Clinical trial NCT06148246: Family Fit Iterative App Development
Official title: Family Fit: Promoting Family-Based Physical Activity and Weight Gain Prevention Through Mobile Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Gain Prevention
Physical Inactivity
Keywords: family-based
physical activity
exercise
mobile technology
wearables
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 9
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment
timeFrame: Baseline
measure: Use rates
timeFrame: 12 weeks
measure: Acceptability
timeFrame: 12 weeks
measure: Retention
timeFrame: 12 weeks
Secondary outcomes:
measure: Sustainability
timeFrame: 12 weeks
measure: Usability
timeFrame: 12 weeks
measure: Contamination
timeFrame: 12 weeks
measure: Average minutes/day of moderate- to vigorous-intensity physical activity, accelerometry
timeFrame: Baseline, 12 weeks
measure: Average minutes/day of moderate- to vigorous-intensity physical activity, self-report
timeFrame: Baseline, 12 weeks
measure: BMI (parents)
timeFrame: Baseline, 12 weeks
measure: BMI percentile (child)
timeFrame: Baseline, 12 weeks
measure: Family cohesion
timeFrame: Baseline, 12 weeks
measure: Social support
timeFrame: Baseline, 12 weeks
measure: Family communication
timeFrame: Baseline, 12 weeks
measure: Family engagement
timeFrame: Baseline, 12 weeks
measure: Family closeness
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF College of Health and Human Performance
state: Florida
Study officials:
affiliation: University of Florida
name: Danielle E Jake-Schoffman, PhD
role: PRINCIPAL_INVESTIGATOR
References: