SCHOOL-BASED INTERVENTIONS TO PREVENT OBESITY RELEASE DATE: August 16, 2004 PA NUMBER: PA-04-145 Updates: This PA has been reissued as PA-06-415 for submission of R01 applications as of May 22, 2006 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. Replacement R03 (PA-06-416) and R21 (PA-06-417) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R01 Applications: May 22, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Child Health and Human Development (NICHD) ( National Heart, Lung, and Blood Institute (NHLBI) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ( National Institute of Nursing Research (NINR) ( Office of Behavioral and Social Sciences Research (OBSSR) ( National Cancer Institute (NCI) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865; 93.307; 93.837; 93.848; 93.361; 93.393 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This Program Announcement (PA) encourages the formation of partnerships between academic institutions and school systems in order to develop and implement controlled, school-based intervention strategies designed to reduce the prevalence of obesity in childhood. This initiative also encourages evaluative comparisons of different intervention strategies, as well as the use of methods to detect synergistic interactions between different types of interventions. RESEARCH OBJECTIVES Background This country is in the midst of a twin epidemic of childhood obesity and adolescent type 2 diabetes. The prevalence of obesity in children, defined as a body mass index at or above the 95th percentile for age and gender according to the National Health and Nutrition Examination Survey I, has nearly quadrupled over the past 30 years, and the incidence of type 2 diabetes in adolescents has increased by a factor of ten over the past 20 years. Research has shown that childhood obesity tracks with fidelity into adulthood. Other research in obese children has shown that weight loss is more readily maintained if achieved prior to, rather than after, puberty. Even more effective is preventing weight gain in the first place. However, preventive programs may need to be initiated in elementary school, since by the time children reach middle school more than 20 percent of them are obese. This initiative is designed to encourage partnerships between academic institutions and school systems, for example, those school systems involved with the Action for Healthy Kids Program. Such partnerships would involve getting baseline data on children in elementary or middle schools, devising and implementing intervention programs in a controlled fashion, and assessing dependent outcome variables at varying lengths of time after the intervention. Scope School systems are ideal places to develop and evaluate innovative interventions designed to prevent childhood obesity. Children spend much of their time in school where they can be exposed to randomized, controlled interventions. Entire schools within a school system can be chosen at random for either intervention or control conditions in order to reduce the possibility of cross-group contamination. Possible areas within the school system that might be targeted for controlled interventions include the content of school curricula, teaching methodologies, staff education, physical education programs, the school environment, school food service programs, food service worker education, content and availability of vending machine snacks in school, school administrators, and parents. Examples of research projects that would be responsive to this solicitation include, but are not limited to: o Curriculum changes designed to improve knowledge of healthy food choices and active lifestyles, and behavioral modification programs designed to attain healthy diets and active lifestyles. Specifically, this initiative encourages academic institutions and school systems to work together to develop and implement behavioral interventions designed to increase children's physical activity and/or decrease the amount of time that children devote to sedentary activities, such as watching television or playing computer games. Such interventions might involve curriculum changes or curriculum changes coupled with periods of increased physical activity, either before, during or after school. Interventions also might be designed to induce and maintain long-term behavioral change regarding eating habits, food choices, exercise habits, and lifestyle. o Evaluations of various controlled dietary interventions would also be responsive to this PA, for example, changes in school food service programs for school breakfast and/or school lunch. Intervention programs designed for parents who prepare their children's lunches would also be responsive. In order to detect synergistic interactions between dietary interventions and interventions involving physical activity, grant applications featuring factorial designs are encouraged. Factorial designs could also be employed to detect possible synergies among various other interventions, such as curriculum changes, alterations in availability of various kinds of snack foods and drinks, and content of school breakfasts and lunches. MECHANISM OF SUPPORT This PA will use the NIH Research Project Grant (R01), Small Grant (R03) and Exploratory/Developmental Grant (R21) award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The small grant (R03) research mechanism should be used for support of pilot and/or feasibility studies for concepts that are sound and justifiable, but not sufficiently developed for the R01 mechanism. The R21 mechanism is intended to encourage new exploratory and developmental research projects and/or exploration of novel hypotheses and strategies. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system. These projects should be exploratory and novel, and distinct from the type of project supported through the traditional R01. Applicants for the NIH Small Grant (R03) should follow the guidelines published in the NIH Guide for Grants and Contracts at: For further information on the R21 mechanism, go to This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her 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 NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Gilman Grave, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, 4B-11, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5593 FAX: (301) 480-9791 Email: Charlotte Pratt, Ph.D., RD National Heart, Lung and Blood Institute Division of Epidemiology and Clinical Applications 6701 Rockledge Drive MSC 7936, Room 8134 Bethesda, MD 20892 Tel: 301-435-0382 Fax: 301-480-1669 E-mail: Robert Kuczmarski, Program Director National Institute of Diabetes, Digestive and Kidney Diseases National Institutes of Health 2 Democracy Plaza, Room 673 Bethesda, MD 20892 Tel: 301-451-8354 Fax: 301-480-8300 E-mail: Yvonne Bryan, PhD, RN Program Director Office of Extramural Programs National Institute of Nursing Research National Institutes of Health, NIH/NINR 6701 Democracy Blvd, Room 710 One Democracy Plaza Bethesda, MD 209892-4870 Tel: 301-594-6908 Fax: 301-480-8260 E-mail: Deborah H. Olster, Ph.D., Senior Advisor Office of Behavioral and Social Sciences Research Office of the Director National Institutes of Health Building 1, Room 256 Center Drive, NIH Campus Bethesda, MD 20892-0210 Tel: 301-451-4286 Fax: 301-402-1150 E-mail: Amy Lazarus Yaroch, Ph.D. Health Promotion Research Branch Behavioral Research Program Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Blvd/EPN 4074 Bethesda, MD 20892-7335 MSC 7335 Tel: 301-451-9530 Fax: 301- 480-2087 E-mail: o Direct your questions about financial or grants management matters to: Lisa Moeller Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: Holly Atherton Senior Grants Management Specialist National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, Rockledge 2 Bethesda, Maryland 20892-7926 Tel: 301-435-0177 Fax: 301-480-3310 E-mail: Sharon Bourque Grants Management Specialist National Institute of Diabetes, Digestive, and Kidney Disease National Institutes of Health 2 Democracy Plaza, Room 719 Bethesda, MD 20892 Tel: 301-594-8846 Fax: 301-480-3504 E-mail: Lawrence Haller, Grants Management Specialist Office of Grants/Contract Management National Institute of Nursing Research, NIH 6701 Democracy Blvd, Rm. 710 One Democracy Plaza Bethesda, MD 20892-4870 Tel: 301-402-1878 Fax: 301-451-5652 E-mail: Ms. Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892-7340 Rockville, MD 20852 Tel: 301-496-8634 E-mail: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (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 The D&B number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least six weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures ( will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the appropriate national advisory council or board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The 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. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator 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 (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.) ADDITIONAL CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting $500,000 or more in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks 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 . DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible ( Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (; a complete copy of the updated Guidelines is available at The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at 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 Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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