Department of Family and Preventive Medicine, University of Arkansas for Medical Sciences, 4301 W. Markham St, #530, Little Rock, AR, 72205-7199, USA.
Department of Pediatrics, University of Colorado School of Medicine, 12700 East 19th Avenue Box C225, Auora, CO, 80045, USA.
Implement Sci. 2017 Jul 18;12(1):90. doi: 10.1186/s13012-017-0624-6.
Despite the potential to reach at-risk children in childcare, there is a significant gap between current practices and evidence-based obesity prevention in this setting. There are few investigations of the impact of implementation strategies on the uptake of evidence-based practices (EBPs) for obesity prevention and nutrition promotion. This study protocol describes a three-phase approach to developing and testing implementation strategies to support uptake of EBPs for obesity prevention practices in childcare (i.e., key components of the WISE intervention).
Informed by the i-PARIHS framework, we will use a stakeholder-driven evidence-based quality improvement (EBQI) process to apply information gathered in qualitative interviews on barriers and facilitators to practice to inform the design of implementation strategies. Then, a Hybrid Type III cluster randomized trial will compare a basic implementation strategy (i.e., intervention as usual) with an enhanced implementation strategy informed by stakeholders. All Head Start centers (N = 12) within one agency in an urban area in a southern state in the USA will be randomized to receive the basic or enhanced implementation with approximately 20 classrooms per group (40 educators, 400 children per group). The educators involved in the study, the data collectors, and the biostastician will be blinded to the study condition. The basic and enhanced implementation strategies will be compared on outcomes specified by the RE-AIM model (e.g., Reach to families, Effectiveness of impact on child diet and health indicators, Adoption commitment of agency, Implementation fidelity and acceptability, and Maintenance after 6 months). Principles of formative evaluation will be used throughout the hybrid trial.
This study will test a stakeholder-driven approach to improve implementation, fidelity, and maintenance of EBPs for obesity prevention in childcare. Further, this study provides an example of a systematic process to develop and test a tailored, enhanced implementation strategy.
ClinicalTrials.gov, NCT03075085.
尽管儿童保育机构有潜力接触到高危儿童，但目前的实践与该环境下基于证据的肥胖预防之间仍存在显著差距。几乎没有研究调查实施策略对基于证据的肥胖预防实践（即WISE 干预的关键组成部分）的采用的影响。本研究方案描述了一种分三个阶段的方法，用于开发和测试实施策略，以支持儿童保育中肥胖预防实践采用基于证据的实践（即 WISE 干预的关键组成部分）。
受 i-PARIHS 框架的启发，我们将使用利益相关者驱动的基于证据的质量改进（EBQI）过程，将对实践障碍和促进因素的定性访谈中收集的信息应用于实施策略的设计。然后，将比较一项基本实施策略（即常规干预）与一项由利益相关者提供信息的增强型实施策略的混合 III 型集群随机试验。美国南部一个城市一个机构内的所有 Head Start 中心（N=12）将被随机分配接受基本或增强的实施，每组约有 20 个教室（每组 40 名教育工作者，400 名儿童）。参与研究的教育工作者、数据收集者和生物统计学家将对研究条件保持盲态。基本和增强型实施策略将根据 RE-AIM 模型规定的结果进行比较（例如，家庭的参与程度、对儿童饮食和健康指标的影响的有效性、机构的采用承诺、实施的保真度和可接受性以及 6 个月后的维持）。形成性评价原则将贯穿整个混合试验。
本研究将检验一种利益相关者驱动的方法，以改善儿童保育肥胖预防基于证据的实践的实施、保真度和维持。此外，本研究提供了一个系统开发和测试定制化、增强型实施策略的示例。
ClinicalTrials.gov，NCT03075085。
