Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473785
Status:
COMPLETED
Last Update Posted:
2007-05-15
First Post:
2007-05-11
Brief Title:
CVD Risk Reduction Trial
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Community Outreach Heart Health and Risk Reduction Trial
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COHRT
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 UCLifestyle CounsellingLC 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSFO Grant 4857 | None | None | None |