NUR 590 EBP Proposal Section F Evaluation of Process

Responding to the dramatic increase in obesity and type 2 diabetes among children and adolescents, in 2002 the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health sponsored a collaborative agreement to develop and conduct both a treatment and a prevention trial of type 2 diabetes in children and adolescents. After a series of pilot studies, the prevention arm of this effort culminated in the development and conduct of the HEALTHY primary prevention trial. Seven centers across the country recruited 42 middle schools, and half were randomly assigned to receive a multicomponent intervention. The study followed students through the 3 years of middle school (sixth grade to eight grade) from 2006 to 2009.¹

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The HEALTHY intervention was designed to make changes in the school nutrition and physical education (PE) environments, provide opportunities for behavior change and education, and disseminate communications campaigns and promotional messages, events and activities. The four components—nutrition, PE, behavior and communications—interacted synergistically within a single integrated intervention. The HEALTHY study group recognized the importance of documenting delivery of the intervention components to address problems and make modifications, as well as for use in the interpretation of study findings. Data collected during an intervention study, either for the purpose of analyzing factors that may explain the intervention’s success or failure or for the purpose of fine-tuning intervention delivery, are generally referred to as process evaluation data.² Experts from across the study group and representing each of the intervention components formed a Process Evaluation Committee to develop the methods as well as to monitor and report findings on an ongoing basis.

NUR 590 EBP Proposal Section F Evaluation of Process

This paper describes the design and methods of the process evaluation of the HEALTHY study. The procedures used to obtain both qualitative and quantitative data are described, and the methods for rapidly summarizing the data to fine-tune intervention delivery are delineated. Valuable lessons learned are shared on the basis of our experience in conducting process evaluation in a study that was complex not only because of its multifaceted intervention goals but also because of its implementation across widely diverse geographical locations with multiple schools within each center and the inherently challenging delivery environment—middle school.

Large multi-site public health interventions are challenging to implement and difficult to evaluate. Many such efforts have omitted from their planned data collection any systematic documentation or evaluation of how the intervention was delivered and/or received.³ Only three out of ten long-term (that is, at least 12 months) randomized childhood obesity prevention intervention studies reported information that might be used to explain the success or failure of the intervention.⁴

Process evaluation data collection and procedures are being increasingly incorporated into public health intervention studies.⁵ Process evaluation of a school-based intervention designed to increase physical activity and reduce bullying reported that only 39% of planned intervention events were implemented and pointed to institutional barriers that impeded the implementation of the intervention.⁶ Three other recently reported community-based interventions designed to alter health behaviors also reported rigorously designed process evaluation components.^7–9 In all three cases, the process evaluation data offered valuable insights into reasons why the programs may have been more or less effective in achieving their goals.

Process evaluation adds value to the analysis of multi-component, community-based interventions by documenting characteristics of the intervention and by eliciting information about barriers to and/or facilitators of the intervention components. These functions are particularly salient in a multi-site trial such as HEALTHY, where the intervention may be implemented and received in different ways.¹⁰ In terms of documenting the extent to which an intervention is delivered as intended, process evaluation is typically described as encompassing three dimensions: fidelity, dose and reach.² The fidelity of intervention delivery includes the extent to which the intervention is delivered as intended. The intervention dose refers to how much of the intended intervention is delivered. The reach is the proportion of intended recipients who actually participate in an intervention. These three dimensions can be tracked using various forms of monitoring, including observations, surveys and program documentation. The elicitation of barriers to and facilitators of successful intervention implementation is often accomplished using qualitative research methods such as interviews and focus groups. The HEALTHY study made use of all these methods to document program administration and identify factors that enhanced or impeded the intervention implementation.