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

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ClinicalTrials.gov Identifier: NCT00829283
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Carlos Grilo, Yale University

Tracking Information
First Submitted Date  ICMJE January 26, 2009
First Posted Date  ICMJE January 27, 2009
Results First Submitted Date  ICMJE October 27, 2015
Results First Posted Date  ICMJE February 1, 2016
Last Update Posted Date February 1, 2016
Study Start Date  ICMJE November 2008
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2015)
Number of Subjects Who Reached Binge Eating Remission [ Time Frame: 12 months follow-up ]
Binge Remission (abstinence from binge eating)
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2009)
Binge Eating [ Time Frame: 6 months treatment; 6 and 12 months follow-up post-treatment ]
Change History Complete list of historical versions of study NCT00829283 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2015)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2009)
BMI [ Time Frame: 6 months treatment; 6 and 12 months follow-up post-treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
Official Title  ICMJE Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
Brief Summary 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Binge Eating
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Standard Care
    Intervention: Behavioral: Behavioral Weight Loss
  • Experimental: 2
    Stepped-care
    Interventions:
    • Behavioral: Behavioral Weight Loss
    • Behavioral: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy
    • Drug: Placebo
    • Drug: Sibutramine/Orlistat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2015)
191
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2009)
175
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00829283
Other Study ID Numbers  ICMJE DK49587
R01DK049587 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carlos Grilo, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Carlos M Grilo, PhD Yale University
PRS Account Yale University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP