International Journal of Environmental Research and Public Health · 8 authors, 6 centres
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This protocol describes a pilot randomised controlled trial testing a sustainment strategy (SPSH) to maintain indoor–outdoor free-play programs in Australian ECEC services that were adopted during COVID-19. The 8-strategy intervention targets barriers to sustainment and will be tested in 20 services over 6 months. If feasible and acceptable, this work will inform a fully powered trial to prevent attenuation of physical activity programs as pandemic guidance eases.
**Background:** Physical inactivity is the fourth leading risk factor for mortality globally, contributing to approximately 3.2 million deaths each year and 198.4 DALYs per 100,000 people. In Australia, 2.5% of the total disease burden is due to physical inactivity, and only about 61% of children aged 2–5 met PA guidelines in 2018. Early Childhood Education and Care (ECEC) settings are important for physical activity promotion, as children aged 3–5 spend an average of 25–35 hours per week in care. Indoor–outdoor free-play programs, where children can move freely between indoor and outdoor environments, are recommended to increase outdoor free play. During COVID-19, state education authorities in Australia recommended these programs to support social distancing, leading to increased uptake. However, as COVID-19 guidance has eased, there is concern that implementation may attenuate. There is a lack of research on how to sustain public health interventions in community settings, with no randomised or non-randomised trials identified that assessed interventions to improve sustainment of programs targeting PA, nutrition, smoking, or alcohol in community-based settings.
**Methods:** This is a 6-month pilot parallel-group RCT conducted in New South Wales, Australia. Twenty ECEC services that have implemented indoor–outdoor free-play programs since July 2021 (defined as <20% of indoor-only free-play time during core operating hours) will be recruited from a sampling frame of 99 eligible services identified via telephone survey. Services are excluded if they implemented indoor–outdoor free-play before July 2021, cater exclusively for children with special needs, have staff who do not understand English, or are Department of Education community-run services. Services will be randomly allocated to receive the SPSH program or usual care using block randomisation via REDCap. The trial is open-label (services and data collectors not blinded), but data analysts will be blinded for the main impact outcome. The SPSH program was developed using the Integrated Sustainability Framework and addresses 20 barriers across five domains. It comprises eight strategies: (i) identifying opinion leaders, (ii) affirming intent to continue, (iii) providing technical support via two video calls and two emails, (iv) developing a formal sustainment blueprint, (v) distributing educational materials, (vi) engaging with family members, (vii) reviewing and embedding change into policy, and (viii) developing an ongoing monitoring plan. The intervention is delivered by health-promotion officers with tertiary qualifications who have undergone behaviour-change training. Control services receive usual care (a generic email with a link to benefits of outdoor free play). Data collection occurs at baseline (September–December 2022), 6 months, and 12 months post-baseline via telephone/online surveys and the Free Play Record (FPR), a self-reported measure of minutes of indoor-only, indoor–outdoor, and outdoor-only free play over 5 consecutive days. The FPR has been pilot-tested and overestimates outdoor free play by just 7.6 minutes (95% CI −15, 15) compared to direct observations (p < 0.3651).
**Key Results:** This is a protocol paper; no results are reported. The trial is currently in the intervention-delivery stage. The study will assess: (1) acceptability of the SPSH program using the Theoretical Framework of Acceptability (7 Likert-scale items plus 1 open-ended question); (2) feasibility using a 4-item adapted Feasibility of Intervention measure; (3) sustainment of indoor–outdoor free-play programs measured as minutes of indoor-only free play; (4) adoption of SPSH-program recommendations (completion of at least 4 strategies in the Sustainability Action Plan); (5) feasibility of trial methods (consent rate, missing data, attrition, contamination); (6) fidelity to delivering the SPSH program; (7) barriers and facilitators using an adapted 9-item scale measuring outer contextual factors and processes; and (8) costs (HPO labour and service staff time). Progression to a fully powered trial requires the team to deem the intervention sufficiently acceptable and feasible to be adopted by >25% of ECEC services.
**Clinical Implications:** This study addresses a critical evidence gap regarding how to sustain health-promotion programs in ECEC settings after initial implementation. If the SPSH program is found to be feasible and acceptable, it could prevent the attenuation of indoor–outdoor free-play programs as COVID-19 guidance eases, thereby maintaining physical activity opportunities for young children. The study will provide proof-of-concept data to support the first fully powered trial of sustainment strategies in ECEC settings. Given that only 11.26% of pre-schoolers globally adhere to 24-Hour Movement Guidelines, sustaining effective physical activity programs in ECEC settings could have meaningful population health impact. The theory-informed approach using the Integrated Sustainability Framework and the systematic mapping of strategies to identified barriers provides a replicable methodology for developing sustainment interventions in other community settings.