A Randomized Controlled Trial of Meditation and Health Education on Carotid Intima-Media Thickness and Major Adverse Cardiovascular Events in Black Women and Men
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 197
- Primary Endpoint
- Carotid Intima Medial Thickness (CIMT)
Study Overview
Brief Summary
This was a randomized, single-blind, controlled, community-based trial comparing the clinical efficacy of the Transcendental Meditation program on carotid intima-media thickness and major adverse cardiovascular events in 197 African American men and women at risk for atherosclerotic CVD. After baseline testing, participants were randomly assigned to either a stress reduction program (Transcendental Meditation) or a standard health education program. Follow up was conducted over one year and 12 years.
Detailed Description
This was a randomized, single-blind, controlled, community-based trial comparing the clinical efficacy of the Transcendental Meditation (TM) program carotid intima-media thickness and major adverse cardiovascular events (MACE) in 197 African American men and women at high risk for ASCVD. This trial compared the efficacy of the TM program to health education over one year on cIMT. Eligible participants were randomly allocated to either the TM program or health education (HE). The primary outcome was carotid intima-media thickness (IMT) assessed by B-mode ultrasonography at baseline and 12 months. Secondary outcomes were blood pressure, lipids, lifestyle, psychosocial stress and MACE. Fatal and nonfatal clinical events were assessed over one year, and mortality after 12 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description
All investigators and clinic staff were blinded to treatment assignment, except the project manager who did not collect data from participants. Primary care physicians were blinded to the treatment assignments of their patients. Since participants were necessarily aware of their treatment status.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •race/ethnicity: African American, self-identified, age: no upper limit, gender: male or female, minimum carotid artery intima medial thickness (IMT) of at least .72 mm for men and .65 mm for women or long-term history of diabetes, myocardial infarction, coronary artery revascularization or coronary angiography indicating at least one vessel with 50% stenosis.
Exclusion Criteria
- •myocardial infarction, unstable angina, CABG, percutaneous transluminal coronary angioplasty (PTCA), or stroke within the previous three months, carotid artery endarterectomy, arrhythmia - atrial fibrillation, second or third degree AV block, congestive heart failure - class III or IV or ejection fraction less than 30 %, clinically significant valvular heart disease, clinically significant hepatic or renal failure, major psychiatric disorders, current alcohol or other drug abuse dependency disorder, non-cardiac life-threatening illness, and participating in a formal stress management program
Arms & Interventions
Transcendental Meditation
The TM technique is a simple, natural, effortless mental procedure that is practiced 20 minutes twice a day while sitting comfortably with the eyes closed. During the practice, it is reported that ordinary thinking processes settle down, and a distinctive "wakeful hypometabolic" state characterized by neural coherence and physiological rest is gained. The TM technique was taught in a 7-step course of instruction consisting of six 1.5-2 hour individual and group meetings taught by a certified instructor.
Intervention: Transcendental Meditation technique (Behavioral)
Health Education
The control intervention was a cardiovascular health education program designed to match the format of the experimental intervention for instructional time, instructor attention, participant expectancy, social support, and other nonspecific factors. The classroom content was based on standard, published materials. The instructors were professional health educators.
Intervention: didactic health education control (Behavioral)
Outcomes
Primary Outcomes
Carotid Intima Medial Thickness (CIMT)
Time Frame: 12 months
This measure of wall thickness of the carotid artery was assessed by B-mode ultrasonography
Secondary Outcomes
- blood pressure(baseline, 3 and 12 months)
- lipid profile(baseline and 12 months)
- lifestyle factors(baseline, 3 and 12 months)
- major adverse cardiovascular events (MACE) - fatal and nonfatal(one year)
- major adverse cardiovascular events (MACE) - fatal(12 years)
Investigators
Robert Schneider, MD
Director and Professor, Institute for Natural Medicine and Prevention
Maharishi International University