As no similar study has been conducted in Italy, the Local Health District (USL) of Rozzano (Milano), decided to carry on a randomized controlled trial on the efficacy of a Smoking Prevention Program. In this article we describe study protocol and give data related to program steps already carried out. A team of four MDs involved in school health and a Health Research consultant were in charge for the study. 1013 students from the second class of the secondary school (12y age) were stratified into four subgroups, according to their risk of becoming a smoker and their teachers smoking status. They were subsequently randomized (with blocking) to two groups: the smoking prevention (which was based on the Waterloo Smoking Program) and the cardiovascular risk prevention (based on an ad hoc program by the USL) which was the control group. Both interventions consisted in six weekly lessons which were delivered in 37 classrooms (777 students or 61% of all the eligible student population, 72% of randomized students) by an equal number of teacher who voluntarily joined the program, during school hours. A larger number of teachers (53) formerly joined the program but not all accomplished it. Problems with program planning and delivering are described, together with the criteria which guided this approach.
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