A cluster randomised controlled trial to assess the effectiveness of a multi-strategy sustainability intervention on teachers' sustained implementation of classroom physical activity breaks (energisers): study protocol.

BACKGROUND: Governments internationally have invested hugely in the implementation and scale-up of school-based physical activity interventions, but have little evidence of how to best sustain these interventions once active implementation support ceases. This study will assess the effectiveness of a multi-strategy sustainability intervention on classroom teachers' sustainment of energisers (short 3-5 min physical activity breaks during class-time) scheduled across the school day from baseline to 12 and 24-month follow-up. METHODS: A cluster randomised controlled trial will be conducted in 50 primary schools within the Hunter New England, Illawarra Shoalhaven, Murrumbidgee and Northern New South Wales (NSW) Local Health Districts of NSW Australia. Schools will be randomly allocated to receive either usual support or the multi-strategy sustainability intervention that includes: centralised technical assistance from a trained project officer; formal commitment and mandated change obtained from school principals; training in-school champions; reminders for teachers; educational materials provided to teachers; capturing and sharing local knowledge; and engagement of parents, carers and the wider school community. The primary trial outcome will be measured via a teacher logbook to determine the between-group difference in the change in mean minutes of energisers scheduled across the school day at 12 and 24-month follow-up compared to baseline. Analyses will be performed using an intention to treat framework. Linear mixed models will be used to assess intervention effects on the primary outcome at both follow-up periods. DISCUSSION: This study will be one of the first randomised controlled trials to examine the impact of a multi-strategy sustainability intervention to support schools' sustainment of a physical activity intervention. The proposed research will generate new evidence needed for the partnering organisations to protect their considerable investments to date in physical activity promotion in this setting and will provide seminal evidence for the field globally. TRIAL REGISTRATION: ACTRN12620000372987 version 1 registered 17th March 2020. Version 3 (current version) updated 4th August 2023.

Cluster randomised controlled trial to determine the impact of an activity enabling uniform on primary school student's fitness and physical activity: study protocol for the Active WeAR Everyday (AWARE) study.

IntroductionMulticomponent school-based physical activity (PA) interventions can improve students' cardiorespiratory fitness (CRF) and PA. Due to the complex nature of such interventions when delivered at scale their effect sizes markedly reduce. Modifying student school uniforms, so that they are more PA enabling, may be a simple intervention that could enhance student health. The primary aim of this trial is to assess the effectiveness of an activity enabling uniform intervention (shorts, polo shirt and sports shoes) in improving children's CRF. METHODS AND ANALYSIS: A cluster randomised controlled trial will be conducted in 24 primary schools in New South Wales (NSW), Australia. Schools will be randomly allocated to either intervention or usual practice following baseline data collection. Active WeAR Everyday intervention schools will allow students in grades 4-6 (aged approx. 9-12 years) to wear their existing sports uniform (shorts, polo shirt and sports shoes) every day. To avoid any financial cost to students they will be provided with two additional sports shirts and one pair of shorts. Study outcomes will be assessed at baseline and 9 months postbaseline. The primary outcome is students' CRF measured using the 20 m multistage fitness test. Secondary outcomes include students': mean daily steps and steps/minute measured via accelerometer, quality of life, mental well-being and perceived PA self-efficacy. The acceptability, feasibility and cost of the intervention will be assessed. Analyses will be performed using an intention-to-treat framework. Linear mixed effects regression models will be used to assess intervention effects on the primary outcome at follow-up. Planned exploratory analyses will examine effects by subgroups (eg, gender). ETHICS AND DISSEMINATION: This study has received approval from Hunter New England Local Health District Human Ethics Committee (2020/ETHO2602) the University of Newcastle, Human Research Ethics Committee (H-2021-0013), NSW Department of Education (SERAP: 2020387) and Catholic School Offices. TRIAL REGISTRATION NUMBER: ACTRN12621000201875.

Multi-strategy intervention increases school implementation and maintenance of a mandatory physical activity policy: outcomes of a cluster randomised controlled trial.

OBJECTIVES: To assess if a multi-strategy intervention effectively increased weekly minutes of structured physical activity (PA) implemented by classroom teachers at 12 months and 18 months. METHODS: A cluster randomised controlled trial with 61 primary schools in New South Wales Australia. The 12-month multi-strategy intervention included; centralised technical assistance, ongoing consultation, principal's mandated change, identifying and preparing school champions, development of implementation plans, educational outreach visits and provision of educational materials. Control schools received usual support (guidelines for policy development via education department website and telephone support). Weekly minutes of structured PA implemented by classroom teachers (primary outcome) was measured via teacher completion of a daily log-book at baseline (October-December 2017), 12-month (October-December 2018) and 18-month (April-June 2019). Data were analysed using linear mixed effects regression models. RESULTS: Overall, 400 class teachers at baseline, 403 at 12 months follow-up and 391 at 18 months follow-up provided valid primary outcome data. From baseline to 12-month follow-up, teachers at intervention schools recorded a greater increase in weekly minutes of PA implemented than teachers assigned to the control schools by approximately 44.2 min (95% CI 32.8 to 55.7; p<0.001) which remained at 18 months, however, the effect size was smaller at 27.1 min (95% CI 15.5 to 38.6; p≤0.001). CONCLUSION: A multi-strategy intervention increased mandatory PA policy implementation. Some, but not all of this improvement was maintained after implementation support concluded. Further research should assess the impact of scale-up strategies on the sustainability of PA policy implementation over longer time periods. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12617001265369).

A cluster randomised controlled trial of an intervention to increase the implementation of school physical activity policies and guidelines: study protocol for the physically active children in education (PACE) study.

BACKGROUND: In an attempt to improve children's physical activity levels governments have introduced policies specifying the minimum time schools are to schedule physical activity each week. Despite this, the majority of schools in many jurisdictions fail to implement these policies. This study will assess the effectiveness of a multi-component implementation strategy on increasing the minutes of planned physical activity scheduled by primary school teachers each week. METHODS: A cluster randomised controlled trial will be conducted in 62 primary schools in the Hunter New England region of New South Wales, Australia. Schools will be randomly allocated to receive either a multi-component implementation strategy that includes; obtaining executive support, training in-school champions, provision of tools and resources, implementation prompts, reminders and feedback; or usual practice. The study will employ an effectiveness-implementation hybrid design, assessing both policy implementation and individual (student) behavioural outcomes. The primary trial outcome of mean minutes of physical activity scheduled by classroom teachers across the school week will be measured via teacher log-book at baseline and approximately 12 and 18 months post baseline. A nested evaluation of the impact of policy implementation on child physical activity will be undertaken of students in Grades 2 and 3. Analyses will be performed using an intention to treat framework. Linear mixed effects regression models will be used to assess intervention effects on the primary outcome at both follow-up periods. DISCUSSION: This study will be the one of the first well powered randomised trials internationally to examine the impact of an implementation strategy for a physical activity policy in primary schools and will address a fundamental research translation gap. Given the dearth of research, the findings will be important in informing future implementation efforts in this setting. TRIAL REGISTRATION: ANZCTR ACTRN12617001265369 version 1 registered 1st September 2017.