Abstract: Objective: To evaluate, in the context of a randomized study, the 'Sole Si Sole No GISED' project, the effectiveness of an educational intervention to improve sun protection behaviour in schoolchildren. Methods: A large number of primary schools (classes II and III) in Italy were randomized to an educational intervention or control group: The intervention was conducted by trained teachers using ad hoc developed materials. Attitudes toward sun exposure and behaviour while in the sun were assessed at baseline and 1 year after concluding the educational intervention. In a subgroup of children, melanocytic naevi were counted on the upper limbs at the same intervals. The pilot phase of the study was started in 2001. Results: During the pilot phase, a total of 4,233 children was recruited. Of these, 2,116 were randomized to the active intervention and 2,117 to the control group. No difference for any of the study variables was documented between the 2 groups at baseline. About 20% of the children reported intense sun exposure during the year preceding the study. About 88% of the children reported adequate modalities of sun protection. Sunscreens were commonly used. A total of 508 children (12%) reported a history of sunburns in the year preceding the start of the study. Melanocytic naevi were counted in a total of 1,503 children (852 in the experimental and 651 in the control group). No differences in terms of skin, hair and eye colours were documented between the experimental and the control groups. The mean naevus count at baseline was 9.6 (median 7) in the experimental group and 10.1 (median 8) in the control group. Conclusion: About 50% of the total expected number of children was recruited during the pilot phase of the study. Randomization proved to be an excellent modality to select 2 samples similar for all the important study variables examined. A history of sunburns was reported less frequently than expected. The 'Sole Si Sole No GISED programme' is one of the few examples of a controlled evaluation of the effectiveness of an educational intervention in Italy
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