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Background: Many programs which aim to reduce tobacco consumption in young people are carried out in the school environment, addressing a "captive audience" and monitoring the actions over a period of several years. The approaches identified as promising involve putting in place a tobacco prevention program throughout the entire school years incorporated in the school program. Several studies showed that early initiation to psychoactive substances is a strong predictor of addiction. Considering the above points, an intervention trial on tobacco prevention covering the four years of secondary school (±11-15 years old) was implemented in the Essonne area, in France., Method: This study was based on a cluster randomized trial comparing three groups: two intervention groups and a control group. The present paper describes the school children (1st year in six secondary schools) included in the trial. It studies the national representativity of this population, the comparability between the control and intervention groups and the items link to tobacco initiation., Results: When considering tobacco behavior in 2014, the included population was representative of the school children in 1st year of secondary school in France with 11.5% of tobacco initiation and 2.5% of regular smokers. The groups were comparable except for four items (family and friends smoking, only child, sensitive urban areas). With this knowledge on factors linked to smoking behaviors this population can be included in the trial analysis., Conclusion: The study of the included population will help to perform the trial analysis and authorize the transferability of the trial results if positive., (Copyright © 2019 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)

Background: In France smoking initiation rates amongst 11 to 16 year-olds are worryingly high. Several studies show that early initiation to psycho-active substances is a strong predictor of tobacco addiction. Decreasing the age at which tobacco use starts represents a key challenge for reducing tobacco usage. Implementing an intervention trial using educational workshops based on the Theory of Planned Behavior (TPB) and covering the 4 years of secondary school could be effective., Methods: "PEPITES" is an interventional research, using a cluster randomized design. It will allow assessing the effectiveness of interventions both in reducing the tobacco initiation rate and the regular smoking rate of secondary school pupils. We will also evaluate the process of the implementation of the study and thus will help to the transferability of the intervention. A partnership convention was signed between the JDB Foundation and the National Education authority which designated 6 secondary state schools for the PEPITES trial. The 6 schools were randomly allocated to 3 groups of 2 clusters each: 1 control group, 2 different intervention groups with 2 workshops per year during 4 years; In one of this group the 2 last workshops will be dedicated to measure the loss of taste due to tobacco smoking. In each school, all pupils in year 1 with a signed parental authorization (744 pupils) have been included in the trial. The interventions targets one of the variables of the TPB and the reinforcement of psycho-social competencies. We estimated that we could detect a reduction of increase ≥5.5 and 8% respectively in the 2 principal outcomes (risk α of 5%, and β of 80%)., Discussion: Carrying out a randomized prevention trial in the school environment raises specific problems which it seems useful to detail for other educational actors who would like to perform a similar study. This discussion concerns the acceptation and cooperation of the National Education partners, the risks of contamination, the information given to parents and pupils and their consent, and the representativeness of the schools involved., Trial Registration: ISRCTN85812512 . Registered 15 May 2018 by BioMed Central. (retrospectively registered).