Scale-up of the Physical Activity 4 Everyone (PA4E1) intervention in secondary schools: 24-month implementation and cost outcomes from a cluster randomised controlled trial.

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.

Scale-up of the Physical Activity 4 Everyone (PA4E1) intervention in secondary schools: 12-month implementation outcomes from a cluster randomized controlled trial.

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.

Cost effectiveness of a multi-component school-based physical activity intervention targeting adolescents: the 'Physical Activity 4 Everyone' cluster randomized trial.

BACKGROUND: Few school-based interventions have been successful in reducing physical activity decline and preventing overweight and obesity in adolescent populations. As a result, few cost effectiveness analyses have been reported. The aim of this paper is to report the cost and cost effectiveness of the Physical Activity 4 Everyone (PA4E1) intervention which was a multi-component intervention implemented in secondary schools located in low-income communities. Cost effectiveness was assessed using both the physical activity and weight status trial outcomes. METHODS: Intervention and Study Design: The PA4E1 cluster randomised controlled trial was implemented in 10 Australian secondary schools (5 intervention: 5 control) and consisted of intervention schools receiving seven physical activity promotion strategies and six additional strategies that supported school implementation of the intervention components. Costs associated with physical activity strategies, and intervention implementation strategies within the five intervention schools were estimated and compared to the costs of usual physical activity practices of schools in the control group. The total cost of implementing the intervention was estimated from a societal perspective, based on the number of enrolled students in the target grade at the start of the intervention (Grade 7, n = 837). Economic Outcomes: The economic analysis outcomes were cost and incremental cost effectiveness ratios for the following: minutes of moderate-to-vigorous physical activity (MVPA) per day gained, MET hours gained per person/day; Body Mass Index (BMI) unit avoided; and 10% reduction in BMI z-score. RESULTS: The intervention cost AUD $329,952 over 24 months, or AUD$394 per student in the intervention group. This resulted in a cost effectiveness ratio of AUD$56 ($35-$147) per additional minute of MVPA, AUD$1 ($0.6-$2.7) per MET hour gained per person per day, AUD$1408 ($788-$6,570) per BMI unit avoided, and AUD$563 ($282-$3,942) per 10% reduction in BMI z-score. CONCLUSION: PA4E1 is a cost effective intervention for increasing the physical activity levels and reducing unhealthy weight gain in adolescence, a period in which physical activity typically declines. Additional modelling could explore the potential economic impact of the intervention on morbidity and mortality. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612000382875.

An implementation intervention to encourage healthy eating in centre-based child-care services: impact of the Good for Kids Good for Life programme.

OBJECTIVE: To determine the impact of an implementation intervention designed to introduce policies and practices supportive of healthy eating in centre-based child-care services. Intervention strategies included staff training, resources, incentives, follow-up support, and performance monitoring and feedback. DESIGN: A quasi-experimental design was used to assess change over 20 months in healthy eating policy and practice in intervention and comparison child-care services. SETTING: The Hunter New England (HNE) region of New South Wales (NSW), Australia. SUBJECTS: All centre-based child-care services (n 287) in the intervention region (HNE) were invited and 240 (91% response rate) participated. Two hundred and ninety-six services in the rest of NSW were randomly selected as a comparison region and 191 participated (76% response rate). A sub-analysis was conducted on those services that provided children food (n 196 at baseline and n 190 at follow-up). Ninety-six provided menus for analysis at baseline (HNE, n 36; NSW, n 50) and 102 provided menus at follow-up (HNE, n 50; NSW, n 52). RESULTS: Services in the intervention region were significantly more likely to provide only plain milk and water for children (P = 0.018) and to engage parents in nutrition policy or programmes (P = 0.002). They were also more likely (P = 0.056) to have nutrition policy on home packed food. In addition, menus of services that provided lunch were significantly more likely to comply with healthy eating guidelines for sweetened drinks (P < 0.001), fruit (P < 0.001) and vegetables (P = 0.01). CONCLUSIONS: An implementation intervention was able to modify policy and practice in a large number of child-care services so that they were more supportive of healthy eating.

Process Evaluation of a Scaled-Up School-Based Physical Activity Program for Adolescents: Physical Activity 4 Everyone.

BACKGROUND: Physical Activity 4 Everyone (PA4E1) is a whole-school physical activity program, with demonstrated efficacy (2012-2014). PA4E1 was adapted (scaled-up) and tested in a scale-up trial (2017-2020). This process evaluation study of the scale-up trial had 2 aims. First, to describe the acceptability, appropriateness, and feasibility of PA4E1 in the scale-up trial, from the perspective of school staff involved in the program management and delivery. Second, to generate themes that may explain school staff assessments of acceptability, appropriateness, and feasibility. METHODS: Data were collected at various time points throughout the 2-year implementation phase. Online surveys were collected from In-School Champions, Head Physical Education teachers, Principals, and Physical Education teachers (quantitative data). Focus groups and interviews were conducted with In-School Champions, Principals, and Physical Education teachers (qualitative data). Existing published data on website engagement, adaptations, modifications, and the scale-up trial primary outcome (implementation of physical activity practices) were triangulated with the quantitative and qualitative during analysis, to generate themes. RESULTS: School staff delivering PA4E1 reported it was highly acceptable, appropriate, and feasible. Seven themes were generated relating to acceptability, appropriateness, and feasibility. The themes related to how the program was funded, the delivery modes of implementation support, the identification of easy-wins, the recruitment of the right in-school champion, facilitating principal buy-in, mitigating the impact of school staff turnover, and engaging the whole school. CONCLUSIONS: Recommendations are made to inform future adaptations for PA4E1 and potentially school-based physical activity programs more generally. The findings may inform future scalability assessments of the suitability of programs for scale-up.

A cluster randomised trial of a school-based intervention to prevent decline in adolescent physical activity levels: study protocol for the 'Physical Activity 4 Everyone' trial.

BACKGROUND: Adolescence is an established period of physical activity decline. Multi-component school-based interventions have the potential to slow the decline in adolescents' physical activity; however, few interventions have been conducted in schools located in low-income or disadvantaged communities. This study aims to assess the effectiveness of a multi-component school-based intervention in reducing the decline in physical activity among students attending secondary schools located in disadvantaged communities. METHODS/DESIGN: The cluster randomised trial will be conducted with 10 secondary schools located in selected regions of New South Wales, Australia. The schools will be selected from areas that have a level of socio-economic status that is below the state average. Five schools will be allocated to receive an intervention based on the Health Promoting Schools framework, and will be supported by a part-time physical activity consultant placed in intervention schools who will implement a range of intervention adoption strategies. Study measures will be taken at baseline when students are in Year 7 (12-13 years) and again after 12- and 24-months. The primary outcome, minutes of moderate- to-vigorous- intensity physical activity per day and percentage of time in moderate- to vigorous-intensity physical activity (MVPA), will be objectively assessed using accelerometers (Actigraph GT3x+). Group allocation and intervention delivery will commence after baseline data collection. The intervention will continue during school terms through to 24-month follow-up. DISCUSSION: The study will provide evidence regarding the effectiveness of a multi-component school-based intervention that includes an in-school physical activity consultant targeting the physical activity levels of adolescents in disadvantaged Australian secondary schools. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612000382875.

Healthier choices in an Australian health service: a pre-post audit of an intervention to improve the nutritional value of foods and drinks in vending machines and food outlets.

BACKGROUND: Vending machines and shops located within health care facilities are a source of food and drinks for staff, visitors and outpatients and they have the potential to promote healthy food and drink choices. This paper describes perceptions of parents and managers of health-service located food outlets towards the availability and labelling of healthier food options and the food and drinks offered for sale in health care facilities in Australia. It also describes the impact of an intervention to improve availability and labelling of healthier foods and drinks for sale. METHODS: Parents (n = 168) and food outlet managers (n = 17) were surveyed. Food and drinks for sale in health-service operated food outlets (n = 5) and vending machines (n = 90) in health care facilities in the Hunter New England region of NSW were audited pre (2007) and post (2010/11) the introduction of policy and associated support to increase the availability of healthier choices. A traffic light system was used to classify foods from least (red) to most healthy choices (green). RESULTS: Almost all (95%) parents and most (65%) food outlet managers thought food outlets on health service sites should have signs clearly showing healthy choices. Parents (90%) also thought all food outlets on health service sites should provide mostly healthy items compared to 47% of managers. The proportion of healthier beverage slots in vending machines increased from 29% to 51% at follow-up and the proportion of machines that labelled healthier drinks increased from 0 to 26%. No outlets labelled healthier items at baseline compared to 4 out of 5 after the intervention. No changes were observed in the availability or labelling of healthier food in vending machines or the availability of healthier food or drinks in food outlets. CONCLUSIONS: Baseline availability and labelling of healthier food and beverage choices for sale in health care facilities was poor in spite of the support of parents and outlet managers for such initiatives. The intervention encouraged improvements in the availability and labelling of healthier drinks but not foods in vending machines.

Extent, Type and Reasons for Adaptation and Modification When Scaling-Up an Effective Physical Activity Program: Physical Activity 4 Everyone (PA4E1).

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.

School-Based Nutrition Interventions in Children Aged 6 to 18 Years: An Umbrella Review of Systematic Reviews.

Schools are identified as a key setting to influence children's and adolescents' healthy eating. This umbrella review synthesised evidence from systematic reviews of school-based nutrition interventions designed to improve dietary intake outcomes in children aged 6 to 18 years. We undertook a systematic search of six electronic databases and grey literature to identify relevant reviews of randomized controlled trials. The review findings were categorised for synthesis by intervention type according to the World Health Organisation Health Promoting Schools (HPS) framework domains: nutrition education; food environment; all three HPS framework domains; or other (not aligned to HPS framework domain). Thirteen systematic reviews were included. Overall, the findings suggest that school-based nutrition interventions, including nutrition education, food environment, those based on all three domains of the HPS framework, and eHealth interventions, can have a positive effect on some dietary outcomes, including fruit, fruit and vegetables combined, and fat intake. These results should be interpreted with caution, however, as the quality of the reviews was poor. Though these results support continued public health investment in school-based nutrition interventions to improve child dietary intake, the limitations of this umbrella review also highlight the need for a comprehensive and high quality systematic review of primary studies.

An RCT to Facilitate Implementation of School Practices Known to Increase Physical Activity.

INTRODUCTION: Although comprehensive school-based physical activity interventions are efficacious when tested under research conditions, they often require adaptation in order for implementation at scale. This paper reports the effectiveness of an adapted efficacious school-based intervention in improving children's moderate to vigorous physical activity. The impact of strategies to support program implementation was also assessed. DESIGN: A cluster RCT of low socioeconomic elementary schools in New South Wales, Australia. SETTING/PARTICIPANTS: Consenting schools were randomized (25 intervention, 21 control) using a computerized random number function. Follow-up measures were taken at 6 months post-randomization (May-August 2015) by blinded research assistants. The multicomponent school-based intervention, based on an efficacious school-based physical activity program (Supporting Children's Outcomes using Rewards, Exercise and Skills), consisted of four physical activity strategies and seven implementation support strategies. The intervention was adapted for scalability and delivery by a local health service over 6 months. The primary outcome was accelerometer assessed, student mean daily minutes spent in moderate to vigorous physical activity. Physical education lesson quality and other school physical activity practices were also assessed. RESULTS: Participants (n=1,139, 49% male) were third- through sixth-grade students at follow-up (May-August 2015). Valid wear time and analysis of data were provided for 989 (86%) participants (571 intervention, 568 control). At 6-month follow-up, there were no significant effects in overall daily minutes of moderate to vigorous physical activity between groups (1.96 minutes, 95% CI= -3.49, 7.41, p=0.48). However, adjusted difference in mean minutes of overall vigorous physical activity (2.19, 95% CI=0.06, 4.32, p=0.04); mean minutes of school day moderate to vigorous physical activity (2.90, 95% CI=0.06, 5.85, p=0.05); and mean minutes of school day vigorous physical activity (1.81, 95% CI=0.78, 2.83, p≤0.01) were significantly different in favor of the intervention group. Physical education lesson quality and school physical activity practices were significantly different favoring the intervention group (analyzed October 2015-January 2016). CONCLUSIONS: The modified intervention was not effective in increasing children's overall daily minutes of moderate to vigorous physical activity, when adapted for implementation at scale. However, the intervention did improve daily minutes of vigorous physical activity and school day moderate to vigorous physical activity, lesson quality, and school physical activity practices. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12615000437561.

The Physical Activity 4 Everyone Cluster Randomized Trial: 2-Year Outcomes of a School Physical Activity Intervention Among Adolescents.

INTRODUCTION: Few interventions have been successful in reducing the physical activity decline typically observed among adolescents. The aim of this paper is to report the 24-month effectiveness of a multicomponent school-based intervention (Physical Activity 4 Everyone) in reducing the decline in moderate to vigorous physical activity (MVPA) among secondary school students in disadvantaged areas of New South Wales, Australia. STUDY DESIGN: A cluster RCT was conducted in five intervention and five control schools with follow-up measures taken at 24 months post-randomization. SETTING/PARTICIPANTS: The trial was undertaken within secondary schools located in disadvantaged communities in New South Wales, Australia. INTERVENTION: A multicomponent school-based intervention based on the Health Promoting Schools Framework was implemented. The intervention consisted of seven physical activity promotion strategies that targeted the curriculum (teaching strategies to increase physical activity in physical education lessons, student physical activity plans, and modification of school sport program); school environment (recess/lunchtime activities, school physical activity policy); parents (parent newsletters); and community (community physical activity provider promotion). Six additional strategies supported school implementation of the physical activity intervention strategies. MAIN OUTCOME MEASURE: Minutes per day spent in MVPA, objectively measured by accelerometer. RESULTS: Participants (N=1,150, 49% male) were a cohort of students aged 12 years (Grade 7) at baseline (March-June 2012) and 14 years (Grade 9) at follow-up (March-July 2014). At 24-month follow-up, there were significant effects in favor of the intervention group for daily minutes of MVPA. The adjusted mean difference in change in daily MVPA between groups was 7.0 minutes (95% CI=2.7, 11.4, p<0.002) (analysis conducted December 2014-February 2015). Sensitivity analyses based on multiple imputation were consistent with the main analysis (6.0 minutes, 95% CI=0.6, 11.3, p<0.031). CONCLUSIONS: The intervention was effective in increasing adolescents' minutes of MVPA, suggesting that implementation of the intervention by disadvantaged schools has the potential to slow the decline in physical activity. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612000382875.