Follow-up of Adolescent Bariatric Surgery

Completed

• Conditions: Morbid Obesity

• Registration Number: NCT00776776
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2007-04
• Status Verified: 2008-08
• Study First Submitted: 2008-10-20
• Study First Submitted QC: 2008-10-20
• Study First Posted: 2008-10-21
• Study Completion: 2010-04
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• All patients seeking treatment for Obesity at Cincinnati

Exclusion Criteria

• Currently Enrolled in Teen LABS Study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BMI	Annually

Secondary Outcome Measures

Name	Time	Method
Medical Co-morbidities	Annual

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States