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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carlos Grilo, Yale University
ClinicalTrials.gov Identifier:
NCT00829283
First received: January 26, 2009
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with 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

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:
  • Binge Eating [ Time Frame: 6 months treatment; 6 and 12 months follow-up post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BMI [ Time Frame: 6 months treatment; 6 and 12 months follow-up post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 175
Study Start Date: November 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 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
15 mg daily

  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
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
Investigators
Principal Investigator: Carlos M Grilo, PhD Yale University
  More Information

No publications provided

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
Last Updated: January 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Experimental
Comparator

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Obesity
Weight Loss
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Body Weight Changes
Sibutramine
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014