LABS-3 Psychosocial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00582595
First received: December 20, 2007
Last updated: November 12, 2012
Last verified: November 2012

December 20, 2007
November 12, 2012
January 2007
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Complete list of historical versions of study NCT00582595 on ClinicalTrials.gov Archive Site
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LABS-3 Psychosocial
Psychosocial Issues and Bariatric Surgery

The overall goal of this study is to obtain detailed information that will allow a careful assessment of psychopathology, quality of life and eating behavior pre-surgically and at regular intervals for 2 years after the surgical intervention.

Hypotheses

  1. Patients undergoing bariatric surgery will experience significant decreases in the rates of psychopathology, in particular depressive illness, and significant improvements in quality of life, post-operatively.
  2. Untreated psychopathology that persists well beyond the surgery (e.g. to one-year follow-up) or that develops post-operatively will be associated with less weight loss and decreased quality of life.
  3. Untreated psychopathology at the time of bariatric surgery, including affective disorders and substance abuse/alcohol abuse will be associated with increased short-term (e.g. 90 day) complications (e.g. problems with plugging, vomiting, and dehydration)
  4. Syndromal/subsyndromal eating disorders prior to surgery including binge eating disorder and night eating syndrome will be associated with eating disorder symptoms and less weight loss at long-term follow-up.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Participants will be selected from bariatric surgical candidates at participating LABS sites in New York and Fargo, ND.

  • Obesity
  • Depression
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
June 2014
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Inclusion Criteria:

  • Male and female patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
  • Previous enrollment in LABS-1 and LABS-2.
  • BMI at baseline of greater than or equal to 35.

Exclusion Criteria:

  • Informed consent not obtained
  • Type 1 Diabetes Mellitus
  • Unlikely to comply with follow-up protocol (ie: geographically inaccessible for study visits)
  • Unable to communicate with local study staff
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582595
DK6657_3a, U01DK066557
Yes
University of Pittsburgh
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
University of Pittsburgh
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP