An Urban Trail Network and Cardiovascular Disease: A Natural Experiment

NCT ID: NCT04057417

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-05
• Study Completion Date: 2020-12-31

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.

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.

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factor; Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Urban Trail

Intervention Type: OTHER

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.

Control

Neighbourhoods that are located beyond 400 to 800m of a newly built greenway

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The entire population of Winnipeg

Exclusion Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: collaborator

Ontario Agency for Health Protection and Promotion

OTHER_GOV

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Jon McGavock

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital Research Institute of Manitoba

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Jonathan McGavock, PhD

Role: primary

jmcgavock@chrim.ca

204-480-1359

References

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.

Reference Type: DERIVED

PMID: 35346244 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32075847 (View on PubMed)

Other Identifiers

HS20928

Identifier Type: -

Identifier Source: org_study_id