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| Tracking Information | |||||
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| First Received Date ICMJE | March 9, 2004 | ||||
| Last Updated Date | August 16, 2006 | ||||
| Start Date ICMJE | July 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00079573 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Popular Weight Loss Diets | ||||
| Official Title ICMJE | Benefits & Risks of Popular Weight Loss Diets | ||||
| Brief Summary | This study will compare the safety and effectiveness of three popular weight loss plans. These plans will be compared with the USDA Dietary Guidelines. |
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| Detailed Description | Obesity is the single most significant, nutrition-related health issue of the new millennium. Several “medical experts” have designed and promoted weight loss diets that dramatically differ from one another and from the USDA Dietary Guidelines. These diets have gained surprisingly widespread and persistent popularity among Americans despite the lack of evidence supporting their claims. This clinical trial will provide preliminary feasibility data for a full-scale study that will examine health outcomes (e.g., benefits, risks, success) of three popular weight loss diets. The study will investigate behavioral and physiological factors that influence adherence and retention to these diet plans. Overweight women will be randomly assigned to one of four diets for 1 year: Atkins (extremely low carbohydrate), Zone (low carbohydrate, high protein), Ornish (very low fat), or USDA/Food Pyramid (high carbohydrate/moderate-low fat). Behavioral and physiological data will be collected. Participants attend study visits at baseline, 8 weeks, 6 months, and 1 year. At these visits, measurements will include that will include weight and blood pressure measurements and blood tests. Participants will be asked to complete ten questionnaires over the course of the study to assess behavior and appetite. Participants will also undergo a DEXA scan to assess body composition. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Gardner CD, Kiazand A, Alhassan S, Kim S, Stafford RS, Balise RR, Kraemer HC, King AC. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial. JAMA. 2007 Mar 7;297(9):969-77. | ||||
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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 | 300 | ||||
| Completion Date | June 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Female | ||||
| Ages | 30 Years to 50 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 | NCT00079573 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R21 AT001098-01A1 | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | Community Foundation of Southeastern Michigan | ||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | August 2006 | ||||
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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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