Interventions for Adolescent Obesity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03004378|
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Obesity||Device: Fitbit||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 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 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||September 2021|
No Intervention: Control
Subjects will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a nutritionist, and a fitness instructor who are present at every visit.
Receive Fitbit (activity tracking device) + subjects will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a nutritionist, and a fitness instructor who are present at every visit.
- Weight loss in obese adolescents after Fitbit intervention [ Time Frame: 3 years ]Total change in BMI, percent change in BMI
- Change in nutrition habits after Fitbit intervention, through survey administration [ Time Frame: 3 years ]Measure nutritional goals/type of food intake to determine if change occurred after the Fitbit was provided.
- Change in exercise habits after Fitbit intervention, through survey administration [ Time Frame: 3 years ]Measure mean number of steps per day, and mean active minutes per day
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
|Contact: Kanika Bowen-Jallow, MD, MMSfirstname.lastname@example.org|
|Contact: Lindsey Berry, MSN, PNP||409-772-5666 ext email@example.com|
|United States, Texas|
|University of Texas Medical Branch||Recruiting|
|Galveston, Texas, United States, 77555|
|Contact: Kanika A Bowen-Jallow, MD, MMS 409-772-5666 firstname.lastname@example.org|
|Contact: Lindsey Berry, MSN, PNP 409-772-5666 ext 1028 email@example.com|
|Principal Investigator:||Kanika K Bowen-Jallow, MD, MMS||University of Texas|