CVD Risk Reduction Trial (COHRT)

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00473785
First received: May 11, 2007
Last updated: May 14, 2007
Last verified: May 2007
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Community Outreach Heart Health and Risk Reduction Trial

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Psychometric assessment of change in exercise, diet and smoking [ Time Frame: Post-treatment and 6-month follow-up ]

Secondary Outcome Measures:
  • SBP, DBP, total cholesterol, HDL, LDL, triglycerides and 10-year absolute CVD risk [ Time Frame: 6-month follow-up ]
  • Psychometric assessment of symptoms of depression, psychological stress, and social support. [ Time Frame: post-treatment and 6-month follow-up ]

Enrollment: 827
Study Start Date: January 2002
Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   35 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473785

Locations
Canada, Ontario
Grey-Bruce Health Unit
Owen Sound, Ontario, Canada, N4K 4K5
Laurentian University / Sudbury and District Health Unit
Sudbury, Ontario, Canada, P3E 2C6
University Health Network / Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Robert P Nolan, PhD University Health Network/University of Toronto
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00473785     History of Changes
Other Study ID Numbers: HSFO4857, HSFO Grant # 4857
Study First Received: May 11, 2007
Last Updated: May 14, 2007
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Cardiovascular disease
Prevention
Lifestyle

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014