LABS-3 Psychosocial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2007 |
| End Date: | July 2019 |
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.
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.
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.
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
We found this trial at
4
sites
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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