Tully Mark A, Cunningham Conor, Cupples Margaret E, Farrell Duane, Hardeman Wendy, Hunter Ruth F, Laventure Bob, McDonough Suzanne M, Morgan Joanne, Murphy Marie H, Simpson Ellen E A, Tudor-Locke Catrine, Wright Ashlene, Kee Frank
1Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.
UKCRC Centre of Excellence for Public Health (Northern Ireland), Belfast, UK.
Pilot Feasibility Stud. 2018 Jun 21;4:117. doi: 10.1186/s40814-018-0308-2. eCollection 2018.
Levels of physical activity decline with age. Some of the most disadvantaged individuals in society, such as those from lower socio-economic position, are also the most inactive. Increasing physical activity levels, particularly among those most inactive, is a public health priority. Peer-led physical activity interventions may offer a model to increase physical activity in the older adult population. This study aims to test the feasibility of a peer-led, multicomponent physical activity intervention in socio-economically disadvantaged community dwelling older adults.
The Medical Research Council framework for developing and evaluating complex interventions will be used to design and test the feasibility of a randomised controlled trial (RCT) of a multicomponent peer-led physical activity intervention. Data will be collected at baseline, immediately after the intervention (12 weeks) and 6 months after baseline measures. The pilot RCT will provide information on recruitment of peer mentors and participants and attrition rates, intervention fidelity, and data on the variability of the primary outcome (minutes of moderate to vigorous physical activity measured with an accelerometer). The pilot trail will also assess the acceptability of the intervention and identify potential resources needed to undertake a definitive study. Data analyses will be descriptive and include an evaluation of eligibility, recruitment, and retention rates. The findings will be used to estimate the sample size required for a definitive trial. A detailed process evaluation using qualitative and quantitative methods will be conducted with a variety of stakeholders to identify areas of success and necessary improvements.
This paper describes the protocol for the 'Walk with Me' pilot RCT which will provide the information necessary to inform the design and delivery of a fully powered trial should the Walk with Me intervention prove feasible.
ISRCTN23051918. Date of registration, November 18, 2015.
身体活动水平会随着年龄增长而下降。社会中一些最弱势的群体,比如社会经济地位较低的人群,身体活动也最为缺乏。提高身体活动水平,尤其是在最缺乏运动的人群中,是公共卫生的一项优先任务。同伴主导的身体活动干预措施可能为增加老年人群的身体活动提供一种模式。本研究旨在测试在社会经济条件不利的社区居住老年人中,由同伴主导的多组分身体活动干预措施的可行性。
将使用医学研究理事会制定和评估复杂干预措施的框架来设计和测试一项多组分同伴主导身体活动干预的随机对照试验(RCT)的可行性。在基线、干预后立即(12周)以及基线测量后6个月收集数据。试点RCT将提供有关同伴导师和参与者招募情况、损耗率、干预保真度以及主要结局(用加速度计测量的中度至剧烈身体活动分钟数)变异性的数据。试点试验还将评估干预措施的可接受性,并确定进行确定性研究所需的潜在资源。数据分析将采用描述性方法,包括对合格性、招募率和保留率的评估。研究结果将用于估计确定性试验所需的样本量。将与各类利益相关者一起使用定性和定量方法进行详细的过程评估,以确定成功之处和必要的改进之处。
本文描述了“与我同行”试点RCT的方案,如果“与我同行”干预措施被证明可行,该方案将为全面开展试验的设计和实施提供必要信息。
ISRCTN23051918。注册日期,2015年11月18日。