60 schools with more than 2221 children were recruited; valid
data were available for fruit and vegetable consumption for 2121 children,
for accelerometer assessed physical activity and sedentary behaviour
for 1252 children, and for secondary outcomes for between 1825 and
2212 children for the main analyses. None of the three primary outcomes
differed between children in schools allocated to the AFLY5 intervention
and those allocated to the control group. The difference in means
comparing the intervention group with the control group was –1.35 (95%
confidence interval –5.29 to 2.59) minutes per day for moderate to
vigorous physical activity, –0.11 (–9.71 to 9.49) minutes per day for
sedentary behaviour, and 0.08 (–0.12 to 0.28) servings per day for fruit
and vegetable consumption. The intervention was effective for three out
of nine of the secondary outcomes after multiple testing was taken into
account: self reported time spent in screen viewing at the weekend (–21
(–37 to –4) minutes per day), self reported servings of snacks per day
(–0.22 (–0.38 to –0.05)), and servings of high energy drinks per day
(–0.26 (–0.43 to –0.10)) were all reduced. Results from a series of
sensitivity analyses testing different assumptions about missing data
and from per protocol analyses produced similar results.