NCT06148246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 18, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2025

Completed
Last Updated

March 9, 2026

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

November 17, 2023

Last Update Submit

March 5, 2026

Conditions

Weight Gain PreventionPhysical Inactivity

Keywords

family-basedphysical activityexercisemobile technologywearables

Outcome Measures

Primary Outcomes (4)

  • Recruitment

    Number of dyads screened and enrolled; rate of recruitment

    Baseline

  • Use rates

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

    12 weeks

  • 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

  • Retention

    Number of dyads per condition who complete follow-up assessments

    12 weeks

Secondary Outcomes (12)

  • Sustainability

    12 weeks

  • Usability

    12 weeks

  • Contamination

    12 weeks

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

    Baseline, 12 weeks

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

    Baseline, 12 weeks

  • +7 more secondary outcomes

Study Arms (1)

Family Fit Condition (Intervention)

EXPERIMENTAL
Behavioral: Family Fit Condition

Interventions

Family Fit ConditionBEHAVIORAL

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.

Family Fit Condition (Intervention)

Eligibility Criteria

Age9 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF College of Health and Human Performance

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Danielle E Jake-Schoffman, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 28, 2023

Study Start

January 18, 2024

Primary Completion

July 6, 2025

Study Completion

July 16, 2025

Last Updated

March 9, 2026

Record last verified: 2025-09

Locations

US(1)