Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Psychiatric |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | November 2008 |
| End Date: | November 2013 |
This controlled study will test the effectiveness of a stepped-care approach to a standard
behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The
major question is whether the stepped-care approach, which begins with behavioral weight
loss and then follows a decision tree for additional interventions based on early treatment
response is superior to standard behavioral treatment.
behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The
major question is whether the stepped-care approach, which begins with behavioral weight
loss and then follows a decision tree for additional interventions based on early treatment
response is superior to standard behavioral treatment.
The stepped-care arm of this study included an obesity medication intervention. At the start
of the study, the active medication was sibutramine and was compared to a placebo control.
On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the
market in light of clinical trial data pointing to an increased risk for stroke and
myocardial infarction. In response to this event, the investigators submitted an IRB
amendment to change the active obesity medication from sibutramine to Orlistat. The IRB
amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer
Robert Kuczmarski to enact this change.
of the study, the active medication was sibutramine and was compared to a placebo control.
On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the
market in light of clinical trial data pointing to an increased risk for stroke and
myocardial infarction. In response to this event, the investigators submitted an IRB
amendment to change the active obesity medication from sibutramine to Orlistat. The IRB
amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer
Robert Kuczmarski to enact this change.
Inclusion criteria:
- Obese (BMI>=30)
Exclusion criteria:
- Medication regimen that represents medical contraindication to sibutramine
- Serious unstable or uncontrolled medical conditions that represent contraindication
to sibutramine
- Pregnancy
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