Skip to main content
OpenTrials
Completed

NCT Number: NCT03004378

Interventions for Adolescent Obesity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adolescent Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activity Tracker

Behavioral

Fitbit Alta

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

The Role of Activity Tracking on Weight Loss in Obese Adolescents

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2016
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.