Department of Planning, Policy and Design, University of California at Irvine, Irvine CA 92697, USA.
Int J Obes (Lond). 2009 Aug;33 Suppl 4(Suppl 4):S60-7. doi: 10.1038/ijo.2009.118.
The HEALTHY study was a multi-site randomized trial designed to determine whether a 3-year school-based intervention targeting nutrition and physical activity behaviors could effectively reduce risk factors associated with type 2 diabetes in middle school children. Pilot and formative studies were conducted to inform the development of the intervention components and the process evaluation methods for the main trial. During the main trial, both qualitative and quantitative assessments monitored the fidelity of the intervention and motivated modifications to improve intervention delivery. Structured observations of physical education classes, total school food environments, classroom-based educational modules, and communications and promotional campaigns provided verification that the intervention was delivered as intended. Interviews and focus groups yielded a multidimensional assessment of how the intervention was delivered and received, as well as identifying the barriers to and facilitators of the intervention across and within participating schools. Interim summaries of process evaluation data were presented to the study group as a means of ensuring standardization and quality of the intervention across the seven participating centers. Process evaluation methods and procedures documented the fidelity with which the HEALTHY study was implemented across 21 intervention schools and identified ways in which the intervention delivery might be enhanced throughout the study.
HEALTHY 研究是一项多中心随机试验，旨在确定针对营养和身体活动行为的为期 3 年的学校干预措施是否可以有效降低中学生 2 型糖尿病相关的风险因素。进行了试点和形成性研究，为干预措施的制定和主要试验的过程评估方法提供信息。在主要试验期间，定性和定量评估监测了干预措施的保真度，并促使进行了改进，以提高干预措施的实施效果。对体育课、学校整体食物环境、课堂教育模块、以及交流和宣传活动进行了结构化观察，从而验证了干预措施的实施符合预期。访谈和焦点小组提供了对干预措施的实施和接受情况的多维评估，同时确定了在参与学校之间和内部实施干预措施的障碍和促进因素。向研究小组提交了过程评估数据的中期总结，作为确保七个参与中心的干预措施标准化和质量的一种手段。过程评估方法和程序记录了 HEALTHY 研究在 21 所干预学校中的实施保真度，并确定了在整个研究过程中可以改进干预措施实施的方式。
