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| Sponsors and Collaborators: |
Yale University Donaghue Medical Research Foundation |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00516919 |
Purpose
This is a research study designed to examine the effectiveness of an obesity medication (orlistat) given in addition to behavioral weight loss therapy.
Participants will be obese monolingual (Spanish-speaking only) men and women.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Binge Eating |
Drug: Xenical + behavioral intervention Behavioral: Behavioral intervention + placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Controlled Trial of Orlistat With Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons |
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2007 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Xenical + behavioral intervention
|
Drug: Xenical + behavioral intervention
120 mg TID; Behavioral weight loss in Spanish
|
|
2: Active Comparator
Placebo + behavioral intervention
|
Behavioral: Behavioral intervention + placebo
Behavioral weight loss treatment in Spanish Placebo TID
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Luis M Anez, PsyD | 203-789-7812 | Luis.Aneznava@yale.edu |
| Contact: Manuel Paris, PsyD | 203-789-7812 | Manuel.Paris@yale.edu |
| United States, Connecticut | |
| Hispanic Clinic of the Connecticut Mental Health Center | Recruiting |
| New Haven, Connecticut, United States, 06511 | |
| Contact: Luis M Anez, PsyD 203-789-7812 | |
| Contact: Manuel Paris, PsyD 203-789-7812 | |
| Sub-Investigator: Luis M Anez, PsyD | |
| Sub-Investigator: Manuel Paris, PsyD | |
| Yale Department of Psychiatry | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Principal Investigator: Carlos M Grilo, PhD | |
| Sub-Investigator: Marney A White, PhD | |
| Principal Investigator: | Carlos M Grilo, PhD | Yale University |
More Information
| Responsible Party: | Yale University School of Medicine ( Carlos M. Grilo, PhD ) |
| Study ID Numbers: | DF-06-018 |
| Study First Received: | August 15, 2007 |
| Last Updated: | April 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00516919 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Obesity Binge Eating Monolingual Hispanic Persons Orlistat Behavioral Weight Loss Treatment |
|
Obesity Signs and Symptoms, Digestive Overweight Hyperphagia Body Weight Anti-Obesity Agents Bulimia Nervosa Signs and Symptoms |
Orlistat Mental Disorders Weight Loss Bulimia Body Weight Changes Nutrition Disorders Overnutrition Eating Disorders |
|
Obesity Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Enzyme Inhibitors Overweight Pharmacologic Actions Hyperphagia Body Weight Anti-Obesity Agents Bulimia Nervosa Signs and Symptoms |
Orlistat Mental Disorders Therapeutic Uses Bulimia Weight Loss Body Weight Changes Nutrition Disorders Overnutrition Central Nervous System Agents Eating Disorders |
