Multicenter Trial of Meditation and Health Education for Cardiometabolic Disease in Black Women

A Clinical Trial on the Prevention of Coronary Artery Disease, Insulin Resistance and Hyperlipidemia in Black Women With Meditation and Health Education

This randomized controlled trial compared the efficacy of stress reduction with meditation to a health education (HE) group in 201 older African American women over a one-year study period. They were randomly allocated to either of two behavioral treatment groups-the Transcendental Meditation (TM) program or a health education (HE) program. Participants were recruited, tested, and instructed at two clinical sites: Howard University Hospital, Washington, DC and Morehouse (School of Medicine) Healthcare, Atlanta, GA. Main outcome measures were carotid intima-media thickness, insulin resistance, and behavioral factors.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Atherosclerotic Cardiovascular Disease
• Intervention / Treatment: Behavioral: Transcendental Meditation; Behavioral: Health Education

Detailed Description

This was a randomized controlled trial that compared the effects of stress reduction using the Transcendental Meditation technique (TM) to a health education (HE) group in 201 African American women >55 years with CVD or at high CVD risk over a one-year intervention and follow-up period.

All participants were randomly allocated to either of two behavioral treatment groups-1) the Transcendental Meditation (TM) program or 2) a health education (HE) program of healthy diet, exercise and substance use control. Women participants were recruited, tested, and instructed at two sites:139 were recruited and randomized in Washington, DC and 61 in Atlanta, GA. Outcome measures were carotid intima-media thickness (IMT), insulin resistance, serum lipids, blood pressure and lifestyle (diet, exercise, substance use).

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, DC, District of Columbia, United States
      • Howard University Heart Center
  • Georgia
    • Atlanta, Georgia, United States
      • Morehouse School of Medicine - Morehouse Medical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• African American women,
• 55 years or older with at least one of the five cardiovascular conditions (below):

Either/or:

• coronary heart disease or
• positive coronary angiography or
• previous MI or
• coronary revascularization or
• percutaneous transluminal coronary angioplasty (PTCA).

OR a risk factor assessment score of at least two points based on the Framingham study/ATP III report. Risk factors included diabetes, high systolic or diastolic BP, high cholesterol, high LDL-low HDL or smoking.

Exclusion Criteria:

Recent (last 3 months):

• myocardial infarction
• unstable angina
• coronary artery by-pass grafting (CABG)
• percutaneous transluminal coronary angioplasty (PTCA)
• stroke within the preceding three months
• carotid artery endarterectomy
• atrial fibrillation
• second or third degree AV block
• heart failure
• clinically significant valvular heart disease
• major psychiatric disorders,
• current alcohol/dependency disorder
• other drug abuse dependency disorder
• non-cardiac life-threatening illness
• participating in a formal stress management program
• plans to move out of the study area or travel extensively
• unwillingness to accept randomization into any study group.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcendental Meditation; The TM technique is practiced for 20 minutes twice a day. Participants were instructed by a certified teacher in 7-step course to learn how to meditate according to previously standardized and validated procedures.	Behavioral: Transcendental Meditation; TM was taught in a standardized and validated format as a simple, natural mental technique practiced for 20 minutes twice a day (morning and evening) to give rest and relaxation to mind and body. TM was taught by a certified instructor and a 7-step process taking place over 4 consecutive days after which the meditator can practice at home twice a day.; Other Names: TM technique, TM
Active Comparator: Health Education; The health education group was matched for instructor time and attention to the TM group. The classroom-based health education group received AHA-based guidelines for healthy diet, exercise and control of substance use. No stress management techniques are taught in this group.	Behavioral: Health Education; This was a didactic classroom-based control which educates the patient on adapting a healthier lifestyle through proper diet, exercise, and moderating substance usage according to current AHA guidelines. This intervention does not include a stress management component.; Other Names: HE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotid intima-media thickness (CIMT)	B mode ultrasound measurement of carotid artery wall thickness	0 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	Exercise --using the Folsom Physical Activity Questionaire	0, 4 and 12 months
Hemoglobin A1c	Hb1c as surrogate endpoint for diabetes	Before and after 12 months of intervention and follow up
Insulin resistance	HOMA index utilizing glucose and insulin levels at timed intervals	0 and 12 months
Lipids	fasting levels of serum LDL, HDL, TC, TG	0 and 12 months
Blood pressure	measured three times with a mercury sphygmomanometer 5 minutes apart and last two reading averaged	0, 4 and 12 months

Collaborators and Investigators

• Sponsor: Robert Schneider, MD
• Collaborators: Howard University; Morehouse School of Medicine
• Investigators: Study Director: Linda Heaton, Institute for Natural Medicine and Prevention, Maharishi International University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2001
• Primary Completion (Actual): November 1, 2004
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Prevention; Meditation; Health Education; Women's Health; Health Disparities; Transcendental Meditation
• Additional Relevant MeSH Terms: Vascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Metabolic Syndrome; Atherosclerosis
• Other Study ID Numbers: 1P50AT000082-03 (U.S. NIH Grant/Contract); 1P50AT000082 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No