ENVIRONMENTAL APPROACHES TO THE PREVENTION OF OBESITY Release Date: October 26, 2001 RFA: RFA-DK-02-021 National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) National Heart, Lung, and Blood Institute (http://www.nhlbi.nih.gov) National Institute of Environmental Health Sciences (http://www.niehs.nih.gov) National Center for Minority Health and Health Disparities Office of Behavioral and Social Sciences Research (http://obssr.od.nih.gov/) Office of Research on Women"s Health (http://www4.od.nih.gov/orwh/) Office of Disease Prevention (http://odp.od.nih.gov/) Centers for Disease Control and Prevention (http://www.cdc.gov) Letter of Intent Receipt Date: February 14, 2002 Application Receipt Date: March 14, 2002 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Environmental Health Sciences (NIEHS), National Center for Minority Health and Health Disparities (NCMHD), Office of Behavioral and Social Sciences Research (OBSSR), Office of Research on Women’s Health (ORWH), Office of Disease Prevention (ODP), and Division of School and Adolescent Health, Centers for Disease Control and Prevention, Division of Nutrition and Physical Activity, Centers for Disease Control and Prevention, Division of Diabetes Translation, Centers for Disease Control and Prevention and Division of Adult and Community Health, Centers for Disease Control and Prevention invite applications to study primary and secondary prevention approaches targeting environmental factors that contribute to inappropriate weight gain in children, adolescents, and adults. 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 Request for Applications (RFA), Environmental Approaches to the Prevention of Obesity, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or foreign for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. All current policies and requirements that govern the research grant programs of the National Institutes of Health (NIH) will apply to grants awarded under this RFA. Among the disciplines and expertise that may be appropriate for this program are obesity, nutrition and dietetics, exercise physiology, public health, internal medicine, family medicine, pediatrics, epidemiology, prevention, behavioral science, economics, communication and marketing, and clinical trials management. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. Pilot studies, also using the R01 mechanism, will be considered, if limited in scope and duration. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested project period for an application submitted in response to this RFA may not exceed five years for full-scale clinical trials, and three years for pilot studies. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE For the initial year of funding, approximately $4,000,000 will be committed to fund applications submitted in response to this RFA. It is anticipated that 5 to 12 awards will be made. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK, NHLBI, NCMHD and NIEHS, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Direct costs will be limited to $500,000 in any year for full-scale RO1s (excluding facilities and administration costs of subcontracts) and $450,000 over three years (average $150,000 per year) for pilot studies (excluding facilities and administration costs of subcontracts). The anticipated award date is September 30, 2002. RESEARCH OBJECTIVES Background Obesity is the most common nutritional disorder in the US, and its prevalence is increasing in both children and adults. (Kuczmarski, R. J., Carroll, M. D., Flegal, K. M., & Troiano, R. P., 1997, National Center for Health Statistics, 2000, National Center for Health Statistics, 2001). Minority populations, particularly African American, Hispanic, and Native American women, are disproportionately affected.(Flegal, K. M., Carroll, M. D., Kuczmarski, R. J., & Johnson, C. L., 1998) Although genetic factors are believed to contribute substantially to the predisposition towards obesity, environmental factors play an important role. The dramatic increase in obesity prevalence over the past two decades is believed to be a consequence of environmental factors that favor increased energy intake along with decreased energy expenditure.(Hill, J. O. & Peters, J. C., 1998) It has been suggested that while genetic factors may account for a significant proportion of within-population variability in body weight, environmental factors may account for most variability in body weight between populations or over time. (Allison, D. B., Matz, P. E., Pietrobelli, A., Zannolli, R., & Faith, M. S., 2001) Genetic approaches will undoubtedly provide important insights into the control of body weight, which may eventually lead to improved efforts in prevention and treatment. However, it is unlikely that addressing genetic factors alone will overcome the substantial environmental pressures for over- consumption and sedentary behavior that currently affect Americans. (Egger, G. & Swinburn, B., 1997) Environmental factors believed to play a role in the development of obesity include those that increase energy intake, such as advertisements for and low price of high-energy density foods, marketing of larger portion sizes, and changes in the number of working women, leading to greater frequency of restaurant meals and the use of more fast-foods and convenience foods.(French, S. A., Story, M., & Jeffery, R. W., 2001) For infants, bottle feeding may also increase energy intake relative to breast feeding. (Gillman, M. W. et al., 2001, Hediger, M. L., Overpeck, M. D., Kuczmarski, R. J., & Ruan, W. J., 2001) Numerous environmental factors also lead to decreased energy expenditure. Work is more likely to be sedentary than in the past, with near universal use of automated equipment and electronic communications. At home, wireless phones, remote controls, and various labor saving devices for household chores also decrease physical activity. More time is spent using the computer, watching television, and playing videogames, particularly among children and adolescents.(Dowda, M., Ainsworth, B. E., Addy, C. L., Saunders, R., & Riner, W., 2001, Crespo, C. J. et al., 2001, Dietz, W. H., 2001) At the same time, the number of schools requiring daily physical education has declined.(Hill, J. O. & Peters, J. C., 1998) Suburban communities often lack sidewalks, and lack of neighborhood resources make it difficult to walk even short distances to stores and recreation. Many individuals report difficulties going out to exercise because their neighborhoods are perceived as unsafe.(MMWR, 1999) In addition, children in day care or before and after school care often lack facilities to engage in, or adequate supervision for, active play. Prevention of obesity is frequently attempted through educational approaches aimed at improving knowledge and motivation, with consequent presumed impact on individual lifestyle choices. (Kumanyika, S. K., 2001) Such approaches have been largely ineffective at preventing weight gain.(Jeffery, R. W., 2001, Nestle, M. & Jacobson, M. F., 2000) In contrast, environmental and policy approaches attempt to modify the environment in which such choices are made, rather than relying on individual will. (Kumanyika, S. K., 2001, Glanz, K. et al., 1995) Environmental changes that reinforce factors supporting healthy lifestyles and reduce barriers to healthy lifestyles may also serve to diminish health disparities, as barriers may be more prevalent in disadvantaged and ethnic minority communities.(Kumanyika, S. K., 2001) Approaches that modify the environment to promote healthful eating , increase physical activity, and decrease sedentary behaviors offer the potential for safe and effective programs for obesity prevention that could be widely disseminated. The NIDDK, NHLBI, NIEHS, CMHD, OBSSR, ORWH, ODP, and CDC invite applications to study promising interventions that would target environmental factors that contribute to inappropriate weight gain in children, adolescents, and adults. Investigators applying to this RFA should propose to collaborate with organizations/institutions such as schools, supermarkets, restaurants, religious organizations, recreation facilities, industry, governmental, public health, or community groups, worksites, and so forth, to develop approaches that, if successful, could potentially be translated into larger-scale interventions. The need for an obesity prevention initiative has been recognized by a number of NIH advisory groups. In 1994, the National Task Force on Prevention and Treatment of Obesity developed a long range plan focused on prevention of obesity(National Task Force on Prevention and Treatment of Obesity, 1994) and recently reaffirmed obesity prevention as a priority area for clinical research. The recently issued NHLBI/NIDDK Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults include a discussion of the importance of preventing obesity and suggestions for strategies to be attempted.(National Institutes of Health, 1998) The February 1998 NHLBI Report of the Task Force on Behavioral Research in Cardiovascular Lung and Blood Health and Disease also has recommended development of obesity prevention research efforts.(National Heart Lung and Blood Institute, 1998) Nestle and Jacobson note that there is an urgent need for research to determine effective obesity prevention strategies on which to base public health policies.(Nestle, M. & Jacobson, M. F., 2000) In December 2000, the Surgeon General held a listening session in an effort to develop a national action plan to combat overweight and obesity.(U.S.Department of Health and Human Services, 2001) The session identified obesity prevention as a critical target, and suggested that efforts focus on environmental factors targeting the family and community, schools, work sites, the health care delivery system, and the media. Research Goals and Topics This RFA responds to the need for systematic studies of environmental approaches to the prevention of obesity. Although many environmental factors have been cited as contributing to obesity, there have been few controlled studies showing that changes in these factors will prevent weight gain. For the purposes of this RFA, environmental interventions are those that attempt to modify the external surroundings with a goal of effecting behavioral changes such as improvement in diet, increased physical activity, and or decreased sedentary behaviors. The goal of such interventions is to prevent inappropriate weight gain, without exclusive reliance on an individual’s knowledge or motivation. Behavioral and/or educational interventions (for example, self-monitoring, motivational interviewing, skills training) may be included in combination with environmental changes, however, the primary focus of the application should be on environmental modification. For purposes of this RFA, prevention of obesity includes the primary prevention of overweight and/or obesity, the prevention of additional weight gain or increase in body fat in those already overweight and/or obese, and prevention of weight regain following weight loss. However, studies of weight management programs or use of medications or dietary supplements to prevent weight gain are not appropriate. Applications should address: the content of the intervention (e.g., relative focus on aspects of diet, physical activity, sedentary behaviors, combinations of these, or other factors), the setting of the intervention (e.g., in health care setting, worksite, community center, neighborhood, recreation facility, home, school), and the method of intervention delivery (e.g., individual, family, group, community). Applications targeting groups or populations at high risk for the development of obesity are encouraged. Novel or innovative aspects of study design and the rationale for their use should be highlighted. The examples listed below are illustrative, and are not meant to comprise an exhaustive list. It is expected that additional important strategies and topics will be identified by investigators who respond to this RFA. Theory- based interventions are encouraged, however, due to the need to explore innovative approaches, "experience-based" interventions not based on formal theory and other less well-developed concepts will be considered if they are well-justified. Applications for full-scale studies should provide evidence from pilot data supporting the intervention. Examples of types of studies include, but are not limited to: Studies to determine the impact of changes in food advertising, food promotion, or packaging on encouraging more healthful food choices Studies on the impact of economic factors, such as pricing, on food choice or physical activity. Studies that compare the effectiveness of innovative environmental changes with individual behavior therapy for prevention of weight gain Studies on the efficacy of establishing or reinforcing policies for environments supportive of physically active/and or healthful dietary lifestyles. Studies evaluating the influence of neighborhood characteristics on levels of physical activity and nutrition, for example, available venues for safe indoor/outdoor exercise and accessibility of fresh produce and other health promoting foods Studies to implement culturally appropriate interventions in collaboration with community-based organizations to enhance physical activity and improve nutrition. Studies examining sex and gender differences in response to environmental interventions to prevent obesity. Studies to evaluate the impact of environmental interventions to prevent obesity in underserved populations, including racial and ethnic minority populations and rural women. Examples of environmental interventions include, but are not limited to: - Providing designated safe walking routes in the context of a walk to school campaign - Offering smaller portion sizes, at lower prices, in a cafeteria and/or vending machines. - Providing timer devices to limit television/video game time in children, along with an educational/social marketing program geared towards children and parents - Providing access to bicycle racks, lockers, showers, and other incentives to encourage biking to work and increased physical activity during the workday - Making stairways more accessible and attractive, through lighting, signage, and open access, while discouraging use of elevators Some of the behavioral goals of environmental interventions might include (but are not limited to): - Increasing physical activity during the school day in children and adolescents - Increasing participation in recreational sports and physical activity by adolescent girls - Promoting walking or bicycling to school or to worksites - Increasing physical activity during before and after school care - Decreasing sedentary behaviors in children and adolescents - Improving the quality and moderating the quantity of snack foods and foods and beverages consumed in schools outside of the school lunch program, and increasing fruit and vegetable intake - Promoting physical activity at worksites - Decreasing consumption of large portion sizes in restaurants and cafeterias - Improving food choices when shopping - Decreasing use of labor saving devices in the home - Increasing family participation in physical activity - Increasing energy expenditure during leisure-time activities (such as television viewing) - Promoting alternatives to food consumption during social and business events SPECIAL REQUIREMENTS o Applicants should include plans to assess the feasibility of the intervention for long-term use by the target population. This process evaluation should address adherence, acceptability, and ease of delivery of the intervention. It is anticipated that some interventions may be ongoing up to the point of assessment, whereas others may include a brief, defined intervention with post-intervention follow-up at a later time, however, applicants are encouraged to assess program effectiveness at least 36 months from the beginning of the intervention (18-24 months for pilot studies). o The study should include a comparison group or control intervention with adequate justification of the active intervention-control comparison . With the exception of pilot studies, sample size calculation should be included. o Eligibility criteria as well as recruitment and retention strategies should be well-specified. o Primary outcomes should be clearly justified. For full-scale trials, change in body weight, BMI (or relative BMI in children) or body fat should be the primary outcome measure. For pilot studies objective primary outcome measures of behavior change that would be expected to lead to prevention of weight gain are acceptable (for example, showing increased walking as measured by accelerometry, increase in percentage of children walking to school, decreased television viewing measured by a tracking device, or change in patterns of food consumption in a restaurant or cafeteria). In the case of pilot studies, change in weight or body fat, if not the primary outcome, should be measured as a secondary outcome wherever feasible. Secondary outcomes relating to health, independent of weight loss or weight maintenance are encouraged, and should be assessed where feasible. These outcomes may include assessment of factors such as insulin resistance, blood pressure, lipids, fitness, quality of life, economic impact, and psychosocial status. Applicants also may evaluate the effects of intervention on other factors such as body composition (e.g., percent body fat, bone density, visceral adiposity). o All applicants are required to collaborate with one or more groups or organizations that will participate in the development and/or implementation of the environmental modifications, (including, but not limited to, schools, worksites, religious or community organizations, governmental organizations, restaurants, food markets or purveyors, health care settings, parks and recreational facilities, health clubs or exercise facilities, state public health departments, and neighborhood associations). A letter of intent to collaborate from this organization should be included with the application, describing the proposed collaboration in detail. A listing of governmental and non-governmental organizations that have expressed an interest in participating in this project is available at: http://www.niddk.nih.gov/fund/crfo/eapo.htm. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/women_min.htm. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. DATA AND SAFETY MONITORING IN CLINICAL TRIALS Applicants are directed to the full text of the NIH Policies regarding Data and Safety Monitoring and Reporting of Adverse Events that are found in the NIH Guide for Grants and Contracts Announcements at the following web sites: http://grants.nih.gov/grants/guide/notice-files/not98-084.html, http://grants.nih.gov/grants/guide/notice-files/not99-107.html, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. All applicants receiving an award under this RFA must comply with the NIH policy cited in these NIH Announcements and any other data safety and monitoring requirements found elsewhere in this RFA. The following is a brief summary of the Data and Safety Monitoring and Adverse Event Reporting Requirements: Data and Safety Monitoring (DSM) is required for every clinical trial. Monitoring must be performed on a regular basis and the conclusions of the monitoring reported to the extramural Program Director. The DSM plan is established at the time the protocol is developed and must be approved by both the Institutional Review Board (IRB) and the NIH and be in place before the trial begins. If the protocol will be developed during the research funded under this RFA, a general description of the Data and Safety Monitoring plan must be submitted as part of the proposal and will be reviewed by the initial review group. If the protocol has been developed and is included as part of the submitted proposal, the complete and specific data and safety monitoring plan must be submitted as part of the proposal. Monitoring plans, at a minimum, must include the prompt reporting of adverse events to the IRB, Food and Drug Administration and the NIH. The frequency of reporting of the conclusions of the monitoring activities should also be described in the plan. The overall elements of each plan may vary depending on the size and complexity of the trial. Examples of monitoring activities to be considered are described in the NIH Policy for Data and Safety Monitoring at http://grants.nih.gov/grants/guide/notice-files/not98-084.html. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the policy that was published in the NIH Guide for Grants an Contracts, June 5, 2000 (Revised August 25, 2000), and is available at the following URL address http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA 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. LETTER OF INTENT Prospective applicants are asked to submit, by February 14, 2002 , a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDDK staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to: Dr. Francisco O. Calvo, Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard Room 752, MSC 5452 Bethesda, MD 20892-5452 (courier service use Zip 20817). APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Submit a signed, typewritten original of the application, including the Checklist, and three 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) At time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Applications must be received by March 14, 2002. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 substantial revisions of applications previously reviewed, but such applications must include an Introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. If the application is not responsive to the RFA, CSR 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 review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group, convened in accordance with NIH peer review procedures by the NIDDK. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council, the National Heart, Lung, and Blood Advisory Council, the National Advisory Environmental Health Sciences Council and the National Center for Minority Health and Health Disparities Advisory Council. 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. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that is not innovative but is essential to move a field forward. o 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? o 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? o Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o 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)? o 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o Adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o Reasonableness of the proposed budget and duration in relation to the proposed research. o Adequacy of the proposed protection of humans or the environment, to the extent that they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: February 14, 2002 Application Receipt Date: March 14, 2002 Peer Review Date: July-August 2002 Council Review: September 18-19, 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA The anticipated date of award is September 30, 2002. Award criteria that will be used to make award decisions include: o Scientific and technical merit as determined by peer review o Availability of funds o Programmatic priorities INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. A website on the NIDDK homepage containing information pertaining to this RFA is located at: http://www.niddk.nih.gov/fund/crfo/eapo.htm. Answers to frequently asked questions and other information updates concerning this RFA will be posted on the site as they are developed. Applicants are highly encouraged to visit this website on a regular basis in the course of preparing their applications. Direct inquiries regarding programmatic issues to: Robert Kuczmarski, DR.P.H.,, R.D. Director, Obesity Prevention and Treatment Program Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Disease 6707 Democracy Blvd, Room 673, MSC 5450 Bethesda, MD 20892-5450 (20817 for Express Mail) Telephone: (301) 451-8354 FAX: (310) 480-8300 Email: rk191r@nih.gov Direct inquiries regarding fiscal and administrative matters to: Sharon Bourque Division of Extramural Activities Grants Management Branch National Institute of Diabetes and Digestive Kidney Diseases 6707 Democracy Blvd, Room 719, MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8846 FAX: (310) 480-4237 Email: sb114m@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848, 93.837, 93.866, and 93.865. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 o Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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. REFERENCE LIST Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. (1998). Obes Res, 6 Suppl 2, 51S-209S. Neighborhood safety and the prevalence of physical inactivity--selected states, 1996 (1999). MMWR Morb.Mortal.Wkly.Rep., 48, 143-146. Allison, D. B., Matz, P. E., Pietrobelli, A., Zannolli, R., & Faith, M. S. (2001). Genetic and environmental influences on obesity. In A.Bendich & R. J. Deckelbaum (Eds.), Primary and Secondary Preventive Nutrition (pp. 147-164). Totowa, NJ: Humana Press. Crespo, C. J., Smit, E., Troiano, R. P., Bartlett, S. J., Macera, C. A., & Andersen, R. E. (2001). 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., 155, 360-365. Dietz, W. H. (2001). The obesity epidemic in young children. Reduce television viewing and promote playing. BMJ, 322, 313-314. Dowda, M., Ainsworth, B. E., Addy, C. L., Saunders, R., & Riner, W. (2001). Environmental influences, physical activity, and weight status in 8- to 16- year-olds. Arch.Pediatr.Adolesc.Med., 155, 711-717. Egger, G. & Swinburn, B. (1997). An "ecological" approach to the obesity pandemic. BMJ, 315, 477-480. Flegal, K. M., Carroll, M. D., Kuczmarski, R. J., & Johnson, C. L. (1998). Overweight and obesity in the United States: prevalence and trends, 1960- 1994. Int J Obes Relat Metab Disord, 22, 39-47. French, S. A., Story, M., & Jeffery, R. W. (2001). Environmental influences on eating and physical activity. Annu.Rev.Public Health, 22, 309-335. Gillman, M. W., Rifas-Shiman, S. L., Camargo, C. A., Jr., Berkey, C. S., Frazier, A. L., Rockett, H. R., Field, A. E., & Colditz, G. A. (2001). Risk of overweight among adolescents who were breastfed as infants. Journal of the American Medical Association, 285, 2461-2467. Glanz, K., Lankenau, B., Foerster, S., Temple, S., Mullis, R., & Schmid, T. (1995). Environmental and policy approaches to cardiovascular disease prevention through nutrition: opportunities for state and local action. Health Educ.Q., 22, 512-527. Hediger, M. L., Overpeck, M. D., Kuczmarski, R. J., & Ruan, W. J. (2001). Association between infant breastfeeding and overweight in young children. Journal of the American Medical Association, 285, 2453-2460. Hill, J. O. & Peters, J. C. (1998). Environmental contributions to the obesity epidemic. Science, 280, 1371-1374. Jeffery, R. W. (2001). Public health strategies for obesity treatment and prevention. Am.J.Health Behav., 25, 252-259. Kuczmarski, R. J., Carroll, M. D., Flegal, K. M., & Troiano, R. P. (1997). Varying body mass index cutoff points to describe overweight prevalence among U.S. adults: NHANES III (1988 to 1994). Obes Res, 5, 542-548. Kumanyika, S. K. (2001). Minisymposium on obesity: overview and some strategic considerations. Annu.Rev.Public Health, 22, 293-308. National Center for Health Statistics. Prevalence of overweight and obesity among adults: United States, 1999. http://www.cdc.gov/nchs/products/pubs/pubd/hestats/obese/obse99.htm. Health E-Stats . 12-11-2000. Ref Type: Internet Communication National Center for Health Statistics. Prevalence of overweight among children and adolescents: United States, 1999. http://www.cdc.gov/nchs/products/pubs/pubd/hestats/overwght99.htm. Health E- Stats . 2001. Ref Type: Internet Communication National Heart Lung and Blood Institute (1998). NHLBI Report of the Task Force on Behavioral Research in Cardiovascular Disease. http://www.nhlbi.nih.gov/resources/docs/taskforc.htm [On-line]. Available: http://www.nhlbi.nih.gov/resources/docs/taskforc.htm National Task Force on Prevention and Treatment of Obesity (1994). Towards Prevention of Obesity: Research Directions. Obes Res, 2, 571-584. Nestle, M. & Jacobson, M. F. (2000). Halting the obesity epidemic: a public health policy approach. Public Health Rep., 115, 12-24. U.S.Department of Health and Human Services (2001). Surgeon General Launches Effort to develop action plan to combat overweight, obesity. http://www.surgeongeneral.gov/news/pressreleases/obesitypressrelease.htm [On- line]. Available: http://www.surgeongeneral.gov/news/pressreleases/obesitypressrelease.htm

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