Factors associated with child and adolescent electronic nicotine and non-nicotine delivery systems use: A scoping review.

OBJECTIVES: To identify, characterise and broadly synthesise factors associated with child and adolescent electronic nicotine delivery systems (ENDS) and/or electronic non-nicotine delivery systems (ENNDS) ever-use and/or current use. METHODS: Four electronic databases were searched from inception to 3rd June 2022. Non-experimental studies that provided quantitative factors associated with adolescent and/or child ENDS or ENNDS ever-use and/or current use were included. Factors associated with ever-use (any lifetime use) and/or current use (use in past 30 days) were included. All screening and data extraction was conducted independently by paired review authors. Frequencies for country, study design, sample size, measure of ENDS/ENNDS use and factors examined were calculated. Factors were categorised according to the Theory of Triadic Influence domains and sub-domains. RESULTS: The search of electronic databases identified 4756 records, 240 of which were included. The majority of studies examined factors categorised within the Biology and Personality domain of the Theory of Triadic Influence (89.2%; 95%CI 84.6, 82.5), followed by the Social Context (50.8%; 95%CI 44.5, 57.2) and Broader Environment domains (30.4%; 95%CI 24.6, 36.3). The proportion of factors significantly associated with ENDS/ENNDS use was >75% for the Behavioural (78.0%; factors included use of tobacco, other drugs and alcohol), Peer Attitudes and Behaviours (80.0%; factors included peer use of ENDS/ENNDS and tobacco), and Legislation/Policy sub-domains (78.6%; factors included accessibility and advertising). CONCLUSIONS: The evidence base on factors associated with ENDS/ENNDS use in children and adolescents is rapidly developing, predominately by research concentrated in high income regions and focused on behavioural- and personality-related factors.

A bibliographic review of sustainability research output and investment in 10 leading public health journals across three time periods.

Objectives: Long-term delivery, or sustainability, of evidence-based interventions is necessary for public health benefits to be realised. However, sustainment of effective interventions is poor. Understanding the evidence-base and identifying potential gaps is necessary to inform where future research efforts are most warranted. Study design: We undertook a repeat cross-sectional bibliographic review of research published in 10 public health journals across three time periods (2010, 2015 and 2020/2021). Methods: Studies were eligible if they were a data-based study or review article. Studies were assessed as to whether they focused on sustainability. The percentage of public health research studies assessing sustainability overall and by the three time periods was calculated. The association between time period and the proportion of sustainability articles was assessed using logistic regression. Descriptive statistics were used to summarise study characteristics overall and by time period. Results: 10,588 data-based articles were identified, of which 1.3 % (n = 136) focused on sustainability. There was a statistically significant association between time period and the proportion of sustainability research, with a slight increase across the three time periods: 0.3 % (95 % CI: 0.1 %, 0.7 %) in 2010, 1.4 % (95 % CI: 1.0 %, 1.9 %) in 2015 and 1.6 % (95 % CI: 1.3 %, 1.9 %) in 2020/2021. Most research was descriptive/epidemiological (n = 69, 51 %), few focused on measurement (n = 2, 1.5 %) and none on cost effectiveness. Only one intervention study assessed the effect of specific sustainability strategies. Conclusions: This bibliographic review highlights the need for more public health research on sustainability, particularly in the areas of measurement, sustainability interventions, and cost effectiveness.

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.

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.

Healthy eating interventions delivered in early childhood education and care settings for improving the diet of children aged six months to six years.

BACKGROUND: Dietary intake during early childhood can have implications on child health and developmental trajectories. Early childhood education and care (ECEC) services are recommended settings to deliver healthy eating interventions as they provide access to many children during this important period. Healthy eating interventions delivered in ECEC settings can include strategies targeting the curriculum (e.g. nutrition education), ethos and environment (e.g. menu modification) and partnerships (e.g. workshops for families). Despite guidelines supporting the delivery of healthy eating interventions in this setting, little is known about their impact on child health. OBJECTIVES: To assess the effectiveness of healthy eating interventions delivered in ECEC settings for improving dietary intake in children aged six months to six years, relative to usual care, no intervention or an alternative, non-dietary intervention. Secondary objectives were to assess the impact of ECEC-based healthy eating interventions on physical outcomes (e.g. child body mass index (BMI), weight, waist circumference), language and cognitive outcomes, social/emotional and quality-of-life outcomes. We also report on cost and adverse consequences of ECEC-based healthy eating interventions. SEARCH METHODS: We searched eight electronic databases including CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, ERIC, Scopus and SportDiscus on 24 February 2022. We searched reference lists of included studies, reference lists of relevant systematic reviews, the World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov and Google Scholar, and contacted authors of relevant papers. SELECTION CRITERIA: We included randomised controlled trials (RCTs), including cluster-RCTs, stepped-wedge RCTs, factorial RCTs, multiple baseline RCTs and randomised cross-over trials, of healthy eating interventions targeting children aged six months to six years that were conducted within the ECEC setting. ECEC settings included preschools, nurseries, kindergartens, long day care and family day care. To be included, studies had to include at least one intervention component targeting child diet within the ECEC setting and measure child dietary or physical outcomes, or both. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently screened titles and abstracts and extracted study data. We assessed risk of bias for all studies against 12 criteria within RoB 1, which allows for consideration of how selection, performance, attrition, publication and reporting biases impact outcomes. We resolved discrepancies via consensus or by consulting a third review author. Where we identified studies with suitable data and homogeneity, we performed meta-analyses using a random-effects model; otherwise, we described findings using vote-counting approaches and via harvest plots. For measures with similar metrics, we calculated mean differences (MDs) for continuous outcomes and risk ratios (RRs) for dichotomous outcomes. We calculated standardised mean differences (SMDs) for primary and secondary outcomes where studies used different measures. We applied GRADE to assess certainty of evidence for dietary, cost and adverse outcomes. MAIN RESULTS: We included 52 studies that investigated 58 interventions (described across 96 articles). All studies were cluster-RCTs. Twenty-nine studies were large (≥ 400 participants) and 23 were small (< 400 participants). Of the 58 interventions, 43 targeted curriculum, 56 targeted ethos and environment, and 50 targeted partnerships. Thirty-eight interventions incorporated all three components. For the primary outcomes (dietary outcomes), we assessed 19 studies as overall high risk of bias, with performance and detection bias being most commonly judged as high risk of bias. ECEC-based healthy eating interventions versus usual practice or no intervention may have a positive effect on child diet quality (SMD 0.34, 95% confidence interval (CI) 0.04 to 0.65; P = 0.03, I2 = 91%; 6 studies, 1973 children) but the evidence is very uncertain. There is moderate-certainty evidence that ECEC-based healthy eating interventions likely increase children's consumption of fruit (SMD 0.11, 95% CI 0.04 to 0.18; P < 0.01, I2 = 0%; 11 studies, 2901 children). The evidence is very uncertain about the effect of ECEC-based healthy eating interventions on children's consumption of vegetables (SMD 0.12, 95% CI -0.01 to 0.25; P =0.08, I2 = 70%; 13 studies, 3335 children). There is moderate-certainty evidence that ECEC-based healthy eating interventions likely result in little to no difference in children's consumption of non-core (i.e. less healthy/discretionary) foods (SMD -0.05, 95% CI -0.17 to 0.08; P = 0.48, I2 = 16%; 7 studies, 1369 children) or consumption of sugar-sweetened beverages (SMD -0.10, 95% CI -0.34 to 0.14; P = 0.41, I2 = 45%; 3 studies, 522 children). Thirty-six studies measured BMI, BMI z-score, weight, overweight and obesity, or waist circumference, or a combination of some or all of these. ECEC-based healthy eating interventions may result in little to no difference in child BMI (MD -0.08, 95% CI -0.23 to 0.07; P = 0.30, I2 = 65%; 15 studies, 3932 children) or in child BMI z-score (MD -0.03, 95% CI -0.09 to 0.03; P = 0.36, I2 = 0%; 17 studies; 4766 children). ECEC-based healthy eating interventions may decrease child weight (MD -0.23, 95% CI -0.49 to 0.03; P = 0.09, I2 = 0%; 9 studies, 2071 children) and risk of overweight and obesity (RR 0.81, 95% CI 0.65 to 1.01; P = 0.07, I2 = 0%; 5 studies, 1070 children). ECEC-based healthy eating interventions may be cost-effective but the evidence is very uncertain (6 studies). ECEC-based healthy eating interventions may have little to no effect on adverse consequences but the evidence is very uncertain (3 studies). Few studies measured language and cognitive skills (n = 2), social/emotional outcomes (n = 2) and quality of life (n = 3). AUTHORS' CONCLUSIONS: ECEC-based healthy eating interventions may improve child diet quality slightly, but the evidence is very uncertain, and likely increase child fruit consumption slightly. There is uncertainty about the effect of ECEC-based healthy eating interventions on vegetable consumption. ECEC-based healthy eating interventions may result in little to no difference in child consumption of non-core foods and sugar-sweetened beverages. Healthy eating interventions could have favourable effects on child weight and risk of overweight and obesity, although there was little to no difference in BMI and BMI z-scores. Future studies exploring the impact of specific intervention components, and describing cost-effectiveness and adverse outcomes are needed to better understand how to maximise the impact of ECEC-based healthy eating interventions.

A systematic review to determine the effect of strategies to sustain chronic disease prevention interventions in clinical and community settings: study protocol.

Background: The primary purpose of this review is to synthesise the effect of strategies aiming to sustain the implementation of evidenced based interventions (EBIs) targeting key health behaviours associated with chronic disease (i.e., physical inactivity, poor diet, harmful alcohol use and tobacco smoking) in clinical and community settings. The field of implementation science is bereft of an evidence base of effective sustainment strategies, and as such this review will provide important evidence to advance the field of sustainability research. Methods: This systematic review protocol is reported in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis Protocol (PRISMA-P) checklist (Additional file 1). Methods will follow Cochrane gold-standard review methodology. The search will be undertaken across multiple databases, adapting filters previously developed by the research team; data screening and extraction will be performed in duplicate; strategies will be coded using an adapted sustainability-explicit taxonomy; evidence will be synthesised using appropriate methods (i.e. meta-analytic following Cochrane or non-meta-analytic following SWiM guidelines). We will include any randomised controlled study that targets any staff or volunteers delivering interventions in clinical or community settings. Studies which report on any objective or subjective measure of the sustainment of a health prevention policy, practice, or program within any of the eligible settings will be included. Article screening, data extraction, risk of bias and quality assessment will be performed independently by two review authors. Risk of bias will be assessed using Version 2 of the Cochrane risk-of-bias tool for randomised trials (RoB 2). A random effect meta-analysis will be conducted to estimate the pooled effect of sustainment strategies separately by setting (i.e. clinical and community). Sub-group analyses will be undertaken to explore possible causes of statistical heterogeneity and may include: time period, single or multi strategy, type of setting and type of intervention. Differences between sub-groups will be statistically compared. Discussion/Conclusion: This will be the first systematic review to determine the effect of strategies designed to support sustainment on sustaining the implementation of EBIs in clinical and community settings. The findings of this review will directly inform the design of future sustainability-focused implementation trials. Further, these findings will inform the development of a sustainability practice guide for public health practitioners. Registration: This review was prospectively registered with PROSPERO (registration ID: CRD42022352333).

Healthy eating interventions delivered in early childhood education and care settings for improving the diet of children aged six months to six years.

BACKGROUND: Dietary intake during early childhood can have implications on child health and developmental trajectories. Early childhood education and care (ECEC) services are recommended settings to deliver healthy eating interventions as they provide access to many children during this important period. Healthy eating interventions delivered in ECEC settings can include strategies targeting the curriculum (e.g. nutrition education), ethos and environment (e.g. menu modification) and partnerships (e.g. workshops for families). Despite guidelines supporting the delivery of healthy eating interventions in this setting, little is known about their impact on child health. OBJECTIVES: To assess the effectiveness of healthy eating interventions delivered in ECEC settings for improving dietary intake in children aged six months to six years, relative to usual care, no intervention or an alternative, non-dietary intervention. Secondary objectives were to assess the impact of ECEC-based healthy eating interventions on physical outcomes (e.g. child body mass index (BMI), weight, waist circumference), language and cognitive outcomes, social/emotional and quality-of-life outcomes. We also report on cost and adverse consequences of ECEC-based healthy eating interventions. SEARCH METHODS: We searched eight electronic databases including CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, ERIC, Scopus and SportDiscus on 24 February 2022. We searched reference lists of included studies, reference lists of relevant systematic reviews, the World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov and Google Scholar, and contacted authors of relevant papers. SELECTION CRITERIA: We included randomised controlled trials (RCTs), including cluster-RCTs, stepped-wedge RCTs, factorial RCTs, multiple baseline RCTs and randomised cross-over trials, of healthy eating interventions targeting children aged six months to six years that were conducted within the ECEC setting. ECEC settings included preschools, nurseries, kindergartens, long day care and family day care. To be included, studies had to include at least one intervention component targeting child diet within the ECEC setting and measure child dietary or physical outcomes, or both. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently screened titles and abstracts and extracted study data. We assessed risk of bias for all studies against 12 criteria within RoB 1, which allows for consideration of how selection, performance, attrition, publication and reporting biases impact outcomes. We resolved discrepancies via consensus or by consulting a third review author. Where we identified studies with suitable data and homogeneity, we performed meta-analyses using a random-effects model; otherwise, we described findings using vote-counting approaches and via harvest plots. For measures with similar metrics, we calculated mean differences (MDs) for continuous outcomes and risk ratios (RRs) for dichotomous outcomes. We calculated standardised mean differences (SMDs) for primary and secondary outcomes where studies used different measures. We applied GRADE to assess certainty of evidence for dietary, cost and adverse outcomes.  MAIN RESULTS: We included 52 studies that investigated 58 interventions (described across 96 articles). All studies were cluster-RCTs. Twenty-nine studies were large (≥ 400 participants) and 23 were small (< 400 participants). Of the 58 interventions, 43 targeted curriculum, 56 targeted ethos and environment, and 50 targeted partnerships. Thirty-eight interventions incorporated all three components. For the primary outcomes (dietary outcomes), we assessed 19 studies as overall high risk of bias, with performance and detection bias being most commonly judged as high risk of bias. ECEC-based healthy eating interventions versus usual practice or no intervention may have a positive effect on child diet quality (SMD 0.34, 95% confidence interval (CI) 0.04 to 0.65; P = 0.03, I2 = 91%; 6 studies, 1973 children) but the evidence is very uncertain. There is moderate-certainty evidence that ECEC-based healthy eating interventions likely increase children's consumption of fruit (SMD 0.11, 95% CI 0.04 to 0.18; P < 0.01, I2 = 0%; 11 studies, 2901 children). The evidence is very uncertain about the effect of ECEC-based healthy eating interventions on children's consumption of vegetables (SMD 0.12, 95% CI -0.01 to 0.25; P =0.08, I2 = 70%; 13 studies, 3335 children). There is moderate-certainty evidence that ECEC-based healthy eating interventions likely result in little to no difference in children's consumption of non-core (i.e. less healthy/discretionary) foods (SMD -0.05, 95% CI -0.17 to 0.08; P = 0.48, I2 = 16%; 7 studies, 1369 children) or consumption of sugar-sweetened beverages (SMD -0.10, 95% CI -0.34 to 0.14; P = 0.41, I2 = 45%; 3 studies, 522 children). Thirty-six studies measured BMI, BMI z-score, weight, overweight and obesity, or waist circumference, or a combination of some or all of these. ECEC-based healthy eating interventions may result in little to no difference in child BMI (MD -0.08, 95% CI -0.23 to 0.07; P = 0.30, I2 = 65%; 15 studies, 3932 children) or in child BMI z-score (MD -0.03, 95% CI -0.09 to 0.03; P = 0.36, I2 = 0%; 17 studies; 4766 children). ECEC-based healthy eating interventions may decrease child weight (MD -0.23, 95% CI -0.49 to 0.03; P = 0.09, I2 = 0%; 9 studies, 2071 children) and risk of overweight and obesity (RR 0.81, 95% CI 0.65 to 1.01; P = 0.07, I2 = 0%; 5 studies, 1070 children). ECEC-based healthy eating interventions may be cost-effective but the evidence is very uncertain (6 studies). ECEC-based healthy eating interventions may have little to no effect on adverse consequences but the evidence is very uncertain (3 studies). Few studies measured language and cognitive skills (n = 2), social/emotional outcomes (n = 2) and quality of life (n = 3). AUTHORS' CONCLUSIONS: ECEC-based healthy eating interventions may improve child diet quality slightly, but the evidence is very uncertain, and likely increase child fruit consumption slightly. There is uncertainty about the effect of ECEC-based healthy eating interventions on vegetable consumption. ECEC-based healthy eating interventions may result in little to no difference in child consumption of non-core foods and sugar-sweetened beverages. Healthy eating interventions could have favourable effects on child weight and risk of overweight and obesity, although there was little to no difference in BMI and BMI z-scores. Future studies exploring the impact of specific intervention components, and describing cost-effectiveness and adverse outcomes are needed to better understand how to maximise the impact of ECEC-based healthy eating interventions.

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.

Optimising a multi-strategy implementation intervention to improve the delivery of a school physical activity policy at scale: findings from a randomised noninferiority trial.

BACKGROUND: To maximise their potential health benefits, school-based physical activity policies need to be implemented at scale. This paper describes the third in a sequence of trials that sought to optimise an effective strategy (PACE) to assist schools' implementation of a physical activity policy. Specifically, it aimed to determine the probability that a multi-strategy intervention adapted to reduce in-person contact (Adapted PACE) was "as good as" the original intervention (PACE) in increasing the weekly minutes of structured physical activity implemented by classroom teachers. METHODS: A noninferiority cluster randomised controlled trial was undertaken with 48 primary schools in New South Wales, Australia. Schools were randomised to receive PACE or a model with adaptations made to the delivery modes (Adapted PACE). Teachers' scheduled minutes of weekly physical activity was assessed at baseline (Oct 2018-Feb 2019) and 12-month follow-up (Oct-Dec 2019). The noninferiority margin was set at - 16.4 minutes based on previous data and decision panel consensus. A linear mixed model analysed within a Bayesian framework was used to explore noninferiority between the two PACE models. A cost minimisation analysis was conducted from the health service provider perspective, using the Australian dollar (AUD). RESULTS: The posterior estimate for the between group difference at follow-up was - 2.3 minutes (95% credible interval = - 18.02, 14.45 minutes). There was an estimated 96% probability of Adapted PACE being considered noninferior (only 4% of the posterior samples crossed the noninferiority margin of - 16.4 minutes). That is, the minutes of physical activity implemented by teachers at Adapted PACE schools was not meaningfully less than the minutes of physical activity implemented by teachers at PACE schools. The mean total cost was AUD$25,375 (95% uncertainty interval = $21,499, $29,106) for PACE and AUD$16,421 (95% uncertainty interval = $13,974, $19,656) for Adapted PACE; an estimated reduction of AUD$373 (95% uncertainty interval = $173, $560) per school. CONCLUSIONS: It is highly probable that Adapted PACE is noninferior to the original model. It is a cost-efficient alternative also likely to be a more suitable approach to supporting large scale implementation of school physical activity policies. TRIAL REGISTRATION: Retrospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619001229167).

School-level factors associated with the sustainment of weekly physical activity scheduled in Australian elementary schools: an observational study.

BACKGROUND: We aimed to: (1) identify school-level factors associated with the sustainment of weekly physical activity (PA) scheduled in elementary schools following withdrawal of effective implementation support; and (2) determine teacher's perceived usefulness of suggested strategies for sustaining the scheduling of weekly PA. METHODS: A secondary exploratory analysis was employed of data from the intervention arm (n = 31 schools) of a randomised controlled trial. Self-report survey data from 134 classroom teachers in New South Wales, Australia, collected following withdrawal of initial implementation support (follow-up T1) and six-months following completion of support (follow-up T2) were used. The outcomes of sustainment of weekly overall PA and energisers (short classroom PA breaks) scheduled were measured via teachers' completion of a daily activity logbook, with results presented as the difference in mean minutes of PA and energisers scheduled at T1 and T2. An adapted version of the Program Sustainability Assessment Tool (PSAT) was used to measure capacity for program sustainability across seven key domains at follow-up T2. Linear mixed regressions were conducted to evaluate associations between school-level sociodemographic characteristics (e.g., school size, remoteness, and type), teacher-reported school factors (i.e., seven adapted PSAT domains) and the sustainment of PA and energisers scheduled across the school week. Perceived usefulness of 14 proposed sustainability strategies was measured via the teacher survey at follow-up T2 and reported descriptively. RESULTS: No school-level factor was statistically associated with the sustainment of overall weekly PA or energisers scheduled. Teacher-reported factors in two PSAT domains - 'strategic planning' and 'program evaluation' were statistically negatively associated with the sustainment of weekly energisers scheduled (- 6.74, 95% CI: - 13.02; - 0.47, p = 0.036 and - 6.65, 95% CI: - 12.17; - 1.12, p = 0.019 respectively). The proposed support sustainability strategy - 'provision of PA equipment packs that enable energisers or integrated lessons' was perceived useful by the most teachers (85%). CONCLUSIONS: Further research is required to explore additional contextual-specific, and end-user appropriate factors associated with schools' sustainment of weekly PA scheduled. This will help accurately inform the development of strategies to address these determinants and support the sustainment and long-term benefits of school-based health interventions more broadly.

Economic evaluation of a multi-strategy intervention that improves school-based physical activity policy implementation.

BACKGROUND: Internationally, government policies mandating schools to provide students with opportunities to participate in physical activity are poorly implemented. The multi-component Physically Active Children in Education (PACE) intervention effectively assists schools to implement one such policy. We evaluated the value of investment by health service providers tasked with intervention delivery, and explored where adaptations might be targeted to reduce program costs for scale-up. METHODS: A prospective trial-based economic evaluation of an implementation intervention in 61 primary schools in New South Wales (NSW), Australia. Schools were randomised to the PACE intervention or a wait-list control. PACE strategies included centralised technical assistance, ongoing consultation, principal's mandated change, identifying and preparing in-school champions, educational outreach visits, and provision of educational materials and equipment. Effectiveness was measured as the mean weekly minutes of physical activity implemented by classroom teachers, recorded in a daily log book at baseline and 12-month follow-up. Delivery costs (reported in $AUD, 2018) were evaluated from a public finance perspective. Cost data were used to calculate: total intervention cost, cost per strategy and incremental cost (overall across all schools and as an average per school). Incremental cost-effectiveness ratios (ICERs) were calculated as the incremental cost of delivering PACE divided by the estimated intervention effect. RESULTS: PACE cost the health service provider a total of $35,692 (95% uncertainty interval [UI] $32,411, $38,331) to deliver; an average cost per school of $1151 (95%UI $1046, $1236). Training in-school champions was the largest contributor: $19,437 total; $627 ($0 to $648) average per school. Educational outreach was the second largest contributor: $4992 total; $161 ($0 to $528) average per school. The ICER was $29 (95%UI $17, $64) for every additional minute of weekly physical activity implemented per school. CONCLUSION: PACE is a potentially cost-effective intervention for increasing schools implementation of a policy mandate. The investment required by the health service provider makes use of existing funding and infrastructure; the additional cost to assist schools to implement the policy is likely not that much. PACE strategies may be adapted to substantially improve delivery costs. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12617001265369; Prospectively registered 1st September 2017 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373520.

Identifying essential implementation strategies: a mixed methods process evaluation of a multi-strategy policy implementation intervention for schools.

BACKGROUND: Physically Active Children in Education (PACE) is composed of eight implementation strategies that improves schools' implementation of a government physical activity policy. A greater understanding of each discrete implementation strategy could inform improvements to PACE for delivery at-scale. This study aimed to: (A) measure the dose delivered, fidelity, adoption and acceptability of each strategy using quantitative data; (B) identify implementation barriers and facilitators using qualitative data; and (C) explore the importance of each strategy by integrating both data sets (mixed methods). METHODS: This study used data from a cluster randomised noninferiority trial comparing PACE with an adapted version (Adapted PACE) that was delivered with reduced in-person external support to reduce costs and increase scalability. Data were collected from both trials arms for between-group comparison. Descriptive statistics were produced using surveys of principals, in-school champions and teachers; and project records maintained by PACE project officers (objective A). Thematic analysis was performed using in-school champion and project officer interviews (objective B). Both data sets were integrated via a triangulation protocol and findings synthesized in the form of meta-inferences (objective C). RESULTS: Eleven in-school champions and six project officers completed interviews; 33 principals, 51 in-school champions and 260 teachers completed surveys. Regardless of group allocation, implementation indicators were high for at least one component of each strategy: dose delivered =100%, fidelity ≥95%, adoption ≥83%, acceptability ≥50%; and several implementation barriers and facilitators were identified within three broad categories: external policy landscape, inner organizational structure/context of schools, and intervention characteristics and processes. All strategies were considered important as use varied by school, however support from a school executive and in-school champions' interest were suggested as especially important for optimal implementation. CONCLUSION: This study highlights the importance of both executive support and in-school champions for successful implementation of school physical activity policies. In particular, identifying and supporting an in-school champion to have high power and high interest is recommended for future implementation strategies. This may reduce the need for intensive external support, thus improving intervention scalability.

Exploring a parent-focused physical literacy intervention for early childhood: a pragmatic controlled trial of the PLAYshop.

BACKGROUND: Parents play a key role in young children's physical activity and physical literacy development. Little research has explored parent-focused interventions to improve young children's physical literacy. We examined if a theory-based, feasible physical literacy training workshop (PLAYshop) for parents could improve their physical literacy knowledge and confidence and improve parenting practices related to facilitating the physical literacy development of their preschool-aged child (3-5 years). The secondary objective was to explore implementation facilitators and barriers. METHODS: We conducted a pragmatic controlled trial in two Canadian cities (Edmonton and Victoria) from November 2019 - March 2020. A total of 143/151 parents were eligible and assigned to intervention (n = 71) or control group (n = 72). The PLAYshop included: (i) a 75-min in-person workshop with interactive activities and physical literacy educational messages, (ii) educational materials, (iii) an equipment pack, and (iv) two post-workshop booster emails. Surveys measured parents' knowledge and confidence at baseline and follow-up. Application of PLAYshop concepts and implementation facilitators and barriers were explored with interviews of parents and workshop leaders. Repeated measures ANOVAs and thematic analyses were completed. RESULTS: Parents' knowledge and confidence improved significantly over time; intervention group changes were significantly greater than control group changes (p < 0.001; ɳ2 = .32). Parents applied PLAYshop concepts at-home, including child-led play, making activities fun, and promoting child manipulative and locomotor skills. Time was a key parental implementation barrier. Program implementation issues varied by context (location and participants). CONCLUSIONS: PLAYshop participation changed parents' physical literacy knowledge and confidence and physical literacy enhancing play with their children. Implementation feasibility was high. The findings from this real-world trial highlight an efficacious and scalable intervention that warrants further testing. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04394312 . Registered 19/05/2020.

A systematic review of adaptations and effectiveness of scaled-up nutrition interventions.

CONTEXT: Public health nutrition interventions shown to be effective under optimal research conditions need to be scaled up and implemented in real-world settings. OBJECTIVES: The primary aim for this review was to assess the effectiveness of scaled-up public health nutrition interventions with proven efficacy, as examined in a randomized controlled trial. Secondary objectives were to: 1) determine if the effect size of scaled-up interventions were comparable to the prescale effect, and; 2) identify any adaptations made during the scale-up process. DATA SOURCES: Six electronic databases were searched and field experts contacted. STUDY SELECTION: An intervention was considered scaled up if it was delivered on a larger scale than a preceding randomized controlled trial ("prescale") in which a significant intervention effect (P ≤ 0.05) was reported on a measure of nutrition. DATA EXTRACTION: Two reviewers independently performed screening and data extraction. Effect size differences between prescale and scaled-up interventions were quantified. Adaptations to scale-up studies were coded according to the Adaptome model. RESULTS: Ten scaled-up nutrition interventions were identified. The effect size difference between prescale trials and scaled-up studies ranged from -32.2% to 222% (median, 50%). All studies made adaptations between prescale to scaled-up interventions. CONCLUSION: The effects of nutrition interventions implemented at scale typically were half that achieved in prior efficacy trials. Identifying effective scale-up strategies and methods to support retainment of the original prescale effect size is urgently needed to inform public health policy. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no.CRD42020149267.

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).

Adaptation and Validation of the Program Sustainability Assessment Tool (PSAT) for Use in the Elementary School Setting.

There is a lack of valid and reliable measures of determinants of sustainability specific to public health interventions in the elementary school setting. This study aimed to adapt and evaluate the Program Sustainability Assessment Tool (PSAT) for use in this setting. An expert reference group adapted the PSAT to ensure face validity. Elementary school teachers participating in a multi-component implementation intervention to increase their scheduling of physical activity completed the adapted PSAT. Structural validity was assessed via confirmatory factor analysis. Convergent validity was assessed using linear mixed regression evaluating the associations between scheduling of physical activity and adapted PSAT scores. Cronbach's alpha was used to evaluate internal consistency and intracluster correlation coefficients for interrater reliability. Floor and ceiling effects were also evaluated. Following adaptation and psychometric evaluation, the final measure contained 26 items. Domain Cronbach's alpha ranged from 0.77 to 0.92. Only one domain illustrated acceptable interrater reliability. Evidence for structural validity was mixed and was lacking for convergent validity. There were no floor and ceiling effects. Efforts to adapt and validate the PSAT for the elementary school setting were mixed. Future work to develop and improve measures specific to public health program sustainment that are relevant and psychometrically robust for elementary school settings are needed.

Barriers and facilitators influencing the sustainment of health behaviour interventions in schools and childcare services: a systematic review.

BACKGROUND: Sustainment has been defined as the sustained use or delivery of an intervention in practice following cessation of external implementation support. This review aimed to identify and synthesise factors (barriers and facilitators) that influence the sustainment of interventions (policies, practices, or programmes) in schools and childcare services that address the leading risk factors of chronic disease. METHODS: Seven electronic databases and relevant reference lists were searched for articles, of any design, published in English, from inception to March 2020. Articles were included if they qualitatively and/or quantitatively reported on school or childcare stakeholders' (including teachers, principals, administrators, or managers) perceived barriers or facilitators to the sustainment of interventions addressing poor diet/nutrition, physical inactivity, obesity, tobacco smoking, or harmful alcohol use. Two independent reviewers screened texts, and extracted and coded data guided by the Integrated Sustainability Framework, an existing multi-level sustainability-specific framework that assesses factors of sustainment. RESULTS: Of the 13,158 articles identified, 31 articles met the inclusion criteria (8 quantitative, 12 qualitative, 10 mixed-methods, and 1 summary article). Overall, 29 articles were undertaken in schools (elementary n=17, middle n=3, secondary n=4, or a combination n=5) and two in childcare settings. The main health behaviours targeted included physical activity (n=9), diet (n=3), both diet and physical activity (n=15), and smoking (n=4), either independently (n=1) or combined with other health behaviours (n=3). Findings suggest that the majority of the 59 barriers and 74 facilitators identified to impact on intervention sustainment were similar across school and childcare settings. Factors predominantly relating to the 'inner contextual factors' of the organisation including: availability of facilities or equipment, continued executive or leadership support present, and team cohesion, support, or teamwork were perceived by stakeholders as influential to intervention sustainment. CONCLUSIONS: Identifying strategies to improve the sustainment of health behaviour interventions in these settings requires a comprehensive understanding of factors that may impede or promote their ongoing delivery. This review identified multi-level factors that can be addressed by strategies to improve the sustainment of such interventions, and suggests how future research might address gaps in the evidence base. TRIAL REGISTRATION: This review was prospectively registered on PROSPERO: CRD42020127869 , Jan. 2020.

A real-world feasibility study of the PLAYshop: a brief intervention to facilitate parent engagement in developing their child's physical literacy.

BACKGROUND: Development of physical literacy, defined as "the motivation, confidence, physical competence, knowledge and understanding to value and take responsibility for engagement in physical activities for life," can support children's physically active behaviors and consequent health benefits. Little research has explored interventions to improve children's physical literacy, although substantive evidence shows parents play a key role in children's physically active behaviors and development of fundamental movement skills. The purpose of this study was to explore the feasibility of a novel, physical literacy program (the PLAYshop) designed to build parents' self-efficacy to support their child's physical literacy. METHODS: A non-randomized, one-arm concurrent nested design was used. Thirty-five parents of young children (3-8 years of age) attended a 75-min workshop inclusive of interactive activities, educational messages, and the provision of resources focused on core physical literacy concepts. Pre- and post-workshop surveys used quantitative measures to assess parents' satisfaction, knowledge, confidence, and intention to adopt practices. Follow-up interviews qualitatively explored the implementation experiences of both parents and facilitators. Paired t tests and thematic analysis were undertaken. RESULTS: Of the 33 eligible parents, 23 completed both pre- and post-workshop surveys. Follow-up interviews were completed with 11 parents and four workshop facilitators. Parents' self-reported knowledge and confidence to support their child's physical literacy development significantly increased after PLAYshop participation. The majority of parents were satisfied with the workshop and motivated to apply learnings at home with their child. Workshop facilitators identified seven workshop strengths (e.g., workshop champions and skilled facilitators) and four challenges (e.g., recruitment and unfavorable spaces). Limitations include the lack of control group and recruitment challenges. CONCLUSIONS: The PLAYshop was perceived positively by parents and facilitators and appeared to improve parent self-efficacy and intention to promote physical literacy with their child. Recruitment and attendance were key implementation challenges. The findings from this real-world study support the preliminary feasibility of the PLAYshop intervention and highlight areas to improve the intervention and recruitment prior to efficacy testing in a more rigorous trial format.

Consolidating evidence on the effectiveness of interventions promoting fruit and vegetable consumption: an umbrella review.

BACKGROUND: The overarching objective was to examine the effectiveness of intervention strategies to promote fruit and vegetable consumption. To do this, systematic review evidence regarding the effects of intervention strategies was synthesized; organized, where appropriate, by the setting in which the strategies were implemented. Additionally, we sought to describe gaps in the review of evidence; that is, where evidence regarding the effectiveness of recommended policy actions had not been systematically synthesised. METHODS: We undertook a systematic search of electronic databases and the grey literature to identify systematic reviews describing the effects of any intervention strategy targeting fruit and/or vegetable intake in children or adults of any age. RESULTS: The effects of 32 intervention strategies were synthesised from the 19 included reviews. The strategies were mapped across all three broad domains of the NOURISHING framework (i.e. food environment, food system and behaviour change communication), but covered just 14 of the framework's 65 sub-policy areas. There was evidence supporting the effectiveness of 19 of the 32 intervention strategies. The findings of the umbrella review suggest that intervention strategies implemented within schools, childcare services, homes, workplaces and primary care can be effective, as can eHealth strategies, mass media campaigns, household food production strategies and fiscal interventions. CONCLUSIONS: A range of effective strategy options are available for policy makers and practitioners interested in improving fruit and/or vegetable intake. However, the effects of many strategies - particularly those targeting agricultural production practices, the supply chain and the broader food system - have not been reported in systematic reviews. Primary studies assessing the effects of these strategies, and the inclusion of such studies in systematic reviews, are needed to better inform national and international efforts to improve public health nutrition. TRIAL REGISTRATION: The review protocol was deposited in a publicly available Open Science framework prior to execution of the search strategy. https://osf.io/unj7x/.

The impact of school uniforms on primary school student's physical activity at school: outcomes of a cluster randomized controlled trial.

BACKGROUND: Many school-based physical activity (PA) interventions are complex and have modest effects when delivered in real world contexts. A commonly reported barrier to students' PA, particularly among girls, are uniforms that are impractical (e.g. tunic/dress and black leather shoes). Modifying student uniforms may represent a simple intervention to enhance student PA. The primary aim of this trial was to assess the impact of a PA enabling uniform intervention (shorts, polo shirt and sports shoes) on girls' moderate-to-vigorous physical activity (MVPA) and total PA i.e. counts per minute (cpm). METHODS: A cluster randomized controlled trial was undertaken in 42 primary schools in New South Wales, Australia. Schools were randomized on one school day to the intervention group, where students wore a PA enabling uniform (their sports uniform) or a control group, where students wore their usual traditional uniform. Student PA was measured using wrist-worn Actigraph GT3X and GT9X accelerometers. Linear mixed models controlling for student characteristics were used to examine the effects of the intervention.. RESULTS: Of the 3351 eligible students, 2315 (69.1%) had parental consent and 2180 of these consenting students participated (94.2%) of which 1847 (84.7%) were included in the analysis. For the primary aim the study found no significant differences between girls at schools allocated to the intervention relative to the control on change in MVPA (0.76 min, 95% CI - 0.47 to 1.99, p = 0.22) or cpm (36.99, 95% CI - 13.88 to 87.86, p = 0.15). Exploratory analysis revealed small effects for a number of findings, including significant reduction in sedentary activity (- 1.77, 95% CI - 3.40 to - 0.14, p = 0.035) among all students at schools allocated to the intervention, and non-significant improvements in girls' light intensity PA (1.47 min, 95% CI - 0.06 to 3.00, p = 0.059) and sedentary activity (- 2.23 min; 95% CI - 4.49 to 0.02, p = 0.052). CONCLUSION: The findings suggests that the intervention may yield small improvements in some measure of PA and require substantiation in a larger RCT with longer-term follow-up. The inclusion of additional intervention components may be required to achieve more meaningful effects. TRIAL REGISTRATION: The trial was prospectively registered with Australian New Zealand Clinical Trials Register ACTRN12617001266358 1st September 2017.