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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Carlos Grilo, Yale University
ClinicalTrials.gov Identifier:
NCT00829283
First received: January 26, 2009
Last updated: December 28, 2015
Last verified: December 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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 Yale University:

Primary Outcome Measures:
  • Number of Subjects Who Reached Binge Eating Remission [ Time Frame: 12 months follow-up ] [ Designated as safety issue: No ]
    Binge Remission (abstinence from binge eating)


Secondary Outcome Measures:
  • BMI [ Time Frame: 12 months follow-up post-treatment ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: January 26, 2009
Results First Received: October 27, 2015
Last Updated: December 28, 2015
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Experimental
Comparator

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Bulimia Nervosa
Obesity
Body Weight
Feeding and Eating Disorders
Hyperphagia
Mental Disorders
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Signs and Symptoms, Digestive
Sibutramine
Anti-Obesity Agents
Antidepressive Agents
Appetite Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2016