Family Fit Iterative App Development

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

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Inactivity; Weight Gain Prevention
• Intervention / Treatment: Behavioral: Family Fit Condition; Behavioral: Fitbit Only Condition

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle E Jake-Schoffman, PhD; Phone Number: (352) 294-1816; Email: djakeschoffman@ufl.edu
• Study Contact Backup: Name: Trish Wright, MS; Phone Number: (352) 294-8547; Email: caldwellpa@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • UF College of Health and Human Performance
      • Contact: Trish Wright

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 25 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 BMI >95th percentile
6. Child current use of Fitbit (or similar physical activity device)
7. History of eating disorder
8. One parent and one child per family unit may enroll

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Fit Condition (Intervention)	Behavioral: Family Fit Condition; 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.
Active Comparator: Fitbit Only Condition	Behavioral: Fitbit Only Condition; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Danielle E Jake-Schoffman, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; exercise; wearables; mobile technology; family-based
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: IRB202102295; R21HD100743 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No