Stress Reduction and Hypertension Prevention in African Americans
- Conditions
- High Blood Pressure
- Interventions
- Behavioral: Transcendental MeditationBehavioral: Health Education
- Registration Number
- NCT04821505
- Lead Sponsor
- Maharishi International University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meditation Transcendental Meditation The Transcendental Meditation program is described as a simple natural technique practiced for 20 minutes twice daily for deep rest and relaxation. Previous studies have shown its feasibility, validity, and reliability in Blacks at risk for CVD. Health Education Health Education Health education program matched to the experimental intervention for time, attention, and other non-specific factors.
- Primary Outcome Measures
Name Time Method Blood pressure 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 Outcome Measures
Name Time Method Heart rate baseline 0 to 36 months after baseline Heart rate (bpm) was measured manually by the technician/nurse who counted the subjects pulse in the right radial artery
Anger baseline 0 to 36 months after baseline Anger is measured using the Spielberger State-Trait scale (24 item, 4 pt likert response scale-'almost never to almost always'). Anger-in, anger-out and anger-total scores were recorded as secondary outcomes because anger has been reported to be associated with the progression of BP
Hypertensive events baseline 0 to 36 months after baseline Hypertensive events were defined as SBP ≥140 and/or DBP ≥90 mm Hg on two successive occasions or first prescribed use of antihypertensive medications.