Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005748 |
| Other study ID # |
5056 |
| Secondary ID |
R01HL060703 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
February 17, 2016 |
| Start date |
May 1998 |
| Est. completion date |
April 2004 |
Study information
| Verified date |
March 2005 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To examine the role of Transcendental Meditation in stress reduction and prevention of
hypertension in Blacks.
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.
