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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00829283 |
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 |
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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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study |
Official Title: | Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care |
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 |
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1: Active Comparator
Standard Care
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Behavioral: Behavioral Weight Loss
weekly individual sessions for 6 months
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2: Experimental
Stepped-care
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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
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
United States, Connecticut | |
Yale School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: Kerstin Blomquist, Ph.D. 203-737-5537 kerstin.blomquist@yale.edu | |
Contact: Robin M Masheb, Ph.D. 203-785-7807 robin.masheb@yale.edu | |
Sub-Investigator: Robin M Masheb, Ph.D. | |
Sub-Investigator: Marney White, Ph.D. | |
Principal Investigator: Carlos M Grilo, Ph.D. |
Responsible Party: | Yale School of Medicine ( Carlos M. Grilo, Ph.D. ) |
Study ID Numbers: | DK49587 |
Study First Received: | January 26, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00829283 History of Changes |
Health Authority: | United States: Federal Government |
Experimental Comparator |
Obesity Signs and Symptoms, Digestive Psychotropic Drugs Overweight Hyperphagia Sibutramine Body Weight Anti-Obesity Agents Bulimia Nervosa Signs and Symptoms |
Mental Disorders Weight Loss Bulimia Body Weight Changes Appetite Depressants Nutrition Disorders Overnutrition Antidepressive Agents Eating Disorders |
Obesity Signs and Symptoms, Digestive Psychotropic Drugs Overweight Pharmacologic Actions Hyperphagia Sibutramine Body Weight Anti-Obesity Agents Bulimia Nervosa Signs and Symptoms |
Mental Disorders Therapeutic Uses Bulimia Weight Loss Body Weight Changes Appetite Depressants Nutrition Disorders Overnutrition Central Nervous System Agents Antidepressive Agents Eating Disorders |