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Completed

NCT Number: NCT06148246

Family Fit Iterative App Development

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.

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Key information

Conditions

Weight Gain Prevention Behavior Motor Activity Physical Inactivity Sedentary Behavior

Age range

9 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF College of Health and Human Performance

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 75 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 current use of Fitbit (or similar physical activity device)
  • History of eating disorder
  • One parent and one child per family unit may enroll

Treatment and study plan

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.

Primary outcomes

  1. Recruitment

    Time frame: Baseline

    Number of dyads screened and enrolled; rate of recruitment

  2. Use rates

    Time frame: 12 weeks

    Use rates of the Family Fit app summarized from back-end data from the app

  3. Acceptability

    Time frame: 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

  4. Retention

    Time frame: 12 weeks

    Number of dyads per condition who complete follow-up assessments

Secondary outcomes

  1. Sustainability

    Time frame: 12 weeks

    Use of Family Fit app, Fitbit app, and Fitbit devices from weeks 13-18

  2. Usability

    Time frame: 12 weeks

    Scores from System Usability Scale

  3. Contamination

    Time frame: 12 weeks

    Use of outside physical activity programs, devices, and apps during the study

  4. Average minutes/day of moderate- to vigorous-intensity physical activity, accelerometry

    Time frame: Baseline, 12 weeks

    Actigraph accelerometers to be used; 7 days of wear time will be requested from participants at each time point

  5. Average minutes/day of moderate- to vigorous-intensity physical activity, self-report

    Time frame: Baseline, 12 weeks

    Godin Leisure-Time Exercise Questionnaire

  6. BMI (parents)

    Time frame: 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

  7. BMI percentile (child)

    Time frame: 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

  8. Family cohesion

    Time frame: Baseline, 12 weeks

    Moos et al. family environment scale

  9. Social support

    Time frame: Baseline, 12 weeks

    Kiernan et al. adaptation of social support scale

  10. Family communication

    Time frame: Baseline, 12 weeks

    Measure from the National Longitudinal Study of Adolescent Health (Add Health)

  11. Family engagement

    Time frame: Baseline, 12 weeks

    Measure from the National Longitudinal Study of Adolescent Health (Add Health)

  12. Family closeness

    Time frame: Baseline, 12 weeks

    Measure from the National Longitudinal Study of Adolescent Health (Add Health)

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2023
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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