CVD Risk Reduction Trial

Not Applicable

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT00473785
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-01
• Study Completion: 2005-12
• Status Verified: 2007-05
• Study First Submitted: 2007-05-11
• Study First Submitted QC: 2007-05-14
• Last Update Submitted: 2007-05-14
• Study First Posted: 2007-05-15
• Last Update Posted: 2007-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 827

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Psychometric assessment of change in exercise, diet and smoking	Post-treatment and 6-month follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Grey-Bruce Health Unit; 🇨🇦 Owen Sound, Ontario, Canada

Laurentian University / Sudbury and District Health Unit; 🇨🇦 Sudbury, Ontario, Canada

University Health Network / Sunnybrook and Women's College Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada