Interventions for Adolescent Obesity

Not Applicable

Completed

• Conditions: Adolescent Obesity
• Interventions: Behavioral: Activity Tracker

• Registration Number: NCT03004378
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-28
• Study Start: 2018-01-01
• Status Verified: 2018-04
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-31
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Activity Tracker	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of the pilot trial will be measured by an attrition rate of ≤50%.	18 weeks	We set a study attrition rate of participants at ≤50% as the feasibility measure for the study.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States