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Practical factors such as weather and illness may impact on attendance at a KICk-OFF course.
Our hypothesis is that behaviour change as a result of attending a KICk-OFF course is likely to take place within 6 12 months of the intervention.
Centres are randomised to one of two groups: (1) usual care (control), (2) KICk-OFF course (intervention), in a 1 1 ratio, using a computer generated allocation schedule prepared in advance of the trial to conceal centre allocation.
The KICk-OFF course potentially provides participants with the freedom to widen their dietary choices, although healthy eating is encouraged.
Although the KICk-OFF course is not specifically designed for those on pumps, many of the skills required to successfully manage a pump are taught on the course.
Every effort is made to support them to remain involved, but subjects are withdrawn if their behaviour during the KICk-OFF course proves, in the view of the educators, to be detrimental to the continued learning of other participants.
Although clinical teams are aware of diagnosed behavioural problems and those children are excluded from recruitment, it is possible that challenging behaviour will emerge in some children during the week of the KICk-OFF course which has not been anticipated.
The Kids In Control OF Food (KICk-OFF) course is based on DAFNE principles and aims to provide young people with self-management skills and strategies to help overcome some of the barriers to effective self-management associated with an intensive insulin regimen.
The total study duration is 60 months, with the intervention (KICk-OFF courses) being delivered over a 15-month period.
KICk-OFF courses are delivered in the intervention centres, with standard care continued in the control arm.
We aim to reduce inter-educator variability by having just three teams of educators who will all receive specialist teacher training prior to teaching KICk-OFF courses.
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