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

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:
        • 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.

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

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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