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Stress Reduction and Prevention of Hypertension in Blacks

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005748
First Posted: May 26, 2000
Last Update Posted: February 18, 2016
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.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To examine the role of Transcendental Meditation in stress reduction and prevention of hypertension in Blacks.

Condition
Cardiovascular Diseases Heart Diseases Hypertension

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: May 1998
Study Completion Date: April 2004
Detailed Description:

BACKGROUND:

African Americans suffer from disproportionate rates of hypertension and related cardiovascular morbidity and mortality due, at least in part, to excessive socioenvironmental and psychosocial stress. Furthermore, despite the substantial individual and population risk burden associated with high normal blood pressure (BP) in African Americans, there had been no controlled studies to evaluate stress reduction approaches in the primary prevention of hypertension targeted to this high risk group. Therefore, recent (mid 1990s) NIH and NIMH policy committees called for a new research focus on primary prevention of hypertension targeted to high risk populations-notably African Americans with high normal BP. In previous randomized controlled trials by the investigator, hypertension and psychosocial stress were significantly reduced in low SES African Americans who practiced stress reduction with the Transcendental Mediation (TM) program compared to relaxation or health education controls. In the most recent long-term trial, African Americans with borderline hypertension showed BP reductions that would be associated with a 17 percent decrease in prevalence of hypertension, a 15 percent reduction in stroke, and a 6 percent reduction in CHD in the population. These BP reductions compared favorably to decreases shown with sodium restriction and weight loss programs in other prevention trials. Also, pilot data from two clinical trials indicated that TM was associated with significantly lower cardiovascular morbidity and mortality in African Americans and in Caucasians with high BP over a 5-year and 15-year period, respectively.

DESIGN NARRATIVE:

A randomized controlled trial of stress reduction for the primary prevention of hypertension was conducted in African Americans with high normal BP. African American males and females (N-352, aged 21-75 years) with high normal BP (SBP 130-139 and/or DBP 85-89 mm Hg) were recruited from the African American Family Heart Health Plan at the Medical College of Wisconsin, Milwaukee, which housed the nation's largest registry of African Americans with known CVD risk factors. After baseline assessment, participants were randomized to either the TM program or to a matched health education control intervention. The primary outcome was change in clinic BP over a 12-month follow-up. Secondary outcomes included changes in ambulatory BP, hypertensive events, psychosocial stress and health behaviors. Also, a model of the pathways through which components of stressful experience affect high BP in African Americans was tested.

This study is described as a clinical trial. The summary statement states that it is not an NIH Phase III clinical trial.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00005748


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Robert Schneider Maharishi University
  More Information

ClinicalTrials.gov Identifier: NCT00005748     History of Changes
Other Study ID Numbers: 5056
R01HL060703 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: February 18, 2016
Last Verified: March 2005

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Heart Diseases
Vascular Diseases