PHYSICAL ACTIVITY AND OBESITY ACROSS CHRONIC DISEASES Release Date: November 15, 2000 PA NUMBER: PA-01-017 National Institute of Diabetes and Digestive and Kidney Diseases National Cancer Institute National Heart, Lung, and Blood Institute National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute of Nursing Research THIS PROGRAM ANNOUNCEMENT (PA) USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA. This Program Announcement is part of a trans-NIH Obesity Initiative, which also includes approaches to obesity prevention and the neuroendocrinology of obesity. The above-named Institutes invite applications from investigators for research studies that will address the relationship between physical activity and obesity. Three general areas of research are encouraged: (1) studies (including observational and prospective) examining physical activity and obesity relationships, (2) studies to improve methodology of assessment of physical activity and energy balance, and (3) studies to test intervention approaches that incorporate physical activity for obesity prevention or treatment related to chronic diseases. 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, Physical Activity And Obesity Across Chronic Diseases, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and nonprofit 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. MECHANISM OF SUPPORT The primary mechanism of support will be the National Institutes of Health (NIH) research project grant (R01). Additional mechanisms of support are available through individual Institutes and Centers (ICs). Potential applicants are encouraged to contact Program Staff in the appropriate ICs (see INQUIRIES, section) for further information about the mechanisms available. Planning, direction, and execution of the program will be the responsibility of the applicant. Any applicant planning to submit a new investigator-initiated grant application requesting $500,000 or more in direct costs in any one year must contact Institute Program Staff before submitting the application. Furthermore, the applicant must obtain agreement from Institute staff that the Institute will accept the application for consideration for award. Additional information about this policy can be found in the NIH Guide Volume 25, Number 14, May 3, 1996. Responses to Program Announcements are subject to this policy. Applications requesting less than $250,000 in direct costs per year must be in modular grant format. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at RESEARCH OBJECTIVES Background An estimated 97 million adults in the U.S. are overweight or obese (Body Mass Index {BMI, kg/(MxM} greater than or equal to 25.0). The Dietary Guidelines for Americans, (published by the World Health Organization) and the 1998 NIH Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults (See all use a body mass index (BMI) of less than 25.0 to define the upper limit of the healthy weight range, greater than 50 percent of the adult population is above this range. According to numerous recent reports, the prevalence of overweight and obesity in the U.S. is increasing dramatically. Based on the BMI cut-point of 30.0, which defines obesity, 20 percent of men and 25 percent of women were obese in 1988- 1994 (NHANES III) compared with 12 percent of men and 16 percent of women in 1971-74 (NHANES I). Overweight is especially prevalent among certain racial and ethnic groups. For example, 66 percent of African-American and Mexican- American women are estimated to be overweight (NHANES III). Furthermore, the increasing prevalence of overweight is not limited to adults, but is observed in children, in both genders and in all subpopulations. Morbidity associated with overweight and obesity is considerable. Obesity is a risk factor for Type II diabetes mellitus and for cardiovascular disease as well as several other medical conditions. The risk of diabetes increases as BMI increases, with the relative risk of diabetes increasing by about 25 percent for each unit of BMI over 22. Overweight and obesity are also associated with increased morbidity and mortality from coronary heart disease (CHD), studies have found a three-fold increase in rate of coronary heart disease in women with BMIs of 29 or greater compared with women with BMIs less than 21, and a 10 percent increase in coronary events in men with each BMI unit above 22. Hypertension prevalence increases from 16-18 percent to 32- 38 percent as BMI goes from less than 25 to greater than 30, and a similar relationship, although not as dramatic, is seen between BMI and high blood cholesterol. These problems can be ameliorated, or sometimes reversed, through weight loss. The relationship between physical activity and obesity appears to be complex, and requires further study. The 1996 Surgeon General’s Report on Physical Activity and Health concluded that physical activity is important for weight control, primarily because of the positive findings from studies testing the effects of physical activity on weight loss. However, the report also stated: It is commonly believed that physically active people are less likely to gain weight over the course of their lives and are thus more likely to have a lower prevalence of obesity than inactive people: accordingly, it is also commonly believed that low levels of physical activity are a cause of obesity. Few data, however, exist to evaluate the truth of these suppositions. The report called for research to determine the most important features of physical activity that confer specific health benefits. For example, what specific combination(s) of type, frequency, duration, intensity, and pattern of physical activity best contributes to weight control or weight loss. The 1998 NIH Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults Report indicates that more research is needed on effects on body weight/obesity of different lengths of physical activity interventions, different formats and intensities of physical activity, and different forms of physical activity in combination with diet, as well as effects of physical activity on body fat distribution, e.g., abdominal fat. The recommendations of this report for future research includes the need to determine the optimal amount of physical activity to promote weight loss, maintenance of weight loss, and prevention of obesity, as well as strategies to preserve muscle and bone in the face of weight loss. Research is needed on the effects of pharmacologic intervention for weight loss on cardiorespiratory fitness. Research is also needed on environmental and population-based intervention methods for weight control that incorporate physical activity. These studies should address high-risk populations for obesity and low levels of physical activity including underserved population segments, e.g., minorities and low socioeconomic (SES) groups. Education about the long-term health consequences and risks associated with overweight and how to achieve and maintain a preferred weight is necessary. While many individuals attempt to lose weight, studies show that within five years a majority of them regain the weight. In order to maintain weight loss, good dietary habits must be coupled with increased physical activity, and these must become permanent lifestyle changes. It is still not clear, however, which behavioral approaches are best for achieving these changes, particularly long-term. A 1998 NHLBI workshop on Maintenance of Behavior Change in Cardiorespiratory Risk Reduction concluded that additional research is needed to examine factors associated with long-term maintenance of weight loss, long-term maintenance of increased physical activity levels, and the relationship between the two. In addition, the question of whether physical activity enhances long-term maintenance of weight loss has not been formally examined in randomized trials. NIDDK, in cooperation with NCI, NHLBI, NIA, NIAMS, and the President’s Council on Physical Fitness and Sports, held a conference on the topic of Physical Activity and Obesity in 1992. This conference assessed research activities in this area and posed several research questions that have yet to be adequately addressed and that are included in this PA. Research Scope A broad range of specific research questions and study approaches are relevant to this Program Announcement. The following are examples of research topics and study approaches that are relevant. Applicants are encouraged to consider these questions, when relevant, in relation to persons with and without morbid conditions (such as hypertension, diabetes, arthritis). Likewise, applicants are encouraged to provide a rationale for the type of physical activity (e.g., aerobic, anaerobic, resistance) that they propose in their applications. 1. Physical Activity and Obesity Relationships o Studies to examine the relationships between type and amount of physical activity and dietary intake, including caloric expenditure, caloric intake and dietary macronutrient composition. o Studies to examine the relationships between patterns of aerobic, anaerobic, and resistance exercise with body weight, body composition, and body fat distribution. o Studies to examine interactions between the genetics of obesity and physical activity levels on obesity phenotypes. o Studies to examine the psychological and quality of life benefits of physical activity. o Studies to examine the determinants (personal, familial, cultural, environmental and policy) for engaging in and maintaining physical activity and good nutrition practices, particular attention can be paid to various subpopulations, defined by gender, age, ethnicity, and/or socioeconomic status who may be at risk for developing obesity. o Prospective studies to examine tracking of dietary intake and eating behavior and physical activity patterns, and the relationships between the two, from childhood to adulthood. o Prospective studies to examine the relationship between physical activity and obesity or weight gain, particularly focusing on life stages where the risk of obesity development is highest (e.g., adolescence, menopause, older age). 2. Assessment Methodology Studies o Validation of improved methods for assessment of energy intake and expenditure and levels of physical activity, as well as, improvement of measures in special population segments based on race/ethnicity and socioeconomic status. o Improved methods for measuring skeletal muscle and adipose tissue metabolic processes in response to exercise. o Improved methods for measuring the type (resistance vs. aerobic) and amount of physical activity behavior (frequency, intensity, duration), the energy cost associated with physical activity, energy intake, and energy balance. o Improved methods for measuring the impact--both positive and negative--of physical activity in subpopulations (defined by gender, age, ethnicity, socioeconomic status) on various outcomes such as quality of life. o Improved methods for assessment of energy metabolism, body fat, and body fat distribution, including visceral fat. 3. Intervention Studies o Test the effects on body weight/obesity of different lengths of physical activity interventions, different formats and intensities of physical activity, and different forms of physical activity in combination with diets, as well as, effects of physical activity on body fat distribution e.g. abdominal fat o Examine the effects of physical activity patterns on changes in eating practices. o Determine the long-term effects of various approaches to physical activity interventions (including different behavioral approaches as well as different type and amount of physical activity) on weight loss and maintenance. o Develop, implement, and evaluate psychobiobehavioral programs for parents and their children utilizing nutritional counseling, dietary changes, and exercise (preferably games and sports) to prevent or attenuate problems of overweight and obesity. o Evaluate the psychological effects of being overweight or obese at different developmental stages of childhood and/ or the psychological effects of participating in successful or unsuccessful weight loss programs. o Compare peer-oriented weight loss programs for overweight and obese children and adolescents with parent-child oriented programs. o Examine the optimal mixture of physical activity and dietary intake for promoting weight loss and long-term maintenance of weight loss, examine whether increased physical activity alone or in combination with diet can prevent obesity or weight gain. o Develop/test interventions to increase physical activity and examine their effects on weight, on the changes in risk factors for obesity- related diseases, and on the use of health care services. These interventions can take place in a variety of settings, for example, health maintenance organizations, primary care practices, work sites, armed services, community groups, schools, etc. o Test the effects the environmental and population-based intervention methods for weight control, including those that incorporate physical activity. 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 August 2, 2000 (, a complete copy of the updated Guidelines are available at The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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: 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. 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e, as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at Applications requesting less than $250,000 in direct costs per year must be submitted in modular grant format. 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 Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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) REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Center for Scientific Review. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. 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, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second-level review by the appropriate National Advisory Council or Board. 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 review, comments on the following aspects of the application will be made 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 the assignment of the overall score: 1. 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? 2. Approach: Is 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? 3. 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? 4. 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)? 5. 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, the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research will be reviewed. Plans for the recruitment and retention of subjects will also be evaluated. The Scientific Review Group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women, Minorities, and Children as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other recommended applications assigned to that Institute. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. We welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Richard P. Troiano, Ph.D., R.D. CDR, USPHS National Cancer Institute, DCCPS, ARP EPN 4005 6130 Executive Blvd, MSC 7344 Bethesda, MD 20892-7344 Telephone: 301/496-8500, direct 301/435-6822 FAX: 301/435-3710 E-mail: or Denise G. Simons-Morton, M.D., Ph.D. Leader, Prevention Scientific Research Group Clinical Applications and Prevention Program Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 8138, MSC 7936 Telephone: (301) 435-0384 FAX: (301) 480-1669 Email: Chhanda Dutta, Ph.D. Geriatrics Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3E-327 Bethesda, MD 20892-9205 Telephone: (301) 435-3048 FAX: (301) 402-1784 Email: James S. Panagis, M.D., M.P.H. Orthopaedics Program NIAMS 6500 Center Drive - Room 5AS-37K Bethesda, MD 20892-6500 TEL: 301-594-5055 FAX: 301-480-4543 Email: Susan Yanovski, M.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive Kidney Diseases 6707 Democracy Blvd, Room 612 Bethesda, MD 20892 Telephone: (301) 594-8882 FAX: (301) 480-3504 Email: Pamela E Starke-Reed, Ph.D. NIH, Division of Nutrition Research Coordination Rockledge 1, Suite 8048, MSC 7973 Bethesda, MD 20892-7973 Telephone: (301) 594-8805 FAX: (301) 480-3768 Email: Lynne M. Haverkos, M.D., MPH Child Development and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05B, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6881 FAX: (301) 480-7773 E-mail: Hilary Sigmon, Ph.D. R.N. Division of Intramural Programs National Institute of Nursing Research 45 Center Drive, Room 3AN18 MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 Email: Direct inquiries regarding fiscal and administrative matters to: Ms. Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: Melinda B. Nelson Grants Management Branch NIAMS 6500 Center Drive - Room 5AS-49F Bethesda, MD 20892-6500 TEL: 301-594-3535 FAX: 301-480-5450 Email: Douglas Shawver Office of Administrative Management National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6999 FAX: (301) 402-0915 Email: Sharon Bourque Division of Extramural Activities National Institute of Diabetes and Digestive Kidney Diseases 6707 Democracy Blvd, Room 612 Bethesda, MD 20892 Telephone: (301) 594-8846 FAX: (301) 480-3504 Email: Ms. Sally York Grants Management Specialist National Institute of Nursing Research 45 Center Drive MSC 6300 Bethesda, Maryland 20892-6300 Tel: 301-594-2154 FAX: 301-480-8260 Email AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393, 93.399, 93.846, 93.865, 93.866, 93.837, 93.847, 93.848, 93.361, and 93.849. Awards are 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 or 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.

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