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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 13, 2009 | ||||||||
| Last Updated Date | August 3, 2011 | ||||||||
| Start Date ICMJE | August 2009 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
weight loss and maintenance of weight loss [ Time Frame: 0,3,6,12,18 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00960414 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons | ||||||||
| Official Title ICMJE | Supporting Health by Integrating Nutrition and Exercise (SHINE) | ||||||||
| Brief Summary | The purpose of this study is to compare two approaches to a diet and exercise-based weight loss program. |
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| Detailed Description | The high prevalence of obesity and its medical consequences make it one of the most important public health issues in the United States today. Few interventions have been consistently successful at reducing obesity. This trial will test an intervention program that lasts 22 weeks, with 16 evening sessions and one weekend day. Participants will be randomized to one of two arms. Both arms will receive diet and exercise intervention elements. The study aims for gradual weight loss, with a calorie target that will maintain ideal body weight, rather than a more calorie restricted diet. The exercise component is based around increasing walking. The arms will compare methods for producing long-lasting behavior change. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase II | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Obesity | ||||||||
| Intervention ICMJE | Behavioral: SHINE
Both groups will receive a diet and exercise based intervention aimed at eating a caloric intake that will maintain ideal body weight and increasing exercise. SHINE A will emphasize awareness of hunger and satiety cues, while SHINE B will receive more detained nutritional education. |
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| Study Arms |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | April 2013 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00960414 | ||||||||
| Other Study ID Numbers ICMJE | P01 AT005013, P01AT005013, NIH P01 AT005013 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Frederick Hecht, MD, UCSF | ||||||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||||||
| Collaborators ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||||||
| Verification Date | August 2011 | ||||||||
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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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