Stress Reduction and Hypertension Prevention in African Americans

Maharishi International University304 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

304

Conditions

High Blood Pressure

Interventions

Health EducationBEHAVIORAL

didactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use.

Transcendental MeditationBEHAVIORAL

TM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Both systolic and diastolic BP are measured using standard clinical trial technique recommended by the American Heart Association (AHA)

Time frame: baseline 0 to 36 months after baseline

Secondary Outcomes

Anger

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

Time frame: baseline 0 to 36 months after baseline

Hypertensive events

Hypertensive events were defined as SBP ≥140 and/or DBP ≥90 mm Hg on two successive occasions or first prescribed use of antihypertensive medications.

Time frame: baseline 0 to 36 months after baseline

Heart rate

Heart rate (bpm) was measured manually by the technician/nurse who counted the subjects pulse in the right radial artery

Time frame: baseline 0 to 36 months after baseline

Data from ClinicalTrials.gov

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