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
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Behavioral: Transcendental Meditation Behavioral: Health Education||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women|
|Study Start Date :||October 1999|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
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
- Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography [ Time Frame: one year ]
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|
|Principal Investigator:||Robert H. Schneider, MD||Center for Health and Aging Studies|