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 301/435-0714, 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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