Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

December 4, 2009 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, Dc, District of Columbia, United States
        • Howard University Medical Center
    • Georgia
      • Atlanta, Georgia, United States
        • Morehouse School of Medicine
    • Iowa
      • Fairfield, Iowa, United States, 52557
        • Maharishi University of Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborators

Howard University
Morehouse College of Medicine

Investigators

  • Principal Investigator: Robert H. Schneider, MD, Center for Health and Aging Studies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

February 2, 2001

First Posted (Estimate)

February 5, 2001

Study Record Updates

Last Update Posted (Estimate)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 4, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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