Viewing Study NCT00010608



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Study NCT ID: NCT00010608
Status: COMPLETED
Last Update Posted: 2009-12-07
First Post: 2001-02-02

Brief Title: Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
Sponsor: National Center for Complementary and Integrative Health NCCIH
Organization: National Center for Complementary and Integrative Health NCCIH

Study Overview

Official Title: Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
Status: COMPLETED
Status Verified Date: 2009-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
P50AT000082-02 NIH None httpsreporternihgovquickSearchP50AT000082-02
P50AT000082-01 NIH None None