Stress Reduction and Hypertension Prevention in African Americans (Milw2)

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.

Study Overview

• Status: Completed
• Conditions: High Blood Pressure
• Intervention / Treatment: Behavioral: Transcendental Meditation; Behavioral: Health Education

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.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Transcendental Meditation; TM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation.; Other Names: TM technique
Active Comparator: Health Education; Health education program matched to the experimental intervention for time, attention, and other non-specific factors.	Behavioral: Health Education; didactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use.; Other Names: lifestyle modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Both systolic and diastolic BP are measured using standard clinical trial technique recommended by the American Heart Association (AHA)	baseline 0 to 36 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	baseline 0 to 36 months after baseline

Collaborators and Investigators

• Sponsor: Maharishi International University
• Collaborators: Medical College of Wisconsin
• Investigators: Principal Investigator: Robert H Schneider, M.D., Maharishi International University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 1998
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): April 30, 2005

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Meditation; Blood pressure; Stress reduction; lifestyle modification
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HL60703-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No