Clinical trial NCT06443814: Multicenter Trial of Meditation and Health Education for Cardiometabolic Disease in Black Women
Official title: A Clinical Trial on the Prevention of Coronary Artery Disease, Insulin Resistance and Hyperlipidemia in Black Women With Meditation and Health Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atherosclerotic Cardiovascular Disease
Metabolic Syndrome
Keywords: Meditation
Transcendental Meditation
Health Education
Prevention
Health Disparities
Women's Health
Lead sponsor: Maharishi International University
Sponsor class: OTHER
Collaborators: name: Morehouse School of Medicine
name: Howard University
First posted: 2024-06-05
Enrollment: 201
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a phase 2 randomized controlled trial of two behavioral interventions-Meditation and Health Education.
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Carotid intima-media thickness (CIMT)
timeFrame: 0 and 12 months
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: Before and after 12 months of intervention and follow up
measure: Insulin resistance
timeFrame: 0 and 12 months
measure: Lipids
timeFrame: 0 and 12 months
measure: Blood pressure
timeFrame: 0, 4 and 12 months
measure: Physical Activity
timeFrame: 0, 4 and 12 months
Other outcomes:
Locations:
city: Washington, DC
country: United States
facility: Howard University Heart Center
state: District of Columbia
city: Atlanta
country: United States
facility: Morehouse School of Medicine - Morehouse Medical Associates
state: Georgia
Study officials:
affiliation: Institute for Natural Medicine and Prevention, Maharishi International University
name: Linda Heaton
role: STUDY_DIRECTOR
References: