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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 4, 2005 | ||||||||
| Last Updated Date | April 10, 2007 | ||||||||
| Start Date ICMJE | November 2005 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Weight Loss | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00249340 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Brief Behavioral Weight Loss Treatment vs. Weight Watchers | ||||||||
| Official Title ICMJE | Comparison of a Brief Behavioral Weight Loss Intervention With the Weight Watchers Program | ||||||||
| Brief Summary | The purpose of this study is to compare the effectiveness of Weight Watchers, brief behavioral treatment, and a combination treatment. We hypothesize that a combination treatment will achieve greater weight losses than Weight Watchers alone. |
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| Detailed Description | Weight Watchers is a popular nonmedical commercial weight loss program. Recent studies suggest that people enrolled in Weight Watchers lose approximately 3-5 kg in 6 months of treatment. These outcomes are substantially lower than average weight losses achieved in 6 months if university/hospital-based standard behavioral treatment (approximately 10 kg). However, standard behavioral weight loss programs are expensive and have limited accessibility to most people seeking weight loss. Therefore, the purpose of the current study is to investigate whether enhancing Weight Watchers by adding an 8-week group-based behavioral weight loss program prior to participation in Weight Watchers will improve weight loss outcomes at 6 months. Comparison: 6 months of Weight Watchers vs. combination treatment (2 months of standard behavioral weight loss treatment followed by 4 months of Weight Watchers) vs. 2 months of standard behavioral treatment. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| 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 | Completed | ||||||||
| Enrollment ICMJE | 60 | ||||||||
| Completion Date | July 2006 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Age 21-65 years BMI 27-45 kg/m2 Able to sign informed consent Exclusion Criteria: Women who are pregnant, nursing, less than 6 months postpartum, or plan to become pregnant during course of study Individuals who report a medical condition that would affect the safety and/or efficacy of a weight management program involving dietary change and physical activity (e.g., heart disease, cancer) Individuals with major psychiatric illness that would interfere with protocol adherence Individuals who are currently participating in a weight loss program or taking weight loss medication or lost >=5% of body weight during 6 months prior to screening Recent (within the past 12 months) participation in Weight Watchers |
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| Gender | Both | ||||||||
| Ages | 21 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00249340 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 2076-05 | ||||||||
| Study Sponsor ICMJE | The Miriam Hospital | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | The Miriam Hospital | ||||||||
| Verification Date | August 2005 | ||||||||
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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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