Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005748
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Stress Reduction and Prevention of Hypertension in Blacks
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
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:
To examine the role of Transcendental Meditation in stress reduction and prevention of hypertension in Blacks
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 andor 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 nations 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
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 andor 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 nations 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL060703 | NIH | None | httpsreporternihgovquickSearchR01HL060703 |