Is level of implementation linked with intervention outcomes? Process evaluation of the TransformUs intervention to increase children's physical activity and reduce sedentary behaviour.

Background: TransformUs was a four-arm school-based intervention to increase physical activity and reduce sedentary behaviour among primary school children. Pedagogical and environmental strategies targeted the classroom, school grounds and family setting. The aims of this study were to evaluate program fidelity, dose, appropriateness, satisfaction and sustainability, and associations between implementation level and outcomes among the three intervention arms.

Methods: At baseline, 18-months (mid-intervention) and 30-months (post-intervention), teachers, parents and children completed surveys, and children wore GT3X ActiGraph accelerometers for 8 days at each time point to determine physical activity and sedentary time. Implementation data were pooled across the three intervention groups and teachers were categorised by level of implementation: (i) 'Low' (< 33% delivered); (ii) 'Moderate' (33-67% delivered); and (iii) 'High' (> 67% delivered). Linear and logistic mixed models examined between group differences in implementation, and the association with children's physical activity and sedentary time outcomes. Qualitative survey data were analysed thematically.

Results: Among intervention recipients, 52% (n = 85) of teachers, 29% (n = 331) of parents and 92% (n = 407) of children completed baseline evaluation surveys. At 18-months, teachers delivered on average 70% of the key messages, 65% set active/standing homework, 30% reported delivering > 1 standing lesson/day, and 56% delivered active breaks per day. The majority of teachers (96%) made activity/sports equipment available during recess and lunch, and also used this equipment in class (81%). Fidelity and dose of key messages and active homework reduced over time, whilst fidelity of standing lessons, active breaks and equipment use increased. TransformUs was deemed appropriate for the school setting and positively received. Implementation level and child behavioural outcomes were not associated. Integration of TransformUs into existing practices, children's enjoyment, and teachers' awareness of program benefits all facilitated delivery and sustainability.

Conclusions: This study demonstrated that intervention dose and fidelity increased over time, and that children's enjoyment, senior school leadership and effective integration of interventions into school practices facilitated improved intervention delivery and sustainability. Teacher implementation level and child behavioural outcomes were unrelated, suggesting intervention efficacy was achieved irrespective of implementation variability. The potential translatability of TransformUs into practice contexts may therefore be increased. Findings have informed scale-up of TransformUs across Victoria, Australia.

Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN83725066; Australian New Zealand Clinical Trials Registry Number ACTRN12609000715279. Registered 19 August 2009. Available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=308387&isReview=true.