Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
This study is ongoing, but not recruiting participants.
Sponsor:
Yale University
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
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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 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 June 17, 2013