Evaluating the scaling up of an effective implementation intervention (PACE) to increase the delivery of a mandatory physical activity policy in primary schools.

BACKGROUND: Physically Active Children in Education (PACE) is an effective implementation intervention for increasing the number of minutes classroom teachers schedule physical activity each week. To date, evaluations of PACE have included a smaller number of schools from only one region in New South Wales Australia. If PACE is to have population-wide benefits we must be able to deliver this support to a larger number of schools across multiple regions. This study aimed to evaluate the scale-up of PACE. METHODS: An uncontrolled before and after study, with 100 schools from three regions was conducted. Participating schools received PACE for approximately 12 months. We assessed the following outcomes: delivery of the evidence-based intervention (EBI) (i.e. minutes of physical activity scheduled by classroom teachers per week); delivery of the implementation strategies (i.e. reach, dose delivered, adherence and indicators of sustainability); and key determinants of implementation (i.e. acceptability of strategies and cost). Data were collected via project officer records, and principal and teacher surveys. Linear mixed models were used to assess EBI delivery by evaluating the difference in the mean minutes teachers scheduled physical activity per week from baseline to follow-up. Descriptive data were used to assess delivery of the implementation strategies and their perceived acceptability (i.e. PACE). A prospective, trial-based economic evaluation was used to assess cost. RESULTS: Delivery of the EBI was successful: teachers increas their average minutes of total physical activity scheduled across the school week by 26.8 min (95% CI: 21.2, 32.4, p < 0.001) after receiving PACE. Indicators for delivery of implementation strategies were high: 90% of consenting schools received all strategies and components (reach); 100% of strategies were delivered by the provider (dose); >50% of schools adhered to the majority of strategies (11 of the 14 components); and acceptability was > 50% agreement for all strategies. The incremental cost per additional minute of physical activity scheduled per week was $27 per school (Uncertainty Interval $24, $31). CONCLUSIONS: PACE can be successfully delivered across multiple regions and to a large number of schools. Given the ongoing and scalable benefits of PACE, it is important that we continue to extend and improve this program while considering ways to reduce the associated cost.

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.

Practice change intervention to improve antenatal care addressing alcohol consumption during pregnancy: a randomised stepped-wedge controlled trial.

BACKGROUND: Clinical guideline recommendations for addressing alcohol consumption during pregnancy are sub-optimally implemented and limited evidence exists to inform practice improvements. The aim of this study was to estimate the effectiveness of a practice change intervention in improving the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. METHODS: A randomised stepped-wedge controlled trial was undertaken with all public maternity services in three sectors (one urban, two regional/rural) of a single local health district in New South Wales, Australia. All antenatal care providers were subject to a seven-month multi-strategy intervention to support the introduction of a recommended model of care. For 35 months (July 2017 - May 2020) outcome data were collected from randomly selected women post an initial, 27-28 weeks and 35-36 weeks gestation antenatal visit. Logistic regression models assessed intervention effectiveness. RESULTS: Five thousand six hundred ninety-four interviews/online questionnaires were completed by pregnant women. The intervention was effective in increasing women's reported receipt of: assessment of alcohol consumption (OR: 2.63; 95% CI: 2.26-3.05; p < 0.001), advice not to consume alcohol during pregnancy and of potential risks (OR: 2.07; 95% CI: 1.78-2.41; p < 0.001), complete care relevant to alcohol risk level (advice and referral) (OR: 2.10; 95% CI: 1.80-2.44; p < 0.001) and all guideline elements relevant to alcohol risk level (assessment, advice and referral) (OR: 2.32; 95% CI: 1.94-2.76; p < 0.001). Greater intervention effects were found at the 27-28 and 35-36 weeks gestation visits compared with the initial antenatal visit. No differences by sector were found. Almost all women (98.8%) reported that the model of care was acceptable. CONCLUSIONS: The practice change intervention improved the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. Future research could explore the characteristics of pregnant women and maternity services associated with intervention effectiveness as well as the sustainment of care practices over time to inform the need for, and development of, further tailored practice change support. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (Registration number: ACTRN12617000882325; Registration date: 16/06/2017) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372985&isReview=true.

A randomised controlled trial of an implementation strategy delivered at scale to increase outdoor free play opportunities in early childhood education and care (ECEC) services: a study protocol for the get outside get active (GOGA) trial.

BACKGROUND: Increased outdoor play time in young children is associated with many health and developmental benefits. This study aims to evaluate the impact of a multi-strategy implementation strategy delivered at scale, to increase opportunities for outdoor free play in Early Childhood Education and Care (ECEC) services. METHODS: The study will employ a parallel-group randomised controlled trial design. One hundred ECEC services in the Hunter New England region of New South Wales, Australia, will be recruited and randomised to receive either a 6-month implementation strategy or usual care. The trial will seek to increase the implementation of an indoor-outdoor routine (whereby children are allowed to move freely between indoor and outdoor spaces during periods of free play), to increase their opportunity to engage in outdoor free play. Development of the strategy was informed by the Behaviour Change Wheel to address determinants identified in the Theoretical Domains Framework. ECEC services allocated to the control group will receive 'usual' implementation support delivered as part of state-wide obesity prevention programs. The primary trial outcome is the mean minutes/day (calculated across 5 consecutive days) of outdoor free play opportunities provided in ECEC services measured at baseline, 6-months (primary end point) and 18-months post baseline. Analyses will be performed using an intention-to-treat approach with ECEC services as the unit of analysis, using a linear mixed effects regression model to assess between-group differences. A sensitivity analysis will be undertaken, adjusting for service characteristics that appear imbalanced between groups at baseline, and a subgroup analysis examining potential intervention effect among services with the lowest baseline outdoor free play opportunities. DISCUSSION: Identifying effective strategies to support the implementation of indoor-outdoor routines in the ECEC setting at scale is essential to improve child population health. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12621000987864 ). Prospectively registered 27th July 2021, ANZCTR - Registration.

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).

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.

Acceptance of smoking cessation support and quitting behaviours of women attending Aboriginal Maternal and Infant Health Services for antenatal care.

BACKGROUND: Acceptance of smoking cessation support during antenatal care and associated quitting behaviours of pregnant Aboriginal women or women having an Aboriginal baby has not been investigated. This study aimed to determine, among pregnant women who smoke and attended AMIHS for their antenatal care: 1. The acceptance of smoking cessation support, factors associated with acceptance and barriers to acceptance; 2. The prevalence of quitting behaviours and factors associated with quitting behaviours. METHODS: A cross-sectional telephone survey of women who attended 11 AMIHSs for their antenatal care during a 12 month period in the Hunter New England Local Health District of New South Wales. RESULTS: One hundred women contacted consented to complete the survey (76%). Of those offered cessation support, 68% accepted NRT, 56% accepted follow-up support and 35% accepted a Quitline referral. Participants accepting NRT had greater odds of quitting smoking at least twice during the antenatal period [OR = 6.90 (CI: 1.59-29.7)] and those reporting using NRT for greater than eight weeks had six times the odds of quitting smoking for one day or more [OR = 6.07 (CI: 1.14-32.4)]. CONCLUSIONS: Aboriginal women or women having an Aboriginal baby who smoke make multiple attempts to quit during pregnancy and most women accept smoking cessation support when offered by their antenatal care providers. Acceptance of care and quitting success may be improved with increased focus on culturally appropriate care and enhanced training of antenatal care providers to increase skills in treating nicotine addiction and supporting women to use NRT as recommended by treatment guidelines.

A Multicomponent mHealth-Based Intervention (SWAP IT) to Decrease the Consumption of Discretionary Foods Packed in School Lunchboxes: Type I Effectiveness-Implementation Hybrid Cluster Randomized Controlled Trial.

BACKGROUND: There is significant opportunity to improve the nutritional quality of foods packed in children's school lunchboxes. Interventions that are effective and scalable targeting the school and home environment are therefore warranted. OBJECTIVE: This study aimed to assess the effectiveness of a multicomponent, mobile health-based intervention, SWAP IT, in reducing the energy contribution of discretionary (ie, less healthy) foods and drinks packed for children to consume at school. METHODS: A type I effectiveness-implementation hybrid cluster randomized controlled trial was conducted in 32 primary schools located across 3 local health districts in New South Wales, Australia, to compare the effects of a 6-month intervention targeting foods packed in children's lunchboxes with those of a usual care control. Primary schools were eligible if they were not participating in other nutrition studies and used the required school communication app. The Behaviour Change Wheel was used to co-design the multicomponent SWAP IT intervention, which consisted of the following: school lunchbox nutrition guidelines, curriculum lessons, information pushed to parents digitally via an existing school communication app, and additional parent resources to address common barriers to packing healthy lunchboxes. The primary outcome, mean energy (kilojoules) content of discretionary lunchbox foods and drinks packed in lunchboxes, was measured via observation using a validated school food checklist at baseline (May 2019) and at 6-month follow-up (October 2019). Additional secondary outcomes included mean lunchbox energy from discretionary foods consumed, mean total lunchbox energy packed and consumed, mean energy content of core lunchbox foods packed and consumed, and percentage of lunchbox energy from discretionary and core foods, all of which were also measured via observation using a validated school food checklist. Measures of school engagement, consumption of discretionary foods outside of school hours, and lunchbox cost were also collected at baseline and at 6-month follow-up. Data were analyzed via hierarchical linear regression models, with controlling for clustering, socioeconomic status, and remoteness. RESULTS: A total of 3022 (3022/7212, 41.90%) students consented to participate in the evaluation (mean age 7.8 years; 1487/3022, 49.22% girls). There were significant reductions between the intervention and control groups in the primary trial outcome, mean energy (kilojoules) content of discretionary foods packed in lunchboxes (-117.26 kJ; 95% CI -195.59 to -39.83; P=.003). Relative to the control, the intervention also significantly reduced secondary outcomes regarding the mean total lunchbox energy (kilojoules) packed (-88.38 kJ; 95% CI -172.84 to -3.92; P=.04) and consumed (-117.17 kJ; 95% CI -233.72 to -0.62; P=.05). There was no significant difference between groups in measures of student engagement, consumption of discretionary foods outside of school hours, or cost of foods packed in children's lunchboxes. CONCLUSIONS: The SWAP IT intervention was effective in reducing the energy content of foods packed for and consumed by primary school-aged children at school. Dissemination of the SWAP IT program at a population level has the potential to influence a significant proportion of primary school-aged children, impacting weight status and associated health care costs. TRIAL REGISTRATION: Australian Clinical Trials Registry ACTRN12618001731280; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376191&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-019-7725-x.

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.

A cross-sectional study to determine the energy density and nutritional quality of primary-school children's lunchboxes.

OBJECTIVE: The present study describes the energy content of primary-school children's lunchboxes and the proportion of lunchbox foods considered discretionary. Subgroup analyses by sex, socio-economic status, age and weight status were undertaken. DESIGN: A cross-sectional study was conducted. Mean kilojoule content, number of items and categorisation of foods and drinks in lunchboxes as 'everyday' (healthy) or discretionary (sometimes) foods were assessed via a valid and reliable lunchbox observational audit. SETTING: Twelve Catholic primary schools (Kindergarten-Grade 6) located in the Hunter region of New South Wales, Australia. PARTICIPANTS: Kindergarten to Grade 6 primary-school students. RESULTS: In total, 2143 children (57 %) had parental consent to have their lunchboxes observed. School lunchboxes contained a mean of 2748 kJ, of which 61·2 % of energy was from foods consistent with the Australian Dietary Guidelines and 38·8 % of energy was discretionary foods. The proportion of lunchboxes containing only healthy foods was 12 %. Children in Kindergarten-Grade 2 packed more servings of 'everyday' foods (3·32 v. 2·98, P < 0·01) compared with children in Grades 3-6. Children in Grades 3-6 had a higher percentage of energy from discretionary foods (39·1 v. 33·8 %, P < 0·01) compared with children in Kindergarten-Grade 2 and children from the most socio-economically disadvantaged areas had significantly higher total kilojoules in the school lunchbox compared with the least disadvantaged students (2842 v. 2544 kJ, P = 0·03). CONCLUSIONS: Foods packed within school lunchboxes may contribute to energy imbalance. The development of school policies and population-based strategies to support parents overcome barriers to packing healthy lunchboxes are warranted.

Making space for Aboriginal and Torres Strait Islander community health workers in health promotion.

Despite a clear need, 'closing the gap' in health disparities for Aboriginal and Torres Strait Islander communities (hereafter, respectfully referred to as Aboriginal) continues to be challenging for western health care systems. Globally, community health workers (CHWs) have proven effective in empowering communities and improving culturally appropriate health services. The global literature on CHWs reflects a lack of differentiation between the types of roles these workers carry out. This in turn impedes evidence syntheses informing how different roles contribute to improving health outcomes. Indigenous CHW roles in Australia are largely operationalized by Aboriginal Health Workers (AHWs)-a role situated primarily within the clinical health system. In this commentary, we consider whether the focus on creating professional AHW roles, although important, has taken attention away from the benefits of other types of CHW roles particularly in community-based health promotion. We draw on the global literature to illustrate the need for an Aboriginal CHW role in health promotion; one that is distinct from, but complementary to, that of AHWs in clinical settings. We provide examples of barriers encountered in developing such a role based on our experiences of employing Aboriginal health promoters to deliver evidence-based programmes in rural and remote communities. We aim to draw attention to the systemic and institutional barriers that persist in denying innovative employment and engagement opportunities for Aboriginal people in health.

A randomized controlled trial to assess the potential efficacy, feasibility and acceptability of an m-health intervention targeting parents of school aged children to improve the nutritional quality of foods packed in the lunchbox 'SWAP IT'.

BACKGROUND: Scalable interventions that improve the nutritional quality of foods in children's lunchboxes have considerable potential to improve child public health nutrition. This study assessed the potential efficacy, feasibility and acceptability of an m-health intervention, 'SWAP IT', to improve the energy and nutritional quality of foods packed in children's lunchboxes. METHODS: The study employed a 2X2 factorial cluster randomized-controlled trial design. Twelve primary schools in New South Wales, Australia were randomly allocated to one of four groups: (i) no intervention;(ii) physical activity intervention only;(iii) lunchbox intervention only; or(iv) physical activity and lunchbox intervention combined. The two intervention strategies were evaluated separately. This paper focuses on the effects of the lunchbox intervention only. The lunchbox intervention comprised four strategies: 1) school nutrition guidelines; 2) lunchbox lessons; 3) information pushed to parents via a school-communication app and 4) parent resources addressing barriers to packing healthy lunchboxes. Outcome measures were taken at baseline and immediately post-intervention (10 weeks) and included measures of effectiveness (mean energy (kJ) packed in lunchboxes, total energy and percentage energy from recommended foods consistent with Australian Dietary Guidelines), feasibility (of delivering intervention to schools, parent app engagement and behaviour change) and acceptability to school staff and parents. Linear mixed models were used to assess intervention efficacy. RESULTS: Of the 1915 lunchbox observations, at follow-up there was no significant differences between intervention and control group in mean energy of foods packed within lunchboxes (- 118.39 kJ, CI = -307.08, 70.30, p = 0.22). There was a significant increase favouring the intervention in the secondary outcome of mean lunchbox energy from recommended foods (79.21 kJ, CI = 1.99, 156.43, p = 0.04), and a non-significant increase in percentage of lunchbox energy from recommended foods in intervention schools (4.57%, CI = -0.52, 9.66, p = 0.08). The views of the messages pushed via the app ranged from 387 to 1550 views per week (mean views =1025 per week). A large proportion (71%) of parents reported awareness of the intervention, making healthier swaps in the lunchbox (55%), and pushed content was helpful (84%). CONCLUSION: The study is the first RCT to assess the potential of a multi-component m-health lunchbox intervention. The intervention was feasible, acceptable and potentially effective in improving the nutritional quality of foods packed within children's lunchboxes. TRIAL REGISTRATION: Australian Clinical Trials Registry ACTRN: ACTRN12616001228471 .

Sustaining the implementation of alcohol management practices by community sports clubs: a randomised control trial.

BACKGROUND: Risky alcohol consumption is responsible for a variety of chronic and acute harms. Individuals involved in organised sport have been identified as one population group who consume risky amounts of alcohol both at the elite and the non-elite level. 'Good Sports', an alcohol management intervention focused on the community sports setting has been successful in addressing risky alcohol use and alcohol-related harm amongst players and sports fans. Sustaining such implementation effects is a common challenge across a variety of community settings. The primary aim of this trial was to assess the effectiveness of a web-based program in sustaining the implementation of best-practice alcohol management practices by community football clubs, relative to usual program care (i.e. control clubs). METHODS: Non-elite, community football clubs in the Australian states of New South Wales and Victoria, that were participating in an alcohol management program (Good Sports) were recruited for the study. Consenting clubs were randomised into intervention (N = 92) or control (N = 96) groups. A web-based sustainability intervention was delivered to intervention clubs over three consecutive Australian winter sports seasons (April-September 2015-2017). The intervention was designed to support continued (sustained) implementation of alcohol management practices at clubs consistent with the program. Control group clubs received usual support from the national Good Sports Program. Primary outcome data was collected through observational audits of club venues and grounds. RESULTS: A total of 92 intervention clubs (574 members) and 96 control clubs (612 members) were included in the final analysis. At follow-up, sustained implementation of alcohol management practices was high in both groups and there was no significant difference between intervention or control clubs at follow-up for both the proportion of clubs implementing 10 or more practices (OR 0.53, 95%CI 0.04-7.2; p = 0.63) or for the mean number of practices being implemented (mean difference 0.10, 95%CI -0.23-0.42; p = 0.55). There were also no significant differences between groups on measures of alcohol consumption by club members. CONCLUSIONS: The findings suggest that sustained implementation of alcohol management practices was high, and similar, between clubs receiving web-based implementation support or usual program support. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614000746639. Prospectively registered 14/7/2014.

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.

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.

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 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12th May 2017. Protocol Version 1.

Protocol for an effectiveness- implementation hybrid trial to assess the effectiveness and cost-effectiveness of an m-health intervention to decrease the consumption of discretionary foods packed in school lunchboxes: the 'SWAP IT' trial.

BACKGROUND: At a population level, small reductions in energy intake have the potential to contribute to a reduction in the prevalence of childhood obesity. In many school systems, there is the potential to achieve a reduction in energy intake through modest improvements in foods packed in children's school lunchboxes. This study will assess the effectiveness and cost-effectiveness of a multi-component intervention that uses an existing school-based communication application to reduce the kilojoule content from discretionary foods and drinks consumed by children from school lunchboxes whilst at school. METHODS: A Type I hybrid effectiveness-implementation cluster randomised controlled trial will be conducted in up to 36 primary schools in the Hunter New England, Central Coast and Mid North Coast regions of New South Wales, Australia. Designed using the Behaviour Change Wheel, schools will be randomly allocated to receive either a 5-month (1.5 school terms) multi-component intervention that includes: 1) school lunchbox nutrition guidelines; 2) curriculum lessons; 3) information pushed to parents via an existing school-based communication application and 4) additional parent resources to address common barriers to packing healthy lunchboxes or a control arm (standard school practices). The study will assess both child level dietary outcomes and school-level implementation outcomes. The primary trial outcome, mean energy (kJ) content of discretionary lunchbox foods packed in children's lunchboxes, will be assessed at baseline and immediately post intervention (5 months or 1.5 school terms). Analyses will be performed using intention to treat principles, assessing differences between groups via hierarchical linear regression models. DISCUSSION: This study will be the first fully powered randomised controlled trial internationally to examine the impact of an m-health intervention to reduce the mean energy from discretionary food and drinks packed in the school lunchbox. The intervention has been designed with scalability in mind and will address an important evidence gap which, if shown to be effective, has the potential to be applied at a population level. TRIAL REGISTRATION: Australian Clinical Trials Registry ACTRN:12618001731280 registered on 17/10/2018. Protocol Version 1.

Efficacy of a free-play intervention to increase physical activity during childcare: a randomized controlled trial.

The primary aim of this study was to assess the efficacy of a childcare-based intervention in increasing child physical activity by allowing children unrestricted access to outdoor areas for free-play when structured activity is not taking place. A randomized controlled trial was conducted in six childcare services. Intervention services provided children unrestricted access outdoors for active free-play, while control services provided their usual scheduled periods of outdoor play. Consent was obtained from 231 children. Child moderate to vigorous activity (MVPA), the primary trial outcome, was assessed via accelerometer at baseline and 3 months post baseline. Intervention effects were examined using Generalised Linear Mixed Models. Controlling for child age, gender and baseline outcome measure, at follow-up there were no significant differences between groups in minutes of MVPA in-care (mean difference: 4.85; 95% CI: -3.96, 13.66; P = 0.28), proportion of wear time in-care spent in MVPA (mean difference: 1.52%; 95% CI: -0.50, 3.53; P = 0.14) or total physical activity in-care (mean difference in counts per minute: 23.18; 95% CI: -4.26, 50.61; P = 0.10), nor on measures of child cognition (P = 0.45-0.91). It was concluded that interventions addressing multiple aspects of the childcare and home environment might provide the greatest potential to improve child physical activity.

Impact of scheduling multiple outdoor free-play periods in childcare on child moderate-to-vigorous physical activity: a cluster randomised trial.

BACKGROUND: Increasing the frequency of periods of outdoor free-play in childcare may represent an opportunity to increase child physical activity. This study aimed to assess the efficacy of scheduling multiple periods of outdoor free-play in increasing the time children spend in moderate-to-vigorous physical activity (MVPA) while attending childcare. METHODS: The study employed a cluster randomised controlled trial design involving children aged 3 to 6 years, attending ten childcare services in the Hunter New England region of New South Wales, Australia. Five services were randomised to receive the intervention and five to a control condition. The intervention involved services scheduling three separate periods of outdoor free-play from 9 am to 3 pm per day, each at least 15 min in duration, with the total equivalent to their usual daily duration of outdoor play period. Control services implemented the usual single continuous period of outdoor free-play over this time. The primary outcome, children's moderate-to-vigorous physical activity (MVPA) while in care per day, was measured over 5 days via accelerometers at baseline and at 3 months post baseline. Secondary outcomes included percentage of time spent in MVPA while in care per day, total physical activity while in care per day and documented child injury, a hypothesised potential unintended adverse event. Childcare services and data collectors were not blind to the experimental group allocation. RESULTS: Parents of 439 (71.6%) children attending participating childcare services consented for their child to participate in the trial. Of these, 316 (72.0%) children provided valid accelerometer data at both time points. Relative to children in control services, mean daily minutes of MVPA in care was significantly greater at follow-up among children attending intervention services (adjusted difference between groups 5.21 min, 95% CI 0.59-9.83 p = 0.03). Percentage of time spent in MVPA in care per day was also greater at follow-up among children in intervention services relative to control services (adjusted difference between groups 1.57, 95% CI 0.64-2.49 p < 0.001). Total physical activity while in care per day, assessed via counts per minute approached but did not reach significance (adjusted difference between groups 14.25, 95% CI 2.26-30.76 p = 0.09). There were no differences between groups in child injury nor subgroup interactions for the primary trial outcome by child age, sex, or baseline MVPA levels. CONCLUSION: Scheduling multiple periods of outdoor free-play significantly increased the time children spent in MVPA while in attendance at childcare. This simple ecological intervention could be considered for broader dissemination as a strategy to increase child physical activity at a population level. TRIAL REGISTRATION: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) ( ACTRN1261000347460 ). Prospectively registered 17th March 2016.

A systematic review and meta-analysis of moderate-to-vigorous physical activity levels in secondary school physical education lessons.

BACKGROUND: Schools play an important role in physical activity promotion for adolescents. The systematic review aimed to determine the proportion of secondary (middle and high) school physical education (PE) lesson time that students spend in moderate to vigorous physical activity (MVPA), and to assess if MVPA was moderated by school level (middle and high school), type of physical activity measurement and type of PE activities. METHODS: A systematic search of nine electronic databases was conducted (PROSPERO2014:CRD42014009649). Studies were eligible if they were published between 2005 and 2014; written in English; assessed MVPA in PE lessons of secondary (middle and high) school students; and used a quantitative MVPA measure (i.e., accelerometry, heart rate monitoring, pedometers or observational measures). Two reviewers examined the retrieved articles, assessed risk of bias, and performed data extraction. Random effects meta-analysis was used to calculate a pooled estimate of the percent of PE lesson time spent in MVPA and to assess moderator effects where data allowed. RESULTS: The search yielded 5,132 potentially relevant articles; 28 articles representing 25 studies (7 middle and 18 high school) from seven countries were included. Twelve studies measured MVPA through observational measures, seven used accelerometers, five used heart rate monitors and four used pedometers (including three studies using a mix of measures). Meta-analysis of 15 studies found that overall, students spent a mean (95% CI) of 40.5% (34.8-46.2%) of PE in MVPA. Middle school students spent 48.6% (41.3-55.9%) of the lesson in MVPA (n = 5 studies) and high school students 35.9% (28.3-43.6%) (n = 10 studies). Studies measuring MVPA using accelerometers (n = 5) showed that students spent 34.7% (25.1-44.4%) of the lesson in MVPA, while 44.4% (38.3-50.5%) was found for lessons assessed via observation (n = 9), 43.1% (24.3-61.9%) of the lesson for a heart rate based study, and 35.9% (31.0-40.8%) for a pedometer-measured study. CONCLUSIONS: The proportion of PE spent in MVPA (40.5%) is below the US Centre for Disease Control and Prevention and the UK Associations for Physical Education recommendation of 50%. Findings differed according to the method of MVPA assessment. Additional strategies and intervention research are needed to build more active lesson time in PE.

Supporting Aboriginal Women to Quit Smoking: Antenatal and Postnatal Care Providers' Confidence, Attitudes, and Practices.

INTRODUCTION: Tobacco use during pregnancy is substantially higher among Aboriginal women compared to non-Aboriginal women in Australia. However, no studies have investigated the amount or type of smoking cessation care that staff from Aboriginal antenatal and postnatal services provide to clients who smoke or staff confidence to do so. This study examined Aboriginal antenatal and postnatal staff confidence, perceived role and delivery of smoking cessation care to Aboriginal women and characteristics associated with provision of such care. METHODS: Staff from 11 Aboriginal Maternal and Infant Health Services and eight Aboriginal Child and Family Health services in the Hunter New England Local Health District in Australia completed a cross-sectional self-reported survey (n = 67, response rate = 97.1%). RESULTS: Most staff reported they assessed clients' smoking status most or all of the time (92.2%). However, only a minority reported they offered a quitline referral (42.2%), provided follow-up support (28.6%) or provided nicotine replacement therapy (4.7%) to most or all clients who smoked. Few staff felt confident in motivating clients to quit smoking (19.7%) and advising clients about using nicotine replacement therapy (15.6%). Staff confident with talking to clients about how smoking affected their health had significantly higher odds of offering a quitline referral [OR = 4.9 (1.7-14.5)] and quitting assistance [OR = 3.9 (1.3-11.6)] to clients who smoke. CONCLUSIONS: Antenatal and postnatal staff delivery of smoking cessation care to pregnant Aboriginal women or mothers with young Aboriginal children could be improved. Programs that support Aboriginal antenatal and postnatal providers to deliver smoking cessation care to clients are needed. IMPLICATIONS: Aboriginal antenatal and postnatal service staff have multiple opportunities to assist Aboriginal women to quit smoking during pregnancy and postpartum. However, staff confidence and practices of offering various forms of smoking cessation support to pregnant Aboriginal women is unexplored. This is the first study to examine the amount and type of smoking cessation support Aboriginal antenatal and postnatal service staff provide to Aboriginal women, staff confidence and their perceived role in delivering smoking cessation care. This information is valuable for developing strategies that assist antenatal and postnatal staff to improve their delivery of smoking cessation care to Aboriginal women.