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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829283
First Posted: January 27, 2009
Last Update Posted: February 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Carlos Grilo, Yale University
  Purpose
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.

Condition Intervention
Obesity Binge Eating Behavioral: Behavioral Weight Loss Behavioral: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy Drug: Placebo Drug: Sibutramine/Orlistat

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care

Resource links provided by NLM:


Further study details as provided by Carlos Grilo, Yale University:

Primary Outcome Measures:
  • Number of Subjects Who Reached Binge Eating Remission [ Time Frame: 12 months follow-up ]
    Binge Remission (abstinence from binge eating)


Secondary Outcome Measures:
  • 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.


Enrollment: 191
Study Start Date: November 2008
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard Care
Behavioral: Behavioral Weight Loss
weekly individual sessions for 6 months
Experimental: 2
Stepped-care
Behavioral: Behavioral Weight Loss
weekly individual sessions for 6 months
Behavioral: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy
weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months
Drug: Placebo
One pill daily
Drug: Sibutramine/Orlistat
Sibutramine 15 mg daily or Orlistat 120mg TID

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829283


Locations
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Carlos M Grilo, PhD Yale University
  More Information

Responsible Party: Carlos Grilo, Professor and Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00829283     History of Changes
Other Study ID Numbers: DK49587
R01DK049587 ( U.S. NIH Grant/Contract )
First Submitted: January 26, 2009
First Posted: January 27, 2009
Results First Submitted: October 27, 2015
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016
Last Verified: December 2015

Keywords provided by Carlos Grilo, Yale University:
Experimental
Comparator

Additional relevant MeSH terms:
Obesity
Weight Loss
Bulimia
Binge-Eating Disorder
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Hyperphagia
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Orlistat
Sibutramine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants