Interventions for Adolescent Obesity

The Role of Activity Tracking on Weight Loss in Obese Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Obesity
• Intervention / Treatment: Behavioral: Activity Tracker

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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; 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; Fitbit Alta

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Kanika K Bowen-Jallow, MD, MMS, University of Texas

Publications and helpful links

General Publications

• Bowen-Jallow K, Nunez-Lopez O, Wright A, Fuchs E, Ahn M, Lyons E, Jupiter D, Berry L, Suman O, Radhakrishnan RS, Glaser AM, Thompson DI. Wearable Activity Tracking Device Use in an Adolescent Weight Management Clinic: A Randomized Controlled Pilot Trial. J Obes. 2021 Jan 7;2021:7625034. doi: 10.1155/2021/7625034. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: obesity; adolescent; fitbit; tracking device
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 16-0241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will provide all data, regardless of publication, collected as part of this project. All external investigators must submit a written request identifying their research question(s) and specifying the data they are requesting. The request must include a data security plan and explanation of how the data will be stored and who will have access.
• IPD Sharing Time Frame: Data will only be available upon request
• IPD Sharing Access Criteria: The request must include a data security plan and explanation of how the data will be stored and who will have access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No