Cardiovascular DiseaseCOHRTNCT00473785
CVD Risk Reduction Trial
A study testing Group-based motivational interviewing, Individual CVD-risk factor feedback and Education for protective health behavior change in people with Cardiovascular Disease, run by University Health Network, Toronto at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 74 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Group-based motivational interviewing, Individual CVD-risk factor feedback and Education for protective health behavior change
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 827 participants
- Where
- 3 sitesCanada
- Study dates
- Jan 2002to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- Family history of CHD or stroke;
- Current smoker, or
- BMI ≥ 27.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Canada3 sites
Laurentian University / Sudbury and District Health Unit
Greater Sudbury, Ontario, P3E 2C6
Grey-Bruce Health Unit
Owen Sound, Ontario, N4K 4K5
University Health Network / Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, M5G 2N2
About this study
Official title: Community Outreach Heart Health and Risk Reduction Trial
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Group-based motivational interviewing, Individual CVD-risk factor feedback, Education for protective health behavior change
- Keywords
- Cardiovascular disease, Prevention, Lifestyle
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based motivational interviewingBehavioural
Individual CVD-risk factor feedbackBehavioural
Education for protective health behavior changeBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric assessment of change in exercise, diet and smoking
Measured: Post-treatment and 6-month follow-up
Secondary outcomes (2)
SBP, DBP, total cholesterol, HDL, LDL, triglycerides and 10-year absolute CVD risk
Measured: 6-month follow-up
Psychometric assessment of symptoms of depression, psychological stress, and social support.
Measured: post-treatment and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startJan 2002
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 827 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Robert P Nolan, PhD, Principal investigator, University Health Network/University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473785
- Sponsor's protocol ID
- HSFO4857
- Other IDs
- HSFO Grant # 4857
- Acronym
- COHRT
- Status last verified
- May 2007
- First submitted
- 11 May 2007
- Last updated
- 15 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17109217
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Outreach Heart Health and Risk Reduction Trial
- ClinicalTrials.gov ID
- NCT00473785
- Acronym / sponsor ID
- COHRT / HSFO4857
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular disease, Prevention, Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 827 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Dec 2005 (actual)
- First posted
- 15 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 35 to 74 years of age,
- Diagnosis of CVD or Type 1 or 2 diabetes, or
- ≥2 of the following CVD risk factors:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based motivational interviewing | Behavioural | – |
| Individual CVD-risk factor feedback | Behavioural | – |
| Education for protective health behavior change | Behavioural | – |
Primary outcome
Psychometric assessment of change in exercise, diet and smoking
Time frame: Post-treatment and 6-month follow-up
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2007.
- Background: PubMed 17109217Grace 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P Nolan, PhD principal investigator
University Health Network/University of Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based motivational interviewing, Individual CVD-risk factor feedback and Education for protective health behavior change in people with Cardiovascular Disease, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric assessment of change in exercise, diet and smoking (time frame: Post-treatment and 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00473785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2007.