Family Fit Iterative App Development

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06148246
• Other study ID #: IRB202102295
• Secondary ID: R21HD100743
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: Danielle E Jake-Schoffman, PhD
• Phone: (352) 294-1816
• Email: djakeschoffman[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Inactivity
• Weight Gain
• Weight Gain Prevention

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.
• 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.

Locations

Country	Name	City	State
United States	UF College of Health and Human Performance	Gainesville	Florida

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Number of dyads screened and enrolled; rate of recruitment	Baseline
Primary	Use rates	Use rates of the Family Fit app summarized from back-end data from the app	12 weeks
Primary	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
Primary	Retention	Number of dyads per condition who complete follow-up assessments	12 weeks 18 weeks
Secondary	Sustainability	Use of Family Fit app, Fitbit app, and Fitbit devices from weeks 13-18	12 weeks and 18 weeks
Secondary	Usability	Scores from System Usability Scale	12 weeks and 18 weeks
Secondary	Contamination	Use of outside physical activity programs, devices, and apps during the study	12 weeks and 18 weeks
Secondary	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
Secondary	Average minutes/day of moderate- to vigorous-intensity physical activity, self-report	Godin Leisure-Time Exercise Questionnaire	Baseline, 12 weeks, 18 weeks
Secondary	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
Secondary	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
Secondary	Family cohesion	Moos et al. family environment scale	Baseline, 12 weeks, 18 weeks
Secondary	Social support	Kiernan et al. adaptation of social support scale	Baseline, 12 weeks, 18 weeks
Secondary	Family communication	Measure from the National Longitudinal Study of Adolescent Health (Add Health)	Baseline, 12 weeks, 18 weeks
Secondary	Family engagement	Measure from the National Longitudinal Study of Adolescent Health (Add Health)	Baseline, 12 weeks, 18 weeks
Secondary	Family closeness	Measure from the National Longitudinal Study of Adolescent Health (Add Health)	Baseline, 12 weeks, 18 weeks