Family Fit Iterative App Development

NCT ID: NCT06148246

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2025-07-16

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.

Conditions

Weight Gain Prevention; Physical Inactivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Family Fit Condition (Intervention)

Group Type: EXPERIMENTAL

Family Fit Condition

Intervention Type: 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.

Interventions

Family Fit Condition

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle E Jake-Schoffman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF College of Health and Human Performance

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R21HD100743

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202102295

Identifier Type: OTHER

Identifier Source: secondary_id

IRB202401844

Identifier Type: -

Identifier Source: org_study_id