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

Abstract

BackgroundIn 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%).DiscussionCarrying 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 registrationISRCTN85812512. Registered 15 May 2018 by BioMed Central. (retrospectively registered).

Four Year Results of a School-Based Anti-Smoking Intervention : The “PEPITES” Cluster Randomized Trial.

“…A detailed protocol has been published [18], and we present here the principal elements of the protocol.…”

“…The Essonne National education authority designated 6 mixed-sex state secondary schools (from 6 th grade to 9th grade) to participate in the PEPITES trial. In the original protocol [18], the 6 schools were randomly allocated to 3 groups of 2 clusters each: one group (I 1 ) with 2 educational workshops per school year over the 4 years of the secondary school duration, one group (I 2 ) with 2 educational workshops per school year over the 4 years, but with one of the workshops dedicated to measuring taste loss linked to tobacco use during the 3 rd and 4 th years, one control group (C) of 2 secondary schools with no intervention planned.…”

Vliianie tabakokureniia na reproduktivnyi potentsial zhenshchin (na primere Pridnestrov'ia)

“…В Молдове наибольшее число (50,6%) вновь выявленных случаев РШМ регистрируется в возрасте 40-59 лет, тогда как в ПМР -53,5% в возрастной категории 50-69 лет (рис. 12) [161]. В Молдове РШМ чаще затрагивает женщин в возрасте до 50 лет.…”

“…В Молдове в 2015 году внедрен Национальный стандарт оперативных процедур скрининга шейки матки, в котором целевой группой являются бессимптомные женщины в возрасте от 25 до 61 лет. При частоте скрининга один раз в три года забор анализа проводится в возрасте 25/28/31/34/37/40/43/46/49/52/55/58/61 лет [161].…”

“…Практика показывает, что почти все эти случаи можно предотвратить с помощью хорошо организованного скрининга шейки матки и вакцинации против ВПЧ в подростковом возрасте [84; 129]. Организованная программа означает, что все женщины, имеющие право на скрининг, получают пользу от этих услуг, поскольку существует стройная система для отбора пациенток, отслеживания посещений и дальнейшей тактики, обеспечивающая высокое качество всех компонентов обслуживания [161].…”