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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
191
weekly individual sessions for 6 months
weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months
One pill daily
Yale School of Medicine
New Haven, Connecticut, United States
Number of Subjects Who Reached Binge Eating Remission
Binge Remission (abstinence from binge eating)
Time frame: 12 months follow-up
BMI
The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m\^2.
Time frame: 12 months follow-up post-treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sibutramine 15 mg daily or Orlistat 120mg TID