Table_1_A collaborative network trial to evaluate the effectiveness of implementation strategies to maximize adoption of a school-based healthy lunchbox program: a study protocol.docx

IntroductionAn important impediment to the large-scale adoption of evidence-based school nutrition interventions is the lack of evidence on effective strategies to implement them. This paper describes the protocol for a “Collaborative Network Trial” to support the simultaneous testing of different strategies undertaken by New South Wales Local Health Districts to facilitate the adoption of an effective school-based healthy lunchbox program (‘SWAP IT’). The primary objective of this study is to assess the effectiveness of different implementation strategies to increase school adoption of the SWAP across New South Wales Local Health Districts.
MethodsWithin a Master Protocol framework, a collaborative network trial will be undertaken. Independent randomized controlled trials to test implementation strategies to increase school adoption of SWAP IT within primary schools in 10 different New South Wales Local Health Districts will occur. Schools will be randomly allocated to either the intervention or control condition. Schools allocated to the intervention group will receive a combination of implementation strategies. Across the 10 participating Local Health Districts, six broad strategies were developed and combinations of these strategies will be executed over a 6 month period. In six districts an active comparison group (containing one or more implementation strategies) was selected. The primary outcome of the trial will be adoption of SWAP IT, assessed via electronic registration records captured automatically following online school registration to the program. The primary outcome will be assessed using logistic regression analyses for each trial. Individual participant data component network meta-analysis, under a Bayesian framework, will be used to explore strategy-covariate interactions; to model additive main effects (separate effects for each component of an implementation strategy); two way interactions (synergistic/antagonistic effects of components), and full interactions.
DiscussionThe study will provide rigorous evidence of the effects of a variety of implementation strategies, employed in different contexts, on the adoption of a school-based healthy lunchbox program at scale. Importantly, it will also provide evidence as to whether health service-centered, collaborative research models can rapidly generate new knowledge and yield health service improvements.
Clinical trial registrationThis trial is registered prospectively with the Australian New Zealand Clinical Trials Registry (ACTRN12623000558628).

引言 以循证为基础的学校营养干预措施之所以难以大规模推广，核心障碍之一在于缺乏关于其有效实施策略的相关研究证据。本研究旨在阐明一项「协作网络试验（Collaborative Network Trial）」的实施方案，该试验将支持新南威尔士州地方卫生辖区（Local Health Districts）同步开展多种策略测试，以推动某款有效的校内健康午餐盒项目「SWAP IT」的落地推广。本研究的首要目标是评估不同实施策略在新南威尔士州地方卫生辖区内提升学校采纳「SWAP IT」项目效果的有效性。

方法 本研究将在主方案（Master Protocol）框架下开展协作网络试验。研究将在新南威尔士州10个不同的地方卫生辖区内的小学中开展独立随机对照试验（randomized controlled trial），以测试提升学校采纳「SWAP IT」项目的各类实施策略。学校将被随机分配至干预组或对照组。被分配至干预组的学校将接受多种实施策略的组合干预。在参与本次研究的10个地方卫生辖区中，共开发出6大类实施策略，并将在6个月的周期内执行这些策略的不同组合方案。其中6个辖区设置了主动对照组，该组将采用一种或多种实施策略。本试验的主要结局指标为学校对「SWAP IT」项目的采纳情况，通过学校完成项目线上注册后自动捕获的电子注册记录进行评估。各项试验的主要结局指标将通过logistic回归分析进行评估。本研究将采用贝叶斯框架（Bayesian framework）下的个体参与者数据成分网络Meta分析（component network meta-analysis），以探究策略-协变量交互作用；同时对相加主效应（即实施策略各组成部分的独立效应）、双向交互作用（即各组成部分的协同/拮抗效应）以及全交互作用进行建模。

讨论 本研究将为不同场景下采用的多种实施策略对大规模推广校内健康午餐盒项目的影响提供严谨的研究证据。尤为重要的是，本研究还将验证以卫生服务为核心的协作式研究模式能否快速产生新知识并推动卫生服务优化。

临床试验注册 本试验已在澳大拉西亚新西兰临床试验注册中心（Australian New Zealand Clinical Trials Registry，ACTRN12623000558628）进行前瞻性注册。