Interventions for Adolescent Obesity

Adolescent Obesity Clinical Trial

Official title:

The Role of Activity Tracking on Weight Loss in Obese Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004378
• Other study ID #: 16-0241
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2018
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Activity Tracker
Fitbit Alta

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body mass index (BMI) (kg/m2)	Absolute change in BMI	Change from 0 to 18 weeks
Secondary	Weight (kg)	Weight change	Change from 0 to 18 weeks
Secondary	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