Stress Reduction and Hypertension Prevention in African Americans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-05-01

Study Completion Date

2005-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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High Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Meditation (Transcendental Meditation, TM) was employed as a lifestyle modification strategy compared to a health education control with exercise and dietary recommendations but with no stress management component

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

This is a single-blind randomized controlled trial with all data collection personnel and investigators blinded to subjects' treatment status. The study coordinator does not collect data but receives subjects assigned treatment and then to informs them of their treatment group

Study Groups

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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.

Group Type EXPERIMENTAL

Transcendental Meditation

Intervention Type BEHAVIORAL

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

Health Education

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

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

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

Interventions

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Health Education

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

Intervention Type BEHAVIORAL

Transcendental Meditation

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

Intervention Type BEHAVIORAL

Other Intervention Names

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lifestyle modification TM technique

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes