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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
197
didactic classroom-based comparison group that follows standard guidelines for diet, exercise and substance use with no stress reduction component
a mental technique derived from the Vedic tradition of ancient India and practiced by anyone for 20 minutes twice a day sitting
Carotid Intima Medial Thickness (CIMT)
This measure of wall thickness of the carotid artery was assessed by B-mode ultrasonography
Time frame: 12 months
blood pressure
systolic and diastolic BP technique. The three readings were taken one minute apart and then averaged for that visit.
Time frame: baseline, 3 and 12 months
lipid profile
blood tests or panel for cholesterol, LDL, HDL, and triglycerides
Time frame: baseline and 12 months
lifestyle factors
diet, exercise and substance use
Time frame: baseline, 3 and 12 months
major adverse cardiovascular events (MACE) - fatal and nonfatal
adverse clinical events - fatal and non-fatal
Time frame: one year
major adverse cardiovascular events (MACE) - fatal
deaths
Time frame: 12 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.