Impact of Fitbit Plus Weight Management Program on Physical Activity and Metabolic Disease in Obese Adolescents

Study Overview
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Brief Summary
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This study is evaluating the feasibility and efficacy of using Fitbit Charge HR devices to remotely track the physical activity of obese pediatric patients who are concurrently enrolled in a comprehensive weight loss intervention program. Patients will receive Fitbit devices and will be called weekly to review their average daily steps and heart rates. Patients will receive the Fitbit either at the beginning of classes or upon completion of classes. Patients will then be followed remotely and called weekly for 12 additional weeks after completing classes. The two groups will be compared to examine for differences.

Detailed Description
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Patients will be randomly assigned into one of two groups. In the first group, patients will undergo an already established multidisciplinary weight loss intervention program and will also wear Fitbit Charge HR devices. Their data will be regularly uploaded to their Fitbit Dashboard, and this information will be reviewed by the study team.

Official Title
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Impact of Fitbit Plus Weight Management Program on Physical Activity and Metabolic Disease in Obese Adolescents

Conditions
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Obesity

Intervention / Treatment
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* Other: Fitbit Charge HR plus weekly phone calls to review physical activity data


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrollment in the Healthy Kids, Healthy Weight assessment and intervention program BMI greater than or equal to the 95th percentile Exclusion Criteria: Compromising medical condition that prevents physical activity (sickle cell disease, severe asthma, fractures, etc) Severe intellectual disability History of smoking Current use of atypical antipsychotics, stimulants

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Early Fitbit<br>Patients will receive Fitbit in the first phase of the study. In addition to attending weekly weight management classes, patients will wear Fitbit Charge HR devices to track heart rate, active minutes, steps taken, calories burned, and sleep patterns. Patients will receive weekly phone calls to review this data, and further recommendations will be given to encourage additional physical activity as clinically indicated based on time spent being physically active. The goal will be for individuals to reach 10,000 steps per day, though if subjects are significantly under that goal, realistic goal-setting (recommended increases of physical activity of 10% at a time). Patients will continue this intervention for 12 weeks. After 12 weeks, they will return for reassessment. This coincides with the completion of the weight loss program. Subjects will then be followed remotely for another 12 weeks and phone call interventions will continue before returning for a final study visit. | Other: Fitbit Charge HR plus weekly phone calls to review physical activity data<br>* Patients during weekly Healthy Kids, Healthy Weight classes will also upload their Fitbit data, which will be remotely accessed by the study team and weekly phone calls will be implemented to discuss activity<br>|
| Active Comparator: Late/Delayed Fitbit<br>These subjects will follow a similar pattern except they will not receive Fitbit Charge HR devices until the second phase of the study (specifically after completion of the 12 week weight loss program). In the first phase, these subjects will receive weekly phone calls to offer them the same attention as the experimental group, but instead of reviewing Fitbit data, these subjects will subjectively report their physical activity in minutes and by qualifying their physical activity as light, moderate, or vigorous. These individuals, after 12 weeks, will return for reassessment. At that time, these individuals will receive Fitbits and receive weekly telephone calls for an additional 12 weeks before returning for a final study visit. | Other: Fitbit Charge HR plus weekly phone calls to review physical activity data<br>* Patients during weekly Healthy Kids, Healthy Weight classes will also upload their Fitbit data, which will be remotely accessed by the study team and weekly phone calls will be implemented to discuss activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI z-score |  | 12 weeks | 
| physical activity as measured by Actigraph |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting lipid panel |  | 12 weeks | 
| fasting glucose |  | 12 weeks | 
| fasting insulin |  | 12 weeks | 
| Hemoglobin A1c |  | 12 weeks | 
| Resting energy expenditure | measured using ReeVue indirect calorimeter | 12 weeks | 
| Body composition measured by bioelectrial impedance analysis |  | 12 weeks | 
| Estimation of VO2 max | Using recovery heart rate s/p 3 minute step test | 12 weeks | 
| Blood pressure |  | 12 weeks | 
| Average steps taken per day | as measured using Fitbit | Daily for 24 weeks | 
| Resting heart rate | as measured using Fitbit | Daily for 24 weeks | 
| Active minutes | as measured using Fitbit | Daily for 24 weeks | 
| Minutes per day in moderate/vigorous physical heart rate range | as measured using Fitbit | Daily for 24 weeks | 
| Physical activity self-efficiacy questionnaire |  | 12 weeks | 
| Responses to sleep questionnaire | Assess subjective reports of snoring, restfulness, hours of sleep | 12 weeks | 
| Responses to self-image questionnaire (SIQYA) | only for individuals greater than 13 years of age | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fitbit, Obesity, Pediatrics