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An Urban Trail Network and Cardiovascular Disease: A Natural Experiment

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ClinicalTrials.gov Identifier: NCT04057417
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Ontario Agency for Health Protection and Promotion
University of Toronto
Information provided by (Responsible Party):
Jon McGavock, University of Manitoba

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Cardiovascular Risk Factor Diabetes Mellitus Other: Urban Trail Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Natural Experiment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: If You Build it, Will They Come?... and Live Longer - A Natural Experiment of an Urban Trail Network Expansion and Cardiovascular Disease
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

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)
Other: Urban Trail
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cardiovascular disease-related risk factors [ Time Frame: 10 years ]
    Seasonal incident rates of diabetes, hypertension, dyslipidemia, gestational diabetes


Other Outcome Measures:
  1. Trail counts [ Time Frame: 12 months ]
    User counts on the intervention trails



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The entire population of Winnipeg

Exclusion Criteria:

  • Individuals < 30 years of age and >65 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057417


Locations
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Canada, Manitoba
Children's Hospital Research Institute of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Contact: Jonathan McGavock, PhD    204-480-1359    jmcgavock@chrim.ca   
Principal Investigator: Jonathan McGavock, PhD.         
Sponsors and Collaborators
University of Manitoba
St. Michael's Hospital, Toronto
Ontario Agency for Health Protection and Promotion
University of Toronto

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Responsible Party: Jon McGavock, Associate Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT04057417     History of Changes
Other Study ID Numbers: HS20928
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jon McGavock, University of Manitoba:
physical activity
built environment
Additional relevant MeSH terms:
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Cardiovascular Diseases