Stress Reduction and Hypertension Prevention in African Americans
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- High Blood Pressure
- Sponsor
- Maharishi International University
- Enrollment
- 304
- Primary Endpoint
- Blood pressure
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
There are major health disparities in Blacks associated with high blood pressure (BP) and psychosocial stress. We evaluated the effects of lifestyle modification with meditation in Black adults with high normal and normal blood pressure.
Participants (n=304) were randomized to either the Transcendental Meditation technique or Health Education control in addition to usual care for up to 36 months for BP and secondary outcomes.
Detailed Description
Background: Blacks suffer from disparities in hypertension, cardiovascular disease (CVD) and currently, coronavirus-19. These conditions are associated with social determinants of health and psychosocial stress. While previous trials demonstrated stress reduction lowering blood pressure in grade I range in Blacks, there is a paucity of clinical trial data in Blacks with high normal and normal BP. Objective: This randomized controlled trial was conducted to evaluate the effect of stress reduction with the Transcendental Meditation (TM) technique in Black adults with high normal BP and normal BP using International Society of Hypertension (ISH) definitions. Methods: A total of 304 Black adults with high normal (130-139/85-89 mm Hg) and normal BP (120-129/80-84 mm Hg) were randomized to either TM or health education (HE) arms. BP was recorded at 3, 6, 9, 12, 24, 30, and 36 months after baseline. Linear mixed model analysis was conducted to compare the BP change between TM and HE participants in the high-normal BP and normal-BP groups. Survival analysis for hypertensive events was conducted.
Investigators
Robert Schneider, MD
Director and Dean
Maharishi International University
Eligibility Criteria
Inclusion Criteria
- •self-identified Black women and men
- •no current antihypertensive medications
- •high normal BP (130-139 mm Hg and/or DBP 85-89 mm Hg) OR
- •normal BP (SBP 120-129 mm Hg and/DBP 80-84 mm Hg)
Exclusion Criteria
- •use of antihypertensive medications within the previous 2 months
- •history of CVD, ie, myocardial infarction, angina, peripheral artery disease, heart failure, stroke, or renal failure, diabetes, major psychiatric or substance use disorder other life-threatening illness
- •lack of signed a consent form
Outcomes
Primary Outcomes
Blood pressure
Time Frame: baseline 0 to 36 months after baseline
Both systolic and diastolic BP are measured using standard clinical trial technique recommended by the American Heart Association (AHA)
Secondary Outcomes
- Heart rate(baseline 0 to 36 months after baseline)
- Anger(baseline 0 to 36 months after baseline)
- Hypertensive events(baseline 0 to 36 months after baseline)