Conditions: Obesity Binge Eating
Keywords: Experimental Comparator
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 191
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Standard Care arm 2: Stepped-care

Interventions: intervention 1: Behavioral Weight Loss intervention 2: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy intervention 3: Placebo intervention 4: Sibutramine/Orlistat
Intervention descriptions: intervention 1: weekly individual sessions for 6 months intervention 2: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months intervention 3: One pill daily intervention 4: Sibutramine 15 mg daily or Orlistat 120mg TID

Protocol document: