Weight Gain PreventionNCT06148246
Family Fit Iterative App Development
A study testing Family Fit Condition in people with Weight Gain Prevention and Physical Inactivity, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Gain Prevention, Physical Inactivity
- What is being tested?
- Family Fit Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to 16 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UF College of Health and Human Performance
Gainesville, Florida, 32611
About this study
Official title: Family Fit: Promoting Family-Based Physical Activity and Weight Gain Prevention Through Mobile Technology
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.
Read the 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
- Being tested
- Family Fit Condition
- Keywords
- family-based, physical activity, exercise, mobile technology, wearables
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Fit ConditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Family Fit Condition (Intervention) | Experimental | Not described Receives: Behavioral: Family Fit Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of dyads screened and enrolled; rate of recruitment
Measured: Baseline
Use rates
Use rates of the Family Fit app summarized from back-end data from the app
Measured: 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
Measured: 12 weeks
Retention
Number of dyads per condition who complete follow-up assessments
Measured: 12 weeks
Secondary outcomes (12)
Sustainability
Use of Family Fit app, Fitbit app, and Fitbit devices from weeks 13-18
Measured: 12 weeks
Usability
Scores from System Usability Scale
Measured: 12 weeks
Contamination
Use of outside physical activity programs, devices, and apps during the study
Measured: 12 weeks
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
Measured: Baseline, 12 weeks
Average minutes/day of moderate- to vigorous-intensity physical activity, self-report
Godin Leisure-Time Exercise Questionnaire
Measured: Baseline, 12 weeks
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
Measured: Baseline, 12 weeks
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
Measured: Baseline, 12 weeks
Family cohesion
Moos et al. family environment scale
Measured: Baseline, 12 weeks
Social support
Kiernan et al. adaptation of social support scale
Measured: Baseline, 12 weeks
Family communication
Measure from the National Longitudinal Study of Adolescent Health (Add Health)
Measured: Baseline, 12 weeks
Family engagement
Measure from the National Longitudinal Study of Adolescent Health (Add Health)
Measured: Baseline, 12 weeks
Family closeness
Measure from the National Longitudinal Study of Adolescent Health (Add Health)
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start18 Jan 2024
- Primary completion6 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight Gain PreventionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Danielle E Jake-Schoffman, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148246
- Sponsor's protocol ID
- IRB202401844
- Other IDs
- R21HD100743, IRB202102295
- Status last verified
- Sep 2025
- First submitted
- 17 Nov 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Fit: Promoting Family-Based Physical Activity and Weight Gain Prevention Through Mobile Technology
- ClinicalTrials.gov ID
- NCT06148246
- Acronym / sponsor ID
- IRB202401844
- Conditions
- Weight Gain Prevention, Physical Inactivity
- Keywords
- family-based, physical activity, exercise, mobile technology, wearables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 6 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family Fit Condition (Intervention) | Experimental | Behavioral: Family Fit Condition |
Who may qualify
- Ages
- 9 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Parent (or legal guardian) must:
- Child must:
- Child and parent must:
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Fit ConditionDyads 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. | Behavioural | Family Fit Condition (Intervention) |
Primary outcome
Recruitment
Time frame: Baseline
Number of dyads screened and enrolled; rate of recruitment
Use rates
Time frame: 12 weeks
Use rates of the Family Fit app summarized from back-end data from the app
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
Retention
Time frame: 12 weeks
Number of dyads per condition who complete follow-up assessments
12 secondary outcomes
Sustainability
Time frame: 12 weeks
Usability
Time frame: 12 weeks
Contamination
Time frame: 12 weeks
Average minutes/day of moderate- to vigorous-intensity physical activity, accelerometry
Time frame: Baseline, 12 weeks
Average minutes/day of moderate- to vigorous-intensity physical activity, self-report
Time frame: Baseline, 12 weeks
BMI (parents)
Time frame: Baseline, 12 weeks
BMI percentile (child)
Time frame: Baseline, 12 weeks
Family cohesion
Time frame: Baseline, 12 weeks
Social support
Time frame: Baseline, 12 weeks
Family communication
Time frame: Baseline, 12 weeks
Family engagement
Time frame: Baseline, 12 weeks
Family closeness
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle E Jake-Schoffman, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Fit Condition in people with Weight Gain Prevention and Physical Inactivity, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.