Stress Reduction and Hypertension Prevention in African Americans

High Blood Pressure Clinical Trial

— Milw2  

Official title:

Stress Reduction and Hypertension Prevention in African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821505
• Other study ID #: HL60703-02
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 1998
• Est. completion date: April 30, 2005

Study information

• Verified date: May 2021
• Source: Maharishi International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: April 30, 2005
• Est. primary completion date: October 1, 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Behavioral:
• Health Education
didactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use.
• Transcendental Meditation
TM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maharishi International University	Medical College of Wisconsin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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