INTRODUCTION: Although comprehensive school-based physical activity interventions are efficacious when tested under research conditions, they often require adaptation in order for implementation at scale. This paper reports the effectiveness of an adapted efficacious school-based intervention in improving children's moderate to vigorous physical activity. The impact of strategies to support program implementation was also assessed. DESIGN: A cluster RCT of low socioeconomic elementary schools in New South Wales, Australia. SETTING/PARTICIPANTS: Consenting schools were randomized (25 intervention, 21 control) using a computerized random number function. Follow-up measures were taken at 6 months post-randomization (May to August 2015) by blinded research assistants. The multicomponent school-based intervention, based on an efficacious school-based physical activity program (Supporting Children's Outcomes using Rewards, Exercise and Skills), consisted of four physical activity strategies and seven implementation support strategies. The intervention was adapted for scalability and delivery by a local health service over 6 months. The primary outcome was accelerometer assessed, student mean daily minutes spent in moderate to vigorous physical activity. Physical education lesson quality and other school physical activity practices were also assessed. RESULTS: Participants (n = 1,139, 49% male) were third- through sixth-grade students at follow-up (May to August 2015). Valid wear time and analysis of data were provided for 989 (86%) participants (571 intervention, 568 control). At 6-month follow-up, there were no significant effects in overall daily minutes of moderate to vigorous physical activity between groups (1.96 minutes, 95% CI -3.49 to 7.41, p = 0.48). However, adjusted difference in mean minutes of overall vigorous physical activity (2.19, 95% CI 0.06, 4.32, p = 0.04); mean minutes of school day moderate to vigorous physical activity (2.90, 95% CI 0.06 to 5.85, p = 0.05); and mean minutes of school day vigorous physical activity (1.81, 95% CI 0.78 to 2.83, p <= 0.01) were significantly different in favor of the intervention group. Physical education lesson quality and school physical activity practices were significantly different favoring the intervention group (analyzed October 2015 to January 2016). CONCLUSIONS: The modified intervention was not effective in increasing children's overall daily minutes of moderate to vigorous physical activity, when adapted for implementation at scale. However, the intervention did improve daily minutes of vigorous physical activity and school day moderate to vigorous physical activity, lesson quality, and school physical activity practices. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000437561.

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