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 socioeconomic 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 socioeconomic 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.

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)

“…The PA4E1 program is a multi-component secondary school physical activity program which targets adolescents (aged 12-17 years) from secondary schools located in low-socioeconomic areas [21]. Briefly, PA4E1 is based on the Health Promoting Schools framework; taking a whole-of-school approach, which includes delivery of seven physical activity practices that span the school curriculum, school environment and partnerships and services levels [21,22]. The design of the program was guided by social cognitive [23] and social-ecological theory [24].…”

“…Schools were offered six implementation support strategies to help them adopt the seven physical activity practices over 24 months, with four of the five program schools adopting all practices and the remaining school adopting six practices [26]. A RCT of the scale-up of the PA4E1 program will be undertaken, employing a hybrid implementation-effectiveness RCT design in up to 76 schools (38 program: 38 control) across four local health districts in NSW, Australia [21]. The PA4E1 program aims to embed the same seven evidence-based physical activity practices that have been retained from the efficacy trial within the school environment (referred to as physical activity 'practices') [21,25].…”

“…A RCT of the scale-up of the PA4E1 program will be undertaken, employing a hybrid implementation-effectiveness RCT design in up to 76 schools (38 program: 38 control) across four local health districts in NSW, Australia [21]. The PA4E1 program aims to embed the same seven evidence-based physical activity practices that have been retained from the efficacy trial within the school environment (referred to as physical activity 'practices') [21,25]. The implementation support strategy consists of seven implementation support strategies, which are behaviour change techniques designed to overcome the barriers to embedding the physical activity practices into the school (referred to as strategies).…”

“…The objective of the study is to conduct a comprehensive process evaluation as part of a cluster RCT of a secondary school-based physical activity program 'Physical Activity 4 Everyone' (PA4E1) [21]. The hybrid implementation-effectiveness trial seeks to evaluate the effectiveness of a multi-component implementation support strategy to improve implementation, at scale, of the seven physical activity practices of the PA4E1 program (primary outcome), and also assesses the effect on student physical activity (secondary outcome); a separate protocol is available for the implementationeffectiveness outcomes [21]. The aims of the process evaluation are to:…”

Measurement of Sustainment of Prevention Programs and Initiatives: The Sustainment Measurement System Scale

“…One of the reasons for developing a valid and reliable measure of sustainment is to provide a means of conducting an audit and providing feedback to organizations engaged in implementing innovative and evidence-based programs and practices. While monitoring and feedback are recognized as important for prevention [19,20], much of the relevant science on feedback in health has involved improvement in clinical performance [21][22][23][24][25][26][27]. This includes clinical supervision and use of technology like electronic dashboards in measurement-based quality improvement (MBQI) strategies that monitor patient behavior and clinician activity [28][29][30], while prevention has a more limited history of using computational technologies for monitoring [31][32][33][34].…”