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Protocol for a mixed methods process evaluation of a hybrid implementation-effectiveness trial of a scaled-up whole-school physical activity program for adolescents: Physical Activity 4 Everyone (PA4E1).

ABSTRACT: BACKGROUND:Physical 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. METHODS:Quantitative 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. DISCUSSION:Results 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 REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12 May 2017.

SUBMITTER: Mclaughlin M

PROVIDER: S-EPMC7077014 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Protocol for a mixed methods process evaluation of a hybrid implementation-effectiveness trial of a scaled-up whole-school physical activity program for adolescents: Physical Activity 4 Everyone (PA4E1).

Mclaughlin Matthew M Duff Jed J Sutherland Rachel R Campbell Elizabeth E Wolfenden Luke L Wiggers John J

Trials 20200317 1

<h4>Background</h4>Physical 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. ...[more]

PMID: 32183902

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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: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: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:BackgroundThe 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.MethodsA 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.DiscussionThis 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 registrationAustralian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017. Protocol Version 1.

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/objectivesObesity prevention during adolescence is a health priority. The 'Physical Activity 4 Everyone' (PA4E1) study tested a multi-component physical activity intervention in 10 secondary schools from socio-economically disadvantaged communities. This paper aimed to report the secondary outcomes of the study; to determine whether the intervention impacted on adiposity outcomes (weight, body mass index (BMI), BMI z-score), and whether any effect was moderated by sex, baseline BMI and baseline physical activity level, at 12 and 24 months.Subjects/methodsA cluster randomised controlled trial was conducted in New South Wales, Australia. The school-based intervention included seven physical activity strategies targeting the following: curriculum (strategies to maximise physical activity in physical education, student physical activity plans, an enhanced school sport programme); school environment (physical activity during school breaks, modification of school policy); and parents and the community (parent engagement, links with community physical activity providers). Students' weight (kg), BMI and BMI z-score, were collected at baseline (Grade 7), 12 and 24 months. Linear Mixed Models were used to assess between-group mean difference from baseline to 12 and 24 months. Exploratory sub-analyses were undertaken according to three moderators of energy balance.ResultsA total of 1150 students (mean age=12 years) provided outcome data at baseline, 1051 (91%) at 12 months and 985 (86%) at 24 months. At 12 months, there were group-by-time effects for weight (mean difference=-0.90 kg (95% confidence interval (CI)=-1.50, -0.30), P<0.01) and BMI (-0.28 kg m-2 (-0.50, -0.06), P=0.01) in favour of the intervention group, but not for BMI z-score (-0.05 (-0.11; 0.01), P=0.13). These findings were consistent for weight (-0.62 kg (-1.21, 0.03), P=0.01) and BMI (-0.28 kg m-2 (-0.49, -0.06), P=0.01) at 24 months, with group-by-time effects also found for BMI z-score (-0.08 (-0.14; -0.02), P=0.02) favouring the intervention group.ConclusionThe PA4E1 school-based intervention achieved moderate reductions in adiposity among adolescents from socio-economically disadvantaged communities. Multi-component interventions that increase adolescents' engagement in moderate-to-vigorous physical activity (MVPA) may assist in preventing unhealthy weight gain.

Project description:BACKGROUND:Process evaluations are critical for interpreting and understanding outcome trial results. By understanding how interventions function across different settings, process evaluations have the capacity to inform future dissemination of interventions. The complexity of Get others Active (GoActive), a 12-week, school-based physical activity intervention implemented in eight schools, highlights the need to investigate how implementation is achieved across a variety of school settings. This paper describes the mixed methods GoActive process evaluation protocol that is embedded within the outcome evaluation. In this detailed process evaluation protocol, we describe the flexible and pragmatic methods that will be used for capturing the process evaluation data. METHODS:A mixed methods design will be used for the process evaluation, including quantitative data collected in both the control and intervention arms of the GoActive trial, and qualitative data collected in the intervention arm. Data collection methods will include purposively sampled, semi-structured interviews and focus group interviews, direct observation, and participant questionnaires (completed by students, teachers, older adolescent mentors, and local authority-funded facilitators). Data will be analysed thematically within and across datasets. Overall synthesis of findings will address the process of GoActive implementation, and through which this process affects outcomes, with careful attention to the context of the school environment. DISCUSSION:This process evaluation will explore the experience of participating in GoActive from the perspectives of key groups, providing a greater understanding of the acceptability and process of implementation of the intervention across the eight intervention schools. This will allow for appraisal of the intervention's conceptual base, inform potential dissemination, and help optimise post-trial sustainability. The process evaluation will also assist in contextualising the trial effectiveness results with respect to how the intervention may or may not have worked and, if it was found to be effective, what might be required for it to be sustained in the 'real world'. Furthermore, it will offer suggestions for the development and implementation of future initiatives to promote physical activity within schools. TRIAL REGISTRATION:ISRCTN, ISRCTN31583496 . Registered on 18 February 2014.

Project description:BACKGROUND:Increasing children's physical activity (PA) at school is critical to obesity prevention and health promotion. Implementing novel, low-cost PA programs offers potential to contribute to children's in-school PA, particularly in resource-constrained schools. This evaluation describes implementation fidelity, reach, and dose of two PA programs in the Fueling Learning through Exercise (FLEX) Study. METHODS:Thirteen diverse, low-income Massachusetts elementary schools were recruited and randomized to the 100 Mile Club walking/running program (n?=?7) or CHALK/Just Move classroom activity break PA program (n?=?6). Intervention programs were delivered across two school years. Surveys with program champions/teachers and children, in-session measurement of children's PA by accelerometry (Actigraph GT3X) in a subset of schools, and key informant interviews were used to collect information on implementation, including fidelity, dose, reach, and sustainability, and to calculate an implementation score. RESULTS:Six CHALK/Just Move schools implemented the program in both years. Two schools randomized to 100 Mile Club did not implement at all, and only three schools implemented both years. Implementing schools had similar implementation scores (range?=?0-3; 100 Mile Club?=?2.0 vs. CHALK/Just Move?=?1.9) but fidelity to core and enhanced elements differed between programs. In 100 Mile Club schools, dose of program delivered was greater than in CHALK/Just Move schools (34.9 vs. 19.7?min per week). Dose of PA received per session was also greater in 100 Mile Club schools (n?=?55, 2 schools) compared with CHALK/Just Move schools (n?=?160, 2 schools) (13.6?min vs. 2.7?min per session). A slightly higher proportion of eligible children participated in CHALK/Just Move compared to 100 Mile Club (54.0% vs. 31.2%). Both programs were well received by champions/teachers and students. CONCLUSIONS:Program implementation varied across programs and schools, and erosion in delivery was seen over the two years. However, among implementing schools, additional PA was delivered and received, and the programs were generally well-received. Although school resource issues remain barriers to implemention, this evaluation demonstrates that low-cost programs may enhance PA opportunities. Future research should evaluate how multiple programs can be implemented to increase children's PA at school. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02810834 . Registered May 11, 2015.

Dataset Information

Protocol for a mixed methods process evaluation of a hybrid implementation-effectiveness trial of a scaled-up whole-school physical activity program for adolescents: Physical Activity 4 Everyone (PA4E1).

Publications

Protocol for a mixed methods process evaluation of a hybrid implementation-effectiveness trial of a scaled-up whole-school physical activity program for adolescents: Physical Activity 4 Everyone (PA4E1).

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