Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care

Conditions
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Obesity, Binge Eating

Intervention / Treatment
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* Behavioral: Behavioral Weight Loss
* Behavioral: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy
* Drug: Placebo
* Drug: Sibutramine/Orlistat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard Care | Behavioral: Behavioral Weight Loss<br>* weekly individual sessions for 6 months<br>|
| Experimental: 2<br>Stepped-care | Behavioral: Behavioral Weight Loss<br>* weekly individual sessions for 6 months<br>Behavioral: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy<br>* weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months<br>Drug: Placebo<br>* One pill daily<br>Drug: Sibutramine/Orlistat<br>* Sibutramine 15 mg daily or Orlistat 120mg TID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Reached Binge Eating Remission | Binge Remission (abstinence from binge eating) | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months follow-up post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Experimental, Comparator