Multicenter Trial of Meditation and Health Education for Cardiometabolic Disease in Black Women
- Conditions
- Metabolic SyndromeAtherosclerotic Cardiovascular Disease
- 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
- 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 Hemoglobin A1c Before and after 12 months of intervention and follow up Hb1c as surrogate endpoint for diabetes
Insulin resistance 0 and 12 months HOMA index utilizing glucose and insulin levels at timed intervals
Lipids 0 and 12 months fasting levels of serum LDL, HDL, TC, TG
Blood pressure 0, 4 and 12 months measured three times with a mercury sphygmomanometer 5 minutes apart and last two reading averaged
Physical Activity 0, 4 and 12 months Exercise --using the Folsom Physical Activity Questionaire
Trial Locations
- Locations (2)
Howard University Heart Center
🇺🇸Washington, DC, District of Columbia, United States
Morehouse School of Medicine - Morehouse Medical Associates
🇺🇸Atlanta, Georgia, United States
Howard University Heart Center🇺🇸Washington, DC, District of Columbia, United States