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.

Integrated Measure of PRogram Element SuStainability in Childcare Settings (IMPRESS-C): development and psychometric evaluation of a measure of sustainability determinants in the early childhood education and care setting.

BACKGROUND: There is a need for valid and reliable measures of determinants of sustainability of public health interventions in early childhood education and care (ECEC) settings. This study aimed to develop and evaluate the psychometric and pragmatic properties of such a measure - the Integrated Measure of PRogram Element SuStainability in Childcare Settings (IMPRESS-C). METHODS: We undertook a two-phase process guided by the COnsensus-based Standards for the selection of health status Measurement INstruments checklist (COSMIN) and Psychometric and Pragmatic Evidence Rating Scale (PAPERS). Phase 1 involved measure development; i.e., determining items and scales through an iterative process and assessment of face and content validity. Phase 2 involved the evaluation of psychometric and pragmatic properties. The 29-item measure completed by service executives (directors and nominated supervisors) was embedded in a larger survey from a national sample of Australian ECEC services assessing their implementation of nutrition and physical activity programs. Structural validity, concurrent validity, known groups validity, internal consistency, floor and ceiling effects, norms, and pragmatic qualities of the measure were assessed according to the PAPERS criteria. RESULTS: The final measure contained 26 items, with respondents reporting how strongly they agreed or disagreed on a five-point Likert scale. Phase 1 assessments confirmed the relevance, and face and content validity of the scale. In Phase 2, we obtained 482 completed surveys, of which 84% (n = 405) completed the entire measure across 405 ECEC settings (one executive per service). Three of the four fit indices for the confirmatory factor analysis met the pre-specified criteria (SRMR = 0.056, CFI = 0.993, RMSEA = 0.067) indicating 'good' structural validity. The IMPRESS-C illustrated: 'good' internal consistency, with Cronbach's alpha values from 0.53 to 0.92; 'emerging' concurrent validity; 'poor' known groups validity; 'good' norms; and 'good' overall pragmatic qualities (cost, readability, length, and assessor burden). CONCLUSIONS: The IMPRESS-C possesses strong psychometric and pragmatic qualities for assessing service executive-level perceptions of determinants influencing sustainment of public health interventions within ECEC settings. To achieve a full range of perspectives in this setting, future work should be directed to also develop and test measures of sustainability determinants at the implementer level (e.g., among individual educators and staff).

A Pilot Randomised Controlled Trial to Increase the Sustainment of an Indoor-Outdoor-Free-Play Program in Early Childhood Education and Care Services: A Study Protocol for the Sustaining Play, Sustaining Health (SPSH) Trial.

Early Childhood Education and Care (ECEC) settings are important environments to support children's physical activity (PA). In 2021, COVID-19 regulations recommended the provision of indoor-outdoor free-play programs in ECEC settings to reduce the transmission of COVID-19, resulting in an increased uptake of this practice. As the context has since changed, research suggests that ECEC services could cease the implementation of these practices. Therefore, this pilot randomised controlled trial (RCT) aims to examine the feasibility, acceptability, and impact of a sustainment strategy to ensure the ongoing implementation (sustainment) of ECEC-delivered indoor-outdoor free-play programs. Twenty ECEC services located in New South Wales, Australia that have implemented indoor-outdoor free-play programs since the release of COVID-19 guidelines will be recruited. The services will be randomly allocated either the sustainment strategy or usual care. The "Sustaining Play, Sustaining Health" program consists of eight strategies, developed to address key barriers against and facilitators of sustainment informed by the Integrated Sustainability Framework. The outcomes will be assessed via internal project records, staff surveys, and a self-reported measure of free play. This study will provide important data to support the performance of a fully powered trial within Australian ECEC settings and to inform the development of future sustainment strategies.

Evaluation of measures of sustainability and sustainability determinants for use in community, public health, and clinical settings: a systematic review.

BACKGROUND: Sustainability is concerned with the long-term delivery and subsequent benefits of evidence-based interventions. To further this field, we require a strong understanding and thus measurement of sustainability and what impacts sustainability (i.e., sustainability determinants). This systematic review aimed to evaluate the quality and empirical application of measures of sustainability and sustainability determinants for use in clinical, public health, and community settings. METHODS: Seven electronic databases, reference lists of relevant reviews, online repositories of implementation measures, and the grey literature were searched. Publications were included if they reported on the development, psychometric evaluation, or empirical use of a multi-item, quantitative measure of sustainability, or sustainability determinants. Eligibility was not restricted by language or date. Eligibility screening and data extraction were conducted independently by two members of the research team. Content coverage of each measure was assessed by mapping measure items to relevant constructs of sustainability and sustainability determinants. The pragmatic and psychometric properties of included measures was assessed using the Psychometric and Pragmatic Evidence Rating Scale (PAPERS). The empirical use of each measure was descriptively analyzed. RESULTS: A total of 32,782 articles were screened from the database search, of which 37 were eligible. An additional 186 publications were identified from the grey literature search. The 223 included articles represented 28 individual measures, of which two assessed sustainability as an outcome, 25 covered sustainability determinants and one explicitly assessed both. The psychometric and pragmatic quality was variable, with PAPERS scores ranging from 14 to 35, out of a possible 56 points. The Provider Report of Sustainment Scale had the highest PAPERS score and measured sustainability as an outcome. The School-wide Universal Behaviour Sustainability Index-School Teams had the highest PAPERS score (score=29) of the measure of sustainability determinants. CONCLUSIONS: This review can be used to guide selection of the most psychometrically robust, pragmatic, and relevant measure of sustainability and sustainability determinants. It also highlights that future research is needed to improve the psychometric and pragmatic quality of current measures in this field. TRIAL REGISTRATION: This review was prospectively registered with Research Registry (reviewregistry1097), March 2021.