NCT04821505

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 1998

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1998

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2005

Completed
15.9 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

6.4 years

First QC Date

March 17, 2021

Last Update Submit

May 4, 2021

Conditions

High Blood Pressure

Keywords

Blood pressureStress reductionMeditationlifestyle modification

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Anger

    baseline 0 to 36 months after baseline

  • Hypertensive events

    baseline 0 to 36 months after baseline

  • Heart rate

    baseline 0 to 36 months after baseline

Study Arms (2)

Meditation

EXPERIMENTAL

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

Health Education

ACTIVE COMPARATOR

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

Behavioral: Health Education

Interventions

Health EducationBEHAVIORAL

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

Also known as: lifestyle modification
Health Education
Transcendental MeditationBEHAVIORAL

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

Also known as: TM technique
Meditation

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Meditation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Robert H Schneider, M.D.

    Maharishi International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Dean

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 29, 2021

Study Start

May 1, 1998

Primary Completion

October 1, 2004

Study Completion

April 30, 2005

Last Updated

May 7, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share