A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers

Summary

The primary aim of the proposed research is to examine the relationship of lifestyle changes to new dietary, biomedical, and cellular parameters among new enrollees entering the "Dr. Dean Ornish Program for Reversing Heart Disease program" at 5 selected sites. Specifically, the investigators will add assessments of emerging cardiac risk factors (e.g., high sensitivity C-reactive protein \[hsCRP\], fibrinogen, lipoprotein(a) \[Lp(a)\], small, dense LDL, apolipoprotein B \[apoB\], apolipoprotein A-I \[apo A1\], the apoB/apoA1 ratio, homocysteine \[Hcy\], B-type natriuretic peptide \[BNP\], oxidized LDL, fasting insulin and waist-to-hip ratio \[WHR\]), protective and pathogenic dietary markers (e.g., folate, carotenoids, trans fatty acids), and measures of social support and cognitive functioning to the already existing assessment variables in the Multisite Cardiac Lifestyle Intervention Program (MCLIP).

Hypothesis 1: Participation in the lifestyle program will not only be associated with favorable changes in standard coronary risk factors and quality of life, but also with improvements in emerging cardiac risk factors \[hsCRP, Hcy, BNP, fibrinogen, Lp(a), small, dense LDL, apoB, apoA1, oxidized LDL, fasting insulin, and abdominal obesity\] and psychosocial well-being (i.e., social support, and cognitive functioning).

Hypothesis 2: High intake of emerging protective dietary factors and low intake of emerging pathogenic dietary factors will be associated with improvements in both standard and emerging cardiac risk factors (e.g. Hcy, oxidized LDL).

Hypothesis 3: Degree of adherence to the lifestyle change program will be associated with differential improvement in standard coronary risk factors, emerging risk factors, cellular aging, and psychosocial variables.

Conditions

• Coronary Heart Disease
• Biomarkers of Cardiovascular Disease

Interventions

BEHAVIORAL

Dr. Dean Ornish Program for Reversing Heart Disease

Exercise: At least 3 hours of aerobic exercise per week, 30 minutes per session. Additionally, patients are asked to perform a minimum of 2 strength training sessions per week. Stress Management: Integrates stretching, relaxation, breathing techniques, meditation and guided imagery. Patients are asked to practice these techniques at least 1 hour per day. Diet: Approximately 10% daily calories from fat, 15% protein and 75% complex carbohydrates (low-fat, whole foods, primarily plant-based). Group Support: Weekly group support sessions provide social support to help patients adhere to and sustain the lifestyle-change program.

Sponsors & Collaborators

• Preventive Medicine Research Institute

  lead OTHER

Principal Investigators

• Edward Kersh, MD, FACC · St. Luke's Hospital/California Pacific Cardiovascular Medical Group, Inc

• Dean Ornish, MD · Preventive Medicine Research Institute

• Gerdi Weidner, PhD · Preventive Medicine Research Institute

• Nita Chainani-Wu, DMD, MS, PhD · Preventive Medicine Research Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2009-05-31

Completion

2009-05-31

Countries

• United States

Study Locations