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

NCT ID: NCT06443814

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31
• Study Completion Date: 2004-11-30

Brief Summary

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.

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).

Conditions

Atherosclerotic Cardiovascular Disease; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcendental Meditation

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

HE; TM technique, TM

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Morehouse School of Medicine

OTHER

Sponsor Role: collaborator

Howard University

OTHER

Sponsor Role: collaborator

Robert Schneider, MD

OTHER

Sponsor Role: lead

Responsible Party

Robert Schneider, MD

Director, Institute for Natural Medicine and Prevention

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Linda Heaton

Role: STUDY_DIRECTOR

Institute for Natural Medicine and Prevention, Maharishi International University

Locations

Howard University Heart Center

Washington D.C., District of Columbia, United States

Morehouse School of Medicine - Morehouse Medical Associates

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

1P50AT000082-03

Identifier Type: NIH

Identifier Source: org_study_id

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