The purpose of this Notice is to inform potential applicants of NIH’s interest in research evaluating large-scale policies or programs implemented at the local, state or national level that are expected to influence obesity-related behaviors (e.g., dietary intake, physical activity, or sedentary behavior) and/or weight outcomes with a goal of preventing or reducing rates of obesity.
Background
Obesity is a major contributor to many serious health conditions that increase morbidity and mortality and reduce quality of life. The prevalence of obesity in children and adults in the United States has dramatically increased in the past four decades. Nationally there is an imperative for action at local, state and federal levels, especially related to obesity in children. While helping people achieve and maintain a healthy weight is a critical public health goal, relatively little is known about the effectiveness of large-scale policies and programs that could help achieve this goal at the population level, or any differential effects on sub-populations. As noted in the 2010 Institute Of Medicine (IOM) report, Bridging the Evidence Gap in Obesity Prevention: A Framework to Inform Decision Making (https://pubmed.ncbi.nlm.nih.gov/25032376/), rigorous scientific evaluation of these policies and programs can help build an evidence base to better inform policy public health approaches to prevent excess weight gain and/or improve weight management
For the purposes of this FOA:
- Policy is broadly defined to include both public policies at local, state and federal levels of government, and organizational level policies, such as those implemented by large organizations, worksites or school districts. Examples include, but are not limited to, the development of supermarkets in underserved areas, calorie labeling requirements, taxes on foods and/or beverages, after-school and summer programs, modification of the built (or human-made) environments to encourage walking or cycling for transportation or leisure.
- Program is defined as a set of activities initiated by governmental or other organizational bodies to enhance obesity prevention and control. Examples might include programs implemented at worksites, healthcare organizations, after-school or summer programs, or communities that can be expected to improve obesity-related behaviors such as energy intake and activity level.
Applications that propose to initiate, continue, modify, or otherwise implement programs or policies would not be responsive to this Notice; rather, this Notice is intended to invite applications proposing to evaluate the effectiveness of programs and/or policies that are being or will be implemented regardless of NIH grant funding.
Research Objectives
The obesity program or policy to be evaluated should reasonably be expected to affect behaviors relevant to obesity such as energy intake, sedentary behavior, or physical activity in the target population. Further, research proposed in response to this FOA should demonstrate that measures collected and evaluated will allow for meaningful and scientifically valid conclusions to be made about the effects of the policy or program on the target behaviors and/or weight.
Primary outcomes under study should be assessed using objective measures, or in the case of dietary intake, by using standardized and comprehensive 24-hour recall methods. Examples of acceptable primary outcomes include objective measures of behavior change (purchasing behavior, use of resources intended for physical activity, energy intake with a focus on lowered calories or lower calorie substitutions, activity changes such as reduced sedentary behavior or increased physical activity) and/or weight related variables (e.g. BMI, body composition). Other self-reported measures of dietary intake and physical activity can be included but should not be the primary outcome measure/s.
Where possible and relevant, grant applications should include secondary outcomes that evaluate potential unintended consequences of a policy or program, degree of implementation, and an assessment of barriers and facilitators associated with implementation. This includes measures that will help identify why the policy or program succeeds or does not succeed.
Examples of appropriate studies include, but are not limited to, the following:
- Introduction of food or beverage taxes/subsidies/price changes/other incentives;
- Infrastructure initiatives such as retailers offering healthier food options in underserved areas;
- Changes to workplace food and/or physical activity environment;
- Polices expected to influence available options and purchasing, such as calorie labeling in restaurants, menu or food product reformulation, and supermarket layout or pricing strategies;
- Significant changes in policy or practice in large healthcare organizations that are expected to improve weight outcomes; such as changes in reimbursement, incentives, or wide scale implementation of prevention or treatment services;
- Modifications to the built environment to encourage active transportation or leisure physical activity, such as the implementation of bike lanes in urban areas, multi-use trails, subsidies for public transit, upgrades of sidewalks, or improved access to parks and recreation facilities;
- Policies or programs that permit improved or longer sleep or sleep patterns in specific populations; and
- Novel opportunities related to housing, transportation, other programs, or a combination of programs or projects that may influence obesity-related behaviors
Applicants are strongly encouraged to focus on obesity related outcomes in populations disproportionately affected by obesity and its comorbidities such as individuals living with disabilities, high risk racial and ethnic minority, or individuals living in low income/low resource settings.
Proposed methods for study design, data analysis, and power should reflect both the level at which the data are collected and analyzed and the level at which the policy or program is implemented. If those two levels are the same, standard methods for analysis and power can be used. For example, if a group of communities that have implemented a policy or program are to be compared to a group of communities that have not implemented that policy or program using data aggregated at the community level, standard methods may be used. However, if the level of data collection is nested within the level of implementation, e.g., observations taken from individuals within each community, special methods may be required to account for the expected correlation among observations taken from participants in the same worksite, community, or other location. Methods must be appropriate for the level at which data are collected and analyzed and the level at which the policies or programs are implemented.
The focus of this FOA is on research in humans, not animals. This FOA encourages innovative scientific partnerships between researchers and public or private partners (e.g., community-based organizations, local governments, school districts, employers, etc.).
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development is interested in applications that propose to evaluate the impact of diet-, nutrition-, or weight-related policies or programs on obesity in children, families, pregnant women, children with disabilities, or individuals undergoing medical rehabilitation.
Application and Submission Information
This notice applies to due dates on or after October 5, 2020 and subsequent receipt dates through September 8, 2023.
Submit applications for this initiative the following funding opportunity announcement (FOA) or any reissues of this announcement through the expiration date of this notice.
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
- PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
For funding consideration, applicants must include “NOT-DK-20-035” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.