Developing Interventions for Health-Enhancing Physical Activity (R21/R33 – Clinical Trial Optional)
NIH - National Institutes of Health (PAR-18-307)
- Proposal: 02/16/2018
- Amount: $275,000 - $750,000
- Duration: 2-3 years
This FOA seeks applications to develop multi-level interventions that are designed to increase physical activity or reduce sedentary behavior among specific populations, and are based well-established theory and existing data. Given the strong evidence that physical activity and limited sedentary time are associated with many health benefits, the proposed intervention must include physical activity change as a primary outcome.
Applicants are encouraged to use the Socio-Ecological Model as a framework for conceptualizing ways to develop a multilevel intervention (i.e. incorporating intervention targets at the intrapersonal, interpersonal, organizational, community, and/or public policy levels).
Settings for the interventions can include but are not limited to healthcare settings, worksites, households, schools, green space, parks and recreation centers, other community organizations and settings, or entire communities.
Physical activity must be one of the outcome measures for an application to be appropriate for these FOAs. While R21/R33 applications must address physical activity change, they are not required to have sample sizes sufficient to measure statistically significant changes in physical activity or related health outcomes. In these developmental or pilot interventions, physical activity should be measured, but with the goal of assessing feasibility and acceptability of the physical activity measurement tool and its administration, such as timing, frequency of measurement, response rate or other issues.
Studies in any age group and special population, including populations at high risk for sedentary behavior, are appropriate for this announcement. Populations of interest include, but are not limited to:
- Healthy but sedentary or inactive individuals
- Persons or groups at high risk for a particular disease or condition (e.g. substance use disorder or nicotine dependence) that can be improved by physical activity
- Persons with an existing disease or condition (e.g., cardiovascular disease, obesity, cancer, or diabetes or Alzheimer’s or related dementias) whose outcomes could be improved by physical activity
- Where the population of interest is those with obesity or overweight, the intervention should principally aim to improve physical activity and/or reduce sedentary behavior rather than weight loss as the primary aim.
- Persons of diverse socioeconomic, ethnic, and racial groups with low activity levels
- Persons with physical, developmental, or intellectual disabilities who may need special approaches for activity promotion
- Inactive or sedentary elderly individuals or groups
- Alzheimer’s and related dementias
- Minority and underserved populations at higher risk for conditions associated with inactivity
- Other groups, if justified by the investigator
- Comparison of male and female populations or subjects on the desired outcome is highly desired
It is anticipated that each award will support multidisciplinary project teams composed of scientists with expertise to enable all the specific aims to be addressed.
This FOA is meant to support developmental work in preparation for a full-scale efficacy study. The R21 phase will support formative assessments and preliminary feasibility studies of the multi-level intervention or intervention components. If the R21 phase milestones are met, the R33 phase will support expanded feasibility work and optimization of the multi-level intervention in preparation for a fully-powered efficacy study. For studies that are ready to implement, test, and evaluate scalable multi-level interventions, please see the companion Research Project Grant (R01) PAR-18-324.