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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 15, 2007 | ||||||||
| Last Updated Date | July 6, 2009 | ||||||||
| Start Date ICMJE | August 2007 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Body weight / BMI [ Time Frame: 4 months and 6 month follow-up ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Body weight / BMI [ Time Frame: 4 months and 6 month follow-up ] | ||||||||
| Change History | Complete list of historical versions of study NCT00516919 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons | ||||||||
| Official Title ICMJE | Controlled Trial of Orlistat With Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons | ||||||||
| Brief Summary | 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00516919 | ||||||||
| Responsible Party | Carlos M. Grilo, PhD, Yale University School of Medicine | ||||||||
| Study ID Numbers ICMJE | DF-06-018 | ||||||||
| Study Sponsor ICMJE | Yale University | ||||||||
| Collaborators ICMJE | Donaghue Medical Research Foundation | ||||||||
| Investigators ICMJE |
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| Information Provided By | Yale University | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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