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NCT Number: NCT06443814

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

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.

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Key information

Conditions

Atherosclerotic Cardiovascular Disease Adherence Interventions Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Glucose Metabolism Disorders Health Behavior Health Education Hyperinsulinism Insulin Resistance Medication Adherence Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Howard University Heart Center, Washington D.C., District of Columbia, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health Education

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.

Other names: HE

Transcendental Meditation

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.

Other names: TM technique, TM

Primary outcomes

  1. Carotid intima-media thickness (CIMT)

    Time frame: 0 and 12 months

    B mode ultrasound measurement of carotid artery wall thickness

Secondary outcomes

  1. Hemoglobin A1c

    Time frame: Before and after 12 months of intervention and follow up

    Hb1c as surrogate endpoint for diabetes

  2. Insulin resistance

    Time frame: 0 and 12 months

    HOMA index utilizing glucose and insulin levels at timed intervals

  3. Lipids

    Time frame: 0 and 12 months

    fasting levels of serum LDL, HDL, TC, TG

  4. Blood pressure

    Time frame: 0, 4 and 12 months

    measured three times with a mercury sphygmomanometer 5 minutes apart and last two reading averaged

  5. Physical Activity

    Time frame: 0, 4 and 12 months

    Exercise --using the Folsom Physical Activity Questionaire

Sponsors and collaborators

Lead sponsor

Robert Schneider, MD

Other

Collaborators

  • Howard University
  • Morehouse School of Medicine

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Jun 5, 2024
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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