Cardiovascular Diseases Clinical Trial
Official title:
Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
The purpose of this study is to evaluate the effectiveness of meditation in preventing of atherosclerotic cardiovascular disease (CVD) in postmenopausal, older African American women.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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