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FABS: Follow-up of Adolescent Bariatric Surgery

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT00776776
Collaborator
Ethicon Endo-Surgery (Industry)
180
Enrollment
1
Location
60
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Very little information is available about extremely obese (body mass index [BMI] > 40 kg/m2) adolescents. The purpose of the Follow up of Adolescent Bariatric Surgery (FABS) study is to collect information obtained during the clinical care of obese adolescents from all over the country that can be used by researchers to study obesity, the complications of obesity, and the outcomes of obesity treatment during adolescence. This information will be used to describe the experience of the obese adolescent, including how obesity during adolescence and its treatment impacts health and well-being. The information may also be used to study causes of obesity, to determine the predictors of successful obesity treatment and for other obesity related research. Because of the importance of understanding the outcome of obesity and obesity treatments (surgical and non-surgical) on the patient over time, the data included in the study will be collected before, during and after any treatments rendered. For those who do not undergo a treatment which results in major weight change, it will be critical to determine the natural history of adolescent severe obesity as the adolescent transitions into adulthood. Finally, another important purpose of the FABS research study is to obtain patients' consent to be contacted for possible participation in future research studies.

SPECIFIC AIMS:

  1. To describe the natural history of morbid obesity among adolescents who seek treatment for their obesity

  2. To describe major outcomes following bariatric surgery in adolescents evaluated at 3, 6, 12, and annually for 10 years post-operatively and compare these to outcomes to patients managed non-surgically

  3. To organize a national cohort of severely obese adolescents who agree to be contacted in the future for research studies

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    180 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Follow-up of Adolescent Bariatric Surgery
    Study Start Date :
    Apr 1, 2005
    Actual Primary Completion Date :
    Apr 1, 2007
    Actual Study Completion Date :
    Apr 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. BMI [Annually]

    Secondary Outcome Measures

    1. Medical Co-morbidities [Annual]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All patients seeking treatment for Obesity at Cincinnati
    Exclusion Criteria:
    • Currently Enrolled in Teen LABS Study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati
    • Ethicon Endo-Surgery

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00776776
    Other Study ID Numbers:
    • 2008-0954
    First Posted:
    Oct 21, 2008
    Last Update Posted:
    Jul 14, 2021
    Last Verified:
    Aug 1, 2008
    Keywords provided by , ,
    BMI > 40
    Obesity
    Adolescents
    Weight Loss Surgery
    Additional relevant MeSH terms:
    Obesity, Morbid

    Study Results

    No Results Posted as of Jul 14, 2021