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A cluster randomised trial of an intervention to increase the implementation of physical activity practices in secondary schools: study protocol for scaling up the Physical Activity 4 Everyone (PA4E1) program.

ABSTRACT: BACKGROUND:The implementation of interventions at-scale is required to maximise population health benefits. 'Physical Activity 4 Everyone (PA4E1)' was a multi-component school-based program targeting adolescents attending secondary schools in low socio-economic areas. An efficacy trial of the intervention demonstrated an increase in students' mean minutes of moderate-to-vigorous physical activity (MVPA) per day and lower weight gain at low incremental cost. This study aims to assess the effectiveness and cost effectiveness of a multi-component implementation support intervention to improve implementation, at-scale, of the evidence based school physical activity (PA) practices of the PA4E1 program. Impact on student PA levels and adiposity will also be assessed, in addition to the cost of implementation. METHODS:A cluster randomised controlled trial, utilising an effectiveness-implementation hybrid design, will be conducted in up to 76 secondary schools located in lower socio-economic areas across four health districts in New South Wales (NSW), Australia. Schools will be randomly allocated to a usual practice control arm or a multi-component implementation support intervention to embed the seven school PA practices of the PA4E1 program. The implementation support intervention incorporates seven strategies including executive support, in-School Champion, teacher training, resources, prompts, audit and feedback and access to an external Support Officer. The primary trial outcome will be the proportion of schools meeting at least four of the seven physical activity practices of the program, assessed via surveys with Head Physical Education teachers at 12 and 24-months. Secondary outcomes will be assessed via a nested evaluation of student PA and adiposity at 12-months (Grade 8 students) and 24 months (Grade 9 students) undertaken in 30 schools (15 per group). Resource use associated with the implementation intervention will be measured prospectively. Linear mixed effects regression models will assess program effects on the primary outcome at each follow-up period. DISCUSSION:This study is one of few evidence-based multi-component PA programs scaled-up to a large number of secondary schools and evaluated via randomised controlled trial. The use of implementation science theoretical frameworks to implement the evidence-based program and the rigorous evaluation design are strengths of the study. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017. Protocol Version 1.

SUBMITTER: Sutherland R

PROVIDER: S-EPMC6610944 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:'Physical Activity 4 Everyone' (PA4E1) was an efficacious multi-component school-based physical activity (PA) program targeting adolescents. PA4E1 has seven PA practices. It is essential to scale-up, evaluate effectiveness and assess implementation of such programs. Therefore, the aim is to assess the impact of implementation support on school practice uptake of the PA4E1 program at 12 and 24?months. METHODS:A cluster randomised controlled trial, utilising a type III hybrid implementation-effectiveness design, was conducted in 49 randomly selected disadvantaged Australian Government and Catholic secondary schools. A blinded statistician randomly allocated schools to a usual practice control (n?=?25) or the PA4E1 program group (n?=?24), with the latter receiving seven implementation support strategies to support school PA practice uptake of the seven practices retained from the efficacy trial. The primary outcome was the proportion of schools adopting at least four of the seven practices, assessed via telephone surveys with Head Physical Education Teachers and analysed using exact logistic regression modelling. This paper reports the 12-month outcomes. RESULTS:Schools were recruited from May to November 2017. At baseline, no schools implemented four of the seven practices. At 12?months significantly more schools in the program group had implemented four of the seven practices (16/24, 66.7%) than the control group (1/25, 4%) (OR?=?33.0[4.15-1556.4], p?<?0.001). The program group implemented on average 3.2 (2.5-3.9) more practices than the control group (p?<?0.001, mean 3.9 (SD 1.5) vs 0.7 (1.0)). Fidelity and reach of the implementation support intervention were high (both >?80%). CONCLUSIONS:Through the application of multiple implementation support strategies, secondary schools were able to overcome commonly known barriers to implement evidence based school PA practices. As such practices have been shown to result in an increase in adolescent PA and improvements in weight status, policy makers and practitioners responsible for advocating PA in schools should consider this implementation approach more broadly when working with schools. Follow-up is required to determine whether practice implementation is sustained. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017.

Project description:BackgroundPhysical Activity 4 Everyone (PA4E1) is an evidence-based program effective at increasing adolescent physical activity (PA) and improving weight status. This study aimed to determine a) the effectiveness of an adapted implementation intervention to scale-up PA4E1 at 24-month follow-up, b) fidelity and reach, and c) the cost and cost-effectiveness of the implementation support intervention.MethodsA cluster randomised controlled trial using a type III hybrid implementation-effectiveness design in 49 lower socio-economic secondary schools, randomised to a program (n = 24) or control group (n = 25). An adapted implementation intervention consisting of seven strategies was developed to support schools to implement PA4E1 over 24-months. The primary outcome was the proportion of schools implementing at least four of the 7 PA practices, assessed via computer assisted telephone interviews (CATI) with Head Physical Education Teachers. Secondary outcomes included the mean number of PA practices implemented, fidelity and reach, cost and cost-effectiveness. Logistic regression models assessed program effects.ResultsAt baseline, no schools implemented four of the 7 PA practices. At 24-months, significantly more schools in the program group (16/23, 69.6%) implemented at least four of the 7 PA practices than the control group (0/25, 0%) (p < 0.001). At 24-months, program schools were implementing an average of 3.6 more practices than control schools (4.1 (1.7) vs. 0.5 (0.8), respectively) (P < 0.001). Fidelity and reach of the implementation intervention were high (> 75%). The total cost of the program was $415,112 AUD (2018) ($17,296 per school; $117.30 per student).ConclusionsThe adapted implementation intervention provides policy makers and researchers with an effective and potentially cost-effective model for scaling-up the delivery of PA4E1 in secondary schools. Further assessment of sustainability is warranted.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12617000681358 prospectively registered 12th May 2017.

Project description:Background: Few studies have described the extent, type and reasons for making changes to a program prior to and during its delivery using a consistent taxonomy. Physical Activity 4 Everyone (PA4E1) is a secondary school physical activity program that was scaled-up for delivery to a greater number of schools. 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). 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). 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. Monthly trial team meetings tracked and coded modifications in "real-time" during the conduct of the scale-up trial. The extent, type and reasons for both adaptations and modifications were summarized descriptively. 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. 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). Reasons for the adaptations varied. Of the 20 modifications, all were "fidelity consistent" and the majority were made "proactively" (n = 12), though most were "unsystematic" (n = 18). Fifteen of the modifications were thought to have a "positive" impact on program effectiveness. The main reason for modification was the "available resources" (n = 14) of the PA4E1 Implementation Team. Conclusions: Adaptations and modifications to public health programs are common. Modifications have the potential to impact the implementation and effectiveness of programs. 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. Clinical Trial Registration: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372870, Identifier ACTRN12617000681358.

Project description:BackgroundEffectively scaled-up physical activity interventions are urgently needed to address the high prevalence of physical inactivity. To facilitate scale-up of an efficacious school-based physical activity program (Physical Activity 4 Everyone [PA4E1]), provision of implementation support to physical education (PE) teachers was adapted from face-to-face and paper-based delivery modes to partial delivery via a website. A lack of engagement (usage and subjective experience) with digital delivery modes, including websites, may in part explain the typical reduction in effectiveness of scaled-up interventions that use digital delivery modes. A process evaluation focused on the PA4E1 website was undertaken.ObjectiveThe 2 objectives were to (1) describe the usage of the PA4E1 program website by in-school champions (PE teachers leading the program within their schools) and PE teachers using quantitative methods; (2) examine the usage, subjective experience, and usability of the PA4E1 program website from the perspective of in-school champions using mixed methods.MethodsThe first objective used website usage data collected across all users (n=273) throughout the 9 school terms of the PA4E1 implementation support. The 4 usage measures were sessions, page views, average session duration, and downloads. Descriptive statistics were calculated and explored across the duration of the 26-month program. The second objective used mixed methods, triangulating data from the first objective with data from a think-aloud survey and usability test completed by in-school champions (n=13) at 12 months. Qualitative data were analyzed thematically alongside descriptive statistics from the quantitative data in a triangulation matrix, generating cross-cutting themes using the "following a thread" approach.ResultsFor the first objective, in-school champions averaged 48.0 sessions per user, PE teachers 5.8 sessions. PE teacher sessions were of longer duration (10.5 vs 7.6 minutes) and included more page views (5.4 vs 3.4). The results from the mixed methods analysis for the second objective found 9 themes and 2 meta-themes. The first meta-theme indicated that the website was an acceptable and appropriate delivery mode, and usability of the website was high. The second meta-theme found that the website content was acceptable and appropriate, and identified specific suggestions for improvement.ConclusionsDigital health interventions targeting physical activity often experience issues of lack of user engagement. By contrast, the findings from both the quantitative and mixed methods analyses indicate high usage and overall acceptability and appropriateness of the PA4E1 website to school teachers. The findings support the value of the website within a multidelivery mode implementation intervention to support schools to implement physical activity promoting practices. The analysis identified suggested intervention refinements, which may be adopted for future iterations and further scale-up of the PA4E1 program.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12617000681358; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372870.

Project description:BackgroundPhysical Activity 4 Everyone (PA4E1) is a physical activity program for secondary schools located in low-socioeconomic areas. Over a 24-month period, schools in the program arm of a cluster randomised controlled trial (n = up to 38 schools) will receive a multi-component implementation support strategy to embed the seven school physical activity practices of the PA4E1 program. This article describes the process evaluation of the PA4E1 hybrid implementation-effectiveness trial. The process evaluation aims to describe the fidelity and reach of the implementation support strategies using quantitative data; and to describe the acceptability, appropriateness and feasibility of the implementation support strategies and physical activity practices to school stakeholders using mixed methods.MethodsQuantitative and qualitative data will be collected from participants (Physical Education teachers, in-School Champions, students) in the program arm. Data collection will involve semi-structured interviews, focus groups, a fidelity monitoring log, a fidelity checklist, surveys, and routinely collected administrative and website data. Quantitative data will be analysed descriptively and qualitative data will be analysed thematically within and across data sets. Triangulation between data sources will be used to synthesise findings regarding the implementation and potential mechanisms of impact of PA4E1 on school physical activity practice adoption, with respect to context.DiscussionResults of the process evaluation will facilitate the interpretation of the findings of the trial outcomes. It will comprehensively describe what was actually implemented and identify the potential contribution of the various components of the implementation support strategy to the school physical activity practice adoption outcomes. Findings will inform future improvement and scale-up of PA4E1 and approaches to implementing secondary school-based physical activity programs more broadly.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12 May 2017.

Project description:BackgroundPhysically Active Children in Education (PACE) is an effective implementation intervention for increasing the number of minutes classroom teachers schedule physical activity each week. To date, evaluations of PACE have included a smaller number of schools from only one region in New South Wales Australia. If PACE is to have population-wide benefits we must be able to deliver this support to a larger number of schools across multiple regions. This study aimed to evaluate the scale-up of PACE.MethodsAn uncontrolled before and after study, with 100 schools from three regions was conducted. Participating schools received PACE for approximately 12 months. We assessed the following outcomes: delivery of the evidence-based intervention (EBI) (i.e. minutes of physical activity scheduled by classroom teachers per week); delivery of the implementation strategies (i.e. reach, dose delivered, adherence and indicators of sustainability); and key determinants of implementation (i.e. acceptability of strategies and cost). Data were collected via project officer records, and principal and teacher surveys. Linear mixed models were used to assess EBI delivery by evaluating the difference in the mean minutes teachers scheduled physical activity per week from baseline to follow-up. Descriptive data were used to assess delivery of the implementation strategies and their perceived acceptability (i.e. PACE). A prospective, trial-based economic evaluation was used to assess cost.ResultsDelivery of the EBI was successful: teachers increas their average minutes of total physical activity scheduled across the school week by 26.8 min (95% CI: 21.2, 32.4, p < 0.001) after receiving PACE. Indicators for delivery of implementation strategies were high: 90% of consenting schools received all strategies and components (reach); 100% of strategies were delivered by the provider (dose); >50% of schools adhered to the majority of strategies (11 of the 14 components); and acceptability was > 50% agreement for all strategies. The incremental cost per additional minute of physical activity scheduled per week was $27 per school (Uncertainty Interval $24, $31).ConclusionsPACE can be successfully delivered across multiple regions and to a large number of schools. Given the ongoing and scalable benefits of PACE, it is important that we continue to extend and improve this program while considering ways to reduce the associated cost.

Project description:BackgroundRural Latino children have higher rates of obesity compared to non-Latino Whites. Schools are in a unique position to address rural childhood obesity through policies. While evidence exists on factors that promote or impede school-based physical activity (PA) and nutrition policies, only a fraction has been in rural communities. This study seeks to understand 1) the knowledge and perceptions of school nutrition and PA policies and 2) barriers and facilitators to their implementation among rural school stakeholders from Washington State.MethodsWe conducted 20 semi-structured, in-depth interviews with school stakeholders (e.g., principals and school nutrition directors) from four K-12 school districts in the Lower Yakima Valley of Eastern Washington State. Thematic analysis was conducted using inductive, constant comparison approach to identify themes around knowledge and perceptions of policies and barriers and facilitators of policy implementation.ResultsThree main themes were identified: perceptions and knowledge of school PA and nutrition policies, barriers to policy implementation, and facilitators of policy implementation. The majority of stakeholders were supportive of school-based policies promoting PA and a healthy diet, even when lacking a specific understanding of these policies. Four subthemes were identified as barriers to policy implementation: viewing PA as a low priority, misuse of recess time, funding constraints, and lack of strong leadership. Facilitators of implementation included strong leadership at the district level, creating healthy norms through school-community linkages and pooling community resources to improve nutrition and PA among children.ConclusionsSchools provide a unique setting to promote healthy diet and PA behaviors among children and their families. Study findings show that while knowledge of specific nutrition and PA policies may vary, support for such policies were high among rural stakeholders. Study findings can inform policy development and support strategies for policy implementation in rural settings. Future studies may want to examine whether implementation of strategies addressing the barriers and enhancing facilitators lead to success in rural school settings.

Project description:BackgroundThe majority of US children do not meet physical activity recommendations. Schools are an important environment for promoting physical activity in children, yet most school districts do not offer enough physical activity opportunities to meet recommendations. This study aimed to identify school districts across the country that demonstrated exemplary efforts to provide students with many physical activity opportunities and to understand the factors that facilitated their programmatic success.MethodsA total of 59 districts were identified as model districts by members of the Physical Activity and Health Innovation Collaborative, an ad hoc activity associated with the Roundtable on Obesity Solutions at the National Academies of Sciences, Engineering, and Medicine. Semi-structured interviews were conducted with consenting stakeholders from 23 school districts to understand physical education and activity efforts and elucidate factors that led to the success of these districts' physical activity programming. Districts were geographically and socioeconomically diverse and varied in their administrative and funding structure.ResultsMost districts did not offer the recommended 150 or 225 min of physical activity a week through physical education alone; yet all districts offered a range of programs outside of physical education that provided additional opportunities for students to be physically active. The average number of school-based physical activity programs offered was 5.5, 3.5 and 2.1 for elementary, middle and high schools, respectively. Three overarching and broadly relevant themes were identified that were associated with successfully enhancing physical activity opportunities for students: soliciting and maintaining the support of champions, securing funding and/or tangible support, and fostering bi-directional partnerships between the district and community organizations and programs. Not only were these three themes critical for the development of physical activity opportunities, but they also remained important for the implementation, evaluation and sustainability of programs. These themes also did not differ substantially by the socioeconomic status of districts.ConclusionsThese findings demonstrate the success of school districts across the nation in providing ample opportunities for physical activity despite considerable variability in socioeconomic status and resources. These results can inform future research and provide actionable evidence for school districts to enhance physical activity opportunities to students.

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A cluster randomised trial of an intervention to increase the implementation of physical activity practices in secondary schools: study protocol for scaling up the Physical Activity 4 Everyone (PA4E1) program.

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