An interventional study of CRC lifestyle modification program in Cardiovascular Disease, Coronary Artery Disease and Hypertension, sponsored by Windber Research Institute. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-05-13.
Sponsored by Windber Research Institute · Not applicable, Interventional, and Prevention
This study was a prospective, randomized trial designed to investigate the efficacy of moderate lifestyle modification for improving the clinical status of patients with coronary artery disease or patients with risk factors that promote coronary artery disease.
The main hypothesis to be tested in the Cardiovascular Risk Clinic was: Can individualized therapeutic lifestyle plans in conjunction with molecular analysis lead to informative assessments of disease risk that can reduce risk factors for diabetes and cardiovascular disease.
Our main objectives were:
A. To investigate the effect of lifestyle modification on: (1) physiological measurements of coronary artery disease (CAD) including carotid intima-media thickness (CIMT), exercise stress tests, blood pressure, body mass index (BMI), and weight; (2) plasma markers associated with development of CAD such as lipids and triglycerides; and (3) molecular characteristics such as gene expression signatures and protein profiles.
B. To determine if patients with heart disease or risk factors that would promote heart disease can achieve and adhere to the goals of a lifestyle change program in a non-residential, out-patient setting.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 207 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Windber Research Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Inclusion Criteria: at least one known risk factor for cardiovascular disease:
Exclusion Criteria:
The intervention group participated in individualized therapeutic lifestyle plans to reduce cardiovascular risk. Participants were introduced to factors contributing to cardiovascular disease and met individually with a registered dietitian, exercise physiologist, stress management instructor, and psychologist to learn effective strategies for integrating healthy changes into their current lifestyle.
Behavioral: CRC lifestyle modification program
Control group received standard care from their primary physicians, but did not participate in any component of the lifestyle program or receive any information, advice, or counseling regarding healthy lifestyle behaviors.
Intervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk.
Body Mass Index
Change in BMI
Time frame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Blood Pressure
Change in systolic and diastolic BP
Time frame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Blood Lipids
Change in HDL, LDL, total cholesterol, and triglycerides
Time frame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
Exercise Capacity
Change in exercise capacity defined by Bruce score on an exercise treadmill test
Time frame: Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years
This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Windber Research Institute