The purpose of this study is to characterize changes in gene and protein expression in peripheral blood in patients with, or at risk for, heart disease during an intensive lifestyle modification program.
This project will use an integrated approach that examines DNA variation and the functional products of genes at both the messenger RNA (mRNA) and protein levels to provide a global view of molecular changes associated with drastic lifestyle modifications designed to reverse coronary heart disease (CHD). DNA variants and/or changes in gene and protein expression associated with CHD reversal may provide important clues to understanding molecular mechanisms of subclinical CHD development and progression.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
422
Prospective, nonrandomized clinical intervention to stabilize or reverse progression of heart disease through changes in lifestyle. Lifestyle intervention consisted of four components: 1) a very low fat vegetarian diet (\<10% of calories from fat); 2) 180 minutes/week of moderate aerobic exercise; 3) one hour of stress management each day; and 4) weekly group support sessions.
Windber Medical Center
Windber, Pennsylvania, United States
Change in body mass index
Change in BMI from baseline to 12 weeks and from baseline to 52 weeks
Time frame: Baseline, 12 weeks, 52 weeks
Change in blood pressure
Change in BP from baseline to 12 weeks and from baseline to 52 weeks
Time frame: Baseline, 12 weeks, 52 weeks
Change in lipids
Change in HDL-, LDL-, total cholesterol, and triglycerides from baseline to 12 weeks and from baseline to 52 weeks
Time frame: Baseline, 12 weeks, 52 weeks
Change in exercise capacity
Change in exercise capacity from baseline to 12 weeks and from baseline to 52 weeks
Time frame: Baseline, 12 weeks, 52 weeks
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