Interventions for Adolescent Obesity

Sponsor

The University of Texas Medical Branch, Galveston (Other)

Overall Status

Completed

CT.gov ID

NCT03004378

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adolescent Obesity	Behavioral: Activity Tracker	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Role of Activity Tracking on Weight Loss in Obese Adolescents

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Nov 30, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Medical Branch	Galveston	Texas	United States	77555

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

Investigators

Principal Investigator: Kanika K Bowen-Jallow, MD, MMS, University of Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Texas Medical Branch, Galveston

ClinicalTrials.gov Identifier:

NCT03004378

Other Study ID Numbers:

16-0241

First Posted:

Dec 28, 2016

Last Update Posted:

Jan 23, 2020

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The University of Texas Medical Branch, Galveston

Additional relevant MeSH terms:

Obesity

Pediatric Obesity

Study Results

No Results Posted as of Jan 23, 2020