MedTrace Logo

Multicenter Trial of Meditation and Health Education for Cardiometabolic Disease in Black Women

NCT06443814 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2025-05-31

No results posted yet for this study

Summary

This randomized controlled trial compared the efficacy of stress reduction with meditation to a health education (HE) group in 201 older African American women over a one-year study period. They were randomly allocated to either of two behavioral treatment groups-the Transcendental Meditation (TM) program or a health education (HE) program. Participants were recruited, tested, and instructed at two clinical sites: Howard University Hospital, Washington, DC and Morehouse (School of Medicine) Healthcare, Atlanta, GA. Main outcome measures were carotid intima-media thickness, insulin resistance, and behavioral factors.

Conditions

Interventions

BEHAVIORAL

Health Education

This was a didactic classroom-based control which educates the patient on adapting a healthier lifestyle through proper diet, exercise, and moderating substance usage according to current AHA guidelines. This intervention does not include a stress management component.

BEHAVIORAL

Transcendental Meditation

TM was taught in a standardized and validated format as a simple, natural mental technique practiced for 20 minutes twice a day (morning and evening) to give rest and relaxation to mind and body. TM was taught by a certified instructor and a 7-step process taking place over 4 consecutive days after which the meditator can practice at home twice a day.

Sponsors & Collaborators

  • Morehouse School of Medicine

    collaborator OTHER

  • Howard University

    collaborator OTHER

  • Robert Schneider, MD

    lead OTHER

Principal Investigators

  • Linda Heaton · Institute for Natural Medicine and Prevention, Maharishi International University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2004-11-30
Completion
2004-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06443814 on ClinicalTrials.gov