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| Tracking Information | |||||
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| First Received Date ICMJE | December 6, 2006 | ||||
| Last Updated Date | June 20, 2008 | ||||
| Start Date ICMJE | May 2002 | ||||
| Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||
| 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 NCT00409422 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
planned to compare dieting with non-dieting approach in weight management group [ Time Frame: 6 months and 1 year ] | ||||
| Original Secondary Outcome Measures ICMJE |
planned to compare dieting with non-dieting approach in weight management group | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children | ||||
| Official Title ICMJE | Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children | ||||
| Brief Summary | To compare anthropometric and metabolic effects of a comprehensive weight management program on obese adolescents and children in comparison to regular clinical weight management visits. |
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| Detailed Description | Patients are randomized (2:1) to either the intensive or standard treatment (control). Those who get randomized into the intensive group go to a family-based weight management program, including exercise, nutrition, behavior modification, and parenting classes. The intensive group is further randomized into a diet or non-dieting class to compare the outcomes of two different nutrition intervention methods. These classes meet twice per week (exercise twice per week and nutrition/behavior modification once per week)for first six months and then only twice per month during last six months. An exercise physiologist supervises the exercise component, which involves 45 minutes of aerobic activity (targeted at 65 to 80 percent of the subject's estimated maximum heart rate. A registered dietitian facilitates the nutrition and behavior component. A social worker facilitates parent classes when the children have a behavior modification topic in their class (parents only attend nutrition sessions). Those who get randomized into the control group go to clinic visits every 6 months. Intervention subjects go to clinic, as well, every 6 months to obtain the same measurements as the controls (weight, BMI, % fat, fasting insulin, fasting glucose, lipids, blood pressure). |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: weight management program | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Savoye M, Shaw M, Dziura J, Tamborlane WV, Rose P, Guandalini C, Goldberg-Gell R, Burgert TS, Cali AM, Weiss R, Caprio S. Effects of a weight management program on body composition and metabolic parameters in overweight children: a randomized controlled trial. JAMA. 2007 Jun 27;297(24):2697-704. | ||||
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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 | 200 | ||||
| Completion Date | February 2007 | ||||
| Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Years to 16 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00409422 | ||||
| Responsible Party | Sonia Caprio, MD, Yale University School of Medicine | ||||
| Study ID Numbers ICMJE | HIC 15994 | ||||
| Study Sponsor ICMJE | Yale University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Yale University | ||||
| Verification Date | June 2008 | ||||
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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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