Is it Helpful to Use Fitbits in a Family Based Weight Loss Program?

Study Overview
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Brief Summary
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This study evaluates the role of personal activity trackers to help improve weight loss or weight maintenance for children and their parents enrolled in a comprehensive weight loss program.

Detailed Description
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Childhood obesity rates have tripled in the last 30 years, with as many as 50% of children in the US being obese or overweight. High-intensity comprehensive behavioral family lifestyle intervention (CBFLI) programs have been shown to be among the most effective interventions for weight loss in children. However, these programs are time- and resource-intensive with high rates of recidivism. Personal activity trackers (PAT) provide objectively measured physical activity data and are more reliable than self-report. These devices can also have a motivational impact. The investigators intend to study the effects of these devices and their data on behavior change and weight loss for both parents and children enrolled in a CBFLI program. The investigators will objectively measure the level of activity of both members of the parent-child dyad, explore the relationship between parent-child activity levels and its effect on each other, as well as on overall weight loss or weight maintenance.

Official Title
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Effect of Personal Activity Trackers on Weight Loss in Children Enrolled in a Comprehensive Behavioral Family Lifestyle Intervention (CBFLI) Program

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Device: Fitbit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All individuals enrolled in BodyWorks who are at least 7 years old meet inclusion criteria for this study. there is no maximum age for participation. Exclusion Criteria: Unable to wear PAT as described in study protocol Unwilling to wear PAT Unwilling to participate in the study

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control group families will participate in the standard Body Works weight loss program. They will fill out brief surveys regarding their physical activity on a weekly basis, but otherwise will receive the standard curriculum. they will receive weekly feedback based on their physical activity surveys. | |
| Experimental: Intervention<br>The intervention group families will be given fitbits on the first day of the Body Works program. They will otherwise receive the same curriculum as the control families. the will fill out the same physical activity surveys as the control families. they will receive weekly feedback based on the objectively measured physical activity. | Device: Fitbit<br>* The Fitbit is a consumer-grade personal activity tracker. It is used to track physical activity. Patients will be given devices at the beginning of the study, and they will continue to use it for 7 weeks. Their data will be collected on a weekly basis, and patients will receive feedback on their level of activity based on the Fitbit data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI-z score | change in BMI-z score | Baseline to program completion ( 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of fitbit on program attendance | The investigators will evaluate if families that receive fitbits attend more sessions (out of 7 total sessions) by recording their attendance at each session | Baseline to program completion ( 8 weeks) | 
| impact of fitbit on program completion rate | The investigators will evaluate if families that receive fitbits complete the program at a higher rate (completion is defined as having attended at least 4 out of 7 sessions). | Baseline to program completion ( 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fitbit, obesity, pediatrics, weight management program, personal activity tracker