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Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

This study has been completed.
Sponsor:
Collaborators:
Howard University
Morehouse College of Medicine
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010608
First received: February 2, 2001
Last updated: December 4, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Cardiovascular Diseases
 Behavioral: Transcendental Meditation
Behavioral: Health Education
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: October 1999
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010608

Locations
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 Alternative Medicine (NCCAM)
Howard University
Morehouse College of Medicine
Investigators
Principal Investigator: Robert H. Schneider, MD Center for Health and Aging Studies
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00010608     History of Changes
Other Study ID Numbers: P50 AT000082-01P2, P50AT000082-01, P50AT000082-02
Study First Received: February 2, 2001
Last Updated: December 4, 2009
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
CVD

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013