BACKGROUND: A growing body of evidence suggest that the children's physical activity (PA) level in early childhood education and care (ECEC) settings are insufficient. Since most children attend ECEC settings for many hours on most days of the week, and these institutions reach children across the socioeconomic spectrum, the ECEC settings may serve as an ideal avenue for increasing physical activity level, reduce sedentary time and enhance the overall health of young children. This paper investigates the effectiveness of the "Active Kindergarten -- Active Children" study to increase children's PA level and reduce sedentary time within the ECEC setting. METHODS: Accelerometers were used to asses PA and sedentary time. A total of 116 three to four-year olds took part in a randomised controlled trial in 11 ECEC settings. Participants were cluster-randomised, by ECEC setting, to either a 12 week staff-led and expert-supported intervention or a waiting list control group. RESULTS: The intervention group increased time spent in moderate- and vigorous intensity PA by 10 min/day (95% CI 3 to 18; p = 0.01), took 1,909 more steps per day (95% CI 1,130 to 2,688; p < 0.01) and reduced sedentary time with 14 min/day (95% CI -27 to -1; p = 0.04) compared to the control group. The intervention group had a 2.4 higher odds (95% CI 1.05 to 5.7; p = 0.04) of meeting the PA recommendations compared to the control group at follow-up. CONCLUSIONS: Our results show that a flexible staff-led and expert-supported multicomponent PA intervention can increase total PA level, moderate- and vigorous intensity PA and reduce time spent sedentary in three to four-year old children during their stay in ECEC settings. TRIAL REGISTRATION: The trial was retrospectively registered on September 19, 2020 and available online at ClinicalTrials.gov number NCT04555746.

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