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临床试验/NCT04057417
NCT04057417Unknown不适用

If You Build it, Will They Come?... and Live Longer - A Natural Experiment of an Urban Trail Network Expansion and Cardiovascular Disease

University of Manitoba2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2018年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
225
试验地点
2
主要终点
Major adverse cardiovascular events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The entire population of Winnipeg

排除标准

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

研究组 & 干预措施

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)

干预措施: Urban Trail (Other)

Control

No Intervention

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

结局指标

主要结局

Major adverse cardiovascular events

时间窗: 10 years

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

次要结局

  • Cardiovascular disease-related risk factors(10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jon McGavock

Associate Professor

University of Manitoba

研究点 (2)

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