Creating African-American Wellness Through Exercise
Tracking Information | |||||
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First Received Date ICMJE | March 23, 2009 | ||||
Last Updated Date | April 11, 2012 | ||||
Start Date ICMJE | June 2009 | ||||
Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in depression severity, as measured by the Depression Scale of the Patient Health Questionnaire (PHQ-9) [ Time Frame: Week 1 (pre-test) and week 6 (post-test) ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00867776 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Creating African-American Wellness Through Exercise | ||||
Official Title ICMJE | Creating African-American Wellness Through Exercise: Community Driven Strategies to Improve Health | ||||
Brief Summary | The purpose of this study is to pilot-test a culturally-tailored, community-based educational program for African-Americans, focusing on how to use exercise and other self-management strategies to reduce depressive symptoms and improve health. This study will explore what type of additional support would encourage depressed African-Americans to exercise regularly. The investigators hypothesize that participants will report greater frequency of exercise and lower depression scores at the end of the program than they did at baseline. However, this study is not adequately powered to test this hypothesis - the main goal is to assess feasibility, acceptability and satisfaction of the pilot intervention. |
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Detailed Description | Several studies have documented the effectiveness of exercise as a treatment for depression. However, these studies have used supervised exercise in medical school or university environments and have included mostly middle-class White populations. Little is known regarding how to translate these findings to real world settings or to minority populations. Exercise may be a particularly beneficial option for African-Americans suffering from depression. African-Americans face significant disparities in depression care. At least a part of these disparities are due to lack of trust in the healthcare system and negative attitudes toward antidepressants. Our goal is to pilot-test a culturally-tailored, community-based exercise support program for depressed African-Americans. We will recruit participants who screened positive for moderate depressive symptoms when they enrolled in the African-American Health Coalition's Free Exercise Card Program, but who are exercising less than 3 times per week. They will participate in a 6-week educational self-care group focusing on how to use exercise and other self-help tools to reduce depressive symptoms. Participants will be encouraged to create action plans regarding exercise and other healthy lifestyle changes. Groups will also provide culturally-tailored information about depression therapies, such as antidepressants and psychotherapy, and discuss strategies for obtaining quality health care. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
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Condition ICMJE | Depression | ||||
Intervention ICMJE | Behavioral: AAHC Exercise Program Support Group
6-week community-based, culturally tailored support group program, focusing on exercise and healthy lifestyle habits. Groups will also include basic psychoeducation about depression and depression care. Groups will have up to 20 participants and will meet weekly for 2 hours. By the end of the program, participants will be encouraged to create a personalized action plan focusing on exercise and other healthy lifestyle choices.
Other Names:
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Study Arm (s) | Experimental: 6 Week Support group
Intervention: Behavioral: AAHC Exercise Program Support Group |
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Publications * | |||||
* 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 | Suspended | ||||
Estimated Enrollment ICMJE | 40 | ||||
Estimated Completion Date | May 2013 | ||||
Estimated Primary Completion Date | May 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 | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00867776 | ||||
Other Study ID Numbers ICMJE | IRB00005105 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Christina M. Nicolaidis, Oregon Health and Science University | ||||
Study Sponsor ICMJE | Oregon Health and Science University | ||||
Collaborators ICMJE | African American Health Coalition | ||||
Investigators ICMJE |
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Information Provided By | Oregon Health and Science University | ||||
Verification Date | April 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |