Multicenter Trial of Meditation and Health Education for Cardiometabolic Disease in Black Women (NCT06443814) | Clinical Trial Compass
CompletedPhase 2
Multicenter Trial of Meditation and Health Education for Cardiometabolic Disease in Black Women
United States201 participantsStarted 2001-07
Plain-language 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.
Who can participate
Age range55 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.