NCT00010608

Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: National Center for Complementary and Integrative Health (NCCIH) · NIH
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
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.
BEHAVIORAL	Health Education	didactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake

Timeline

• Start date: 1999-10-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2001-02-05
• Last updated: 2009-12-07

Locations

3 sites across 1 country: United States