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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD100743 | U.S. NIH Grant/Contract | View source | |
| IRB202102295 | Other Identifier | UF IRB |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The overall aim of this study is to test the acceptability and usability of a mobile application (app) for family-based physical activity and weight gain prevention among parent/guardian and child (ages 9-12 years) dyads.
This study includes a 12-week active intervention period. Interested participants will complete a study orientation webinar, then continue to a baseline visit and online questionnaires if interested. They will then complete 7-days of accelerometry monitoring to measure current physical activity levels. If eligible, they will attend a brief kick-off meeting to receive their Fitbits and study apps. The intervention period is 12 weeks, all remotely delivered. The intervention focuses on families working to increase their moderate- to-vigorous intensity physical activity. At 12 weeks, families will attend a brief in-person assessment visit and complete online questionnaires and 7 days of accelerometry, and complete a semi-structured interview via Zoom to discuss their experiences and provide feedback for future program modifications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family Fit Condition (Intervention) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family Fit Condition | Behavioral | Dyads in the Family Fit condition will use the Family Fit app and a Fitbit for 12 weeks, working to increase their moderate- to vigorous-intensity physical activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Number of dyads screened and enrolled; rate of recruitment | Baseline |
| Use rates | Use rates of the Family Fit app summarized from back-end data from the app | 12 weeks |
| Acceptability | Satisfaction, perceived appropriateness, intent to continue to use intervention materials, likelihood of recommending the program to a friend, open-ended questions: overall satisfaction with program and suggestions for improvement | 12 weeks |
| Retention | Number of dyads per condition who complete follow-up assessments | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sustainability | Use of Family Fit app, Fitbit app, and Fitbit devices from weeks 13-18 | 12 weeks |
| Usability | Scores from System Usability Scale |
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Inclusion Criteria:
Parent (or legal guardian) must:
Child must:
Child and parent must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle E Jake-Schoffman, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF College of Health and Human Performance | Gainesville | Florida | 32611 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2025 | Sep 15, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 12 weeks |
| Contamination | Use of outside physical activity programs, devices, and apps during the study | 12 weeks |
| Average minutes/day of moderate- to vigorous-intensity physical activity, accelerometry | Actigraph accelerometers to be used; 7 days of wear time will be requested from participants at each time point | Baseline, 12 weeks |
| Average minutes/day of moderate- to vigorous-intensity physical activity, self-report | Godin Leisure-Time Exercise Questionnaire | Baseline, 12 weeks |
| BMI (parents) | Body weight (to the nearest 0.1 lbs), height (to the nearest 0.25 inch) with standard protocols; BMI calculated as kg/m^2 | Baseline, 12 weeks |
| BMI percentile (child) | Body weight (to the nearest 0.1 lbs), height (to the nearest 0.25 inch) with standard protocols; BMI percentile using standardized charts | Baseline, 12 weeks |
| Family cohesion | Moos et al. family environment scale | Baseline, 12 weeks |
| Social support | Kiernan et al. adaptation of social support scale | Baseline, 12 weeks |
| Family communication | Measure from the National Longitudinal Study of Adolescent Health (Add Health) | Baseline, 12 weeks |
| Family engagement | Measure from the National Longitudinal Study of Adolescent Health (Add Health) | Baseline, 12 weeks |
| Family closeness | Measure from the National Longitudinal Study of Adolescent Health (Add Health) | Baseline, 12 weeks |