STUDY PROTOCOL article
Front. Public Health
Sec. Children and Health
Volume 13 - 2025 | doi: 10.3389/fpubh.2025.1652485
Design and Methodology of a Cluster Randomized Factorial Trial to Optimize Implementation Strategies for The Healthy School Recognized Campus Initiative
Provisionally accepted
Jacob Szeszulski1*
Allyson Schaefers1
Gabrielli T De Mello1Julie Gardner2
Alisha George1Alexandra Macmillan Uribe1
Chad Rethorst1
Rebecca Seguin-Fowler3Lucy Xin4- 1Texas A&M AgriLife Dallas Research and Extension Center, Dallas, United States
- 2Texas A&M AgriLife Extension, College Station, Texas, United States
- 3Texas A&M AgriLife, College Station, United States
- 4Univeristy of North Texas, Fort Worth, Texas, United States
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Background: The Healthy School Recognized Campus initiative bundles multiple school-and research-based programs for children and adults to improve physical activity and nutrition outcomes that affect cardiovascular disease risk. This study aims to test the individual and combined impact of three implementation strategies on implementation and effectiveness outcomes. Methods: Using the Multiphase Optimization STrategy (MOST) framework and a cluster randomized full factorial study design, two cohorts (n=8; n=16 total) of public elementary schools in North and East Texas will be randomized to receive combinations of the three implementation strategies – additional resources, school-to-school mentoring, and enhanced engagement – over one academic year. We will survey program implementers (e.g., Extension agents, school staff, administrators) to determine the dose of the Healthy School Recognized Campus initiative that each student receives. We will objectively measure changes in students’ MetS risk, cardiovascular fitness measured via the Progressive Aerobic Cardiovascular Endurance Run, dermal carotenoids (an estimate of fruit and vegetable intake) measured via the Veggie Meter, and body mass index pre- and post-intervention. The individual and combined (e.g., synergistic, antagonistic) impact of strategies will be evaluated after each cohort using a general linear model framework, and strategies will be modified and prepared for testing in a future randomized controlled trial. Discussion: By using rigorous implementation science frameworks, developing three implementation strategies, and evaluating implementation and effectiveness outcomes, this study aims to determine which implementation strategy or combination of strategies have the biggest impact on the Healthy School Recognized Campus initiative. Trial Registration: Registered at clinicaltrials.gov on August 2nd, 2023 (NCT05977959).
Keywords: Exercise, Healthy diet, Program Evaluation, metabolic syndrome, Metabolic Diseases, implementation science, Schools
Received: 23 Jun 2025; Accepted: 14 Oct 2025.
Copyright: © 2025 Szeszulski, Schaefers, De Mello, Gardner, George, Uribe, Rethorst, Seguin-Fowler and Xin. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Jacob Szeszulski, jacob.szeszulski@ag.tamu.edu
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.