Yoga for Treating People at Risk for Diabetes or With Both HIV and Depression
| Tracking Information | |||||
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| First Received Date ICMJE | August 26, 2004 | ||||
| Last Updated Date | January 23, 2008 | ||||
| Start Date ICMJE | July 2004 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00090506 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Yoga for Treating People at Risk for Diabetes or With Both HIV and Depression | ||||
| Official Title ICMJE | Yoga, Health, and Meditation | ||||
| Brief Summary | The purpose of this study is to plan and develop an international collaboration for research on the health effects of yoga. This study will also determine the effects of yoga on people who are at an increased risk for developing diabetes and people with both HIV and depression. |
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| Detailed Description | In recent years, western health practitioners have become increasingly aware of the potential health benefits of yoga. This study will comprise two substudies that will evaluate the effects of yoga in two distinct populations. Participants in the first study will be people who are at risk for developing diabetes; participants in the second study will be people with both HIV and depression. All participants will practice yoga 3 to 6 days per week for 3 months. Blood collection will be done and weight and blood pressure measurements will be taken in study 1 participants; questionnaires will be used to measure depression and stress in study 2 participants. All study participants will be assessed at entry and at 3 and 6 months. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Yoga | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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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 | Completed | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Study 1 Participants:
Inclusion Criteria for Study 2 Participants:
Inclusion Criteria for All Participants:
Exclusion Criteria for Study 2 Participants:
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| Gender | Both | ||||
| Ages | 14 Years to 40 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | India | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00090506 | ||||
| Other Study ID Numbers ICMJE | R21 AT001942-01 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | January 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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