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.

The HEALTHY Study was a 3-year school-based intervention designed to change the behaviors of middle school students to reduce their risk for developing type 2 diabetes mellitus. This report examines the relation between exposure to communications campaign materials and behavior change among students in the HEALTHY intervention schools. Using data from campaign tracking logs and student interviews, the authors examined communications campaign implementation and exposure to the communications campaign as well as health behavior change. Campaign tracking documents revealed variability across schools in the quantity of communications materials disseminated. Student interviews confirmed that there was variability in the proportion of students who reported receiving information from the communication campaign elements. Correlations and regression analysis controlling for semester examined the association between campaign exposure and behavior change across schools. There was a significant association between the proportion of students exposed to the campaign and the proportion of students who made changes in health behavior commensurate with study goals. The results suggest that, in the context of a multifaceted school-based health promotion intervention, schools that achieve a higher rate of exposure to communication campaign materials among the students may stimulate greater health behavior change.

The process evaluation of HEALTHY, a large multi-center trial to decrease type 2 diabetes mellitus in middle school children, monitored the implementation of the intervention to ascertain the extent that components were delivered and received as intended. The purpose of this article is to report the process evaluation findings concerning the extent to which the HEALTHY nutrition intervention was implemented during the HEALTHY trial. Overall, the observed fidelity of implementing nutrition strategies improved from baseline to the end of the study. By the last semester, all but two nutrition process evaluation goals were met. The most challenging goal to implement was serving high fiber foods, including grain-based foods and legumes. The easiest goals to implement were lowering the fat content of foods offered and offering healthier beverages. The most challenging barriers experienced by research dietitians and food service staff were costs, availability of foods and student acceptance. Forming strong relationships between the research dietitians and food service staff was identified as a key strategy to meet HEALTHY nutrition goals.