Trial of Meditation for Cardiometabolic Disease in Older Black Women
- Conditions
- Metabolic SyndromeAtherosclerotic Cardiovascular Disease
- Interventions
- Behavioral: Transcendental MeditationBehavioral: Health Education
- Registration Number
- NCT06443814
- Lead Sponsor
- Robert Schneider, MD
- Brief 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.
- Detailed Description
This was a randomized controlled trial that compared the effects of stress reduction using the Transcendental Meditation technique (TM) to a health education (HE) group in 201 African American women \>55 years with CVD or at high CVD risk over a one-year intervention and follow-up period.
All participants were randomly allocated to either of two behavioral treatment groups-1) the Transcendental Meditation (TM) program or 2) a health education (HE) program of healthy diet, exercise and substance use control. Women participants were recruited, tested, and instructed at two sites:139 were recruited and randomized in Washington, DC and 61 in Atlanta, GA. Outcome measures were carotid intima-media thickness (IMT), insulin resistance, serum lipids, blood pressure and lifestyle (diet, exercise, substance use).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 201
- African American women,
- 55 years or older with at least one of the five cardiovascular conditions (below):
Either/or:
- coronary heart disease or
- positive coronary angiography or
- previous MI or
- coronary revascularization or
- percutaneous transluminal coronary angioplasty (PTCA).
OR a risk factor assessment score of at least two points based on the Framingham study/ATP III report. Risk factors included diabetes, high systolic or diastolic BP, high cholesterol, high LDL-low HDL or smoking.
Recent (last 3 months):
- myocardial infarction
- unstable angina
- coronary artery by-pass grafting (CABG)
- percutaneous transluminal coronary angioplasty (PTCA)
- stroke within the preceding three months
- carotid artery endarterectomy
- atrial fibrillation
- second or third degree AV block
- heart failure
- clinically significant valvular heart disease
- major psychiatric disorders,
- current alcohol/dependency disorder
- other drug abuse dependency disorder
- non-cardiac life-threatening illness
- participating in a formal stress management program
- plans to move out of the study area or travel extensively
- unwillingness to accept randomization into any study group.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcendental Meditation Transcendental Meditation The TM technique is practiced for 20 minutes twice a day. Participants were instructed by a certified teacher in 7-step course to learn how to meditate according to previously standardized and validated procedures. Health Education Health Education The health education group was matched for instructor time and attention to the TM group. The classroom-based health education group received AHA-based guidelines for healthy diet, exercise and control of substance use. No stress management techniques are taught in this group.
- Primary Outcome Measures
Name Time Method carotid intima-media thickness (CIMT) 0 and 12 months B mode ultrasound measurement of carotid artery wall thickness
- Secondary Outcome Measures
Name Time Method blood pressure 0, 4 and 12 months measured three times with a mercury sphygmomanometer 5 minutes apart and last two reading averaged
insulin resistance 0 and 12 months HOMA index utilizing glucose and insulin levels at timed intervals
Substance use 0, 4 and 12 months questionnaire for alcohol and illicit drug usage
lipids 0 and 12 months fasting levels of serum LDL, HDL, TC, TG
Dietary habits 0, 4 and 12 months block diet questionaire (food choice with pictures) not scaled to indicate a better or worse outcome)
Physical Activity 0, 4 and 12 months Exercise --using the Folsom Physical Activity Questionaire