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
1 other identifier
interventional
201
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2001
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 13, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2024
CompletedMay 31, 2025
May 1, 2025
3.3 years
November 13, 2023
May 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Carotid intima-media thickness (CIMT)
B mode ultrasound measurement of carotid artery wall thickness
0 and 12 months
Secondary Outcomes (5)
Hemoglobin A1c
Before and after 12 months of intervention and follow up
Insulin resistance
0 and 12 months
Lipids
0 and 12 months
Blood pressure
0, 4 and 12 months
Physical Activity
0, 4 and 12 months
Study Arms (2)
Transcendental Meditation
EXPERIMENTALThe 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.
Health Education
ACTIVE 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- African American women,
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Robert Schneider, MDlead
- Morehouse School of Medicinecollaborator
- Howard Universitycollaborator
Study Sites (2)
Howard University Heart Center
Washington D.C., District of Columbia, United States
Morehouse School of Medicine - Morehouse Medical Associates
Atlanta, Georgia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Linda Heaton
Institute for Natural Medicine and Prevention, Maharishi International University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Investigators, data collectors and usual medical providers were blinded to participant treatment status. Participants in both intervention groups were given similar expectations of positive outcomes.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Institute for Natural Medicine and Prevention
Study Record Dates
First Submitted
November 13, 2023
First Posted
June 5, 2024
Study Start
July 1, 2001
Primary Completion
November 1, 2004
Study Completion
November 1, 2004
Last Updated
May 31, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share