Family Fit Iterative App Development

Study Overview
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Brief Summary
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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.

Detailed Description
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This study includes a 12-week active intervention period, following by a 6-week observational period for a total of 18 weeks. 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 then be randomized to a study group, and attend a brief kick-off meeting to receive their Fitbits and study apps. The intervention period is 12 weeks, all remotely delivered. Both intervention conditions focus 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. There is no active intervention between weeks 13-18. At week 18, families will attend a brief in-person assessment visit and complete online questionnaires and 7 days of accelerometry, as well as complete a semi-structured interview via Zoom to discuss their experiences and provide feedback for future program modifications.

Official Title
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Family Fit: Promoting Family-Based Physical Activity and Weight Gain Prevention Through Mobile Technology

Conditions
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Weight Gain Prevention, Physical Inactivity

Intervention / Treatment
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* Behavioral: Family Fit Condition
* Behavioral: Fitbit Only Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Child must: Be 9-12 years old Live in the residence of parent (at least 50% of the time) 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 25 miles of the UF campus Exclusion Criteria: Parent currently, or trying to become, pregnant. Current participation in a structured physical activity or weight loss program (children playing sports will be permitted) Currently enrolled in a research study focused on changing diet or physical activity. Use of weight loss medications Child BMI >95th percentile Child current use of Fitbit (or similar physical activity device) History of eating disorder One parent and one child per family unit may enroll

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Fit Condition (Intervention)<br> | Behavioral: Family Fit Condition<br>* Dyads in the Family Fit condition will use the Family Fit app and a Fitbit for 18 weeks, working to increase their moderate- to vigorous-intensity physical activity.<br>|
| Active Comparator: Fitbit Only Condition<br> | Behavioral: Fitbit Only Condition<br>* Dyads in the Fitbit only condition will use a Fitbit and the Fitbit app for 18 weeks, working to increase their moderate- to vigorous-intensity physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustainability | Use of Family Fit app, Fitbit app, and Fitbit devices from weeks 13-18 | 12 weeks and 18 weeks | 
| Usability | Scores from System Usability Scale | 12 weeks and 18 weeks | 
| Contamination | Use of outside physical activity programs, devices, and apps during the study | 12 weeks and 18 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, 18 weeks | 
| Average minutes/day of moderate- to vigorous-intensity physical activity, self-report | Godin Leisure-Time Exercise Questionnaire | Baseline, 12 weeks, 18 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, 18 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, 18 weeks | 
| Family cohesion | Moos et al. family environment scale | Baseline, 12 weeks, 18 weeks | 
| Social support | Kiernan et al. adaptation of social support scale | Baseline, 12 weeks, 18 weeks | 
| Family communication | Measure from the National Longitudinal Study of Adolescent Health (Add Health) | Baseline, 12 weeks, 18 weeks | 
| Family engagement | Measure from the National Longitudinal Study of Adolescent Health (Add Health) | Baseline, 12 weeks, 18 weeks | 
| Family closeness | Measure from the National Longitudinal Study of Adolescent Health (Add Health) | Baseline, 12 weeks, 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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family-based, physical activity, exercise, mobile technology, wearables