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Interventions for Adolescent Obesity

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ClinicalTrials.gov Identifier: NCT03004378
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
This study will be the first to evaluate whether the short- and long-term use of activity tracking devices improve short- and long-term weight loss in adolescents. The investigators will be the first to establish whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. In addition, the investigators will be the first to 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 Device: Fitbit Not Applicable

Detailed Description:
This study will evaluate the short- and long-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. Ten thousand steps per day is the current recommendation for improving health and decreasing risk of heart disease. Ten thousand steps a day is also a rough equivalent of the US Surgeon General's recommendation to accumulate 30 minutes of activity most days of the week. Activity tracking devices will also monitor daily total body energy expenditure and mean sleep hours.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
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.
Intervention
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.
Device: Fitbit



Primary Outcome Measures :
  1. Weight loss in obese adolescents after Fitbit intervention [ Time Frame: 3 years ]
    Total change in BMI, percent change in BMI


Secondary Outcome Measures :
  1. 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.

  2. 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



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

Inclusion Criteria:

  1. Subject has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
  2. At least 12 and younger than 18 years of age at the time of consent.
  3. BMI ≥ 95th percentile for age and sex group or BMI ≥ 35 kg/m2

Exclusion Criteria:

  1. Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
  2. Use of an investigational agent in the 30 days prior to signing informed consent
  3. History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
  4. Females who are pregnant or lactating
  5. Subjects taking medications that can potentially cause weight gain
  6. Subjects unable to participate in the comprehensive weight loss program due to pre-existing conditions (paralysis, heart failure, severe autism or mental retardation, psychosis, etc.)
  7. Prisoners

Information from the National Library of Medicine

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


Contacts
Contact: Kanika Bowen-Jallow, MD, MMS 409-772-5666 kabowen@utmb.edu
Contact: Lindsey Berry, MSN, PNP 409-772-5666 ext 1028 lmberry@utmb.edu

Locations
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Kanika A Bowen-Jallow, MD, MMS    409-772-5666    kabowen@utmb.edu   
Contact: Lindsey Berry, MSN, PNP    409-772-5666 ext 1028    lmberry@utmb.edu   
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: Kanika K Bowen-Jallow, MD, MMS University of Texas

Publications of Results:
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03004378     History of Changes
Other Study ID Numbers: 160241
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Signs and Symptoms