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Atherosclerotic Cardiovascular DiseasePhase 2NCT06443814

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

A Phase 2 study testing Health Education and Transcendental Meditation in people with Atherosclerotic Cardiovascular Disease and Metabolic Syndrome, run by Robert Schneider, MD at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older, women only
What is being tested?
Health Education and Transcendental Meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
2 sitesUnited States
Study dates
Jul 2001to Nov 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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 locations and contacts

2 sites in 1 country.

United States2 sites

  • Morehouse School of Medicine - Morehouse Medical Associates

    Atlanta, Georgia

  • Howard University Heart Center

    Washington D.C., District of Columbia

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
Health Education, Transcendental Meditation
Keywords
Meditation, Transcendental Meditation, Health Education, Prevention, Health Disparities, Women's Health
Medical subject headings
Atherosclerosis, Metabolic Syndrome, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health EducationBehavioural

    Also called HE

    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.

  • Transcendental MeditationBehavioural

    Also called TM technique, TM

    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.

Study groups in NCT06443814
Study groupRoleWhat they receive
Transcendental MeditationExperimentalThe 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.
Receives: Behavioral: Transcendental Meditation
Health EducationActive comparatorThe 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.
Receives: Behavioral: Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Carotid intima-media thickness (CIMT)

    B mode ultrasound measurement of carotid artery wall thickness

    Measured: 0 and 12 months

Secondary outcomes (5)

  1. Hemoglobin A1c

    Hb1c as surrogate endpoint for diabetes

    Measured: Before and after 12 months of intervention and follow up

  2. Insulin resistance

    HOMA index utilizing glucose and insulin levels at timed intervals

    Measured: 0 and 12 months

  3. Lipids

    fasting levels of serum LDL, HDL, TC, TG

    Measured: 0 and 12 months

  4. Blood pressure

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

    Measured: 0, 4 and 12 months

  5. Physical Activity

    Exercise --using the Folsom Physical Activity Questionaire

    Measured: 0, 4 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2024
  2. Study startJul 2001
  3. Primary completionNov 2004
  4. Study completionNov 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This was a phase 2 randomized controlled trial of two behavioral interventions-Meditation and Health Education.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06443814
Sponsor's protocol ID
1P50AT000082-03
Status last verified
May 2025
First submitted
13 Nov 2023
Last updated
31 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Health Education and Transcendental Meditation in people with Atherosclerotic Cardiovascular Disease and Metabolic Syndrome, run by Robert Schneider, MD at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Carotid intima-media thickness (CIMT) (time frame: 0 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06443814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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