Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
3 other identifiers
interventional
196
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 cardiovascular-diseases
Started Oct 1999
Longer than P75 for phase_2 cardiovascular-diseases
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1999
CompletedFirst Submitted
Initial submission to the registry
February 2, 2001
CompletedFirst Posted
Study publicly available on registry
February 5, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedDecember 7, 2009
December 1, 2009
6.8 years
February 2, 2001
December 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography
one year
Study Arms (2)
Transcendental Meditation program
EXPERIMENTALA 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
ACTIVE COMPARATORA lifestyle modification program for improving diet, exercise, salt intake and substance use.
Interventions
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.
didactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Center for Complementary and Integrative Health (NCCIH)lead
- Howard Universitycollaborator
- Morehouse College of Medicinecollaborator
Study Sites (3)
Howard University Medical Center
Washington D.C., District of Columbia, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Maharishi University of Management
Fairfield, Iowa, 52557, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert H. Schneider, MD
Center for Health and Aging Studies
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 2, 2001
First Posted
February 5, 2001
Study Start
October 1, 1999
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
December 7, 2009
Record last verified: 2009-12