NCT04057417

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

January 29, 2019

Last Update Submit

August 12, 2019

Conditions

Keywords

physical activitybuilt environment

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events

    Seasonal incident rates of CVD-related mortality, new hospital admissions for cardiac-related events, valvular disease, ischemic heart disease and stroke

    10 years

Secondary Outcomes (1)

  • Cardiovascular disease-related risk factors

    10 years

Other Outcomes (1)

  • Trail counts

    12 months

Study Arms (2)

Urban Trail Expansion

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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.

Urban Trail Expansion

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The entire population of Winnipeg

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Research Institute of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

RECRUITING

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Natural Experiment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 29, 2019

First Posted

August 15, 2019

Study Start

January 5, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

August 15, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

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).

Locations