Research from JAMA Pediatrics — Sustainability of Effects of an Early Childhood Obesity Prevention Trial Over Time — A Further 3-Year Follow-up of the Healthy Beginnings Trial

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. 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. 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. Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017. Protocol Version 1.

The effectiveness of many interventions to promote health and prevent disease has been well established. The imperative has therefore shifted from amassing evidence about efficacy to scale-up to maximise population-level health gains. Electronic implementation monitoring, or ‘e-monitoring’, systems have been designed to assist and track the delivery of preventive policies and programs. However, there is little evidence on whether e-monitoring systems improve the dissemination, adoption, and ongoing delivery of evidence-based preventive programs. Also, given considerable difficulties with e-monitoring systems in the clinical sector, scholars have called for a more sophisticated re-examination of e-monitoring’s role in enhancing implementation. In the state of New South Wales (NSW), Australia, the Population Health Information Management System (PHIMS) was created to support the dissemination of obesity prevention programs to 6000 childcare centres and elementary schools across all 15 local health districts. We have established a three-way university-policymaker-practice research partnership to investigate the impact of PHIMS on practice, how PHIMS is used, and how achievement of key performance indicators of program adoption may be associated with local contextual factors. Our methods encompass ethnographic observation, key informant interviews and participatory workshops for data interpretation at a state and local level. We use an on-line social network analysis of the collaborative relationships across local health district health promotion teams to explore the relationship between PHIMS use and the organisational structure of practice. Insights will be sensitised by institutional theory, practice theory and complex adaptive system thinking, among other theories which make sense of socio-technical action. Our working hypothesis is that the science of getting evidence-based programs into practice rests on an in-depth understanding of the role they play in the on-going system of local relationships and multiple accountabilities. Data will be synthesised to produce a typology to characterise local context, PHIMS use and key performance indicator achievement (of program implementation) across the 15 local health districts. Results could be used to continuously align e-monitoring technologies within quality improvement processes to ensure that such technologies enhance practice and innovation. A partnership approach to knowledge production increases the likelihood that findings will be put into practice.

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.

Background: Physical 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. Methods: A 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. Results: At 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). Conclusions: The 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 registration: Australian New Zealand Clinical Trials Registry ACTRN12617000681358 prospectively registered 12th May 2017.