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.

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.

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).

Strategies for enhancing the implementation of school-based policies or practices targeting diet, physical activity, obesity, tobacco or alcohol use.

BACKGROUND: Several school-based interventions are effective in improving child diet and physical activity, and preventing excessive weight gain, and tobacco or harmful alcohol use. However, schools are frequently unsuccessful in implementing such evidence-based interventions. OBJECTIVES: 1. To evaluate the benefits and harms of strategies aiming to improve school implementation of interventions to address student diet, physical activity, tobacco or alcohol use, and obesity. 2. To evaluate the benefits and harms of strategies to improve intervention implementation on measures of student diet, physical activity, obesity, tobacco use or alcohol use; describe their cost or cost-effectiveness; and any harms of strategies on schools, school staff or students. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search was between 1 September 2016 and 30 April 2021 to identify any relevant trials published since the last published review. SELECTION CRITERIA: We defined 'Implementation' as the use of strategies to adopt and integrate evidence-based health interventions and to change practice patterns within specific settings. We included any trial (randomised controlled trial (RCT) or non-randomised controlled trial (non-RCT)) conducted at any scale, with a parallel control group that compared a strategy to implement policies or practices to address diet, physical activity, overweight or obesity, tobacco or alcohol use by students to 'no intervention', 'usual' practice or a different implementation strategy. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Given the large number of outcomes reported, we selected and included the effects of a single outcome measure for each trial for the primary (implementation) and secondary (student health behaviour and obesity) outcomes using a decision hierarchy. Where possible, we calculated standardised mean differences (SMDs) to account for variable outcome measures with 95% confidence intervals (CI). For RCTs, we conducted meta-analyses of primary and secondary outcomes using a random-effects model, or in instances where there were between two and five studies, a fixed-effect model. The synthesis of the effects for non-randomised studies followed the 'Synthesis without meta-analysis' (SWiM) guidelines. MAIN RESULTS: We included an additional 11 trials in this update bringing the total number of included studies in the review to 38. Of these, 22 were conducted in the USA. Twenty-six studies used RCT designs. Seventeen trials tested strategies to implement healthy eating, 12 physical activity and six a combination of risk factors. Just one trial sought to increase the implementation of interventions to delay initiation or reduce the consumption of alcohol. All trials used multiple implementation strategies, the most common being educational materials, educational outreach and educational meetings. The overall certainty of evidence was low and ranged from very low to moderate for secondary review outcomes. Pooled analyses of RCTs found, relative to a control, the use of implementation strategies may result in a large increase in the implementation of interventions in schools (SMD 1.04, 95% CI 0.74 to 1.34; 22 RCTs, 1917 participants; low-certainty evidence). For secondary outcomes we found, relative to control, the use of implementation strategies to support intervention implementation may result in a slight improvement on measures of student diet (SMD 0.08, 95% CI 0.02 to 0.15; 11 RCTs, 16,649 participants; low-certainty evidence) and physical activity (SMD 0.09, 95% CI -0.02 to 0.19; 9 RCTs, 16,389 participants; low-certainty evidence). The effects on obesity probably suggest little to no difference (SMD -0.02, 95% CI -0.05 to 0.02; 8 RCTs, 18,618 participants; moderate-certainty evidence). The effects on tobacco use are very uncertain (SMD -0.03, 95% CIs -0.23 to 0.18; 3 RCTs, 3635 participants; very low-certainty evidence). One RCT assessed measures of student alcohol use and found strategies to support implementation may result in a slight increase in use (odds ratio 1.10, 95% CI 0.77 to 1.56; P = 0.60; 2105 participants). Few trials reported the economic evaluations of implementation strategies, the methods of which were heterogeneous and evidence graded as very uncertain. A lack of consistent terminology describing implementation strategies was an important limitation of the review. AUTHORS' CONCLUSIONS: The use of implementation strategies may result in large increases in implementation of interventions, and slight improvements in measures of student diet, and physical activity. Further research is required to assess the impact of implementation strategies on such behavioural- and obesity-related outcomes, including on measures of alcohol use, where the findings of one trial suggest it may slightly increase student risk. Given the low certainty of the available evidence for most measures further research is required to guide efforts to facilitate the translation of evidence into practice in this setting.

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.

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).

Understanding the sustainment of population health programmes from a whole-of-system approach.

BACKGROUND: Population health prevention programmes are needed to reduce the prevalence of chronic diseases. Nevertheless, sustaining programmes at a population level is challenging. Population health is highly influenced by social, economic and political environments and is vulnerable to these system-level changes. The aim of this research was to examine the factors and mechanisms contributing to the sustainment of population prevention programmes taking a systems thinking approach. METHODS: We conducted a qualitative study through interviews with population health experts working within Australian government and non-government agencies experienced in sustaining public health programs at the local, state or national level (n = 13). We used a deductive thematic approach, grounded in systems thinking to analyse data. RESULTS: We identified four key barriers affecting program sustainment: 1) short term political and funding cycles; 2) competing interests; 3) silo thinking within health service delivery; and 4) the fit of a program to population needs. To overcome these barriers various approaches have centred on the importance of long-range planning and resourcing, flexible program design and management, leadership and partnerships, evidence generation, and system support structures. CONCLUSION: This study provides key insights for overcoming challenges to the sustainment of population health programmes amidst complex system-wide changes.

Increased use of knowledge translation strategies is associated with greater research impact on public health policy and practice: an analysis of trials of nutrition, physical activity, sexual health, tobacco, alcohol and substance use interventions.

BACKGROUND: Greater use of knowledge translation (KT) strategies is recommended to improve the research impact of public health trials. The purpose of this study was to describe (1) the research impact of setting-based public health intervention trials on public health policy and practice; (2) the association between characteristics of trials and their research impact on public health policy and practice; and (3) the association between the use of KT strategies and research impacts on public health policy and practice. METHODS: We conducted a survey of authors of intervention trials targeting nutrition, physical activity, sexual health, tobacco, alcohol or substance use. We assessed the use of KT strategies aligned to domains of the Knowledge-To-Action Framework. We defined "research impact" on health policy and practice as any one or more of the following: citation in policy documents or announcements, government reports, training materials, guidelines, textbooks or court rulings; or endorsement by a (non)governmental organization; use in policy or practice decision-making; or use in the development of a commercial resource or service. RESULTS: Of the included trials, the authors reported that 65% had one or more research impacts. The most frequently reported research impact was citation in a policy document or announcement (46%). There were no significant associations between the effectiveness of the intervention, trial risk of bias, setting or health risk and trial impact. However, for every one unit increase in the total KT score (range 0-8), reflecting greater total KT activity, the odds of a health policy or practice research impact increased by approximately 30% (OR = 1.30, 95% CI: 1.02, 1.66; p = 0.031). Post hoc examination of KT domain scores suggests that KT actions focused on providing tailored support to facilitate program implementation and greater use of research products and tools to disseminate findings to end-users may be most influential in achieving impact. CONCLUSIONS: Trials of public health interventions frequently have public health impacts, and the use of more comprehensive KT strategies may facilitate greater research impact.

A cluster randomised controlled trial of a secondary school intervention to reduce intake of sugar-sweetened beverages: Mid-intervention impact of switchURsip environmental strategies.

ISSUE ADDRESSED: Secondary schools provide an opportune setting for interventions addressing excessive sugar-sweetened beverage (SSB) intake in adolescence. This trial aimed to assess the impact of school environmental strategies, delivered as part of a broader intervention, among Year 7-9 students' SSB consumption. METHODS: Between March and July 2018, we conducted a cluster randomised controlled trial with 862 students attending six secondary schools (3 intervention and 3 control) in New South Wales. The intervention targeted SSB availability, placement, promotion and pricing, and increased availability and promotion of water. Control schools followed their usual programmes. Primary outcomes included mean daily SSB consumption (millilitres) and mean daily percentage energy from SSB (kilojoules). Sub-group analysis explored primary outcomes for gender, school year level and frequency of canteen use. RESULTS: Of the 2265 eligible students, 1092 (50.2%) provided active parental consent and 940 (86.0%) participated in baseline data collection. No significant differences were observed between groups at follow-up for mean daily SSBs consumed (-10.17 mL, CI: -24.78; 45.12, P = 0.57) or mean daily percentage energy from SSBs (-0.20%, CI: -0.87; 0.47, P = .56). Significant effects were observed among girls in intervention compared to girls in control schools for mean daily SSB consumption (-52.02 mL, CI 99.8; 94.14, P = .03) and mean daily percentage of energy from SSBs (-0.90%, CI: -1.82; 0.02, P = .05). CONCLUSIONS: At 3-month mid-intervention evaluation, the intervention failed to impact on mean daily consumption and mean percentage energy from SSBs, overall. However, an intervention effect was observed in girls. The limited overall effect is likely due to inadequate intervention dose related to the short duration, limiting opportunities for schools to fully implement the environmental strategies. SO WHAT?: A longer intervention duration with additional implementation support to allow adequate time to embed the strategies within the school is recommended. Implementation support strategies would ensure staff are supported throughout the process.

Exploring the effect of a school-based cluster-randomised controlled trial to increase the scheduling of physical activity for primary school students on teachers' physical activity.

BACKGROUND: To determine if a school-based physical activity (PA) intervention that supported primary school teachers to schedule PA during school hours impacted their own PA. METHODS: A 2x2 factorial group cluster-randomised controlled trial was undertaken in 12 Australian primary schools. The nine-month intervention supported classroom teachers to increase scheduled weekly PA for their class via physical education, sport, Energisers and integrated lessons. Teachers' PA (n = 76) was measured at follow-up only using accelerometers (Actigraph GT3X or GT9X). Linear mixed models were used to estimate between-group differences in teachers' mean minutes of sedentary, light, moderate-to-vigorous-intensity physical activity (MVPA) across the school day and during class-time. RESULTS: At follow-up, there were non-significant between-group differences favouring intervention teachers, compared to controls, for light PA (4.9 minutes, 95% CI: -6.3, 16.0; P = .33) and MVPA (0.4 minutes, 95% CI: -10.9, 11.6; P = .94) across the school day; although not favouring the intervention for sedentary behaviour (5.1 minutes, 95% CI: -11.4, 21.7; P = .48). Similar patterns were seen during class-time for light PA and sedentary time, but not for MVPA. CONCLUSIONS: Supporting teachers with the scheduling of PA for their class may impact on their own PA. Fully powered studies are needed to better understand the impact of the intervention on teachers' PA. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12616001228471 (http://www.anzctr.org.au/).

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.

How effective are physical activity interventions when they are scaled-up: a systematic review.

BACKGROUND: The 'scale-up' of effective physical activity interventions is required if they are to yield improvements in population health. The purpose of this study was to systematically review the effectiveness of community-based physical activity interventions that have been scaled-up. We also sought to explore differences in the effect size of these interventions compared with prior evaluations of their efficacy in more controlled contexts, and describe adaptations that were made to interventions as part of the scale-up process. METHODS: We performed a search of empirical research using six electronic databases, hand searched reference lists and contacted field experts. An intervention was considered 'scaled-up' if it had been intentionally delivered on a larger scale (to a greater number of participants, new populations, and/or by means of different delivery systems) than a preceding randomised control trial ('pre-scale') in which a significant intervention effect (p < 0.05) was reported on any measure of physical activity. Effect size differences between pre-scale and scaled up interventions were quantified ([the effect size reported in the scaled-up study / the effect size reported in the pre-scale-up efficacy trial] × 100) to explore any scale-up 'penalties' in intervention effects. RESULTS: We identified 10 eligible studies. Six scaled-up interventions appeared to achieve significant improvement on at least one measure of physical activity. Six studies included measures of physical activity that were common between pre-scale and scaled-up trials enabling the calculation of an effect size difference (and potential scale-up penalty). Differences in effect size ranged from 132 to 25% (median = 58.8%), suggesting that most scaled-up interventions typically achieve less than 60% of their pre-scale effect size. A variety of adaptations were made for scale-up - the most common being mode of delivery. CONCLUSION: The majority of interventions remained effective when delivered at-scale however their effects were markedly lower than reported in pre-scale trials. Adaptations of interventions were common and may have impacted on the effectiveness of interventions delivered at scale. These outcomes provide valuable insight for researchers and public health practitioners interested in the design and scale-up of physical activity interventions, and contribute to the growing evidence base for delivering health promotion interventions at-scale. TRIAL REGISTRATION: PROSPERO CRD42020144842 .

Evaluating the reach, effectiveness, adoption, implementation and maintenance of the Resistance Training for Teens program.

BACKGROUND: Physical activity guidelines recommend young people engage in regular muscle-strengthening activities (e.g., resistance training [RT]). However, few school-based physical activity interventions have been delivered at-scale or promoted RT. The aim of this study was to evaluate the reach, effectiveness, adoption, implementation and maintenance of the Resistance Training for Teens (RT for Teens) program. METHODS: Data were collected between August 2015 and October 2020. RE-AIM was operationalized as: (i) Reach: number and characteristics of students estimated to be exposed to the program; (ii) Effectiveness: impact of the program on student-level outcomes measured in a subsample of 750 students from 17 schools; (iii) Adoption: number and representativeness of schools with one or more teachers trained to deliver the program; (iv) Implementation: extent to which the program was delivered as intended; and (v) Maintenance: extent to which the program was sustained in schools. RESULTS: The estimated program reach was ~ 10,000 students, out of a total student population of ~ 200,000 (~ 5%). Students were from diverse socioeconomic and ethnic backgrounds. Improvements in muscular fitness, RT self-efficacy, perceived cardiorespiratory fitness and flexibility, and participation in muscle-strengthening physical activities were documented. A total of 30 workshops were delivered, involving 468 teachers from 249 schools from diverse geographical regions. Implementation varied considerably, with teachers adapting the program to suit the context of their school and student cohorts. However, RT skill development and the promotion of muscular fitness were the session components delivered most during sessions. Teachers' adherence to the SAAFE (Supportive, Active, Autonomous, Fair and Enjoyable) teaching principles was high. Approximately 30% of teachers (144/476) registered to use the RT for Teens app. At the school-level, 37% (93/249) of schools had at least one registered user (teacher and/or student). A total of 2,336 workouts and 3,116 fitness tests were completed by registered users. Of the 249 schools represented, 51 (20.5%) sent an additional (previously untrained) teacher to a second workshop. CONCLUSIONS: The RT for Teens program had broad reach and adoption. However, intervention delivery varied considerably across schools and additional support strategies are required to optimize intervention implementation and maintain program delivery over time. Future studies will benefit from the utilization of accepted frameworks, recommendations and guidelines for implementation research. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12621000352808), retrospectively registered 1st February 2021.

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.

Efficacy of a school-based physical activity and nutrition intervention on child weight status: Findings from a cluster randomized controlled trial.

Despite the benefits of factorial designs in quantifying the relative benefits of different school-based approaches to prevent unhealthy weight gain among students, few have been undertaken. The aims of this 2 × 2 cluster randomized factorial trial was to evaluate the impact of a physical activity and nutrition intervention on child weight status and quality of life. Twelve primary schools in New South Wales, Australia randomly allocated to one of four groups: (i.) physical activity (150 min of planned in-school physical activity); (ii.) nutrition (a healthy school lunch-box); (iii.) combined physical activity and nutrition; or (iv.) control. Outcome data assessing child weight and quality of life were collected at baseline and 9-months post-baseline. Within Grades 4-6 in participating schools, 742 students participated in anthropometric measurements, including child body mass index (BMI) and waist circumference, at baseline and follow-up. Findings indicated that students that received the nutrition intervention had higher odds of being classified in the BMI category of underweight/healthy weight (OR 1.64 95%CI 1.07, 2.50; p = 0.0220), while those who received the physical activity intervention reported a lower waist circumference (mean difference - 1.86 95%CI -3.55, -0.18; p = 0.030). There were no significant effects of the nutrition or physical activity intervention on child BMI scores or child quality of life, and no significant synergistic effects of the two interventions combined. Future research assessing the longer-term impact of both intervention strategies, alone and combined, is warranted to better understand their potential impact on child health. TRIAL REGISTRATION: Australian Clinical Trials Registry ACTRN: ACTRN12616001228471.

Enhancing the potential effects of text messages delivered via an m-health intervention to improve packing of healthy school lunchboxes.

OBJECTIVE: The aim of the study was to assess the impact of different lunchbox messages on parents' intention to pack a healthy lunchbox. DESIGN: This study employed an experimental design. SETTING: A series of messages were developed to align with the six constructs of the Health Belief Model. Messages were also developed that were (and were not) personalised and varied based on the source of the information provided (university, school, dietitian and health promotion service). During a telephone survey, participants were read the content of each message and asked about their intention to pack a healthy lunchbox. PARTICIPANTS: Parents of primary school-aged children were randomised to receive different messages to encourage the packing of healthy lunchboxes. RESULTS: The study was completed by 511 parents. Linear mixed regression analyses identified significant differences (P < 0·05) in intention scores between variant messages targeting the same behavioural constructs for 'susceptibility', 'severity', 'benefits' and 'barriers' but not 'cues to action' or 'self-efficacy'. The highest mean behavioural intention score was for 'benefits', whilst the lowest mean score was for 'barriers'. There were no significant differences in intention scores of parents receiving messages from a dietitian, university, health promotion team or school (P = 0·37). Intention scores did not differ in which messages were personalised based on child's name (P = 0·84) or grade level (P = 0·54). CONCLUSIONS: The findings suggest that messages that focus on the benefits of packing healthy lunchboxes may be particularly useful in improving intentions of parents to pack healthy foods for their children to consume at school.

Feasibility of a Web-Based Implementation Intervention to Improve Child Dietary Intake in Early Childhood Education and Care: Pilot Randomized Controlled Trial.

BACKGROUND: Internationally, the implementation of evidence-based healthy eating policies and practices within early childhood education and care (ECEC) settings that encourage children's healthy diet is recommended. Despite the existence of evidence-based healthy eating practices, research indicates that current implementation rates are inadequate. Web-based approaches provide a potentially effective and less costly approach to support ECEC staff with implementing nutrition policies and practices. OBJECTIVE: The broad aim of this pilot randomized controlled trial is to assess the feasibility of assessing the impact of a web-based program together with health promotion officer (HPO) support on ECEC center implementation of healthy eating policies and practices. Specifically, we seek to describe the completion rate of study evaluation processes (participant consent and data collection rates); examine ECEC center uptake, acceptability, and appropriateness of the intervention and implementation strategies; understand the potential cost of delivering and receiving implementation support strategies; and describe the potential impact of the web-based intervention on the implementation of targeted healthy eating practices among centers in the intervention group. METHODS: A 6-month pilot implementation trial using a cluster-randomized controlled trial design was conducted in 22 ECEC centers within the Hunter New England region of New South Wales, Australia. Potentially eligible centers were distributed a recruitment package and telephoned by the research team to assess eligibility and obtain consent. Centers randomly allocated to the intervention group received access to a web-based program, together with HPO support (eg, educational outreach visit and local technical assistance) to implement 5 healthy eating practices. The web-based program incorporated audit with feedback, development of formal implementation blueprints, and educational materials to facilitate improvement in implementation. The centers allocated to the control group received the usual care. RESULTS: Of the 57 centers approached for the study, 22 (47%) provided consent to participate. Data collection components were completed by 100% (22/22) of the centers. High uptake for implementation strategies provided by HPOs (10/11, 91% to 11/11, 100%) and the web-based program (11/11, 100%) was observed. At follow-up, intervention centers had logged on to the program at an average of 5.18 (SD 2.52) times. The web-based program and implementation support strategies were highly acceptable (10/11, 91% to 11/11, 100%). Implementation of 4 healthy eating practices improved in the intervention group, ranging from 19% (2/11) to 64% (7/11). CONCLUSIONS: This study provides promising pilot data to warrant the conduct of a fully powered implementation trial to assess the impact of the program on ECEC healthy eating practice implementation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001158156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378099. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s40814-020-00707-w.

Long-term Effectiveness of a Multistrategy Behavioral Intervention to Increase the Nutritional Quality of Primary School Students' Online Lunch Orders: 18-Month Follow-up of the Click & Crunch Cluster Randomized Controlled Trial.

BACKGROUND: School food services, including cafeterias and canteens, are an ideal setting in which to improve child nutrition. Online canteen ordering systems are increasingly common and provide unique opportunities to deliver choice architecture strategies to nudge users to select healthier items. Despite evidence of short-term effectiveness, there is little evidence regarding the long-term effectiveness of choice architecture interventions, particularly those delivered online. OBJECTIVE: This study determined the long-term effectiveness of a multistrategy behavioral intervention (Click & Crunch) embedded within an existing online school lunch-ordering system on the energy, saturated fat, sugar, and sodium content of primary school students' lunch orders 18 months after baseline. METHODS: This cluster randomized controlled trial (RCT) involved a cohort of 2207 students (aged 5-12 years) from 17 schools in New South Wales, Australia. Schools were randomized to receive either a multistrategy behavioral intervention or the control (usual online ordering only). The intervention strategies ran continuously for 14-16.5 months until the end of follow-up data collection. Trial primary outcomes (ie, mean total energy, saturated fat, sugar and sodium content of student online lunch orders) and secondary outcomes (ie, the proportion of online lunch order items that were categorized as everyday, occasional, and caution) were assessed over an 8-week period at baseline and 18-month follow-up. RESULTS: In all, 16 schools (94%) participated in the 18-month follow-up. Over time, from baseline to follow-up, relative to control orders, intervention orders had significantly lower energy (-74.1 kJ; 95% CI [-124.7, -23.4]; P=.006) and saturated fat (-0.4 g; 95% CI [-0.7, -0.1]; P=.003) but no significant differences in sugar or sodium content. Relative to control schools, the odds of purchasing everyday items increased significantly (odds ratio [OR] 1.2; 95% CI [1.1, 1.4]; P=.009, corresponding to a +3.8% change) and the odds of purchasing caution items significantly decreased among intervention schools (OR 0.7, 95% CI [0.6, 0.9]; P=.002, corresponding to a -2.6% change). There was no between-group difference over time in canteen revenue. CONCLUSIONS: This is the first study to investigate the sustained effect of a choice architecture intervention delivered via an online canteen ordering systems in schools. The findings suggest that there are intervention effects up to 18-months postbaseline in terms of decreased energy and saturated fat content and changes in the relative proportions of healthy and unhealthy food purchased for student lunches. As such, this intervention approach may hold promise as a population health behavior change strategy within schools and may have implications for the use of online food-ordering systems more generally; however, more research is required. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000855224; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375075.