NCT05642936

RCT of Meditation and Health Education on CIMT and MACE in Black Women and Men

A Randomized Controlled Trial of Meditation and Health Education on Carotid Intima-Media Thickness and Major Adverse Cardiovascular Events in Black Women and Men

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Maharishi International University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
BEHAVIORAL	didactic health education control	didactic classroom-based comparison group that follows standard guidelines for diet, exercise and substance use with no stress reduction component
BEHAVIORAL	Transcendental Meditation technique	a mental technique derived from the Vedic tradition of ancient India and practiced by anyone for 20 minutes twice a day sitting

Timeline

• Start date: 2000-10-01
• Primary completion: 2005-07-01
• Completion: 2014-12-31
• First posted: 2022-12-08
• Last updated: 2025-05-30