BACKGROUND To prevent childhood obesity and promote healthy development, health authorities recommend that child care programs use the evidence-based practices that foster healthy eating and physical habits in children. Go NAPSACC is an intervention shown to improve use of these recommended practices, but it is known to encounter barriers that limit its impact and widespread use. METHODS This study will use a type 3 hybrid effectiveness-implementation cluster-randomized trial to compare effectiveness and implementation outcomes achieved from Go NAPSACC delivered with a basic or enhanced implementation approach. Participants will include approximately 25 coaches from Child Care Aware of Kentucky (serving four geographic regions), 97 child care centers with a director and teacher from each and two cross-sectional samples of 485 3-4-year-old children (one recruitment at baseline, another at follow-up). Coaches will be randomly assigned to deliver Go NAPSACC using either the basic or enhanced implementation approach. "Basic Go NAPSACC" represents the traditional way of delivering Go NAPSACC. "Enhanced Go NAPSACC" incorporates preparatory and support activities before and during their Go NAPSACC work, which are guided by the Quality Implementation Framework and the Consolidated Framework for Implementation Research. Data will be collected primarily at baseline and post-intervention, with select measures continuing through 6, 12, and 24 months post-intervention. Guided largely by RE-AIM, outcomes will assess change in centers' use of evidence-based nutrition and physical activity practices (primary, measured via observation); centers' adoption, implementation, and maintenance of the Go NAPSACC program (assessed via website use); center directors', teachers', and coaches' perceptions of contextual factors (assessed via self-report surveys); children's eating and physical activity behaviors at child care (measured via observation and accelerometers); and cost-effectiveness (assessed via logs and expense tracking). The hypotheses anticipate that "Enhanced Go NAPSACC" will have greater effects than "Basic Go NAPSACC." DISCUSSION This study incorporates many lessons gleaned from the growing implementation science field, but also offers opportunities to address the field's research priorities, including applying a systematic method to tailor implementation strategies, examining the processes and mechanisms through which implementation strategies produce their effects, and conducting an economic evaluation of implementation strategies. TRIAL REGISTRATION ClinicalTrials.gov, NCT03938103, Registered April 8, 2019.

中文翻译：

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基本型和增强型Go NAPSACC对幼儿中心健康饮食和身体活动习惯的影响：3型混合有效性实施聚类随机试验的方案。

背景技术为了防止儿童肥胖并促进健康发展，卫生当局建议儿童保健计划采用循证的做法，以促进儿童的健康饮食和身体习惯。行动NAPSACC被证明可以改善对这些推荐做法的使用，但是众所周知，遇到障碍限制了它的影响和广泛使用。方法本研究将使用3型混合有效性-实施聚类随机试验，比较采用基本或增强实施方法的Go NAPSACC的有效性和实施结果。参加者将包括来自肯塔基州儿童保育中心（服务于四个地理区域）的约25名教练，97个儿童保育中心由一名主任和一名老师组成，分别来自485个3-4岁儿童的两个横断面样本（一次在基线时进行招募，另一次在随访中进行招募）。教练将被随机分配以使用基本或增强实施方法来交付Go NAPSACC。“基本Go NAPSACC”代表了交付Go NAPSACC的传统方式。“增强型Go NAPSACC”在其Go NAPSACC工作之前和期间纳入了准备和支持活动，这些活动均以质量实施框架和实施研究综合框架为指导。数据将主要在基线和干预后收集，选择的措施将持续至干预后的6、12和24个月。结果主要由RE-AIM指导，结果将评估中心的变化 使用循证的营养和身体活动习惯（主要是通过观察来衡量）；中心对Go NAPSACC计划的采用，实施和维护（通过网站使用情况进行评估）；中心主任，老师和教练对情境因素的看法（通过自我报告调查进行评估）；幼儿保育过程中儿童的饮食和体育锻炼行为（通过观察和加速度计进行测量）；和成本效益（通过日志和费用跟踪进行评估）。这些假设预计，“增强型Go NAPSACC”将比“基本型Go NAPSACC”产生更大的影响。讨论本研究吸收了来自不断发展的实施科学领域的许多经验教训，但也提供了解决该领域研究重点的机会，包括应用系统的方法来调整实施策略，检查实施策略产生效果的过程和机制以及对实施策略进行经济评估。试用注册ClinicalTrials.gov，NCT03938103，于2019年4月8日注册。