Cardiovascular Disease, Coronary Artery Disease, Diabetes, Hypertension, Obesity
Conditions
Keywords
lifestyle modification, diet, exercise, cardiovascular disease, gene expression, obesity
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCRC lifestyle modification program
Intervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk.
Sponsors
Walter Reed National Military Medical Center
Windber Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
at least one known risk factor for cardiovascular disease: * Family history of CAD (first degree relative) * Physician-diagnosed diabetes or stroke * Overweight (BMI/=25) or obese (BMI\>/=30) * Total cholesterol \>/=200, documented history of hypercholesterolemia, or currently taking lipid lowering medications * History of smoking * HDL \</=44 mg/dl * LDL \>/=130 mg/dl or documented history of hyperlipidemia * Elevated triglycerides (\>/=200 mg/dl) * Hypertension (systolic blood pressure \>/=130 mmHg, diastolic blood pressure \>/=85 mmHg, documented diagnosis of hypertension, or currently taking antihypertensive medications) * Diabetes (fasting glucose \>/=100 mg/dl, physician diagnosis of diabetes/pre-diabetes, or currently taking anti-glycemic medications) * Post traumatic stress disorder (PTSD) or at risk for PTSD * Insomnia (five hours of sleep per night or less) or sleep apnea
Exclusion criteria
* Age \<18 years of age * Unstable coronary syndromes, refractory congestive heart failure, uncontrolled arrhythmia, or high-grade uncorrected cardiac conduction abnormalities * Any contraindication to components to Program, such as physical disabilities precluding stretching and aerobic exercise or medical conditions that preclude consumption of foods essential to Program diet * Inability or unwillingness to give consent * Significant left main stenosis (\>50%) or ejection fraction \<35% with no revascularization * History of substance abuse (including alcohol) without self-certification of abstinence for at least three months * Non-ambulatory (bedridden) individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years | Change in BMI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years | Change in systolic and diastolic BP |
| Blood Lipids | Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years | Change in HDL, LDL, total cholesterol, and triglycerides |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exercise Capacity | Baseline, 4-6 months, 1 year, 18 months, 2 years, 30 months, 3 years | Change in exercise capacity defined by Bruce score on an exercise treadmill test |
Countries
United States
Outcome results
None listed