Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
207 participants
INTERVENTIONAL
2009-04-30
2013-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Lifestyle modification
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.
CRC lifestyle modification program
Intervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk.
Usual care controls
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.
No interventions assigned to this group
Interventions
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CRC lifestyle modification program
Intervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Walter Reed National Military Medical Center
FED
Windber Research Institute
OTHER
Responsible Party
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Principal Investigators
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Darrell L Ellsworth, PhD
Role: PRINCIPAL_INVESTIGATOR
Windber Research Institute
Locations
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Windber Research Institute
Windber, Pennsylvania, United States
Countries
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Related Links
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Windber Research Institute
Other Identifiers
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W81XWH-10-2-0080
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
08-07
Identifier Type: -
Identifier Source: org_study_id
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