Interventions for Adolescent Obesity
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|ClinicalTrials.gov Identifier: NCT03004378|
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Obesity||Behavioral: Activity Tracker||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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.
- Body mass index (BMI) (kg/m2) [ Time Frame: Change from 0 to 18 weeks ]Absolute change in BMI
- Weight (kg) [ Time Frame: Change from 0 to 18 weeks ]Weight change
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004378
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|
|Principal Investigator:||Kanika K Bowen-Jallow, MD, MMS||University of Texas|