Abstract
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.
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Acknowledgements
Past and present members of the Process Evaluation Committee are Allan Steckler (chair), Tom Baranowski, Stan Bassin, Steve Bruecker, Wendy Burd, Ashanti Canada, Lynn DeBar, Eileen Ford, Debby Ford, Stacy Grau, Natasha Greene, Will Hall, Joanne Harrell, Jill Hartstein, Art Hernandez, Katie Hindes, Ann Jessup, Sean Kolmer, Chung-Hui Lin, Mariam Missaghian, Griselle Montez, A. Gayle Moore, Mia Morris, Patricia Pearce, Trang Pham, Kimari Phillips, Amanda Phillips-Martinez, Leigh Rosen, Margaret Schneider, Sandy Sherman, Linda Simkin, Adriana Sleigh, Debbe Thompson, Victoria Thompson, Thang Trinh, Beth Venditti, Stella Volpe, Alyssa Voss, Maihan Vu, Lisa Wald, Alissa Wheeler, Mamie White and Abby Zeveloff. We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during this research.
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Schneider, M., Hall, W., Hernandez, A. et al. Rationale, design and methods for process evaluation in the HEALTHY study. Int J Obes 33 (Suppl 4), S60–S67 (2009). https://doi.org/10.1038/ijo.2009.118
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DOI: https://doi.org/10.1038/ijo.2009.118
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