Interventions for Adolescent Obesity

Study Overview
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Brief Summary
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This study will evaluate whether the short-term use of activity tracking devices improves short-term weight loss in adolescents. The investigators will evaluate whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. In addition, the investigators will report outcomes after the implementation of activity tracking devices in conjunction with an intense adolescent weight loss program.

Detailed Description
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This study will evaluate the short-term use of activity tracking devices and their effects on short- and long-term weight loss in adolescents. The investigators plan to establish whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. Each participant with an activity tracking device will have the goal of reaching 10,000 steps per day, in addition to their individual fitness plan.

Official Title
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The Role of Activity Tracking on Weight Loss in Obese Adolescents

Conditions
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Adolescent Obesity

Intervention / Treatment
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* Behavioral: Activity Tracker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 12-18 years BMI ≥ 95th percentile for age and sex group Participant able to read and understand English Willingness to be randomized to any condition Exclusion Criteria: Inability to obtain informed parental consent and/or child assent Inability to participate in the program due to pre-existing conditions (e.g., paralysis, heart failure, severe autism or mental retardation, psychosis) Pregnancy Clinical judgment concerning safety Inability of the participant to speak English

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 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>Participants will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a dietitian, and a fitness instructor who are present at every visit. | |
| Experimental: Intervention<br>Fitbit (activity tracker) + participants will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a dietitian, and a fitness instructor who are present at every visit. | Behavioral: Activity Tracker<br>* Fitbit Alta<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the pilot trial will be measured by an attrition rate of ≤50%. | We set a study attrition rate of participants at ≤50% as the feasibility measure for the study. | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) (kg/m2) | Absolute change in BMI | Change from 0 to 18 weeks | 
| Weight (kg) | Weight change | Change from 0 to 18 weeks | 
| Change in obesity related biomarkers | AST: aspartate aminotransferase; ALT: alanine aminotransferase; GGT: gamma glutamyl transferase; CRP: C reactive protein | Change from 0 to 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracking device, fitbit, obesity, adolescent