These changes can take two forms – adaptations to a program prior to it being delivered, and modifications that occur during the delivery of the program. Further, research trials often recruit participant groups that differ markedly from those of the target population ( 11).Īs physical activity programs examined in research trials are often unsuitable for replication in more real-world environments, they are frequently changed by end-users as part of efforts to make them more suitable for implementation and scale-up ( 9, 12). As such, many programs previously tested have utilized technical expertise, skills, resources and infrastructure that are not common in real-world operational environments where they are intended to be implemented ( 9, 10). While there are an abundance of evidence-based programs to address physical activity, many of these have been tested under optimal research conditions ( 5, 6), and few have successfully targeted adolescent physical activity ( 7, 8). One in four adults and four in five adolescents globally are insufficiently active to meet aerobic physical activity guidelines ( 3, 4). Physical activity has extensive benefits for health and society ( 1, 2). Our findings underscore the importance of comprehensive reporting of the extent, type and reasons for modifications as part of process evaluations, as this data may be important to the interpretation of trial findings.Ĭlinical Trial Registration:, Identifier ACTRN12617000681358. Modifications have the potential to impact the implementation and effectiveness of programs. The main reason for modification was the “available resources” ( n = 14) of the PA4E1 Implementation Team.Ĭonclusions: Adaptations and modifications to public health programs are common. Fifteen of the modifications were thought to have a “positive” impact on program effectiveness. Of the 20 modifications, all were “fidelity consistent” and the majority were made “proactively” ( n = 12), though most were “unsystematic” ( n = 18). Few adaptations were “fidelity inconsistent” ( n = 2), made “unsystematically” ( n = 1) and proposed to have a “negative” impact on the effectiveness of the program ( n = 1). ![]() ![]() Results: In total, 20 adaptations and 20 modifications were identified, these were to physical activity practices ( n = 8 n = 3), implementation support strategies ( n = 6 n = 16) and evaluation methods ( n = 6, n = 1), respectively. The extent, type and reasons for both adaptations and modifications were summarized descriptively. Monthly trial team meetings tracked and coded modifications in “real-time” during the conduct of the scale-up trial. A list of adaptations was generated from a comparison of the efficacy and scale-up trials via published PA4E1 protocols, trial registrations and information provided by trial investigators. Methods: The Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) was used to describe adaptations (planned and made prior to the scale-up trial) and modifications (made during the conduct of the trial). We aimed to describe the extent, type and reasons for changes to the PA4E1 program (the evidence-based physical activity practices, implementation support strategies and evaluation methods) made before its delivery at scale (adaptations) and during its delivery in a scale-up trial (modifications). ![]() ![]() Physical Activity 4 Everyone (PA4E1) is a secondary school physical activity program that was scaled-up for delivery to a greater number of schools.
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