Jansson Anna K, Lubans David R, Duncan Mitch J, Smith Jordan J, Bauman Adrian, Attia John, Robards Sara L, Cox Emily R, Beacroft Sam, Plotnikoff Ronald C
Centre for Active Living and Learning, School of Education, University of Newcastle, Callaghan, NSW, Australia.
Active Living and Learning Research Program, Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.
Contemp Clin Trials Commun. 2024 Aug 24;41:101358. doi: 10.1016/j.conctc.2024.101358. eCollection 2024 Oct.
In this paper we outline the protocol for an implementation-effectiveness trial of , a multi-component mHealth intervention aimed at increasing participation in resistance and aerobic physical activity using the outdoor built environment (i.e., outdoor gyms) and social support. We have previously demonstrated the efficacy and effectiveness of the program in insufficiently active people with (or at risk of) type 2 diabetes and community-dwelling adults, respectively. The objective of this trial is to compare the effects of two implementation support models (i.e., 'Low' versus 'Moderate') on the reach (primary outcome), uptake, dose received, impact and fidelity of the program.
This hybrid type III implementation-effectiveness study will be evaluated using a two-arm randomized controlled trial, including 16 outdoor gym locations in two large regional municipalities in New South Wales, Australia. Outdoor gym locations will be pair-matched, based on an established socio-economic status consensus-based index (high versus low), and randomized to the 'Low' (i.e., app only) or 'Moderate' (i.e., app, face-to-face workout sessions and QR codes) implementation support group. The primary outcome of 'reach' will be measured using a modified version of the 'System for Observing Play and Recreation in Communities', capturing outdoor gym use amongst community members.
This implementation-effectiveness trial will evaluate the effects of different levels of implementation support on participation in resistance-focused physical activity using mHealth and outdoor gyms across the broader community. This may guide widespread dissemination for councils (municipalities) nation-wide wanting to promote outdoor gym usage.
This trial was preregistered with the Australian and New Zealand Clinical Trial Registry (ACTRN12624000261516).
在本文中，我们概述了一项实施效果试验的方案，该试验针对一项多组件移动健康干预措施，旨在利用户外建筑环境（即户外健身房）和社会支持来提高对阻力训练和有氧体育活动的参与度。我们之前分别证明了该计划在患有2型糖尿病（或有患2型糖尿病风险）的缺乏运动的人群以及社区居住成年人中的有效性。本试验的目的是比较两种实施支持模式（即“低”与“中”）对该计划的覆盖范围（主要结果）、采用率、接受剂量、影响和保真度的影响。
这项混合型III期实施效果研究将采用双臂随机对照试验进行评估，包括澳大利亚新南威尔士州两个大型地区市政当局的16个户外健身房地点。户外健身房地点将根据既定的基于社会经济地位共识的指数（高与低）进行配对匹配，并随机分配到“低”（即仅应用程序）或“中”（即应用程序、面对面锻炼课程和二维码）实施支持组。“覆盖范围”的主要结果将使用“社区游戏和娱乐观察系统”的修改版本进行测量，以获取社区成员对户外健身房的使用情况。
这项实施效果试验将评估不同水平的实施支持对更广泛社区中使用移动健康和户外健身房参与以阻力训练为主的体育活动的影响。这可能为全国范围内希望推广户外健身房使用的议会（市政当局）的广泛传播提供指导。
该试验已在澳大利亚和新西兰临床试验注册中心（ACTRN12624000261516）进行了预注册。
