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Completed

NCT Number: NCT00829283

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

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.

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Key information

Conditions

Obesity Binge Eating Body Weight Bulimia Hyperphagia Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral weight loss

Behavioral

weekly individual sessions for 6 months

Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy

Behavioral

weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months

Placebo

Drug

One pill daily

Sibutramine/Orlistat

Drug

Sibutramine 15 mg daily or Orlistat 120mg TID

Primary outcomes

  1. Number of Subjects Who Reached Binge Eating Remission

    Time frame: 12 months follow-up

    Binge Remission (abstinence from binge eating)

Secondary outcomes

  1. BMI

    Time frame: 12 months follow-up post-treatment

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 27, 2009
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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