Process evaluation methodology and preliminary results from the HEALTHY Study

BACKGROUND: The HEALTHY study, a middle-school-based, multi-center, primary prevention trial, is using nutritional, physical education (PE), behavioral and communications strategies to decrease rates of obesity and other risk factors for type 2 diabetes mellitus in middle school youth. PURPOSE: Process evaluation assesses fidelity, reach, and dose of the intervention. SIGNIFICANCE/METHODOLOGY: Though many studies have used process evaluation post-intervention, we used it formatively to modify the intervention delivery throughout the life of the project. RESULTS: For example: (1) In 2007, process evaluation data indicated that the nutrition intervention attained high performance on increasing fruits and vegetables served in the cafeteria, but increasing high fiber foods was a difficult goal to achieve. The nutrition study staff were able to concentrate on continuing to seek high fiber foods and working with vending companies to meet the HEALTHY goals. (2) For PE, the data showed that the strengths of the intervention were the high levels of student and teacher engagement; challenges to PE intervention fidelity included inconsistent implementation of various HEALTHY PE components. As a consequence, PE study staff increased their collaboration with teachers to modify the HEALTHY lessons and develop classroom management strategies to improve PE. (3) Though students were highly engaged in the behavioral intervention (health lessons), student disruptive behavior was often cited as a challenge. This finding resulted in study staff working more closely with teachers to develop better classroom management systems. CONCLUSIONS: In conclusion, process evaluation, used in a formative fashion, helped to further improve components of the HEALTHY study.