Stress Reduction and Hypertension Prevention in African Americans (Milw2)

• ClinicalTrials.gov Identifier: NCT04821505
• Recruitment Status: Completed
• First Posted: March 29, 2021
• Last Update Posted: May 7, 2021
• Sponsor: Maharishi International University
• Collaborator: Medical College of Wisconsin
• Information provided by (Responsible Party): Robert Schneider, MD, Maharishi International University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
High Blood Pressure	Behavioral: Health Education; Behavioral: Transcendental Meditation	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 304 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: 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
• Primary Purpose: Prevention
• Official Title: Stress Reduction and Hypertension Prevention in African Americans
• Actual Study Start Date: May 1, 1998
• Actual Primary Completion Date: October 1, 2004
• Actual Study Completion Date: April 30, 2005

Arms and Interventions

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 Name: 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 Name: lifestyle modification

Outcome Measures

Primary Outcome Measures :

1. Blood pressure [ Time Frame: 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 :

1. Anger [ Time Frame: 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
2. Hypertensive events [ Time Frame: 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.
3. Heart rate [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Maharishi International University

Medical College of Wisconsin

Investigators

• Principal Investigator: Robert H Schneider, M.D.; Maharishi International University

More Information

• Responsible Party: Robert Schneider, MD, Director and Dean, Maharishi International University
• ClinicalTrials.gov Identifier: NCT04821505
• Other Study ID Numbers: HL60703-02
• First Posted: March 29, 2021
• Last Update Posted: May 7, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert Schneider, MD, Maharishi International University:

Blood pressure; Stress reduction; Meditation; lifestyle modification

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases