Coronary Heart Disease Clinical Trial
Official title:
Coronary Events, Risk Factors, and Quality of Life in Men and Women Enrolled in Intensive Lifestyle Interventions - A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers
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.
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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