Follow-up of Adolescent Bariatric Surgery (FABS)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00776776
First received: October 20, 2008
Last updated: October 21, 2008
Last verified: August 2008
  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:

  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
Morbid Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Follow-up of Adolescent Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • BMI [ Time Frame: Annually ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

Patients Seeking Treatment for Obesity at Cincinnati Children's Hosptial Medical Center in Cincinnati, OH.

Criteria

Inclusion Criteria:

  • All patients seeking treatment for Obesity at Cincinnati

Exclusion Criteria:

  • Currently Enrolled in Teen LABS Study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776776

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Ethicon Endo-Surgery
  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 October 01, 2014