Metro Atlanta Heart Disease Study - II (MAHDS II)
This study has been completed.
Sponsor:
Morehouse School of Medicine
Information provided by:
Morehouse School of Medicine
ClinicalTrials.gov Identifier:
NCT01235702
First received: November 4, 2010
Last updated: NA
Last verified: March 2003
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 4, 2010 | ||||
| Last Updated Date | November 4, 2010 | ||||
| Start Date ICMJE | September 2002 | ||||
| Primary Completion Date | October 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
blood pressure [ Time Frame: 10/2002 - 11/2003 ] [ Designated as safety issue: No ] a 12-week behavior modification program was implemented to assess the effects of nutrition counseling, stress reduction education, and directed physical activity on African Americans at increased risk for cardiovascular disease. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
body weight [ Time Frame: 10/2002 - 11/2003 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Metro Atlanta Heart Disease Study - II (MAHDS II) | ||||
| Official Title ICMJE | Multiple CVD Risk Reduction in Adult African-Americans: A Pilot Study | ||||
| Brief Summary | A 12-week treatment/control trial was implemented to assess the effects of a multi component lifestyle program on improvements in body mass index, weight, perceived stress and blood pressure in African American men and women who were at increased risk for cardiovascular disease. It was hypothesized that treatment group would experience significant improvements when compared to the control group. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | African Americans With Hypertension. | ||||
| Intervention ICMJE | Behavioral: 12-week lifestyle modification | ||||
| 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 | 210 | ||||
| Completion Date | October 2003 | ||||
| Primary Completion Date | October 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: African American men and women aged >21 with elevated blood pressure and excess body weight who resided in metro Atlanta, GA. - Exclusion Criteria: Individuals with normal blood pressure and body weight, as well as those residing outside of metro Atlanta, GA. Individuals with psychological conditions were also excluded. - |
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| Gender | Both | ||||
| Ages | 21 Years to 65 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 Number ICMJE | NCT01235702 | ||||
| Other Study ID Numbers ICMJE | TS-0724 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sharon K Davis, PhD Director- Social Epidemiology Research Center, Morehouse School of Medicine | ||||
| Study Sponsor ICMJE | Morehouse School of Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Morehouse School of Medicine | ||||
| Verification Date | March 2003 | ||||
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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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