Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 196
- Locations
- 3
- Primary Endpoint
- Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Transcendental Meditation (Behavioral)
Health Education
A lifestyle modification program for improving diet, exercise, salt intake and substance use.
Intervention: Health Education (Behavioral)
Outcomes
Primary Outcomes
Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography
Time Frame: one year
Secondary Outcomes
No secondary outcomes reported