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Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00010608
Recruitment Status : Completed
First Posted : February 5, 2001
Last Update Posted : December 7, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Transcendental Meditation Behavioral: Health Education Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
Study Start Date : October 1999
Primary Completion Date : July 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: Health Education
A lifestyle modification program for improving diet, exercise, salt intake and substance use.
Behavioral: Health Education
didactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake

Outcome Measures

Primary Outcome Measures :
  1. Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010608

United States, District of Columbia
Howard University Medical Center
Washington, Dc, District of Columbia, United States
United States, Georgia
Morehouse School of Medicine
Atlanta, Georgia, United States
United States, Iowa
Maharishi University of Management
Fairfield, Iowa, United States, 52557
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Howard University
Morehouse College of Medicine
Principal Investigator: Robert H. Schneider, MD Center for Health and Aging Studies
More Information

ClinicalTrials.gov Identifier: NCT00010608     History of Changes
Other Study ID Numbers: P50AT000082-01P2 ( U.S. NIH Grant/Contract )
P50AT000082-01 ( U.S. NIH Grant/Contract )
P50AT000082-02 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2001    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):

Additional relevant MeSH terms:
Cardiovascular Diseases