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

Robert Schneider, MD

Status and phase: Completed; Phase 2

Conditions: Atherosclerotic Cardiovascular Disease; Metabolic Syndrome

Treatments: Behavioral: Health Education; Behavioral: Transcendental Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT06443814

1P50AT000082-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 201 patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 2 patient groups

Transcendental Meditation

Experimental group

Description:

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.

Treatment:

Behavioral: Transcendental Meditation

Health Education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Education