CVD Risk Reduction Trial

Study Overview
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Brief Summary
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The purpose of this study is to provide lifestyle counselling for protective health behavior (exercise, diet, smoking cessation) to small groups (6-8 subjects) via teleconference. The sample includes individuals at elevated risk for cardiovascular disease (CVD) as well as individuals with established CVD. Our hypothesis is that telephone-based lifestyle counselling will (1) significantly increase protective lifestyle behavior (diet, exercise, smoke-free living) and (2) significantly reduce CVD risk factors at 6-month follow-up.

Detailed Description
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COHRT was a 2 parallel-group randomized controlled trial that was designed to assess the efficacy of a community outreach strategy for cardiovascular disease (CVD) risk reduction among individuals at elevated risk for CV events. Randomization was stratified for diagnosis of CHD, type 1 or 2 diabetes, sex, and clinical depression, and blocked within our northern, rural, and urban recruitment sites. A 2X3 mixed factorial design was utilized: 2 Groups (Usual Care, UC/Lifestyle Counselling,LC) X 3 Intervals (Baseline, post-treatment, 6-month follow-up). All subjects received personal CVD risk factor feedback and standardized handouts on heart healthy lifestyle change. The LC group received 6 weekly 1-hour sessions of lifestyle counseling that was provided via teleconference in small groups (4-8 persons). Group facilitators were trained in a manualized protocol of motivational interviewing that was designed for CVD risk reduction through lifestyle change. Weekly supervision was also provided. We hypothesized that the LC group (vs. UC) would significantly increase protective health behavior (exercise, diet, smoke-free living) at post-treatment and 6-month follow-up. The secondary hypothesis was that LC would significantly reduce (1) CVD risk factors, (SBP, DBP, total cholesterol, LDL cholesterol), (2) 10-year absolute risk among subjects without CVD, and (3) significantly increase quality of life as measured by symptoms of depression, psychological stress, and social support.

Official Title
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Community Outreach Heart Health and Risk Reduction Trial

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Group-based motivational interviewing
* Behavioral: Individual CVD-risk factor feedback
* Behavioral: Education for protective health behavior change


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 35 to 74 years of age, Diagnosis of CVD or Type 1 or 2 diabetes, or ≥2 of the following CVD risk factors: Confirmed diagnosis of hypertension, Dyslipidemia, Males aged ≥55 years/females aged ≥60 years, Family history of CHD or stroke; Current smoker, or BMI ≥ 27. Exclusion Criteria: Diagnosis of clinically significant cardiac complications (e.g. arrhythmia, unstable angina) or a congenital cardiac condition; Major psychiatric illness (e.g. psychosis), history of alcohol or drug dependence within the previous year, or residence in a non-private setting.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Group-based motivational interviewing|nan|
|Behavioral: Individual CVD-risk factor feedback|nan|
|Behavioral: Education for protective health behavior change|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometric assessment of change in exercise, diet and smoking |  | Post-treatment and 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SBP, DBP, total cholesterol, HDL, LDL, triglycerides and 10-year absolute CVD risk |  | 6-month follow-up | 
| Psychometric assessment of symptoms of depression, psychological stress, and social support. |  | post-treatment and 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular disease, Prevention, Lifestyle