健康步骤™研究方案：一项实用的随机对照试验，在加拿大初级保健和社区诊所中，促进高危成年人积极生活和健康的生活方式。
HealtheSteps™ Study Protocol: a pragmatic randomized controlled trial promoting active living and healthy lifestyles in at-risk Canadian adults delivered in primary care and community-based clinics.
作者信息
Gill Dawn P, Blunt Wendy, Bartol Cassandra, Pulford Roseanne W, De Cruz Ashleigh, Simmavong P Karen, Gavarkovs Adam, Newhouse Ian, Pearson Erin, Ostenfeldt Bayley, Law Barbi, Karvinen Kristina, Moffit Pertice, Jones Gareth, Watson Cori, Zou Guangyong, Petrella Robert J
机构信息
Centre for Studies in Family Medicine, Department of Family Medicine, Western Centre for Public Health and Family Medicine, 2nd Floor, Schulich School of Medicine and Dentistry, Western University, 1465 Richmond St., London, ON, N6G 2M1, Canada.
Lawson Health Research Institute, London, Ontario, Canada.
出版信息
BMC Public Health. 2017 Feb 7;17(1):173. doi: 10.1186/s12889-017-4047-8.
BACKGROUND
Physical inactivity is one of the leading causes of chronic disease in Canadian adults. With less than 50% of Canadian adults reaching the recommended amount of daily physical activity, there is an urgent need for effective programs targeting this risk factor. HealtheSteps™ is a healthy lifestyle prescription program, developed from an extensive research base to address risk factors for chronic disease such as physical inactivity, sedentary behaviour and poor eating habits. HealtheSteps™ participants are provided with in-person lifestyle coaching and access to eHealth technologies delivered in community-based primary care clinics and health care organizations.
METHOD/DESIGN: To determine the effectiveness of Healthesteps™, we will conduct a 6-month pragmatic randomized controlled trial with integrated process and economic evaluations of HealtheSteps™ in 5 clinic settings in Southwestern Ontario. 110 participants will be individually randomized (1:1; stratified by site) to either the intervention (HealtheSteps™ program) or comparator (Wait-list control). There are 3 phases of the HealtheSteps™ program, lasting 6 months each. The active phase consists of bi-monthly in-person coaching with access to a full suite of eHealth technology supports. During the maintenance phase I, the in-person coaching will be removed, but participants will still have access to the full suite of eHealth technology supports. In the final stage, maintenance phase II, access to the full suite of eHealth technology supports is removed and participants only have access to publicly available resources and tools.
DISCUSSION
This trial aims to determine the effectiveness of the program in increasing physical activity levels and improving other health behaviours and indicators, the acceptability of the HealtheSteps™ program, and the direct cost for each person participating in the program as well as the costs associated with delivering the program at the different community sites. These results will inform future optimization and scaling up of the program into additional community-based primary care sites.
TRIAL REGISTRATION
NCT02413385 (Clinicaltrials.gov). Date Registered: April 6, 2015.
背景
缺乏身体活动是加拿大成年人慢性病的主要成因之一。加拿大成年人中只有不到50%达到每日推荐的身体活动量，因此迫切需要针对这一风险因素制定有效的项目。HealtheSteps™是一项健康生活方式处方项目，它基于广泛的研究基础开发，旨在解决诸如缺乏身体活动、久坐行为和不良饮食习惯等慢性病风险因素。HealtheSteps™的参与者会获得面对面的生活方式指导，并可使用社区初级保健诊所和医疗保健机构提供的电子健康技术。
方法/设计：为了确定Healthesteps™的有效性，我们将在安大略省西南部的5个诊所环境中进行一项为期6个月的实用随机对照试验，并对HealtheSteps™进行综合过程和经济评估。110名参与者将被单独随机分组（1:1；按地点分层），分为干预组（HealtheSteps™项目）或对照组（等待名单控制组）。HealtheSteps™项目有3个阶段，每个阶段持续6个月。活跃阶段包括每两个月进行一次面对面指导，并可使用全套电子健康技术支持。在维持阶段I，将取消面对面指导，但参与者仍可使用全套电子健康技术支持。在最后阶段，即维持阶段II，将取消对全套电子健康技术支持的访问权限，参与者只能使用公开可用的资源和工具。
讨论
本试验旨在确定该项目在提高身体活动水平、改善其他健康行为和指标方面的有效性，HealtheSteps™项目的可接受性，以及每个参与项目的人的直接成本，以及在不同社区地点实施该项目的相关成本。这些结果将为该项目未来的优化和扩大到更多社区初级保健地点提供信息。
试验注册
NCT02413385（Clinicaltrials.gov）。注册日期：2015年4月6日。
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