Clinical trial NCT00473785: CVD Risk Reduction Trial
Official title: Community Outreach Heart Health and Risk Reduction Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Cardiovascular disease
Prevention
Lifestyle
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2007-05-15
Enrollment: 827
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Psychometric assessment of change in exercise, diet and smoking
timeFrame: Post-treatment and 6-month follow-up
Secondary outcomes:
measure: SBP, DBP, total cholesterol, HDL, LDL, triglycerides and 10-year absolute CVD risk
timeFrame: 6-month follow-up
measure: Psychometric assessment of symptoms of depression, psychological stress, and social support.
timeFrame: post-treatment and 6-month follow-up
Other outcomes:
Locations:
city: Owen Sound
country: Canada
facility: Grey-Bruce Health Unit
state: Ontario
city: Sudbury
country: Canada
facility: Laurentian University / Sudbury and District Health Unit
state: Ontario
city: Toronto
country: Canada
facility: University Health Network / Sunnybrook and Women's College Health Sciences Centre
state: Ontario
Study officials:
affiliation: University Health Network/University of Toronto
name: Robert P Nolan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grace SL, Barry-Bianchi S, Stewart DE, Rukholm E, Nolan RP. Physical activity behavior, motivational readiness and self-efficacy among Ontarians with cardiovascular disease and diabetes. J Behav Med. 2007 Feb;30(1):21-9. doi: 10.1007/s10865-006-9080-5. Epub 2006 Nov 16.