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. 2018 Jul 31;18(1):942.
doi: 10.1186/s12889-018-5840-8.

Rationale, design and conduct of a school-based anti-smoking intervention: the "PEPITES" cluster randomized trial

Stéphanie Vieira  1 , Fabrice Chéruel  2   3 , Hélène Sancho-Garnier  2   4
Affiliations

Rationale, design and conduct of a school-based anti-smoking intervention: the "PEPITES" cluster randomized trial

Stéphanie Vieira et al. BMC Public Health. .

Abstract

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).

Keywords: Cluster randomized trial; Health education; Long term anti-smoking interventions; Secondary school.

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Conflict of interest statement

Ethics approval and consent to participate

This research protocol has been validated by the CCTIRS (n°15 213Bis) previously to obtain the mandatory CNIL authorization (2,009,002 v 0) and by the Ethical Evaluation Committee of INSERM: Institutional Peer Review Board 00003888 (file N° 15–269).

Written parental authorization was requested for the whole duration of the trial after sending a letter which outlined the principal objectives of the trial and the intervention methods. The pupils could also refuse to participate even if the parents had given their authorization.

Consent for publication

Our study does not contain data from any individual person. Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
PEPITES trial design
Fig. 2
Fig. 2
Electrogustometer (Unpublished figure: created by the authors for this manuscript)
See this image and copyright information in PMC

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