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CVD Risk Reduction Trial (COHRT)

University Health Network, Toronto logo

University Health Network, Toronto

Status

Completed

Conditions

Cardiovascular Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00473785
HSFO4857
HSFO Grant # 4857

Details and patient eligibility

About

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.

Full 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.

Enrollment

827 patients

Sex

All

Ages

35 to 74 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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