an effective medium for teaching self-management behaviors to adolescents and adults with epilepsy

There is a need for an interdisciplinary effort to develop and test theory-driven, interactive computer-based interventions that address epilepsy self-management. A copy of selected CDC epilepsy publications including the 2003 Living Well with Epilepsy symposium proceedings will be made available to applicants.

Project Activities:

The main objective of this project is to develop and test one or more computer-based, theory-driven self-management interventions for adolescents or adults with epilepsy.

Preference will be given to applicants who provide evidence of the following:

1) Documentation of how they will organize and coordinate the activities of an interdisciplinary team to ensure expertise in behavioral science theory-driven methods. CDC recommends that applicants consider a team composed of clinical and behavioral/social science investigators, software engineers or other technical experts, as well as recruit and retain representatives from the priority population affected;

2) Experience in the design and testing of behavioral interventions designed to improve health status in chronic illness (e.g., DiIorio et al. 2004 Project EASE: a study to test a psychosocial model of epilepsy medication management; Gerbert et al. 2003 Using innovative video doctor technology in primary care to deliver brief smoking and alcohol intervention; Bensley et al. 2004, The eHealth Behavior Management Model: A stage-based approach to behavior change and management);

3) Experience in the development and use of multimedia technology for patient education;

4) Current expertise and resources for the technological design and implementation of multimedia program(s);

5) Justification of their choice of multimedia technology given what is known about the priority population's characteristics (e.g., inability to drive, lower levels of education and income, etc.);

6) Justification of their choice of one or more dominant behavioral science theories (e.g., Transtheoretical Model, Social Cognitive Theory, etc.) and targeted constructs (e.g., stage of change, self-efficacy, intentions, etc.);

7) An outline of the relationship of theoretical constructs from identified theories to chronic disease self-management behaviors given what is known in the literature;

8) Identification of self-management domains relevant to epilepsy self-management;

9) Identification of associations between theoretical constructs and epilepsy self-management domains (e.g., medication management, lifestyle management, etc.);

10) Provision of an algorithm for response-dependent communication based on the identified theory of an epilepsy self-management domain;

11) Demonstrated experience with earlier studies related to psychosocial or self-management studies associated with epilepsy;

12) An evaluation methodology to test the program, including evaluation criteria and recruitment strategies of targeted sample;

13) Project activities that are specific, measurable, and time-framed for a two-year funding period;

14) Identification of any anticipated barriers to conducting the project and plans to address them.

Project Proposal Length and Supporting Material: Proposal narratives are limited to 25 pages. Supporting materials included in the appendices should not exceed 40 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $200,000 will be available to fund one Prevention Research Center for the first year of a two-year project period. Funding may vary and is subject to change.

Research Status: It is expected that this project will be exempt research. CDC staff will not serve as investigators on these projects, but will provide technical assistance on both the design and nature of the persuasive communication, and on the technical programming and design of the software program. As applicable, applications should provide a Multiple Project Assurance or a Federal-wide Assurance registration number for each performance site included in the project.

SIP 3-2005

Project Title: Examination of Post-stroke Rehabilitation Referral and Enrollment Rates

Project Description: Stroke is the third leading cause of death in the United States and a leading cause of serious, long-term disability (MMWR, Vo. 50, No. 7, Feb. 23, 2001, CDC/NCHS). Each year, over 700,000 people suffer a new or recurrent stroke, of which 500,000 are first attacks and 200,000 are recurrent episodes. There are an estimated 4,800,000 stroke survivors in the United States alone (American Heart Association Heart Disease and Stroke Statistics – 2004 Update; 2003). Of these individuals, about two-thirds will require ongoing healthcare services including rehabilitation. The goals of rehabilitation are to assist survivors in regaining their independence and to improve their quality of life. In addition to improved quality of life, functional capacity, and motor function, rehabilitation decreases recurrent stroke and cardiac events, prevents complications resulting from prolonged inactivity, and increases aerobic fitness [Circulation, April 2004; 109(16)]. Not only does rehabilitation help stroke survivors relearn skills impaired by damage to the brain, but it also teaches new skills to compensate for disabilities caused by the stroke.

Research has shown that the first stage of rehabilitation should begin within 24 to 48 hours after an acute stroke event based on the stability of the patient. Subsequent rehabilitation for a stroke survivor has been found to increase the quality of life and long-term outcomes. However, survivors of stroke are predisposed to a sedentary lifestyle, limiting their performance of daily activities, increasing their risk of falling and injury, and contributing to an increased risk of recurrent stroke or cardiac events. Most healthcare professionals are limited in their knowledge, guidance, and experience in stroke rehabilitation and its benefits. There also exists a dearth of research examining referral and enrollment rates for outpatient stroke rehabilitation.

The purpose of this proposed research project is to examine referral and enrollment rates for outpatient stroke rehabilitation upon discharge from acute care hospital settings. The referral and enrollment rates are expected to be compared and contrasted between various types of hospital settings such as public and private hospitals and/or small and large hospitals. Potential differences in referrals and patient enrollment based on race/ethnicity, gender, age, and socioeconomic status of the patients should be examined. The results of this project are expected to be reported in various formats (e.g., a report, manuscript, etc.) to inform multiple audiences such as healthcare professionals, administrators, and other stakeholders to increase the quality of care received by all stroke survivors, thus reducing disparities in access to care.

Project Activities:

The specific objectives of this project are to (a) determine if there are disparities in referral to and enrollment in stroke rehabilitation based on race/ethnicity, gender, age, or socioeconomic status; (b) provide information that can be used by hospital administrators and other health professionals when making and enforcing policies regarding stroke rehabilitation; (c) provide a catalyst for further research in stroke rehabilitation regarding health disparities; and (d) examine if there are disparities in access to care for patients in various hospital settings based on demographic variables such as race/ethnicity, gender, age, or socioeconomic status.

To accomplish the objectives of this project, applicants should describe how they will address the following proposed activities:

a. Review and disseminate knowledge of the public health significance of stroke rehabilitation. This should include a review of past and current research in the area of stroke rehabilitation, highlighting the gaps in research and showing how this project addresses one of those gaps. The applicant should describe how results will be summarized and disseminated to audiences and stakeholders that are deemed appropriate;

b. Propose an innovative and comprehensive plan that includes the study design, methods, and analyses which will achieve the objectives of the proposed research project described above. This plan should describe the settings that will be included where stroke patients receive care, how research and analyses will be carried out, and how results will be disseminated. Also, the plan should include a timeline and work plan used to track the progress of the project;

c. Partner with and engage the proper stakeholders for the project, inclusive of hospital administration, healthcare professionals, and staff prior to the development of actual project;

d. Develop a data collection protocol to ensure adequate power for statistical analysis and diversity of patients based on race/ethnicity, gender, age, and socioeconomic status. This protocol should include a detailed description of the proposed methods (i.e., medical chart review, quality assurance, etc.) that are most feasible for the project. A description of human subjects issues should be included.

e. Select the data analysis methodology best suited for the project;

f. Describe a dissemination plan tailored to various audiences that could benefit from the results of this study. For example, a manuscript could be developed for health care practitioners on why referrals for stroke rehabilitation were not made.

Preference will be given to those applications that:

a. Demonstrate the applicant's ability to address each of the above listed activities in a comprehensive manner;

b. Demonstrate previous research performed in the area of cardiovascular health as it pertains to priority populations (i.e., minorities, women, etc.);

c. Demonstrate the applicant's abilities to complete the research in its entirety;

d. Demonstrate relationship with hospital settings named in this proposal through letters of support and/or other documentation;

e. Document experience with funding and conducting extramural projects for related research and producing publications from such research.

Project Proposal Length and Supporting Material: Proposal narratives are limited to 20 pages. Supporting materials included in the appendices should not exceed 30 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $150,000 is available to fund one application in the first year of a 2-year project period. Funding may vary and is subject to change.

Research Status: It is expected that this will be non-exempt research. CDC staff will serve as co-investigators on this project, collaborating on project activities such as study design, methods, sampling, data analysis, and co-authoring manuscripts. It is anticipated that this project will need approval by the IRB at the recipient institution and that CDC IRB approval or deferral to the recipient IRB will be required. The CDC IRB reviews projects on an annual basis. Please include up to 3 months in the timeline for human subjects review. Applications should provide a federal wide assurance registration number for each performance site included in this project.

SIP 4-2005

Project Title: A Community-based Health Promotion Program using Barbers as Peer Educators to Convey Cancer Early Detection Information

Subtitle: The Kujichagulia Health Initiative

Project Description: The purpose of this project is to establish a sustainable community-based cancer health education and awareness campaign using barbers as peer educators to disseminate culturally relevant evidence-based cancer prevention and early detection information within African American communities.

In the United States, African American men experience disproportionately higher rates of morbidity and mortality from the major causes of disease affecting the general population. Cancer is the second major cause of death in this group. The death rates for all cancers combined are 40% higher among black men than white men, with excess deaths largely attributed to lung, colorectal, and prostate cancers. Despite recently reported downward trends in death rates for cancers like colorectal and prostate cancer, the rates of these cancers are not decreasing as rapidly among black men when compared to white men. Prior research has suggested that the higher burden of cancer experienced by black men may be associated with the following factors: genetics, lifestyle, lack of health knowledge, poor access to health care, inadequate prevention practices, and lower health care utilization rates.

Barbershops are cultural cornerstones of many African American communities. Recently, these businesses have granted entrée to public health, medical service, and academic institutions. Non-traditional partnerships have been formed with these businesses to provide outreach services to community residents. The conventional role of the barbershop has been expanded to incorporate educating clients about safe health practices and providing them with greater access to health care service providers. Examples of successful community-based research initiatives and model programs established within barbershops include the following: Take a Health Professional to the People Day (University of Pittsburg Graduate School of Public Health's Center for Minority Health), Down Low Barbershop Program (Seattle, WA), and Lookin' Tight Livin' Right (African American Health Coalition, Portland, OR). The data from community-based programs like the above suggest that these programs have become agents of change in their local communities, serving as catalysts for changing community norms and strengthening relationships of trust and respect between community residents and researchers.

The announcement will provide support for a first phase of research intended to develop culturally-relevant cancer prevention messages for men that can be used by barbers in barbershops. The messages are expected to enhance men's knowledge and risk awareness of colorectal and prostate cancers and promote informed decision making for prostate cancer screening. Researchers are encouraged to distinguish and incorporate strategies that encourage self-determination and self-efficacy among men. Moreover, the first phase of research should support the development of a protocol for educating and training the peer educators.

CDC may provide support for a second phase of research involving the pilot application and evaluation of the community intervention in the barbershop setting; however, funding for the additional phase cannot be guaranteed at this time. Applicants are encouraged, although not required, to address how this research might be conducted.

Project Activities:

The activities listed in the following description of this proposal are specific only to the first phase of the project.

Applicants should address the following two areas:

A. Development and Evaluation of Cancer Prevention Health Messages

1. Document and justify your approach to develop key prevention health messages that are culturally relevant to African American men and easy for the peer educators to effectively deliver to their clients.

2. Document and describe the key components of your key messages. Specifically, the applicant should address how the messages will: a) define the target audience, b) emphasize the importance of self-determination in health maintenance, c) raise men's risk awareness of the principle cancers affecting African American men, and d) promote cancer prevention-oriented behaviors (e.g., informed decision making for prostate cancer screening).

3. Document and describe how community residents and barbers should be involved in message development. For example, an applicant may elect to conduct focus groups of African American men to determine message acceptability, and the preferred format of delivery (e.g., barber, video, poster, or pamphlet).

4. Document and describe if the key prevention-oriented messages have been adapted from previously developed materials.

5. Document and describe how the messages meet quality criteria for inclusion in evidence reviews conducted by The Guide to Community Preventive Services (http://www.thecommunityguide.org).

6. Document and describe your approach to evaluate the impact of key messages on men. For example, the applicant may compare the test message with a control message (i.e., conduct pre and post-intervention survey to examine client perceived cancer risk, health care system trust, likelihood of health care provider encounter/discussion, knowledge, attitudes and beliefs about cancer prevention, including screening, and overall satisfaction with intervention).

7. Document and describe the key staff, established resources and expertise available to conduct this aspect of project. Staff qualifications should be based on demonstrated expertise in message development.

B. Development of the curriculum for training barbers as peer educators

1. Document and describe the approach that will be used to develop and implement the training curriculum for peer educators.

2. Describe how your approach will identify and recruit barbers to serve as peer-educators.

3. Document and describe the key staff, established resources and expertise available to conduct this aspect of project. Staff qualifications should be based on demonstrated expertise in the development of training curriculum for peer educators.

Preference will be given to applicants who:

1. Demonstrate they have participated in prior research related to message development and evaluation.

2. Provide evidence of a record of published similar research.

3. Demonstrate prior experience conducting community-based participatory research, specifically involving African American communities.

4. Propose an intervention study consisting of a randomized preventive trial or one which has a quasi-experimental design, following guidelines for rigorous research identified by the Guide to Community Preventive Services (http://www.thecommunityguide.com).

Proposal Length and Supporting Materials: Proposal narratives are limited to 20 pages. Supporting materials in the appendices should not exceed 20 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $150,000 is available to fund one application in the first year (Phase 1) of a two-year project. Funding may vary and is subject to change.

Research Status: It is expected that the project will be non-exempt research. The CDC staff may provide technical assistance on project activities including: research design, defining target population, and data collection and analysis. The CDC staff may also serve in the capacity of co-investigators on this project. It is expected that the project will require CDC IRB approval or approval of deferral to the local IRB. As applicable, applications should provide federal wide assurance registration number for each performance site included in the project.

SIP 5-2005

Project Title: Use of a community-based intervention to increase utilization of colorectal cancer screening among African American women and men in urban areas.

Project Description: Like other population subgroups in the United States, African American communities have a rich historical and cultural heritage and contextual background. These communities are diverse and include persons with high, average, and low levels of health literacy, educational attainment, and socioeconomic status. Extent of urbanicity and health insurance coverage also varies among and within African American communities.

African Americans experience disproportionately higher rates of morbidity and mortality from the major causes of disease affecting the general population. Cancer is the second major cause of death in this group. The death rates for all cancers combined are higher among black men than white men, with excess deaths largely attributed to lung, colorectal, and prostate cancers. Cancer death rates among black women, including deaths from breast and colorectal cancer, are higher than those among white women. Despite recently reported downward trends in death rates for cancers like colorectal, the rates of these cancers are not decreasing as rapidly among African Americans when compared to white men and women.

Results from prior studies indicate that barriers to routine cancer screening vary by variables such as race, ethnicity, cultural factors, socioeconomic status, urban/rural residence, family history of cancer, health insurance status, and factors related to providers and the health care environment. However, relatively few intervention studies have identified and tested intervention approaches to promote routine colorectal cancer screening among African American men and women.

The proposed project seeks to develop and examine the effectiveness of intervention materials to promote colorectal screening among urban African American men and women, via a community-based intervention trial and participatory research methods. The interventions are expected to recommend routine colorectal cancer screening according to United States Preventive Services Task Force Colorectal Cancer Screening Guidelines, 2002 (see the following website for details: (http://www.ahcpr.gov/clinic/3rduspstf/colorectal/colorr.htm). Applicants are expected to ensure appropriate follow-up care for research participants who have a positive colorectal cancer screening test (e.g., by identifying community resources for follow-up and referral or by targeting members of managed care organizations or persons eligible for Medicare.)

Effective interventions to promote routine colorectal cancer screening are needed for persons with average or above average, and low health literacy. Low literacy, which is common among persons with limited education and low income, may be an important factor in understanding patients' decision making about colorectal cancer screening. The available evidence regarding the effectiveness of specific client-oriented interventions and provider-oriented interventions for colorectal cancer screening is not currently sufficient to justify a Guide to Community Preventive Services recommendation (http://www.thecommunityguide.org). Where evidence is sufficient for a recommendation, there is a need for studies to examine the applicability of the interventions to other populations.

Project Activities:

Applications should address the following:

1. Explain how intervention materials are to be developed and tested, to increase routine colorectal screening among urban African American women and men.

2. Explain how the above intervention materials will fit into an intervention strategy for increasing colorectal cancer screening.

3. Describe how a pilot of the intervention strategy will be conducted, including revisions based upon the pilot.

4. Describe how a community-based intervention trial will be conducted including the: background and rationale, methods (including a description of the intervention materials that will be developed and tested), sample size estimates, desired outcome measures, the plan for analysis, and human subjects considerations.

5. For all aspects of this study, outline plans for engaging African American community partners in implementing the study.

6. Identify a collaborative relationship between the university, representatives of the target population, the relevant state and local health departments, and a major provider of health care services for the target population.

Preference will be given to applicants who:

1. Demonstrate prior experience conducting community-based, participatory research involving African American communities.

2. Propose a community-based intervention trial that would be conducted by a Prevention Research Center, in partnership with a university medical center or other major health care provider and the target populations.

3. Propose an intervention study consisting of a randomized preventive trial or one which has a quasi-experimental design, following guidelines for rigorous research identified by the Guide to Community Preventive Services (http://www.thecommunityguide.org).

4. Demonstrate that research participants who have a positive colorectal cancer screening test will have access to follow-up care and treatment, as appropriate.

Project Proposal Length and Supporting Material:

Proposal narratives are limited to 20 pages. Supporting materials in appendices should not exceed 40 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $400,000 is available to fund 1 Prevention Research Center in the first year of a 4-year project period. Funding may vary and is subject to change.

Research Status: It is expected that the project will be non-exempt research. CDC technical monitors will provide technical assistance on project activities including: design, methods, populations, data collection, and data analysis. CDC staff may also serve as co-investigators on this project. It is expected that the project will require CDC IRB approval or approval of deferral to the local IRB. As applicable, applications should provide a federal wide assurance registration number for each performance site included in the project.

SIP 6-2005

Project title: Intervening on the Social Determinants of Cancer Health Disparities

Project Description: The purpose of this project is to develop a national research agenda that would enhance cancer prevention and control research on social determinants of health disparities. As public health professionals, we are challenged by Healthy People 2010 to understand the reasons for differences in cancer rates among the races and to seize the opportunity to reduce illness and death and improve survival rates (p. 3-5). Vital to this accomplishment is research on individual and environmental links to cancer, and ways to use findings in cancer prevention and control programs (p. 3-6).

The President of the United States and the Secretary of the Health and Human Services (HHS) have made addressing health disparities a priority. In March, 2004, the Trans-HHS Cancer Health Disparities Progress Review Group was established to develop an integrated set of recommendations to be implemented by the Department of Health and Human Services and its agencies 2. The recommendations include the following:

To accomplish this, a planned research agenda is needed specific to determinants of cancer health disparities. Recent recommendations for intervention research suggest moving away from intervening only upon the individual lifestyle behaviors to intervening upon social determinants of health. 3-7 Using a social epidemiology approach, social determinants of health have been defined as “both the specific features of and pathways by which societal conditions affect health and that potentially can be altered by informed action.” 8 The Community Guide for Preventive Services (Guide) 3 describes social determinants as “societal conditions that affect health and can potentially be altered by social and health policies and programs” and recognizes that their incorporation into public health models has to date been limited. 9 Syme 10 argues that any research on the social determinants of health must include the community, and therefore, be multi-level or ecological in its approach.

A number of gaps exist in cancer health disparities research. Numerous frameworks or models show how a particular determinant affects health outcomes, but research on social determinants has been hampered by lack of theory that explains why the relationships exist. 4,11 More importantly, a lack of a framework that explains how to effectively modify those social determents, in particular those that contribute to cancer health disparities, hampers research. Thus, poorly understood pathways limit the development of effective interventions or the evaluation of interventions already in use. Similar to community-based research, research on social determinants would benefit from study design alternatives to randomized control trials for showing efficacy and effectiveness. 4,11

Therefore, a clear research agenda would serve as a road map for public health research and practice where none currently exists. A coordinated, systematic approach to the study of social determinants as they relate to cancer health disparities and to the impact of social determinants on program delivery, adoption, and maintenance would facilitate a reduction of cancer health disparities through effective interventions at the level of most impact.

Project Activities:

Applications should address the following:

1. Describe the methods for developing a national research agenda on social determinants of cancer health disparities.

a. Propose questions to guide development of a social determinants research agenda for cancer health disparities including, but not limited to the following:

i. What theories, models, and frameworks are useful in research pertaining to social determinants for cancer prevention and control?

ii. Which social determinants and their associated intervention research might have the greatest impact and feasibility for reduction of cancer health disparities?

iii. What gaps in research methods and tools exist for studying social determinants related to cancer prevention and control?

iv. What are the challenges to having effective interventions become widespread and how have they been addressed?

b. For each method proposed, describe the relationship to guiding questions, inclusion criteria, decision-making protocol, analysis plan, and reporting of recommendations. Applicants may propose any appropriate method and may consider conducting a systematic review of the literature using methods similar to the Guide3 and providing a forum for experts to exchange ideas. Experts may include, but are not limited to scientists from social epidemiology, medical care, psychology, sociology, and anthropology; practitioners from community based organizations with missions related to cancer prevention and control, state and local health departments, and national voluntaries, and others, such as REACH 2010 awardees; policy-makers from workplaces, government organizations, and health care organizations; and consumers, such as representatives from priority populations for cancer prevention and control, and community leaders.

2. Describe costs of activities proposed in developing and distributing a national research agenda for social determinants of cancer health disparities.

3. Describe audiences and strategies for adoption and implementation of the national research agenda that would have greatest influence on research, practice, and policy.

Preference will be given to applicants who demonstrate prior experience and publications in conducting systematic reviews, cancer prevention and control intervention research, or research on social determinants.

Project Proposal Length and Supporting Material:

Application narrative should total 25 pages. Supporting materials in appendices should not exceed 20 pages. The appendices should include the materials supportive of ability to successfully conduct the project described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $300,000 is available to fund one Prevention Research Center for a 2-year project period. Funding may vary and is subject to change.

NOTE: Applicants must have received funding under the Prevention Research Centers Cancer Prevention and Control Research Network (SIP 16-04) to be eligible to receive funding.

Research Status: The project will not involve human subject research and therefore, should not require CDC IRB approval. CDC staff will serve as technical consultants.

References:

1. U.S. Department of Health and Human Services. Healthy People 2010. 2nd ed. With Understanding and Improving Health and Objectives for Improving Health. 2 vols. Washington, DC: U.S. Government Printing Office, November 2000. Available at http://www.healthypeople.gov. Accessed September 15, 2004.

2. U.S. Department of Health and Human Services. Making Cancer Health Disparities History. Report of the Trans-HHS Cancer Health Disparities Progress Review Group. Submitted to the Secretary, USDHHS, March 2004.

3. The Guide to Community Preventive Services. Available at http://www.thecommunityguide.org. Accessed September 15, 2004.

4. Kaplan GA. What's wrong with social epidemiology, and how can we make it better? Epidemiologic Reviews 2004;26:124-135.

5. Adler NE, Newman K. Socioeconomic disparities in health: Pathways and policies. Health Affairs 2002;21:60-76.

6. Subramanian SV, Kawachi I. Income inequality and health: What have we learned so far? Epidemiologic Reviews 2004;26:78-91.

7. Freeman H. Poverty, culture, and social injustice: determinants of cancer disparities. CA A Cancer Journal for Clinicians 2004;54:72-77.

8. Kreiger N. A glossary for social epidemiology. Journal of Epidemiology and Community Health 2001;16:693-700.

9. Anderson LM, Scrimshaw SC, Fullilove MT, Fielding JE. The Community Guide's model for linking the social environment to health. American Journal of Preventive Medicine 2003;24(3S):12-21.

10. Syme SL. Social determinants of health: The community as an empowered partner. Preventing Chronic Disease 2004;1:1-5.

11. Kreiger N. Theories for social epidemiology in the 21st century: an ecosocial perspective. International Epidemiological Association 2001;30:668-677.

SIP 7-2005

Project Title: Determinants of Patient Dropout from Cancer Treatment and Follow-up

Project Description: The purpose of this project is to assess early treatment discontinuation for cancer patients in the first year of treatment. This project is in response to the concerns listed in the 1999 Institute of Medicine report “Ensuring Quality Cancer Care”. One of the barriers to determining quality of cancer care is the lack of good data systems to follow patients and intervene when problems are identified. Many of these problems are found at the health system level. For example, one study reported that among women who were eligible to receive chemotherapy but did not, physicians were unaware that 45% never saw an oncologist because no tracking system was in place to assure that women followed-up (Med Care 2003;41:442-446). In addition to not receiving care, other patients may be at risk of not receiving the full course of therapy as prescribed by the physician. Researchers reported that 28% of women receiving chemotherapy for breast cancer did not receive the full course of treatment with subsequent decrease in survival (Breast Cancer Research and Treatment 2004; 88 (suppl. 1): Abstract #2063:S97.

To better understand factors that contribute to premature cancer treatment discontinuation and other quality of care related issues that adversely impact patient outcomes requires accurate detailed information about episodes of cancer care for large numbers of patients. In order to support outcomes research, investigators require information and data detailing episodes of cancer treatment that are accurate, complete, and retrievable in an analyzable format. It is unclear whether any cancer treating system (including NCI-designated Comprehensive Cancer Treatment Centers) maintains sufficient patient care data in retrievable formats that can support outcome research efforts. This objective of this project is to engage one or more prevention research centers associated with a major cancer center to assess early treatment discontinuation at 1-year during the preceding 5 years as a gross indicator of the quality of cancer care among patients with breast, colorectal, prostate and lung cancer. A range of traditional and nontraditional factors that may have contributed to observed patterns of premature treatment discontinuation may be considered (including lack of health insurance, transportation, child care, personal violence against the patient with cancer, etc.). The investigators are expected to propose interventions that might be transferred to other cancer treatment centers to improve cancer care for all patients.

CDC encourages applicants to consider the following items when developing their application: (1) could a retrospective analysis to determine patient treatment drop out rates during the first year of treatment and follow-up among lung, prostate, colorectal and breast cancers subgroups by: age, race, gender and health insurance payer among patients treated at two high volume cancer-treating institutions be of benefit to project's objectives, and (2) could findings from such a study provide information to help determine if longer term projects to perform follow-up after treatment and surveillance of survivors is feasible in the future.

Project Activities:

Applicants should address the following:

1) Describe the study design that uses health information databases to identify health system delivery features, patient-related and physician-related factors which may contribute to premature cancer treatment discontinuation among breast, prostate, colorectal and lung cancer patients;

2) Describe how data items will be selected for each area of interest (e.g., health system, patient and physician).

3) Describe how data will be collected inside and outside the local health care system to assure completeness of information available to examine early cancer treatment discontinuation at 1 year among breast, prostate, and colorectal and lung cancer patients. Describe methods to verify completeness of data collected.

4) Describe the methods which will be used to analyze the data.

5) Identify the key staff who will be devoted to the project. Where appropriate, the applicant should describe the person's demonstrated knowledge, experience, and ability in analyzing data as is described in the purpose of the study.

6) Describe a dissemination plan of how the information gained from this study will be made available to improve treatment and follow-up of cancer patients in the future.

Preference will be given to proposals that demonstrate the following:

1. The ability to collaborate with cancer centers with a Community Clinical Oncology Program to allow a broad range of patients and practice settings to be represented in the data;

2. The ability to address concerns listed in the IOM report “Ensuring Quality Cancer Care” (http://www.iom.edu/report.asp?id=5593);

3. A history of related research and of publications from that research;

4. Evidence that the findings of this project can be applied in other settings.

Project Proposal Length and Supporting Material: Proposal narratives are limited to 25 pages. Supporting materials included in appendices should not exceed 30 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $600,000 is available to fund two Prevention Research Centers at approximately $300,000 per center for the first year of a 1-year project period. Funding may vary and is subject to change.

Research Status: It is expected that this project will be non-exempt research. CDC staff will serve as co-investigators on this project and will provide technical assistance on activities such as research design, data collection and analysis, and dissemination of results. It is expected that the project will require local IRB approval and that CDC IRB approval or deferral to the recipient IRB will be required. The CDC IRB reviews projects annually. Applicants should provide a federal wide assurance registration number.

SIP 8-2005

Project Title: Network for Cardiovascular Health Intervention Research and Translation – Coordinating Center

Project Description: The intent of this special interest project (SIP) is to lead the development of a network of Prevention Research Centers (PRCs) for cardiovascular health (CVH) intervention research and translation. The network is expected to 1) develop and implement a coordinated, applied research and translation agenda and 2) conduct high-quality prevention research and translation activities that promote CVH and that can be incorporated into state programs.

The network is intended to address the applied research and translation needs of CDC's State Heart Disease and Stroke Prevention Program,1 CDC's Cardiovascular Health Branch priority areas, Healthy People 2010 goals,2 and A Public Health Action Plan to Prevent Heart Disease and Stroke3--in particular the comprehensive prevention research agenda being developed by the Advancing Knowledge Task Group. This SIP will fund the coordinating center that will lead the development of the infrastructure for up to five PRCs to collaborate as a network and work toward completing a set of activities.

The proposed network will conduct the following types of activities: 1) synthesize scientific information on the determinants of environmental and policy interventions that promote CVH, on intervention research and translation, and on the dissemination of research and tools for CVH; 2) conduct research on the effectiveness of health care system, work site, community, and school-based interventions; 3) research mechanisms for disseminating evidence-based interventions and incorporating them into state programs; 4) evaluate the implementation and effectiveness of state CVH interventions; and 5) develop and disseminate tools and technical assistance products for state CVH programs.

The coordinating center will take the lead in developing the network's plan and infrastructure, as described below.

Project Activities:

Component 1: Develop the Network for Cardiovascular Health Intervention Research and Translation

Objective: Coordinate the development of a network that will address research and translation activities in CVH.

The coordinating center will facilitate the process of developing a PRC Network for Cardiovascular Health Intervention Research and Translation. Applicants should explain how they will interact with the collaborating centers and discuss the relationship and interactions they have with federal and nonfederal stakeholders. Applicants should describe and document how they plan to perform the following activities:

Activity 1: Collect and contribute to recommendations for establishing the network. The plan should address logistics as well as organization and structure.

Activity 2: Outline and gain consensus on a timetable for a fully functioning network.

Activity 3: Oversee the pilot testing of the development and establishment of the network.

Activity 4: Lead the network in developing and disseminating information that documents the development of the network and describes how coordination will be achieved.

Component 2: Research

Objective: Develop a plan for conducting research in CVH that addresses the gaps in knowledge related to the priority areas identified by the Network, CDC, state and other stakeholder assessments.

Activity 1: Lead the design and implementation of a research and translation needs assessment in conjunction with collaborating centers, CDC, States and stakeholders. The assessment will identify priority research activities that would address gaps in knowledge and contribute to the development of a research agenda that can be implemented by the network.

Activity 2: Coordinate the reporting of findings of the research and translation needs assessment with federal and nonfederal stakeholders to reach consensus on how to implement the recommendations from the assessment.

Activity 3: Lead the network in developing a 4-year research and translation plan to address the recommendations made in the needs assessment.

Activity 4: Lead the development of a plan to evaluate, publish, present, and disseminate results and tools resulting from research activities.

Activity 5: Lead the development of a research project proposal that could be developed and initiated within the network and provide recommendations for additional research projects.

Component 3: Translation

Objective: Determine how to synthesize scientific evidence and translate efficacious interventions into the public health setting.

The coordinating center will facilitate the process of developing a plan to evaluate and synthesize current CVH policy and environmental interventions in multiple settings. Translation efforts must be conducted to bridge the research to practice gap. Tools should be developed for diverse audiences, settings, and priority populations and incorporate principles of health literacy, cultural competency, and health equity.

Activities:

1) Lead the development of a plan to identify efficacious interventions related to CVH prevention for translation into public health settings.

2) Lead the development of guidelines for effective translation materials and tools for use by States and stakeholders.

3) Lead the development of a plan for creating and disseminating translation documents and tools.

4) Lead the development of a plan to evaluate the use and impact of translation documents and tools.

Applicants should address the following:

1) Describe how the coordinating center would work with the collaborating centers and other stakeholders in developing an agenda for CVH intervention research and translation.

2) Identify the resources relevant to CVH public health research available to the coordinating center. Discuss how these resources could be enhanced through the proposed network.

3) Explain how the coordinating center will interact with other centers in the network in setting priorities for intervention research and translation.

4) Describe how the coordinating center would lead the CVH network--in particular how it would lead efforts to facilitate translating research into practice.

5) Describe how the research and translation needs of public health practitioners will be identified and addressed and how relevant information will be disseminated in the scientific literature and to multiple stakeholders and audiences--particularly state programs and priority settings.

6) Explain how the coordinating center would draw on partners to enhance research and translation activities that would have public health impact.

7) Describe a project that could be developed and implemented within the 4- year project period.

Preference will be given to those applicants that demonstrate expertise and experience in the following areas:

1) Developing, planning, and implementing prevention research or public health interventions in CVH or other chronic diseases.

2) Leading groups and working with partners, including a group of academic institutions around a common agenda.

3) Building consensus to meet the needs of multiple stakeholders.

4) Conducting CVD prevention research and translation of research into practice in public health settings.

5) Experience working with underserved populations including those of diverse races or ethnicities as well as those that are financially disadvantaged

6) Experience working in priority public health settings, such as health care, work sites, communities, or schools.

7) Synthesizing research literature.

8) Developing methods and tools for public health translation.

9) Evaluating the impact of public health interventions.

Project proposal and length: The application narrative should not exceed 20 pages, exclusive of appendices. The appendices should not exceed 30 pages. The appendices should include the materials supportive of ability to successfully conduct the project described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $175,000 is available to support one Coordinating Center ($125,000 for leadership and coordination and $50,000 for network member center activities) for the first year of a potential 4-year project. Funding may vary and is subject to change.

Research Status: The operations and development of the network will not involve human subject research and therefore, should not require CDC IRB approval. Pilot projects chosen may involve IRB review. CDC staff will assist Centers in making human subject determinations. The CDC staff for this project will serve in an advisory capacity as technical consultants.

References:

1. State Program: http://www.cdc.gov/cvh/state_program/index.htm

2. HP 2010: http://www.cdc.gov/cvh/hp2010/index.htm

3. PH Action Plan: http://www.cdc.gov/cvh/Action_Plan/index.htm

SIP 9-2005

Project Title: Network for Cardiovascular Health Intervention Research and Translation – Collaborating Center

Project Description: The intent of this special interest project (SIP) is to develop and support a network of Prevention Research Centers (PRCs) for cardiovascular health (CVH) intervention research and translation. The network is expected to 1) develop and implement a coordinated, applied research and translation agenda and 2) conduct high-quality prevention research and translation activities that promote CVH and that can be incorporated into state programs.

The network is intended to address the applied research and translation needs relating to cardiovascular health. In particular, this work is expected to facilitate the work in CDC's State Heart Disease and Stroke Prevention Program,1 CDC's Cardiovascular Health Branch priority areas, Healthy People 2010 goals,2 and A Public Health Action Plan to Prevent Heart Disease and Stroke3--in particular the comprehensive prevention research agenda being developed by the Advancing Knowledge Task Group. This SIP will fund the infrastructure for up to five PRCs to collaborate as a network and work toward completing a set of activities.

The proposed network will conduct the following types of activities: 1) synthesize scientific information on the determinants of environmental and policy interventions that promote CVH, on intervention research and translation, and on the dissemination of research and tools for CVH; 2) conduct research on the effectiveness of health care system, work site, community, and school-based interventions; 3) research mechanisms for disseminating evidence-based interventions and incorporating them into state programs; 4) evaluate the implementation and effectiveness of state CVH interventions; and 5) develop and disseminate tools and technical assistance products for state CVH programs.

The collaborating centers will work with each other and a coordinating center to develop an effective network and conduct research and translation activities, as described below.

Project Activities

Component 1: Develop the Network for Cardiovascular Health Intervention Research and Translation

Objective: Coordinate research and translation activities that can be incorporated into public health strategies and practices and used by state programs in achieving their goals in CVH promotion.

The collaborating centers and the coordinating center will create a process for the developing a PRC Network for Cardiovascular Health Intervention Research and Translation. Applicants should explain how they will interact with the network and discuss the relationship and interactions they have with federal and non-federal stakeholders. Applicants should describe and document how they plan to perform the following activities:

Activity 1: Contribute recommendations for establishing the network. The plan should address logistics as well as organization and structure.

Activity 2: Agree on a timetable for a fully functioning network.

Activity 3: Pilot test the development and establishment of the network.

Activity 4: Contribute to developing and disseminating information that documents the development of the network and describes how coordination will be achieved.

Component 2: Research

Objective: Develop a plan for conducting research in CVH that addresses the gaps in knowledge related to the priority areas identified by the Network, CDC, state and other stakeholder assessments.

Activity 1: Contribute to the design and implementation of a research and translation needs assessment in conjunction with collaborating centers, CDC, States and stakeholders. The assessment will identify priority research activities that would address gaps in knowledge and contribute to the development of a research agenda that can be implemented by the network.

Activity 2: Contribute to the reporting of findings of the research and translation needs assessment with federal and nonfederal stakeholders to reach consensus on how to implement the recommendations from the assessment.

Activity 3: Contribute to the development of a 4-year research and translation plan to address the recommendations made in the needs assessment.

Activity 4: Contribute to the development of a plan to evaluate, publish, present, and disseminate results and tools resulting from research activities.

Activity 5: Contribute to the development of a research project proposal that could be developed and initiated within the network and provide recommendations for additional research projects.

Component 3: Translation

Objective: Determine how to synthesize scientific evidence and translate efficacious interventions into the public health setting.

The collaborating centers will work together to develop a plan to evaluate and synthesize current CVH policy and environmental interventions in multiple settings. Translation efforts must be conducted to bridge the research to practice gap. Tools should be developed for diverse audiences, settings, and priority populations and incorporate principles of health literacy, cultural competency, and health equity.

Activities:

1) Contribute to the development of a plan to identify efficacious interventions related to CVH prevention for translation into public health settings.

2) Contribute to the development of guidelines for effective translation materials and tools for use by States and stakeholders.

3) Contribute to the development of a plan for creating and disseminating translation documents and tools.

4) Contribute to the development of a plan to evaluate the use and impact of translation documents and tools.

Applicants should address the following:

1) Describe how the collaborating center would work with the coordinating center and other collaborating centers and other stakeholders in developing an agenda for CVH intervention research and translation.

2) Identify the resources relevant to CVH public health research available to the collaborating center. Discuss how these resources could be enhanced through the proposed network.

3) Explain how the collaborating center will interact with other centers in the network in setting priorities for intervention research and translation.

4) Describe how the collaborating center would contribute to the CVH network--in particular how it would contribute to efforts to facilitate translating research into practice.

5) Describe how the research and translation needs of public health practitioners will be identified and addressed and how relevant information will be disseminated in the scientific literature and to multiple stakeholders and audiences--particularly state programs and priority settings.

6) Explain how the collaborating center would draw on partners to enhance research and translation activities that would have public health impact.

7) Describe a project that could be developed and implemented within the 4- year project period.

Preference will be given to those applicants that demonstrate expertise and experience in the following areas:

1) Developing, planning, and implementing prevention research or public health interventions in CVH or other chronic diseases.

2) Collaborating in groups and working with partners, including a group of academic institutions around a common agenda.

3) Building consensus to meet the needs of multiple stakeholders.

4) Conducting CVD prevention research and translation of research into practice in public health settings.

5) Experience working with underserved populations including those of diverse races or ethnicities as well as those that are financially disadvantaged

6) Experience working in priority public health settings, such as health care, work sites, communities, or schools.

7) Synthesizing research literature.

8) Developing methods and tools for public health translation.

9) Evaluating the impact of public health interventions.

Project proposal and length: The application narrative should not exceed 20 pages, exclusive of appendices. The appendices should not exceed 30 pages. The appendices should include the materials supportive of ability to successfully conduct the project described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $50,000 is available to support each of up to five Collaborating Centers for the first year of a potential 4-year project. Funding may vary and is subject to change.

Research Status: The operations and development of the network will not involve human subject research and therefore, should not require CDC IRB approval. Pilot projects chosen may involve IRB review. CDC staff will assist Centers in making human subject determinations. The CDC staff for this project will serve in an advisory capacity as technical consultants.

References:

1. State Program: http://www.cdc.gov/cvh/state_program/index.htm

2. HP 2010: http://www.cdc.gov/cvh/hp2010/index.htm

3. PH Action Plan: http://www.cdc.gov/cvh/Action_Plan/index.htm

SIP 10-2005

Project Title: Cardiovascular Disease (CVD) Curriculum Modules for American Indian and Alaska Native Youth

Project Description: American Indians and Alaska Natives (AIs/ANs) experience significant disparities in heart disease mortality compared to the total U.S. population. The age-adjusted heart disease death rate was 20% higher than that of the total population for the period of 1996-1998 after adjusting to compensate for misreporting of AI/AN race on death certificates. The proportion of premature deaths due to heart disease, i.e. before age 65, in 2001 was higher for Native Americans (36.0%) than African Americans (31.5%) and whites (14.8%).

In September 2003, the Indian Health Service sponsored a roundtable conference, "Cardiovascular Disease Prevention among American Indians and Alaska Natives," with invited representatives from Tribal governments, Indian health boards, Centers for Disease Control and Prevention (CDC), National Institutes of Health, American Heart Association, American Diabetes Association, and Tribal medical directors, among others. From this meeting a 5-Year Action Plan for the Prevention of CVD among AIs/ANs was developed. One of the objectives of the plan states:

A CVD education and awareness initiative should be developed and targeted at Indian youth schools, (public schools, Bureau of Indian Affairs schools, tribal schools, charter schools). These messages should be developed to be compatible with Native schools cultural curricula. To begin, American Heart Association and other school-based tools might be adapted to Indian country.

The purpose of this project is to develop, pilot-test, evaluate, and make available to interested schools, a culturally appropriate grade 7-12 supplemental health education curriculum focusing on cardiovascular health for American Indian and Alaska Native youth.

Project Activities:

Applicants should address the following:

1) The steps used to develop the culturally sensitive and age appropriate cardiovascular disease curriculum for AI/AN middle and high school youth, including but not limited to, collaboration with school personnel and community members, and the use of existing curricula.

2) What will be included in the curriculum modules and a justification for inclusion? Applicants may want to consider the following items when developing their curriculum modules: anatomy and physiology of the circulatory system, the heart disease process, high blood pressure prevention and control, high cholesterol prevention and control, signs and symptoms of heart attack and stroke (and calling 9-1-1), risk factors for heart disease and stroke, family history, and cardiopulmonary resuscitation.

3) How the curriculum will be implemented or pilot-tested into a school or schools with middle and high school level AI/AN youth.

4) How the curriculum will be evaluated after implementation or pilot-testing.

5) How the curriculum will be revised based on the results of the evaluation.

6) How the curriculum will be made available to other schools systems interested either in using it as is or in modifying it to educate AI/AN youth about cardiovascular disease in their communities.

Preference will be given to applicants who:

1) Demonstrate prior experience collaborating with AI/AN communities;

2) Demonstrate prior experience working with AI/AN youth in a school setting;

3) Demonstrate a history of related research and publications from that research;

4) Provide evidence of support from schools with AI/AN youth and AI/AN communities.

Project Proposal Length and Supporting Material:

Proposal narratives are limited to 20 pages. Supporting materials included in the appendices should not exceed 25 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $200,000 is available to fund one Prevention Research Center in the first year of a 3-year project period. Funding may vary and is subject to change.

Research Status: It is expected that this will be non-exempt research. CDC staff will not serve as co-investigators on this project but will provide technical assistance on activities such as research design, data collection and analysis, and dissemination of results. It is expected that the project will require CDC IRB approval or approval of deferral to the local IRB. As applicable, applications should provide a federal wide assurance registration number for each performance site included in the project.

SIP 11-2005

Project Title: Adapting a cardiovascular health promotion school-based nutrition intervention for obesity prevention and control

Project Description: The prevalence of overweight among 6- to 11-year old US children has nearly doubled since the 1960s, with the most recent prevalence estimates at approximately 16%.1 The prevalence of overweight is also 16% among US children 12- to 19 years old and is 10% among children 2- to 5 years.2 The health risks associated with childhood overweight include elevated blood pressure, dyslipidemia, impaired glucose tolerance, insulin resistance, body image disparagement, and increased mortality in males.3-10

The prevention of childhood overweight is one of the most important public health challenges. Many school-based nutrition interventions have been developed to promote cardiovascular health and focus on reducing saturated fat and sodium intake through educational, behavioral and environmental strategies. Because these programs were developed before the recognition of the obesity epidemic, few give significant attention to nutritional strategies for prevention and reduction of overweight. Other potential areas for overweight prevention and control in a behavioral and environmental school-based nutrition intervention might include:

The objective of this funding is to support the adaptation, evaluation, and packaging of an existing nutrition intervention (or nutrition component of a multi-component intervention) developed to prevent cardiovascular disease in the school setting. The existing nutrition intervention should already show evidence of reducing fat or sodium intake among schoolchildren. The adapted intervention is expected to include additional nutrition strategies targeting obesity and overweight prevention and control. The adapted nutrition intervention should be school-based but may include activities and strategies that link to families and other community institutions, such as community-school after-school programs and family involvement in the development of strategies focused on parental involvement.

CDC will fund the adaptation, evaluation, and packaging of one nutrition intervention set in preschools, elementary, middle, or high schools. This existing nutrition intervention should be currently used in at least 50 schools in the United States. Applicants should demonstrate collaborations with educational agencies.

The evaluation should, at a minimum, include pre- and post-intervention measures of implementation and outcomes relevant to the development, management, and improvement of the adapted nutrition strategies within an existing intervention. The adapted nutrition intervention with additional strategies is expected to be developed, pilot tested and packaged for inclusion in the nutrition intervention.

Project Activities:

1. Document and describe an existing school-based nutrition intervention (or multi-component intervention with a nutrition component) that was developed to promote cardiovascular health and shows evidence of changing dietary intake and nutrition environments. The existing program should have primary nutrition outcomes focused on changing nutrition behaviors and environments related to saturated fat and sodium intake and not on preventing or controlling overweight. The existing intervention should be currently used in at least 50 schools. The existing intervention may target students in preschools, elementary, middle or high schools.

2. Adapt the existing nutrition intervention to go beyond a primary focus of reducing saturated fat and sodium intake to include additional nutrition strategies for preventing and controlling overweight. Demonstrate that the additional nutrition strategies are developed from the literature and are likely to change dietary intake behaviors and environments of schoolchildren to prevent and control overweight. The nutrition intervention should be school-based, but may include activities and strategies that link to families and other community institutions.

Applicants are strongly encouraged to carry out exploratory research and pre-testing with different racial/ethnic and income populations in order to develop the new strategies. The findings of any exploratory research and pre-testing should be incorporated into the development of the additional nutrition component.

3. Pilot and evaluate the adapted nutrition intervention. The evaluation design should include control schools or a matched comparison to determine the impact of the additional nutrition strategies on overweight and dietary intake outcomes relative to controls. Revise the adapted nutrition intervention based on findings from the piloting phase. The adapted nutrition strategies are expected to be packaged for inclusion in the original nutrition program.

Note that all aspects of the design, including conceptualization, sample size estimation, intervention design, data collection and analysis, and reporting will be the responsibility of the investigators. In addition, applicants must agree to obtain permission, when necessary, to use any non-original work or material in which a third party may have a copyright interest.

Preference will be given to applicants who demonstrate experience in developing nutrition interventions focused on school-aged children and for those with experience developing and evaluating behavioral and environmental nutrition interventions to reduce and prevent overweight. The nutrition intervention should be school-based but may include activities and strategies that link to families and other community institutions.

Availability of Funds: Approximately $200,000 is available to fund one application in the first year of a three-year project period. Funding may vary and is subject to change.

Project Proposal Length and Supporting Material: Application proposals should not exceed 15 pages. Appendices should not exceed a total of 35 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Research Status: It is expected that this will be non-exempt research. CDC staff will not serve as co-investigators on this project but will provide technical assistance on activities such as research design, data collection and analysis, and dissemination of results. Applications should provide a federal wide assurance registration number for each performance site included in the project.

References:

1. Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002;288:1728-1732.

2. Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA 2004;291:2847-2850.

3. Sherry B, Mei Z, Scanlon K, Mokdad AH, Grummer-Stawn. Trends in state-specific prevalence of overweight and underweight in 2- through 4-year-old children from low-income families from 1989 through 2000. Arch Pediatr Adolesc Med 2004;158:116-1124.

4. Freedman DS, Dietz WH, Srinivasan SR, Berenson GS. The relation of overweight to cardiovascular risk factors among children and adolescents: the Bogalusa Heart Study. Pediatrics. 1999;103:1175-1182.

5. Ford ES, Galuska DA, Gillespie C, Will JC, Giles WH, Dietz WH. C-reactive protein and body mass index: findings from the Third National Health and Nutrition Examination Survey, 1988-1994. J Pediatr. 2001;138:486-492.

6. American Diabetes Association. Type 2 diabetes in children and adolescents. Pediatrics. 2000;105:671-680.

7. Garn SM, Clark DC. Nutrition, growth, development, and maturation: findings from the ten-state nutrition survey of 1968-1970. Pediatrics. 1975;56:306-319.

8. Kinugasa A, Tsunamoto K, Furukawa N, et al. Fatty liver and its fibrous changes found in a simple obesity of children. J Pediatr Gastroenterol Nutr. 1984;3:408-414.

9. Crichlow RW, Seltzer MH, Jannetta PJ. Cholecystitis in adolescents. Dig Dis. 1972;17:68-72.

10. Dietz WH. Health consequences of obesity in youth: childhood predictors of adult disease. Pediatrics. 1998;101:518-525.

SIP 12-2005

Project Title: Adapting evidence-based strategies for public health practice to the developing world: Applying the Community Guide physical activity recommendations in Brazil

Project Description: In May of 2004, the World Health Assembly approved a World Health Organization (WHO) Global Strategy for Diet, Physical Activity and Health. Comprehensive national, regional and global efforts will be required to implement this strategy and address physical inactivity and associated chronic diseases and conditions such as obesity, diabetes and cardiovascular disease, especially in the developing world. One of the six strategic imperatives identified as part of the CDC Futures Initiative is global health. The application of evidence-based public health strategies appropriate to local circumstances and culture is an important component of CDC's global health efforts. These efforts are being targeted to several high priority regions and countries, including Brazil. Due to rapid urbanization and lifestyle changes Latin America in general, and Brazil specifically, are facing public health crises stemming from chronic diseases, obesity, and physical inactivity. However, public health infrastructure, capacity, and strategies to address chronic disease prevention and health promotion at the population level are sorely lacking. There is a major need to adapt and implement effective policies, disease and risk factor surveillance, health promotion interventions, and program evaluation approaches that can be effectively applied in Brazil and other developing countries.

An important potential tool is the set of physical activity recommendations from the United States Task Force on Community Preventive Services, widely referred to as the Community Guide physical activity recommendations. This rigorous evidence-based review of the English language scientific literature on 14 categories of community-based physical activity interventions identified eight intervention strategies for which sufficient data existed for the Task Force to highly recommend or recommend utilization of these strategies. These recommendations may well apply to public health practice in Brazil, but may also require considerable tailoring to be useful in the context of the Brazilian health care system, economy, community structure, and culture. Lessons learned from adapting, applying, and evaluating the Community Guide physical activity recommendations in Brazil may help inform disease prevention and health promotion efforts across Latin America and elsewhere in the developing world. In addition, the adaptation and implementation of these evidence-based strategies in Brazil will provide evidence on the validity and generalizability of the core components of the Community Guide recommendations. For the past 20 years, CDC's Prevention Research Centers Program, has used applied public health research to identify population-based strategies (e.g., surveillance, policies, interventions) that are effective in promoting health and preventing chronic diseases through reduction of known risk factors such as physical inactivity, smoking, poor diet, obesity and others. The 33 academic and research institutions that compose the Prevention Research Centers Program network are funded for five years to design, develop, implement and disseminate prevention research. These centers will serve as an experienced partner to Brazilian academic centers with infrastructure, experience and interest in developing prevention research. In partnering with a Brazilian academic/research institution to pilot test interventions, the PRCs may also contribute their published research findings of effective and translatable interventions that may not yet have been reviewed in the Community Guide process.

The specific aims of this project are to: 1) Evaluate and synthesize both the peer-reviewed and non-peer-reviewed literature related to community-based strategies designed to increase physical activity levels among adults and children in Brazil; 2) Identify evidence-based community-based strategies for increasing physical activity that may be feasible and effective in Brazil; 3) implement and evaluate one or more community demonstration projects based on the translation and tailoring of evidence-based physical activity promotion strategies for use in Brazil; 4) disseminate the findings from the review process and demonstration projects to additional communities, institutions, public health professionals and countries; and 5) evaluate the feasibility and value of cross-national academic collaboration for developing public health intervention strategies.

Project Activities:

It is anticipated that this project will be conducted in four separate phases. Applicants should address the following items in their proposals:

Phase I: (Year 1)

1. Document and describe your plan for assembling an appropriate working group. It is expected that this group should, at a minimum, consist of investigators from the host Prevention Research Center (PRC), a collaborating school of public health or community medicine in Brazil, CDC staff, and other physical activity, health promotion, and international health experts as needed. To ensure the success of the project, PRCs are encouraged to collaborate with a Brazilian partner institution that meets the following minimal criteria: a) Be an accredited school of medicine with a department of community or social medicine or be an accredited school of public health, b) Have demonstrated experience in community-based research, and c) Establish a strong working relationship with the Federal Ministry of Health and/or State or Municipal Secretariat for Health.

2. Document and describe your plan for identifying, evaluating, and synthesizing the literature (peer-reviewed and non-peer-reviewed) related to community-based strategies designed to increase physical activity levels among adults or children in Brazil and from settings that might apply to Brazil, including the Guide to Community Preventive Services physical activity recommendations. This process may include staff or student exchanges between the PRC and partner institution in Brazil and/or a workshop or series of working meetings in either the U.S. or Brazil. It is anticipated that the PRC should establish a formal institutional agreement with the collaborating academic institution in Brazil.

3. Document and describe your plan for evaluating the results of the systematic review and for proposing a process to reach consensus on the evidence-based strategies designed to increase physical activity among adults or children in Brazil. This process may involve not only content experts in physical activity interventions from the host institutions, but also representatives from other agencies/institutions who represent diverse perspectives, as appropriate. The group should include representatives from either or both the national and state ministries of health as well as representatives from the Pan American Health Organization (PAHO) and the International Union of Health Promotion and Education (IUHPE). This process should determine which of the intervention strategies identified in the systematic review are promising for demonstration purposes in Brazil. It is anticipated that some strategies with potential for replication may need to be modified or tailored in order to be feasible in the chosen setting(s) in Brazil.

Phase II: (Year 1)

Applicants should document and describe a plan for soliciting feedback about each of the evidence-based physical activity strategies on acceptability, relevance, and the potential for effective tailoring of strategies from health professionals, community leaders, and residents who live in the community settings and who would likely be recruited to participate in population-based interventions to promote physical activity. The specific composition and number of groups to be conducted should be delineated by the applicant.

Phase III: (Years 2-3)

Applicants should describe a plan to implement and evaluate one or more demonstration projects. This plan should, at a minimum, describe how applicants will use feedback from a work group and from focus groups, finalize one or more demonstration projects designed to increase physical activity among adults or children utilizing an evidence-based strategy based on the Community Guide physical activity recommendations, implement the demonstration(s) in one or more community settings, and provide an evaluation of each demonstration effort.

Phase IV: (Year 3)

Applicants should describe how they plan to develop a dissemination plan in concert with CDC and Brazilian public health institutions to promote and further translate the findings from the review process and each of the demonstration projects into additional physical activity promotion recommendations for Brazil, other Latin American countries, and potentially other developing countries. Applicants should also delineate how they plan to evaluate the collaborative processes involved in carrying out the project and assess the value of this type of cross-national academic collaboration for developing public health intervention strategies

Project Proposal Length and Supporting Materials: Proposal narratives are limited to 30 pages. Supporting materials included as appendices should not exceed 50 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $300,000 is available to support one center for the first year of a 3-year project. Funding may vary and is subject to change.

Research Status: Phase I of the project will not involve research on human subjects. However, the convening of groups to obtain qualitative information as well as any pilot projects chosen may involve IRB review. CDC staff will assist the recipient institution in making human subject protection determinations.

SIP 13-2005

Project Title: Increasing physical activity among adults in racially/ethnically diverse communities in the United States.

Project Description: While additional research is needed in documenting a relationship between race/ethnicity and reported levels of physical activity, the factors that are associated with physical inactivity (e.g., lower income levels, lower educational attainment, labor-intensive blue collar jobs, safety issues in poor neighborhoods) disproportionately affect adult racial/ethnic minority groups. The demographic composition of the U.S. is changing, whereby a diversity of racial/ethnic groups will comprise almost half the total population by 2050. The health burden of physical inactivity is greatest among these adult racial/ethnic groups, with large disparities compared to their white counterparts. Adult racial/ethnic minority groups are disproportionately affected by poor health outcomes associated with physical inactivity. Currently there is a paucity of published resources addressing effective strategies for increasing physical activity among adult racial/ethnic minority groups.

Non-published strategies for increasing physical activity among adult racial/ethnic minority groups exist, but many are not readily available for public use and/or have not been formally evaluated and, at best, provide only anecdotal evidence of their success. The specific aims of this project are to: 1) evaluate and synthesize both the peer-reviewed and non-peer-reviewed literature related to community-based strategies designed to increase physical activity levels among adults representing a diversity of racial/ethnic groups (i.e., Blacks, Hispanics/Latinos, Native Americans, Asians/Pacific Islanders/Native Hawaiians); 2) identify evidence-based and acceptable community-based strategies for increasing physical activity among adult racial/ethnic minorities; 3) implement and evaluate a series of demonstration projects based on the translation and tailoring of evidence-based physical activity promotion strategies in a variety of communities across the nation; and 4) disseminate the findings from these demonstration projects to additional communities and settings representing diverse racial/ethnic peoples.

Project Activities:

It is anticipated that this project will be conducted in four separate phases. Applicants should address the following items in their proposals:

Phase I: (Year 1)

1. Describe the plan and methods that are to be used to identify, evaluate, and synthesize peer-reviewed materials related to community-based strategies designed to increase physical activity levels among adult racial/ethnic minority groups. [Note: Applicants are encouraged to consider resources such as the Guide to Community Preventive Services physical activity recommendations that identifies the relevant population-based physical activity interventions that: a) targeted adult racial/ethnic minorities specifically; b) included a significant percent of adult racial/ethnic minorities within the study population; and c) were developed in predominantly white communities, yet show promise in relation to their ease and feasibility of their implementation or replication in racial/ethnic minority communities.]

2. Describe the plan and methods that are to be used to: a) explore the non-peer-reviewed literature and “gray literature” (e.g., dissertations, unpublished project reports, conference proceedings), in accordance with the Community Guide evidence-based review process, and b) identify additional interventions designed to increase physical activity among racial/ethnic minorities. [Note: Interventions included in the review of the gray literature are expected to reflect, at a minimum, the three primary approaches identified in the Community Guide: informational, behavioral and social, and environmental and policy approaches.]

3. Describe the plan and methods that will be used to evaluate the results of the systematic review and propose a process to reach consensus on the evidence-based strategies designed to increase physical activity among adult racial/ethnic minorities. This process may involve not only content experts in physical activity interventions from the host institution, but also content representatives from other agencies/institutions who represent a diverse racial/ethnic perspective. This process should determine which of the intervention strategies identified in the systematic review are promising for demonstration purposes. Some strategies with potential for replication may need to be modified/tailored in order to fit the definition of “evidence-based programs and strategies.”

Phase II: (Year 1)

Describe the plan and methods that may be used to solicit feedback about each of the evidence-based physical activity strategies on acceptability, relevance, and effective tailoring of strategies from residents who live in various community settings across the country (e.g., urban, suburban, rural, churches, etc), who represent each racial/ethnic minority group who would likely be recruited to participate in any population-based interventions to promote physical activity. The specific number of groups to be conducted should be delineated by the applicant. Describe the processes, plans, and methods that may be used to implement and evaluate a selected number of demonstration projects.

Phase III: (Years 2-3)

It is expected that applicants should consider using feedback from a work group and from focus groups to finalize a number of demonstration projects designed to increase physical activity among adult racial/ethnic minorities. Applicants should also describe how they plan to implement these in a diversity of community settings, and how they plan to evaluate each demonstration effort.

Phase IV: (Year 3)

Describe the methods and plans that will be used to develop a dissemination plan in concert with CDC to promote and further translate the findings from each of the demonstration projects into additional diverse race/ethnic communities.

Project Proposal Length and Supporting Materials: Proposal narratives are limited to 20 pages. Supporting materials included as appendices should not exceed 50 pages, including publications. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $250,000 is available to support one center for the first year of a 3-year project. Funding may vary and is subject to change

Research Status: Phase I of the project will not involve research on human subjects. However, the convening of groups to obtain qualitative information as well as any pilot projects chosen may involve IRB review. CDC staff will assist the recipient institution in making human subject protection determinations. In addition, CDC will provide the recipient institution with suggestions of members to form a work group (e.g., members of the Community Guide Coordinating Team, academic researchers who have conducted intervention studies to promote physical activity among adult racial/ethnic minority groups, representatives of community-based organizations with experience in physical activity promotion and adult racial/ethnic minority groups.)

SIP 14-2005

Project Title: Improving the Validity of Questionnaires for U.S. Physical Activity Surveillance using Technology Integration

Project Description: The purpose of this project is to improve the validity of self-report physical activity questionnaires by integrating communications technologies into current methodologies used in U.S. surveillance systems. Physical activity surveillance questionnaires are currently used to assess populations for participation in moderate and vigorous intensity activity. Communications technologies may be most feasible and applicable to improve the accuracy of “in-person” questionnaire methodologies. For more information on physical activity questionnaire methodologies, please see web sites for the National Health Interview Survey (NHIS) http://www.cdc.gov/nchs/nhis, and the National Health and Nutrition Examination Survey (NHANES) http://www.cdc.gov/nchs/nhanes.

The validity of responses to questions about physical activity may depend on demographic, psychometric, or cognitive factors. Cognitive testing of physical activity surveillance questions showed demographic differences in how walking and other activities are recalled and reported (Ann Epidemiol 1997;7:334-342). The same study found differences in how frequency and duration are estimated and reported. Comparisons of prevalences from several similar questionnaires suggested that minor differences in question wording and order may affect prevalence (J Physical Activity and Health 2004;1:98-113). Using two questionnaires, investigators showed that some participants reported activity on one questionnaire but reported no activity on a different questionnaire (Am J Pub Health 2001; 91:2010-2012). Cognitive research with demographic groups (racial/ethnic, gender, education, age), therefore, is needed to further understand participant responses to physical activity surveillance questions to improve the accuracy of reporting physical activity frequency, duration, intensity, and mode.

Recent technological advances in communications and personalized messaging devices and technologies enables the development of new tools that can be used to enhance the accuracy of a participant's recall and reporting on physical activity questionnaires. For example, short videos of activities integrated into laptop software for in-person interviews may prompt better recall of physical activity frequency, intensity, duration, mode, or domain.

Working in collaboration with appropriate community and research partners, the objective of this funding is to support research on the development and validation of technology-enhanced tool(s) to improve the validity of physical activity questionnaires for use in the U.S. adult population.

Project Activities:

Applicants should address the following activities:

1. Describe the physical activity questionnaires the technology will seek to improve. Questionnaires that are interviewer-administered and provide nationally representative estimates of physical activity participation should be considered.

2. Describe the process used (e.g., cognitive interviewing) to examine and assess potential inaccuracies in participant responses to physical activity questionnaires (as described in #1 above);

3. Based on the process (from #2), describe the technology(ies) that will be developed and tested in this study and the physical activity measurement characteristic(s) the technology(ies) will seek to improve (frequency, intensity, duration, type, mode, domain).

4. Conduct a field test of the newly-developed technology.

5. Describe the “questionnaire with technology” format to include the financial cost of materials, interviewer training, data collection format, and time to conduct an interview.

6. Conduct a validation study comparing the responses to the questionnaire administered with and without technology using an appropriate validation standard of physical activity.

Preference will be given to proposals that demonstrate the following:

1. The ability to address each of the project activities listed above, particularly with regard to consistency with physical activity recommendations, national public health objectives for physical activity of physical activity behaviors.

2. The applicants' abilities to successfully complete the research.

3. A history of extramural funding for related research and of publications from that research;

4. Evidence that the modified instruments can be made available in a format and at a cost that will allow them to be easily used by public health agencies to conduct physical activity surveillance.

5. Use materials and methods previously developed for physical activity surveillance and new communications technology.

Project Proposal Length and Supporting Material:

Proposal narratives are limited to 25 pages. Supporting materials included in the appendices should not exceed 40 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $200,000 is available to fund one application in the first year of a 2-year project period. Funding may vary and is subject to change.

Research Status: It is expected that this project will be human subjects research subject to Institutional Review Board approval. CDC staff will serve as technical advisors on this project. CDC staff are expected to consult on project activities including study design, methods, sampling, data analysis, and co-authoring manuscripts. It is anticipated that this project will need approval by the IRB at the recipient institution and that CDC IRB approval or deferral to the recipient IRB will be required. The CDC IRB reviews projects annually. Applicants should provide a federal wide assurance registration number for each performance site included in this project.

SIP 15-2005

Project Title: Development of a “ready to use” plan to evaluate readily or commercially available nutrition and physical activity programs in new school settings.

Project Description: The prevalence of overweight among 6- to 11-year old US children has nearly doubled since the 1960s, with the most recent prevalence estimates at approximately 16% 1,2. The health risks associated with childhood overweight include elevated blood pressure, dyslipidemia, impaired glucose tolerance, insulin resistance, and body image disparagement3-9.

The prevention of childhood overweight is one of the most important public health challenges. There are a number of readily or commercially available nutrition and physical activity intervention programs currently in use in schools, such as CATCH or Planet Health. However, program evaluation tools that monitor the management and effectiveness of these programs are frequently not available. One barrier to program evaluation is that many of these readily or commercially available nutrition and physical activity school health programs do not include a “ready to use” evaluation component for use in new settings.

The purpose of the project is develop a “ready to use” evaluation component with tools to monitor implementation and outcomes of a readily or commercially available nutrition and physical activity school health program. The availability of evaluation data at the school level is expected to enhance program management and implementation, and provide important information for program improvement. The readily or commercially available health program used in this project must not currently have a “ready to use” evaluation component for use at the school level. Funding for this evaluation component is not limited to those school health intervention programs developed by a Prevention Research Center (PRC).

CDC expects to fund one Prevention Research Center to develop a “ready to use” evaluation for a commercially available nutrition and physical activity elementary or middle school health program that is currently used in at least 50 schools in the United States. Priority will be given to health programs designed for use in culturally and socio-economically diverse school populations. The funded evaluation plan is expected to include pre- and post-intervention measurement of implementation and outcome indicators relevant to the school health program, including policy, environmental, dietary, physical activity, and child weight and height measures. The “ready to use” evaluation plan is also expected to be developed, implemented (tested) in at least one school, revised, and packaged for inclusion in the commercially available nutrition and physical activity school health program.

Project Activities:

Applicants for this project should address the following in their proposals:

1. Describe their plan for working with CDC staff to design and implement a “ready to use” evaluation component for inclusion in a commercially available nutrition and physical activity school health program.

2. Document and describe the proposed evaluation component which, at a minimum, should: 1) include measurement of implementation and outcome indicators relevant to the commercially available school health program; 2) include measurement of relevant variables, such as policy, environmental, dietary, physical activity, and child body mass index change; 3) be user-friendly and feasible for implementation by school staff; 4) identify who at the school level will carry out specific tasks of the ongoing evaluation (e.g. data collection, management, and analysis); and 5) be useful for program management and improvement at the school level.

3. Describe their plan for implementing the evaluation component in at least one school that is implementing the commercially available nutrition and physical activity health program. Investigators may additionally want to consider describing, if applicable, their measure pre- and post-intervention indicators that are not part of the final “ready to use” component but would help validate indicators included in the final component.

4. Describe their plan for how the evaluation component will be revised based on findings from the implementation phase (if applicable).

5. Describe how the revised evaluation component is expected to be packaged as a “ready to use” evaluation component for inclusion in the commercially available nutrition and physical activity school health program.

All aspects of the design, including conceptualization, sample size estimation to assure adequate statistical power to detect specified differences, intervention design, data collection and analysis, and reporting will be the responsibility of the investigators. In addition, applicants must agree to obtain permission, when necessary, to use any non-original work or material in which a third party may have a copyright interest.

Project Proposal Length and Supporting Material:

Proposal narratives are limited to 20 pages. Supporting materials included in the appendices should not exceed 40 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel. NOTE: Letters of support from at least one school and the readily or commercially available nutrition and physical activity program are encouraged.

Availability of Funds: Approximately $150,000 is available to fund one application in the first year of a 3-year project period. Funding may vary and is subject to change.

Research Status: It is expected that this will be non-exempt research. CDC staff will not serve as co-investigators on this project but will provide technical assistance on activities such as research design, data collection and analysis, and dissemination of results. Applications should provide a federal wide assurance registration number for each performance site included in the project.

References:

1. Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002;288:1728-1732.

2. Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA 2004;291:2847-2850.

3. Freedman DS, Dietz WH, Srinivasan SR, Berenson GS. The relation of overweight to cardiovascular risk factors among children and adolescents: the Bogalusa Heart Study. Pediatrics. 1999;103:1175-1182.

4. Ford ES, Galuska DA, Gillespie C, Will JC, Giles WH, Dietz WH. C-reactive protein and body mass index: findings from the Third National Health and Nutrition Examination Survey, 1988-1994. J Pediatr. 2001;138:486-492.

5. American Diabetes Association. Type 2 diabetes in children and adolescents. Pediatrics. 2000;105:671-680.

6. Garn SM, Clark DC. Nutrition, growth, development, and maturation: findings from the ten-state nutrition survey of 1968-1970. Pediatrics. 1975;56:306-319.

7. Kinugasa A, Tsunamoto K, Furukawa N, et al. Fatty liver and its fibrous changes found in a simple obesity of children. J Pediatr Gastroenterol Nutr. 1984;3:408-414.

8. Crichlow RW, Seltzer MH, Jannetta PJ. Cholecystitis in adolescents. Dig Dis. 1972;17:68-72.

9. Dietz WH. Health consequences of obesity in youth: childhood predictors of adult disease. Pediatrics. 1998;101:518-525.

SIP 16-2005

Project Title: Evaluate the effectiveness of a readily available nutrition and physical activity health program to prevent overweight in the preschool setting

Project Description: The prevalence of overweight among 2- to 5-year old US children has doubled since the early 1970s, with the most recent prevalence estimates at approximately 10% 1, 2. The health risks associated with childhood overweight include elevated blood pressure, dyslipidemia, impaired glucose tolerance, insulin resistance, and body image disparagement3-9.

The prevention of childhood overweight is one of the most important public health challenges. Yet, many ongoing nutrition and physical activity preschool health programs have not been evaluated for their effectiveness in preventing overweight.

CDC is designating funds for the evaluation of the implementation and outcomes of a readily available nutrition and physical activity preschool-based health program to prevent pediatric overweight. The available program should not have been evaluated for its effectiveness in preventing overweight in the preschool setting. The availability of evaluation data is expected to provide important information for program improvement. CDC expects to fund the evaluation of one nutrition and physical activity preschool program that is currently used in the United States. Priority will be given to health programs designed for use in culturally and socio-economically diverse preschool populations. The funded evaluation should include pre- and post-intervention measurement of implementation and outcome indicators relevant to the health program, including primarily changes in BMI and secondarily behavioral changes in dietary intake and physical activity.

Project Activities:

Investigators on the project, working with CDC staff, are expected to design and implement an evaluation of a readily available nutrition and physical activity preschool health program. The proposed evaluation is expected, at a minimum, to include: 1) measurement of implementation and outcome indicators relevant to the preschool health program; 2) measurement of policy, environmental, dietary, physical activity, and child weight-for-height (body mass index) change; and 3) a control group for comparison to the intervention group. Investigators are expected to consider conducting the evaluation in at least one preschool. Investigators should also consider how to make recommendations for revision of the readily available preschool health program if their findings suggest that changes in the program could be beneficial.

All aspects of the design, including conceptualization, sample size estimation to assure adequate statistical power to detect specified differences, intervention design, data collection and analysis, and reporting will be the responsibility of the investigators. In addition, the applicant must agree to obtain permission, when necessary, to use any non-original work or material in which a third party may have a copyright interest.

Project Proposal Length and Supporting Material:

Application proposals should not exceed 20 pages, excluding appendices and supporting materials. Appendices should not exceed a total of 30 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $150,000 is available to fund one application in the first year of a 2-year project period. Funding may vary and is subject to change.

Research Status: It is expected that this will be non-exempt research. CDC staff will not serve as co-investigators on this project but will provide technical assistance on activities such as research design, data collection and analysis, and dissemination of results. Applications should provide a federal wide assurance registration number for each performance site included in the project.

References:

1. Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002;288:1728-1732.

2. Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA 2004;291:2847-2850.

3. Freedman DS, Dietz WH, Srinivasan SR, Berenson GS. The relation of overweight to cardiovascular risk factors among children and adolescents: the Bogalusa Heart Study. Pediatrics. 1999;103:1175-1182.

4. Ford ES, Galuska DA, Gillespie C, Will JC, Giles WH, Dietz WH. C-reactive protein and body mass index: findings from the Third National Health and Nutrition Examination Survey, 1988-1994. J Pediatr. 2001;138:486-492.

5. American Diabetes Association. Type 2 diabetes in children and adolescents. Pediatrics. 2000;105:671-680.

6. Garn SM, Clark DC. Nutrition, growth, development, and maturation: findings from the ten-state nutrition survey of 1968-1970. Pediatrics. 1975;56:306-319.

7. Kinugasa A, Tsunamoto K, Furukawa N, et al. Fatty liver and its fibrous changes found in a simple obesity of children. J Pediatr Gastroenterol Nutr. 1984;3:408-414.

8. Crichlow RW, Seltzer MH, Jannetta PJ. Cholecystitis in adolescents. Dig Dis. 1972;17:68-72.

9. Dietz WH. Health consequences of obesity in youth: childhood predictors of adult disease. Pediatrics. 1998;101:518-525.

SIP 17-2005

Project Title: Development and Testing of a Parent-focused Intervention to Reduce Children's Television Viewing

Project Description: National cross-sectional surveys have shown a positive association between the number of hours children watch television and prevalence of overweight (Andersen, et al., 1998, Crespo et al, 2001; Dowda, et al., 2001). Longitudinal and experimental studies have suggested a causal relationship between increased television hours and overweight in children (Gortmaker, et al., 1996, 1999; Robinson, 1999). Television viewing is the most common sedentary behavior of children in the U.S.; on average, children 2-17 years old spend approximately 2.5 hours a day watching television (Roberts, et al., 1999; Woodard & Gridina, 2000).

Few evaluations of interventions to reduce television watching have been reported in the literature. Three programs addressed children directly through school-based curricula (Gortmaker, et al., Apr 1999; Gortmaker, et al., Sep 1999; Robinson, 1999). Other published studies include pilot tests of clinic-based, primarily counseling interventions for families of at-risk or overweight children (Ford, et al, 2002; Epstein, et al, 2000), of an after-school and family-based intervention with African American girls (Robinson, et al, 2003), and of behavioral contingency strategies (Jason & Fries, 2004; Faith, et al., 2001).

In 2003, CDC funded a qualitative study of children and their parents to examine barriers and incentives to reducing TV time to identify potentially effective audience-centered strategies. During focus group sessions, the following promising TV reduction strategies were discussed with parents and children: 1) not putting a TV in the child's bedroom; 2) disconnecting TV viewing and eating (not putting a TV in eating areas, turning the TV off during meals, not allowing snacking while watching); 3) monitoring and limiting child's TV time, especially on school days; 4) setting media use rules early and enforcing them consistently; and 5) active parenting - acting as a role model to children by limiting own TV time, identifying enjoyable alternatives to TV.

The study concluded that parents must play a major role to reduce children's TV viewing; thus interventions directed to modify parents and families TV behaviors are necessary (Jordan, et al, unpublished report available from the CDC contact). Main findings from the qualitative study included the following:

The purpose of this project is to support the development, evaluation, and dissemination of parent-focused (rather than child-based or school-based) interventions to reduce television viewing among children 6-9 years of age.

Project Activities:

Investigators on the project, working closely with CDC staff, are expected to design, conduct, and evaluate an experimental investigation of parent-focused strategies to reduce television viewing time in children 6-9 years of age and, if the intervention is found to reduce TV time, to develop a plan for disseminating the intervention more widely. All aspects of the project, including conceptualization, intervention design and implementation, data collection and analysis, reporting, and development of the dissemination plan will be the responsibility of the investigators.

CDC is interested in interventions that take an audience-focused approach (based on existing and new formative research, especially about barriers and motivators in parent's and children's lives and situation) and that address the five promising practices identified above. Interventions that do not focus on parents and families will not be considered. CDC also is interested in interventions that can be widely used in ethnically-diverse communities and families. Effective and feasible interventions that can be implemented on a wider scale are a priority.

Project Proposal Length and Supporting Material:

Application proposals should not exceed 20 pages, excluding appendices and supporting materials. Appendices should not exceed a total of 30 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel.

Availability of Funds: Approximately $250,000 is available to fund one application in the first year of a 3-year project period. Funding may vary and is subject to change.

Research Status: It is expected that this project will be human subjects research subject to Institutional Review Board approval. CDC staff will provide consultation and technical support to this project. CDC staff are expected to consult on project activities including study design, methods, sampling, data analysis, and co-authoring manuscripts. It is anticipated that this project will need approval by the IRB at the recipient institution and that CDC IRB approval or deferral to the recipient IRB will be required. The CDC IRB reviews projects annually. Applicants should provide a federal wide assurance registration number for each performance site included in this project.

References:

Andersen, R., Crespo, C., Bartlett, S., Cheskin, L., Pratt, M. Relationship of Physical Activity and TV Watching with Body Weight and Level of Fatness Among Children: Results from the Third National Health and Nutrition Examination Survey. JAMA 1998: 279(12) 938-942.

Crespo CJ, Smit E, Troiano RP, Bartlet SJ, Macera CA, Andersen RE. Television Watching, Energy Intake, and Obesity in US Children: Results from the Third National Health and Nutrition Examination Survey, 1988-1994. Arch Pediatr Adolesc Med. 2001; 155(3): 360-365.

Epstein LH, Paluch RA, Gordy CC, Dorn J. Decreasing Sedentary Behaviors in Treating Pediatric Obesity. Arch Pediatr Adolesc Med. 2000; 154(3), 220-226.

Epstein LH, Paluch RA, Gordy CC, Dorn J. Decreasing Sedentary Behaviors in Treating Pediatric Obesity. Arch Pediatr Adolesc Med. 2000; 154(3), 220-226.

Faith MS, Berman N, Heo M, Pietrobello A, Gallagher D, Epstein LH, Eiden MT, Allison DB. Effects of Contingent Television on Physical Activity and Television Viewing in Obese Children. Pediatrics. 2001; 107(5), 1043-1048.

Ford B, Tiffany BS, McDonald E, Owens AS, Robinson TN. Primary Care Interventions to Reduce Television Viewing in African-American Children. Am J Prev Med 2002;22(2), 106-109.

Gortmaker, S., Must, A., Sobol, A., Peterson, KI, Colditz, G, Dietz, W. TV Viewing as a Cause of Increasing Obesity Among Children in the United States, 1986-1990. Arch Pediatr Adolesc Med. 1996: 150 356-362.

Gortmaker SL, Peterson K, Wiecha J, Sobol AM, Dixig S, Fox MK, Laird N. Reducing Obesity via a School-based Interdisciplinary Intervention Among Youth: Planet Health. Arch Pediatr Adolesc Med, April 1999; 153(4), 409-418.

Gortmaker Sl, Cheung, LWY, Peterson, KE, Chomitz G, Cradle JH, Dart H, Fox MK, Bullock RB, Socol, AM, Colditz G, Field AE, Laird N. Impact of a School-based Interdisciplinary Intervention on Diet and Physical Activity Among Urban Primary School Children: Eat Well and Keep Moving. Arch Pediatr Adolesc Med. September 1999; 153(9), 975-983.

Jason LA, Fries M. Helping Parents Reduce Children's Television Viewing. Research on Social Work Practice. 2004; 14(2), 121-131.

Roberts DF, Foehr UG, Rideout VJ, Brodie M. Kids and Media @ the New Millennium. 1999, A Kaiser Family Foundation Report. (Available at http://www.kff.org/entmedia/1535-index.cfm)

Robinson TN. Reducing Children's Television Viewing to Prevent Obesity: A Randomized Controlled Trial. JAMA 1999: 282(16) 1561-1567.

Robinson TN. Television Viewing and Childhood Obesity. Pediatric Clinics of North America 2001; 48(4), 1017-1025.

Robinson, T.N., Killen JD, Kraemer HC, Wilson, DM, et al. Dance and Reducing Television Viewing to Prevent Weight Gain in African American Girls: The Stanford GEMS Pilot Study. Ethnicity and Disease. 2003; 13, S1-65 - S1-77.

Woodard EH, Gridina N. Media in the Home 2000: The Fifth Annual Survey of Parents and Children. 2000, The Annenberg Public Policy Center.

SIP 18-2005

Project Title: Intervention component to reduce television viewing for incorporation into an evidence-based multi-component school-based nutrition and physical activity intervention

Project Description: The prevalence of overweight among 6- to 11-year old US children has nearly doubled since the 1960s, with the most recent prevalence estimates at approximately 16%. 1 The prevalence of overweight is also 16% among US children 12-19 years old. 2 The health risks associated with childhood overweight include elevated blood pressure, dyslipidemia, impaired glucose tolerance, insulin resistance, body image disparagement, and increased mortality in males. 3-10

The prevention of childhood overweight is one of the most important public health challenges. Despite the availability of many multi-component school-based nutrition and physical activity interventions, few that are effective for increasing physical activity or changing dietary intake have proven effective for preventing or reducing overweight among school children. There are many potential reasons for an intervention not having a clear effect on overweight prevalence, including time needed to show weight change, insufficient intensity of the intervention, and lack of family and community involvement in the intervention. Enhancements of evidence based nutrition and physical activity interventions might result in more effects on overweight prevention and reduction.

Published studies have shown a positive association between the number of hours children spend viewing television and prevalence of overweight. 11-13 Longitudinal and experimental studies have suggested a causal relationship between increased television hours and overweight in children. 14-15 Two school-based studies using randomized controlled trial designs showed that children who reported a decrease in time watching TV also showed a reduction in overweight. 15-16

The objective of this funding is to support the development of an intervention to reduce television viewing time among school-aged children that can be incorporated into an existing multi-component school-based nutrition and physical activity intervention. The existing intervention should already show evidence of increasing physical activity and/or changing dietary intake and should not already include a television reduction component. CDC will fund one elementary, middle, or high school multi-component nutrition and physical activity program that is currently used in at least 50 schools in the United States.

Priority will be given to multi-component school-based nutrition and physical activity programs designed for use in culturally and socio-economically diverse school populations. The television reduction component should be school-based but may include activities and strategies that link to families and other community institutions. Priority will be given to interventions that include behavioral and environmental television reduction strategies that extend to the family and household setting. Applicants should demonstrate collaborations with educational agencies.

The funded television reduction component should, at a minimum, include pre- and post-intervention measurement of process and outcome indicators relevant to the development, management and improvement of the television component within a broader multi-component school-based nutrition and physical activity intervention. At a minimum, data collection should include behavioral and environmental measures centered on television viewing, dietary intake, physical activity, and child weight and height measures. The television reduction component is expected to be developed, pilot tested, and packaged for inclusion in the multi-component school-based nutrition and physical activity program.

Project Activities:

1. Document and describe an existing multi-component school-based nutrition and physical activity intervention currently used in at least 50 schools and that is already proven effective for increasing physical activity and/or changing dietary intake. The primary intervention outcomes for the existing intervention should focus on changing physical activity and nutrition behaviors and environments, and not on reducing television viewing.

2. Develop a new component for the existing intervention centered on changing television viewing behaviors and the television viewing environment of school children. Demonstrate that the television component has been developed using sound scientific methods and has the potential to change television viewing behaviors and environments of school children based on the literature. The television component should be school-based but may include activities and strategies that link to families and other community institutions.

Applicants are strongly encouraged to carry out exploratory research and pre-testing with different racial/ethnic and income populations in order to develop the new strategies. The findings of any exploratory research and pre-testing should be incorporated into the development of the new television reduction component.

3. Applicants should describe their plans to pilot and evaluate the multi-component intervention with the new television component. The evaluation design should include control schools to determine the effect of the intervention on indicators related to television viewing, nutrition, and physical activity among school children relative to controls. Revise the television component based on findings from the piloting phase. The revised television component is expected to be packaged as a component for inclusion in the multi-component nutrition and physical activity program.

Note that all aspects of the design, including conceptualization, sample size estimation, intervention design, data collection and analysis, and reporting will be the responsibility of the investigators. In addition, applicants must agree to obtain permission, when necessary, to use any non-original work or material in which a third party may have a copyright interest.

Preference will be given to applicants who demonstrate experience in developing multicomponent nutrition and physical activity interventions focused on school-aged children and for those with experience developing and evaluating interventions to reduce television viewing.

Project Proposal Length and Supporting Material:

Application proposals should not exceed 15 pages, excluding appendices and supporting materials. Appendices should not exceed a total of 35 pages. The appendices should include the materials supportive of ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal. Any pages received in excess of the stated limits will be discarded and will not be considered by the peer review panel. Note: Applicants are encouraged to demonstrate collaborations with educational agencies in the appendix materials.

Availability of Funds: Approximately $200,000 is available to fund one application in the first year of a three-year project period. Funding may vary and is subject to change.

Research Status: It is expected that this will be non-exempt research. CDC staff will not serve as co-investigators on this project but will provide technical assistance on activities such as research design, data collection and analysis, and dissemination of results. Applications should provide a federal wide assurance registration number for each performance site included in the project.

References:

1. Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002;288:1728-1732.

2. Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA 2004;291:2847-2850.

3. Sherry B, Mei Z, Scanlon K, Mokdad AH, Grummer-Stawn. Trends in state-specific prevalence of overweight and underweight in 2- through 4-year-old children from low-income families from 1989 through 2000. Arch Pediatr Adolesc Med 2004;158:116-1124.

4. Freedman DS, Dietz WH, Srinivasan SR, Berenson GS. The relation of overweight to cardiovascular risk factors among children and adolescents: the Bogalusa Heart Study. Pediatrics. 1999;103:1175-1182.

5. Ford ES, Galuska DA, Gillespie C, Will JC, Giles WH, Dietz WH. C-reactive protein and body mass index: findings from the Third National Health and Nutrition Examination Survey, 1988-1994. J Pediatr. 2001;138:486-492.

6. American Diabetes Association. Type 2 diabetes in children and adolescents. Pediatrics. 2000;105:671-680.

7. Garn SM, Clark DC. Nutrition, growth, development, and maturation: findings from the ten-state nutrition survey of 1968-1970. Pediatrics. 1975;56:306-319.

8. Kinugasa A, Tsunamoto K, Furukawa N, et al. Fatty liver and its fibrous changes found in a simple obesity of children. J Pediatr Gastroenterol Nutr. 1984;3:408-414.

9. Crichlow RW, Seltzer MH, Jannetta PJ. Cholecystitis in adolescents. Dig Dis. 1972;17:68-72.

10. Dietz WH. Health consequences of obesity in youth: childhood predictors of adult disease. Pediatrics. 1998;101:518-525.

11. Andersen, R., Crespo, C., Bartlett, S., Cheskin, L., Pratt, M. Relationship of Physical Activity and TV Watching with Body Weight and Level of Fatness Among Children: Results from the Third National Health and Nutrition Examination Survey. JAMA 1998: 279(12) 938-942.

12. Crespo CJ, Smit E, Troiano RP, Bartlet SJ, Macera CA, Andersen RE. Television Watching, Energy Intake, and Obesity in US Children: Results from the Third National Health and Nutrition Examination Survey, 1988-1994. Archives of Pediatrics and Adolescent Medicine. 2001; 155(3): 360-365.

13. Dowda M, Ainsworth BE, Addy CL, Saunder R, Riner W. Environmental Influences, Physical Activity, and Weight Status in 8-to 16-Year-Olds. Archives of Pediatrics and Adolescent Medicine. 2001; 155(6), 711-717.

14. Gortmaker, S., Must, A., Sobol, A., Peterson, KI, Colditz, G, Dietz, W. TV Viewing as a Cause of Increasing Obesity Among Children in the United States, 1986-1990. Archives of Pediatric Medicine 1996: 150 356-362.

15. Robinson, TN. Reducing Children's Television Viewing to Prevent Obesity: A Randomized Controlled Trial. JAMA 1999: 282(16) 1561-1567.

16. Gortmaker SL, Peterson K, Wiecha J, Sobol AM, Dixig S, Fox MK, Laird N. Reducing Obesity via a School-based Interdisciplinary Intervention Among Youth: Planet Health. Archives of Pediatrics and Adolescent Medicine, April 1999; 153(4), 409-418.


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