- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00010608
Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Older African American women suffer from disproportionately high rates of cardiovascular (CVD) morbidity and mortality compared to white Americans. Numerous controlled studies suggest that this disparity is associated with chronic psychosocial and environmental stress. Research indicates that Transcendental Meditation (TM) may result in significant improvements in CVD risk factors in this high risk population.
Participants in this study will be randomly assigned to either active stress reduction with TM or health education control, both in addition to usual medical care, for 12 months. The primary outcome will be carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography. Secondary measures will include traditional CVD risk factors (blood pressure, serum glucose and insulin levels, obesity, and sedentary lifestyle), stress-related neurohormones (catecholamine metabolite and cortisol), psychosocial stress, and quality of life. The results of this trial will yield valuable new knowledge for the prevention of CVD through a CAM intervention in high risk older African American women.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
District of Columbia
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Washington, Dc, District of Columbia, United States
- Howard University Medical Center
-
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Georgia
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Atlanta, Georgia, United States
- Morehouse School of Medicine
-
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Iowa
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Fairfield, Iowa, United States, 52557
- Maharishi University of Management
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- African American, self-identified
- Coronary artery disease (CAD/CHD) defined by laboratory examination or documented clinical history of: a)myocardial infarction; b) coronary revascularization procedure--CABG, PTCA; c) coronary angiography--at least one coronary artery with >50% stenosis
- Informed consent
- Written Permission of participant's referring physician
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transcendental Meditation program
A mental technique for stress reduction which is natural, easy and effortless and is practiced sitting in a chair with eyes closed for 20 minutes twice a day.
|
a mantra meditation technique which originated from the Vedic tradition of India.
It is practiced from 20 minutes twice a day sitting comfortably in a chair with eyes closed.
|
Active Comparator: Health Education
A lifestyle modification program for improving diet, exercise, salt intake and substance use.
|
didactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography
Time Frame: one year
|
one year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robert H. Schneider, MD, Center for Health and Aging Studies
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P50AT000082-01P2 (U.S. NIH Grant/Contract)
- P50AT000082-01 (U.S. NIH Grant/Contract)
- P50AT000082-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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