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Teen LABS: Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT00721838
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), Children's Hospital Medical Center, Cincinnati (Other), Baylor College of Medicine (Other), University of Pittsburgh (Other), University of Alabama at Birmingham (Other)
160
Enrollment
5
Locations
88.9
Duration (Months)
32
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The dietary and eating behavior outcomes for adolescents who undergo bariatric surgery are virtually unknown. The main trial of the Teen-LABS consortium is not studying dietary intake and eating behavior before and after bariatric surgery. The consortium, however, provides a unique opportunity to investigate these issues in a large and diverse sample through the context of the proposed ancillary study.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    160 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery
    Study Start Date :
    Feb 1, 2009
    Actual Primary Completion Date :
    Jul 1, 2016
    Actual Study Completion Date :
    Jul 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Surgery group
    2

    Control - Lifestyle modification program

    Outcome Measures

    Primary Outcome Measures

    1. dietary intake [BL, 3, 6, 12, and 24 mo]

    2. eating behavior [BL, 3, 6, 12, and 24 mo]

    Secondary Outcome Measures

    1. nausea, vomiting, and gastric dumping [BL, 3, 6, 12 and 24 mo]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 19 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 19 years old or younger

    • have a BMI > 30 kg/m2

    • have attained or nearly attained physical maturity and have a history of unsuccessful, organized attempts at weight management.

    • must demonstrate reasonable decision making abilities

    • must also fit the following criteria: (1) no prior bariatric surgical procedure, (2) no physical illness not due to obesity, and (3) no full-time special education (due to the high reading demand of study participation).

    • Participants will be from all racial and ethnic groups and be both male and female.

    Exclusion Criteria:
    • We will not exclude participants from this trial based on health status or medication usage. Instead, we will track medical conditions and medication usage at every assessment point throughout the investigation to assess the possible influence of these variables on changes in weight, dietary intake, and eating behavior.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    3 The University of Pennsylvania Weight and Eating Disorder Program Philadelphia Pennsylvania United States 19104
    4 University of Pittsburgh School of Medicine Pittsburgh Pennsylvania United States 15260
    5 Baylor College of Medicine Houston Texas United States 77030

    Sponsors and Collaborators

    • University of Pennsylvania
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    • Children's Hospital Medical Center, Cincinnati
    • Baylor College of Medicine
    • University of Pittsburgh
    • University of Alabama at Birmingham

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT00721838
    Other Study ID Numbers:
    • DK072493
    • U01DK072493
    First Posted:
    Jul 24, 2008
    Last Update Posted:
    Aug 22, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by University of Pennsylvania
    adolescent obesity
    eating behavior
    dietary intake
    Additional relevant MeSH terms:
    Pediatric Obesity

    Study Results

    No Results Posted as of Aug 22, 2016