An interventional study of Standard Intervention and Community-enhanced intervention in Physical Activity, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Prevention
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.
2,649 studies on the registry are indexed under Motor Activity; 1,205 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 2,309 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Pennington Biomedical Research Center is the lead sponsor of 284 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
"Fathers" Inclusion criteria
Children Inclusion criteria
Designed to increase physical activity
Behavioral: Standard Intervention · Behavioral: Community-enhanced intervention
This is a control arm
Behavioral: Dietary modification
This is an 8-week intervention. Each session is 60 minutes. Each PA group session will end with group exercise (gradually progressing from 15 to 30 min) that is fun and engaging for the children. These activities will include rough-and-tumble play, collaborative dyad activities (e.g. sack races), and rewards for children for engaging in PA. Elements include behavioral strategies to increase children's PA, emotional regulation, monitoring, adaptive step goals, and competition.
This is the standard intervention plus a community element. The local non-profit organization will build upon their existing infrastructure to host regularly planned activities in the community and events at their facility. This will serve to alter the current community social environment and overcome barriers in the built environment to create an environment conducive to fathers exercising with their children.
This is an 8-week behavioral intervention. Sessions are planned to take place within the institution's dietary kitchen as well as remotely. The importance of the father/male role model to their child's dietary intake will be emphasized. Topics will be adapted from the Traffic Light Diet. Fathers will not receive any behavioral strategies for increasing PA.
Attendance: The percent of the total number of participants who attend each group session.
Attendance is defined as the number of participants who attend each group session. The outcome will be reported as a percentage calculated as follows: the number who attend each group divided by the number of participants enrolled in the group across all group sessions. This pertains to all study groups.
Time frame: 8 weeks
The percent of participants who are enrolled at study completion
Retention is defined as the number of participants who complete the study. Retention will be defined as the number of participants who formally drop out of the study or do not complete any end of study assessments. Retention will be calculated as the number of participants who formally drop out of the study or do not complete any end of study assessments divided by the number of participants who enrolled in the study.
Time frame: Through study completion, an average of 8 weeks
Satisfaction with the program as measured by the Program Satisfaction scale
The questionnaire will assess overall satisfaction with the program. Specific areas of assessment include helpfulness of the content, enjoyment of the group sessions, and relevance of the information received.
Time frame: 8 weeks
Moderate intensity physical activity as measured by the ActiGraph WGT3X+BT device.
The ActiGraph WGT3X+BT accelerometer (ActiGraph LLC, Pensacola, FL) will be used to report the number of daily steps taken.
Time frame: 8 weeks
The number of steps participants take daily as measured by the Fitbit Charge device.
The Fitbit Charge will be used to measure the child's daily step count. Children will wear the Fitbit daily on their wrist.
Time frame: Through study completion, an average of 8 weeks
Children's perceived support for activity as measured by the Activity Support Scale for Multiple Groups (ACTS-MG).
Children will complete the Activity Support Scale for Multiple Groups (ACTS-MG). Scores range from 9-36, with higher scores indicating more support for physical activity.
Time frame: 8 weeks
Chilren's sedentary behavior as measured by the sedentary behavior questionnaire (SBQ).
Father's sedentary behavior will be assessed using the sedentary behavior questionnaire (SBQ)
Time frame: 8 weeks
Strategies parents use to promote dietary intake and physical activity as measured by the Parenting Strategies for Eating and Activity Scale.
The Parenting Strategies for Eating and Activity Scale which is a 33-item measure of parenting strategies for PA and eating habits. Higher scores indicating more frequent use of perceived paternal control, limit setting, monitoring, reinforcement, permission, and discipline.
Time frame: 8 weeks
Father/father figure involvement in their child's lives as measured by the Index of Paternal Involvement scale.
Fathers will complete the Index of Paternal Involvement. This 19-item measure assesses fathers' involvement with their children in a variety of ways, such as spending time with the child, being a part of special celebrations and rituals, providing financial, support, and providing discipline). Total scale scores range from 0 to 76 with higher scores indicating higher paternal involvement.
Time frame: 8 weeks
The availability of media devices in the home as measured by the Physical Activity and Media Inventory (PAMI).
The Physical Activity and Media Inventory (PAMI) is designed to be a self-report inventory of both the availability and accessibility of equipment to support PA and sedentary behavior.
Time frame: 8 weeks
Neighborhood disorder as measured by the Neighborhood Psychosocial Hazards (NPH) scale.
Physical disorder will be measured via the physical disorder construct of the Neighborhood Psychosocial Hazards (NPH) scale. The NPH is a 12-item scale with higher values indicate more neighborhood psychosocial hazards.
Time frame: 8 weeks
Food consumed by children as measured by the NCI's Automated Self-Administered 24-hour Recall (ASA24).
The NCI's Automated Self-Administered 24-hour Recall (ASA24) will be used to estimate daily intake of nutrients and macronutrients, food group servings, and alcohol.
Time frame: 8 weeks
Plan to share: Yes — Deidentified data can be shared via request to the study PI.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: IPD is available after findings have been published. Anticipated date is March 2027.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pennington Biomedical Research Center →