Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

NCT ID: NCT00010608

Last Updated: 2009-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases

Keywords

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CVD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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Transcendental Meditation program

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.

Group Type EXPERIMENTAL

Transcendental Meditation

Intervention Type BEHAVIORAL

a mantra meditation technique which originated from the Vedic tradition of India. It is practiced from 20 minutes twice a day sitting comfortably in a chair with eyes closed.

Health Education

A lifestyle modification program for improving diet, exercise, salt intake and substance use.

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

didactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake

Interventions

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Transcendental Meditation

a mantra meditation technique which originated from the Vedic tradition of India. It is practiced from 20 minutes twice a day sitting comfortably in a chair with eyes closed.

Intervention Type BEHAVIORAL

Health Education

didactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Howard University

OTHER

Sponsor Role collaborator

Morehouse College of Medicine

UNKNOWN

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Robert H. Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Health and Aging Studies

Locations

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Howard University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Morehouse School of Medicine

Atlanta, Georgia, United States

Site Status

Maharishi University of Management

Fairfield, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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P50AT000082-01

Identifier Type: NIH

Identifier Source: secondary_id

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P50AT000082-02

Identifier Type: NIH

Identifier Source: secondary_id

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P50AT000082-01P2

Identifier Type: NIH

Identifier Source: org_study_id

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