| Registry | NCT07862062, acronym FACEiT |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 26 (Actual) |
| Sponsor | Pennington Biomedical Research Center (Other); collaborators: National Institute on Minority Health and Health Disparities (NIMHD) |
| Conditions | Physical Activity |
| Interventions | Standard Intervention, Community-enhanced intervention, Dietary modification (Behavioral) |
| Dates | start 2025-09-01, primary completion 2026-03-31, completion 2026-03-31, first posted 2026-10-07, last updated 2026-10-07 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Physical Activity All trials of Standard Intervention All trials of Community-enhanced intervention
Children engage in low amounts of activity, which predisposes them to develop health disparities as they age. Fathers may be instrumental in helping to promote physical activity in their children. The current proposal is designed to use community-engaged research methods to develop a physical activity intervention for children in which their fathers are the agents of change, and to determine the feasibility of implementing this intervention.
The high prevalence of chronic disease in adults places African American children at increased risk of developing these conditions. Adults experience several chronic diseases that are modifiable via behavior change, including coronary heart disease, hypertension, stroke, diabetes, and obesity. One of the major modifiable risk factors for these chronic diseases is a lack of regular physical activity (PA). Neither adults nor children are engaging in PA at nationally recommended levels. Parents play an important role in shaping their children's PA. Cross-sectional research has shown that mothers and fathers exert unique influences on their child's PA. The role of mothers has been clearly explicated, and the research field is saturated with studies where mothers are the participating parent in an intervention. However, the unique contributions of fathers, especially African American fathers, and the benefits that they bring to a family-based intervention, are just beginning to be studied. To address this research gap, the investigators propose to assess the feasibility of a family-based PA promotion intervention in families that utilizes the father as the participating parent and to obtain preliminary evidence of efficacy. Phase I of the study involves conducted focus groups with fathers to determine key intervention components. Phase II will involve iterative refinement of the intervention materials through a series of focus groups. Phase III involves a randomized clinical trial to determine feasibility and preliminary evidence of efficacy. Father-child dyads will be randomly assigned into a standard intervention, a community-enhanced intervention, or an attention matched active control group. "Fathers" are defined as the resident or non-resident biological father, step-father, or male role model. Children must be insufficiently active and 6 - 10 years of age. Father-child dyads randomized into the standard intervention will receive the FACEiT family-based PA promotion intervention for 12 weeks. Father-child dyads randomized into the community-enhanced intervention will receive the standard intervention in addition to community supports. For this group, the investigators will work with Fathers On A Mission (F.O.A.M.) to provide community-based PA opportunities specifically for this group. This intervention is theoretically based. Father-child dyads randomized into the attention-matched active control group will receive the family-based healthy eating intervention for 8-weeks. This will be a standard behavioral program targeting improved nutrition. All study groups will have 8 group meetings. Dyads will be recruited through a variety of methods the investigators have utilized previously to recruit men and children into research studies including outreach, paid media, earned media, and school-based efforts. Dyads will complete a number of assessments including accelerometry, feasibility, satisfaction, anthropometry, activity readiness, sociodemographics, dietary intake, and questionnaires that tap into the theoretical underpinnings of the study. It is hypothesized that the FACEiT physical activity promotion intervention will be feasible to deliver and that participants will be highly satisfied with the program. Feasibility will be determined based on current recommendations utilizing clear thresholds and benchmarks. It is also hypothesized that the study will show preliminary evidence of efficacy, i.e. the physical activity intervention will result in a significantly greater increased daily step counts compared to the attention matched active control group. Finally, the investigators expect a greater change in secondary outcomes. It is expected that the feasibility data and estimated intervention effect sizes outcomes from this R21 proposal will be used to determine the requisite sample size for a larger R01 randomized trial. The overall goal of FACEiT is to refine the intervention to be an effective tool to promote physical activity in fathers and their children. In addition, not only will the investigators' community-based partner, F.O.A.M., work to ensure that the PA intervention is appropriate for fathers, but F.O.A.M. will also help to disseminate the intervention if it is shown to be effective.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Physical activity | Experimental | Behavioral: Standard Intervention; Behavioral: Community-enhanced intervention | Designed to increase physical activity |
| Control | Experimental | Behavioral: Dietary modification | This is a control arm |
Sex: All, ages: 6 Years to any, accepts healthy volunteers
"Fathers" Inclusion criteria * self-identified male * at least 18 years of age * self-classify as a father/father figure of a 6-10 year old child * willing to attend group sessions (virtual and in person) * physically capable of exercise Exclusion criteria * cognitive or physical impairment that would interfere with participating in a group discussion or activity * unwilling to be audio recorded * unwilling to give written informed consent Children Inclusion criteria * 6-10 years of age * willing to attend group sessions (in person) * average steps per day of less than the 50th percentile for age and gender * physically capable of exercise Exclusion criteria * cognitive or physical impairment that would interfere with participating in a group discussion or activity * unwilling to be audio recorded * unwilling to give written informed consent
| Facility | City | Country | Status |
|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge, Louisiana | United States |
NIH grants: R21MD019097