Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

Phase 2

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: Transcendental Meditation; Behavioral: Health Education

• Registration Number: NCT00010608
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Brief Summary

The purpose of this study is to evaluate the effectiveness of meditation in preventing of atherosclerotic cardiovascular disease (CVD) in postmenopausal, older African American women.

Detailed Description

Older African American women suffer from disproportionately high rates of cardiovascular (CVD) morbidity and mortality compared to white Americans. Numerous controlled studies suggest that this disparity is associated with chronic psychosocial and environmental stress. Research indicates that Transcendental Meditation (TM) may result in significant improvements in CVD risk factors in this high risk population.

Participants in this study will be randomly assigned to either active stress reduction with TM or health education control, both in addition to usual medical care, for 12 months. The primary outcome will be carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography. Secondary measures will include traditional CVD risk factors (blood pressure, serum glucose and insulin levels, obesity, and sedentary lifestyle), stress-related neurohormones (catecholamine metabolite and cortisol), psychosocial stress, and quality of life. The results of this trial will yield valuable new knowledge for the prevention of CVD through a CAM intervention in high risk older African American women.

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 2001-02-02
• Study First Submitted QC: 2001-02-02
• Study First Posted: 2001-02-05
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 196

Inclusion Criteria

• African American, self-identified
• Coronary artery disease (CAD/CHD) defined by laboratory examination or documented clinical history of: a)myocardial infarction; b) coronary revascularization procedure--CABG, PTCA; c) coronary angiography--at least one coronary artery with >50% stenosis
• Informed consent
• Written Permission of participant's referring physician

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcendental Meditation program	Transcendental Meditation	A mental technique for stress reduction which is natural, easy and effortless and is practiced sitting in a chair with eyes closed for 20 minutes twice a day.
Health Education	Health Education	A lifestyle modification program for improving diet, exercise, salt intake and substance use.

Primary Outcome Measures

Name	Time	Method
Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography	one year

Trial Locations

Locations (3)

Howard University Medical Center; 🇺🇸 Washington, Dc, District of Columbia, United States

Morehouse School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Maharishi University of Management; 🇺🇸 Fairfield, Iowa, United States