Interventions for Adolescent Obesity

• ClinicalTrials.gov Identifier: NCT03004378
• Recruitment Status: Completed
• First Posted: December 28, 2016
• Last Update Posted: January 23, 2020
• Sponsor: The University of Texas Medical Branch, Galveston
• Information provided by (Responsible Party): The University of Texas Medical Branch, Galveston

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	Not Applicable

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 (Clinical Trial)
• 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: January 1, 2018
• Actual Primary Completion Date: November 30, 2018
• Actual Study Completion Date: December 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

United States, Texas

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT03004378
• Other Study ID Numbers: 16-0241
• First Posted: December 28, 2016
• Last Update Posted: January 23, 2020
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: Data will only be available upon request
• Access Criteria: The request must include a data security plan and explanation of how the data will be stored and who will have access.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Texas Medical Branch, Galveston:

obesity; adolescent; tracking device; fitbit

Additional relevant MeSH terms:

Obesity; Pediatric Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight