Department of Family and Preventive Medicine, University of Arkansas for Medical Sciences, 4301 W. Markham St, #530, Little Rock, AR, 72205-7199, USA.
ENRICH Center, College of Applied and Natural Sciences, Louisiana Tech University, Ruston, USA.
Implement Sci. 2022 Mar 18;17(1):25. doi: 10.1186/s13012-021-01185-1.
Despite the potential for Early Care and Education (ECE) settings to promote healthy habits, a gap exists between current practices and evidence-based practices (EBPs) for obesity prevention in childhood.
We will use an enhanced non-responder trial design to determine the effectiveness and incremental cost-effectiveness of an adaptive implementation strategy for Together, We Inspire Smart Eating (WISE), while examining moderators and mediators of the strategy effect. WISE is a curriculum that aims to increase children's intake of carotenoid-rich fruits and vegetables through four evidence-based practices in the early care and education setting. In this trial, we will randomize sites that do not respond to low-intensity strategies to either (a) continue receiving low-intensity strategies or (b) receive high-intensity strategies. This design will determine the effect of an adaptive implementation strategy that adds high-intensity versus one that continues with low-intensity among non-responder sites. We will also apply explanatory, sequential mixed methods to provide a nuanced understanding of implementation mechanisms, contextual factors, and characteristics of sites that respond to differing intensities of implementation strategies. Finally, we will conduct a cost effectiveness analysis to estimate the incremental effect of augmenting implementation with high-intensity strategies compared to continuing low-intensity strategies on costs, fidelity, and child health outcomes.
We expect our study to contribute to an evidence base for structuring implementation support in real-world ECE contexts, ultimately providing a guide for applying the adaptive implementation strategy in ECE for WISE scale-up. Our work will also provide data to guide implementation decisions of other interventions in ECE. Finally, we will provide the first estimate of relative value for different implementation strategies in this setting.
NCT05050539 ; 9/20/21.
尽管早期照护和教育（ECE）环境有潜力促进健康习惯的养成，但在当前实践与儿童肥胖预防的循证实践（EBP）之间仍存在差距。
我们将采用增强型无应答试验设计，以确定针对“一起激励明智饮食（WISE）”的适应性实施策略的有效性和增量成本效益，同时检验该策略效果的调节因素和中介因素。WISE 是一项旨在通过在早期照护和教育环境中实施四项循证实践，增加儿童类胡萝卜素丰富的水果和蔬菜摄入量的课程。在这项试验中，我们将随机分配对低强度策略无反应的地点，使其继续接受低强度策略或接受高强度策略。这种设计将确定在无反应地点中，与继续采用低强度策略相比，采用高强度策略的适应性实施策略的效果。我们还将应用解释性、顺序混合方法，以提供对实施机制、背景因素以及对不同强度实施策略有反应的地点特征的细致理解。最后，我们将进行成本效益分析，以估计与继续采用低强度策略相比，通过高强度策略增强实施对成本、保真度和儿童健康结果的增量效果。
我们预计我们的研究将有助于为在现实世界的 ECE 背景下构建实施支持提供依据，最终为在 ECE 中应用适应性实施策略提供 WISE 推广的指南。我们的工作还将为 ECE 中其他干预措施的实施决策提供数据。最后，我们将为该环境中不同实施策略的相对价值提供第一个估计。
NCT05050539；2021 年 9 月 20 日。
