Family Fit Iterative App Development

Not Applicable

Recruiting

• Conditions: Weight Gain Prevention; Physical Inactivity
• Interventions: Behavioral: Fitbit Only Condition; Behavioral: Family Fit Condition

• Registration Number: NCT06148246
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-11-28
• Study Start: 2024-01-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Parent (or legal guardian) must:

   • Be between 18-65 years old
   • Use a mobile Apple or Android device (e.g., smartphone, tablet)
   • Have a mobile data plan or reliable access to home Wi-Fi
   • Have an active Facebook account

2. Child must:

   • Be 9-12 years old
   • Live in the residence of parent (at least 50% of the time)

3. Child and parent must:

   • Be able to speak and read English.
   • Be insufficiently physically active (adult: <150 minutes/week moderate physical activity or <75 minutes/week vigorous physical activity, child: <6 days/week of 60 minutes moderate- to vigorous-intensity physical activity)
   • Be able to engage in physical activity.
   • Live within 75 miles of the UF campus

Exclusion Criteria

1. Parent currently, or trying to become, pregnant.
2. Current participation in a structured physical activity or weight loss program (children playing sports will be permitted)
3. Currently enrolled in a research study focused on changing diet or physical activity.
4. Use of weight loss medications
5. Child current use of Fitbit (or similar physical activity device)
6. History of eating disorder
7. One parent and one child per family unit may enroll

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fitbit Only Condition	Fitbit Only Condition	-
Family Fit Condition (Intervention)	Family Fit Condition	-

Primary Outcome Measures

Name	Time	Method
Recruitment	Baseline	Number of dyads screened and enrolled; rate of recruitment
Use rates	12 weeks	Use rates of the Family Fit app summarized from back-end data from the app
Acceptability	12 weeks	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
Retention	12 weeks	Number of dyads per condition who complete follow-up assessments

Secondary Outcome Measures

Name	Time	Method
Social support	Baseline, 12 weeks	Kiernan et al. adaptation of social support scale
Contamination	12 weeks	Use of outside physical activity programs, devices, and apps during the study
Average minutes/day of moderate- to vigorous-intensity physical activity, accelerometry	Baseline, 12 weeks	Actigraph accelerometers to be used; 7 days of wear time will be requested from participants at each time point
Average minutes/day of moderate- to vigorous-intensity physical activity, self-report	Baseline, 12 weeks	Godin Leisure-Time Exercise Questionnaire
BMI (parents)	Baseline, 12 weeks	Body weight (to the nearest 0.1 lbs), height (to the nearest 0.25 inch) with standard protocols; BMI calculated as kg/m\^2
Family cohesion	Baseline, 12 weeks	Moos et al. family environment scale
Sustainability	12 weeks	Use of Family Fit app, Fitbit app, and Fitbit devices from weeks 13-18
Usability	12 weeks	Scores from System Usability Scale
BMI percentile (child)	Baseline, 12 weeks	Body weight (to the nearest 0.1 lbs), height (to the nearest 0.25 inch) with standard protocols; BMI percentile using standardized charts
Family engagement	Baseline, 12 weeks	Measure from the National Longitudinal Study of Adolescent Health (Add Health)
Family communication	Baseline, 12 weeks	Measure from the National Longitudinal Study of Adolescent Health (Add Health)
Family closeness	Baseline, 12 weeks	Measure from the National Longitudinal Study of Adolescent Health (Add Health)

Trial Locations

Locations (1)

UF College of Health and Human Performance; 🇺🇸 Gainesville, Florida, United States