一项在大规模环境下实施的干预策略随机对照试验，旨在增加幼儿教育和保育（ECEC）服务中的户外自由游戏机会：GOGA 试验研究方案。
A randomised controlled trial of an implementation strategy delivered at scale to increase outdoor free play opportunities in early childhood education and care (ECEC) services: a study protocol for the get outside get active (GOGA) trial.
机构信息
School of Health Sciences, Department of Nursing and Allied Health, Swinburne University of Technology, Hawthorn, VIC, 3122, Australia.
School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia.
出版信息
BMC Public Health. 2022 Mar 29;22(1):610. doi: 10.1186/s12889-022-12883-w.
BACKGROUND
Increased outdoor play time in young children is associated with many health and developmental benefits. This study aims to evaluate the impact of a multi-strategy implementation strategy delivered at scale, to increase opportunities for outdoor free play in Early Childhood Education and Care (ECEC) services.
METHODS
The study will employ a parallel-group randomised controlled trial design. One hundred ECEC services in the Hunter New England region of New South Wales, Australia, will be recruited and randomised to receive either a 6-month implementation strategy or usual care. The trial will seek to increase the implementation of an indoor-outdoor routine (whereby children are allowed to move freely between indoor and outdoor spaces during periods of free play), to increase their opportunity to engage in outdoor free play. Development of the strategy was informed by the Behaviour Change Wheel to address determinants identified in the Theoretical Domains Framework. ECEC services allocated to the control group will receive 'usual' implementation support delivered as part of state-wide obesity prevention programs. The primary trial outcome is the mean minutes/day (calculated across 5 consecutive days) of outdoor free play opportunities provided in ECEC services measured at baseline, 6-months (primary end point) and 18-months post baseline. Analyses will be performed using an intention-to-treat approach with ECEC services as the unit of analysis, using a linear mixed effects regression model to assess between-group differences. A sensitivity analysis will be undertaken, adjusting for service characteristics that appear imbalanced between groups at baseline, and a subgroup analysis examining potential intervention effect among services with the lowest baseline outdoor free play opportunities.
DISCUSSION
Identifying effective strategies to support the implementation of indoor-outdoor routines in the ECEC setting at scale is essential to improve child population health.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry ( ACTRN12621000987864 ). Prospectively registered 27th July 2021, ANZCTR - Registration.
背景
增加幼儿的户外游戏时间与许多健康和发展益处相关。本研究旨在评估一种多策略实施策略的影响，该策略在大规模实施时可增加幼儿教育和护理（ECEC）服务中户外自由游戏的机会。
方法
该研究将采用平行组随机对照试验设计。澳大利亚新南威尔士州亨特新英格兰地区的 100 家 ECEC 服务机构将被招募并随机分为接受 6 个月实施策略或常规护理的两组。该试验旨在增加室内外常规活动（即允许儿童在自由游戏期间在室内外空间自由移动）的实施，以增加他们进行户外自由游戏的机会。该策略的制定是基于行为改变轮，以解决理论框架中确定的决定因素。分配给对照组的 ECEC 服务将获得作为全州肥胖预防计划的一部分提供的“常规”实施支持。主要试验结果是 ECEC 服务中提供的户外自由游戏机会的平均分钟/天（在连续 5 天内计算），在基线、6 个月（主要终点）和 18 个月后进行基线测量。分析将采用意向治疗方法进行，以 ECEC 服务为分析单位，使用线性混合效应回归模型评估组间差异。将进行敏感性分析，根据组间基线不平衡的服务特征进行调整，并进行亚组分析，以检查干预对户外自由游戏机会最低的服务的潜在影响。
讨论
确定在 ECEC 环境中以大规模支持室内外常规实施的有效策略对于改善儿童人群的健康至关重要。
试验注册
澳大利亚新西兰临床试验注册中心（ACTRN12621000987864）。于 2021 年 7 月 27 日前瞻性注册，ANZCTR-注册。
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