- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04057417
An Urban Trail Network and Cardiovascular Disease: A Natural Experiment
August 12, 2019 updated by: Jon McGavock, University of Manitoba
If You Build it, Will They Come?... and Live Longer - A Natural Experiment of an Urban Trail Network Expansion and Cardiovascular Disease
Associations between the built environment and health behaviours are robust, however (1) it remains unclear if the behaviours they elicit lead to meaningful improvements in health outcomes, at the population level and (2) little experimental evidence exists supporting these associations.
The primary objective of this study is to capitalize on an urban natural experiment to determine if changing the built environment to support physical activity will (1) reduce the burden of CVD within a population and (2) if it's a cost-effective population intervention.
An interrupted time series analysis will be performed over a period of 19 years to determine if the expansion of an urban trail network is associated with reductions in major advserse cardiovascular events (MACE) and CVD-related risk factors within a large urban centre in Canada.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Two different time series methods will be used to estimate the effect of an urban trail expansion (i.e.
"intervention") that occured in WInnipeg, Manitoba Canada, between 2010 and 2012.
The study is designed to determine if a reduction in Major Adverse Cardiovascular Events (MACE) was observed in neighbourhoods that received the intervention relative to trends among the control neighbourhoods that did not receive the intervention.
First, a multi-group segmented regression of interrupted time series data will be used to assess the effect of the intervention on CVD incidence, both immediately (change in level) and over time (change in trend) by creating indicator variables .
The level will be the base rate of CVD-related end-points at the beginning of the pre-intervention period (2000) and the value immediately following each change point at which successive segments join until 2010.
The trend is the rate of change in MACE end-points (in other words, the slope) during a segment.
Autoregressive errors will be modeled to account for correlated outcomes.
Second, an autoregressive integrated moving average (ARIMA) model will be fitted for the CVD incidence time series by using the standard approach to identification, estimation, and checking.
A trend and periodic seasonal terms will be applied to the entire study period (November 2000 to October 2019).
A separate ARIMA model will also be built for the pre-intervention period to forecast CVD evolution of the treated neighbourhoods.
The number of CVD end-points prevented by the intervention will be estimated by calculating the difference between the predicted number and the observed number of cases.
Should there by difficulty fitting an ARIMA model to a relatively small dataset, exponential smoothing models or the Holt Winters Algorithm will be used.
Although they require larger sample sizes, they are ideal for this project as (1) they permit a variety of different types of intervention effect to be modeled explicitly, and (2) they are well suited to forecasting future trends.
Study Type
Interventional
Enrollment (Anticipated)
225
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 3P4
- Recruiting
- Children's Hospital Research Institute of Manitoba
-
Contact:
- Jonathan McGavock, PhD
- Phone Number: 204-480-1359
- Email: jmcgavock@chrim.ca
-
Principal Investigator:
- Jonathan McGavock, PhD.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The entire population of Winnipeg
Exclusion Criteria:
- Individuals < 30 years of age and >65 years of age.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Urban Trail Expansion
Neighbourhoods within 400m to 800m of a neely built greenway, defined as a multi-use concrete/asphalt trail that was >4km in length)
|
A newly built urban trail that was part of a large policy/infrastructure investment from the city/province to enhance the built environment for active transport and recreational physical activity in the city of Winnipeg, Manitoba Canada between 2010 and 2012.
|
No Intervention: Control
Neighbourhoods that are located beyond 400 to 800m of a newly built greenway
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiovascular events
Time Frame: 10 years
|
Seasonal incident rates of CVD-related mortality, new hospital admissions for cardiac-related events, valvular disease, ischemic heart disease and stroke
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular disease-related risk factors
Time Frame: 10 years
|
Seasonal incident rates of diabetes, hypertension, dyslipidemia, gestational diabetes
|
10 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trail counts
Time Frame: 12 months
|
User counts on the intervention trails
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McGavock J, Hobin E, Prior HJ, Swanson A, Smith BT, Booth GL, Russell K, Rosella L, Isaranuwatchai W, Whitehouse S, Brunton N, Burchill C. Multi-use physical activity trails in an urban setting and cardiovascular disease: a difference-in-differences analysis of a natural experiment in Winnipeg, Manitoba, Canada. Int J Behav Nutr Phys Act. 2022 Mar 28;19(1):34. doi: 10.1186/s12966-022-01279-z.
- Hobin E, Swanson A, Booth G, Russell K, Rosella LC, Smith BT, Manley E, Isaranuwatchai W, Whitehouse S, Brunton N, McGavock J. Physical activity trails in an urban setting and cardiovascular disease morbidity and mortality in Winnipeg, Manitoba, Canada: a study protocol for a natural experiment. BMJ Open. 2020 Feb 18;10(2):e036602. doi: 10.1136/bmjopen-2019-036602.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2018
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
January 29, 2019
First Submitted That Met QC Criteria
August 12, 2019
First Posted (Actual)
August 15, 2019
Study Record Updates
Last Update Posted (Actual)
August 15, 2019
Last Update Submitted That Met QC Criteria
August 12, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS20928
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
These data are anonymized within a population health and social repository.
Data are available via request to the stewards of the repository - Manitoba Centre for Health Policy (MCHP).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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