Follow-up of Adolescent Bariatric Surgery (FABS)
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Purpose
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:
- To describe the natural history of morbid obesity among adolescents who seek treatment for their obesity
- 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
- To organize a national cohort of severely obese adolescents who agree to be contacted in the future for research studies
| Condition |
|---|
|
Morbid Obesity |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Follow-up of Adolescent Bariatric Surgery |
- BMI [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Medical Co-morbidities [ Time Frame: Annual ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients Seeking Treatment for Obesity at Cincinnati Children's Hosptial Medical Center in Cincinnati, OH.
Inclusion Criteria:
- All patients seeking treatment for Obesity at Cincinnati
Exclusion Criteria:
- Currently Enrolled in Teen LABS Study.
Contacts and Locations
More Information
Publications:
| Responsible Party: | Thomas H. Inge, MD, PhD, Principal Investigator, Cincinnati Children's Hospital Medical Center |
| ClinicalTrials.gov Identifier: | NCT00776776 History of Changes |
| Other Study ID Numbers: | 2008-0954 |
| Study First Received: | October 20, 2008 |
| Last Updated: | October 21, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
|
BMI > 40 Obesity Adolescents Weight Loss Surgery |
Additional relevant MeSH terms:
|
Obesity Obesity, Morbid Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013