Family Fit Iterative App Development

Sponsor
University of Florida (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06148246
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
60
2
12.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Family Fit Condition
  • Behavioral: Fitbit Only Condition
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Family Fit: Promoting Family-Based Physical Activity and Weight Gain Prevention Through Mobile Technology
Anticipated Study Start Date :
Nov 19, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Recruitment [Baseline]

    Number of dyads screened and enrolled; rate of recruitment

  2. Use rates [12 weeks]

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

  3. 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

  4. Retention [12 weeks 18 weeks]

    Number of dyads per condition who complete follow-up assessments

Secondary Outcome Measures

  1. Sustainability [12 weeks and 18 weeks]

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

  2. Usability [12 weeks and 18 weeks]

    Scores from System Usability Scale

  3. Contamination [12 weeks and 18 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 [Baseline, 12 weeks, 18 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 [Baseline, 12 weeks, 18 weeks]

    Godin Leisure-Time Exercise Questionnaire

  6. BMI (parents) [Baseline, 12 weeks, 18 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) [Baseline, 12 weeks, 18 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 [Baseline, 12 weeks, 18 weeks]

    Moos et al. family environment scale

  9. Social support [Baseline, 12 weeks, 18 weeks]

    Kiernan et al. adaptation of social support scale

  10. Family communication [Baseline, 12 weeks, 18 weeks]

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

  11. Family engagement [Baseline, 12 weeks, 18 weeks]

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

  12. Family closeness [Baseline, 12 weeks, 18 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  1. Child must:
  • Be 9-12 years old

  • Live in the residence of parent (at least 50% of the time)

  1. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Danielle E Jake-Schoffman, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT06148246
Other Study ID Numbers:
  • IRB202102295
  • R21HD100743
First Posted:
Nov 28, 2023
Last Update Posted:
Nov 28, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Florida
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 28, 2023