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
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
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 July 29, 2014