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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN85812512
Enrollment
750
Registered
2018-05-15
Start date
2014-09-15
Completion date
Unknown
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco use prevention Not Applicable

Interventions

The 6 schools were randomly allocated to 3 groups of 2 clusters each: 1 control group and 2 different intervention groups with 2 workshops per year during 4 years. In each school, all pupils in year 1
that is 8 interventions per secondary school over the 4 years 2. One group of 2 secondary schools with 2 educational workshops per school year
that is 8 interventions per secondary school over the 4 years, with one of the workshops dedicated to measure taste with the electrogustometer during the 3rd and 4th years 3. One contr

Sponsors

JDB Foundation Cancer Prevention
Lead Sponsor
University Paris-Saclay
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In each secondary school, all pupils in year 1 (grade 6) at the time of the survey, with a signed parental authorization form, have been included in the PEPITES trial 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 undertaken. The pupils could also refuse to participate even if the parents had given their authorization

Exclusion criteria

Exclusion criteria: All pupils (grade 6) either without parental authorization form or refusing to participate

Design outcomes

Primary

MeasureTime frame
1. The prevalence of pupils having experimented (at least once) tobacco smoking at the end of year 2 and year 4 as compared to beginning of year 1 (comparison of the 2 intervention groups together versus the control group) 2. The prevalence of regular (at least weekly) cigarette smokers at the end of year 4 (comparisons of the 3 groups 2 by 2) Outcomes collected by pupil questionnaire at the beginning of each year (October 2014, October 2015, October 2016, October 2017) and at the end of year 2 (May 2016) and 4 (May 2018)

Secondary

MeasureTime frame
1. Experimentation with hookah, cannabis, electronic cigarettes 2. Perception of norms, attitudes and future intentions of the participants with regard to smoking 3. The various determinants which may have a role in starting smoking or becoming a regular smoker (gender, siblings, sporting activity, home area (ZUS), smokers in the entourage (parents, friends) Outcomes collected by pupil questionnaire at the beginning of each year (October 2014, October 2015, October 2016, October 2017) and at the end of year 2 (May 2016) and 4 (May 2018) The detailed evaluation of the process aims to study the context of the implementation of PEPITES in the school environment by identifying the external factors which might have an impact on the implementation (levers and obstacles) and on its effectiveness (such as: how well the rule forbidding smoking in the school is applied, other tobacco sessions carried out in the control schools, national campaigns, etc). The aim of this evaluation is to be able, if the results are positive, to transfer these interventions to other secondary schools. If the results are inconclusive, such an analysis might help to explain the reasons.

Countries

France

Contacts

Public ContactStéphanie Vieira
stephanie.vieira@fondationJdb.org+33 (0)1 60 80 64 65

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026