Stress Reduction and Hypertension Prevention in African Americans (Milw2)

Maharishi International University

Status and phase: Completed; Phase 2

Conditions: High Blood Pressure

Treatments: Behavioral: Health Education; Behavioral: Transcendental Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT04821505

HL60703-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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304 participants in 2 patient groups

Meditation

Experimental group

Description:

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.

Treatment:

Behavioral: Transcendental Meditation

Health Education

Active Comparator group

Description:

Health education program matched to the experimental intervention for time, attention, and other non-specific factors.

Treatment:

Behavioral: Health Education