NCT06655038

Brief Summary

The goal of this cluster randomized controlled trial is to learn if the set up of an advocacy coalition in secondary schools can improve the implementation of tobacco-free school policies (TFSP) to prevent adolescent smoking. The main questions it aims to answer are:

  • Set up a task force composed of school stakeholders (students, teachers, educators, principle,...)
  • Share their good practices regarding implementation with the other schools of the intervention arm
  • Be supported to reffer nicotine-dependant students and staff members to smoking cessation programs Continuous evaluation is planned to assess the effectiveness of this intervention.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Apr 2024Jun 2026

Study Start

First participant enrolled

April 25, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

2.1 years

First QC Date

October 22, 2024

Last Update Submit

October 22, 2024

Conditions

Keywords

SchoolPreventionAdvocacy coalitionSocial norms

Outcome Measures

Primary Outcomes (1)

  • Smoking prevalence

    Impact of the advocacy coalition on smoking prevalence and smoking initiation

    2 years

Secondary Outcomes (1)

  • Smoking norm

    2 years

Study Arms (2)

Advocacy coalition

EXPERIMENTAL

Feedback + advocacy coalition

Behavioral: Advocacy coalitionBehavioral: Feedback

Control

ACTIVE COMPARATOR

Only feedback

Behavioral: Feedback

Interventions

* set up a task force composed of school stakeholders (students, teachers, educators, principle,...). These stakeholders will meet 4 times a year to improve the implementation and enforcement of TFSP through rules that are accepted, adopted and to which all school actors adhere. * share of good practices in implementation with the other schools of the intervention arm through a sharing platform and two annual meetings. * support to reffer nicotine-dependant students and staff members to smoking cessation programs. * support in the implementation of TFSP and in getting all school actors on board, by the research team, but also by local health promotion partners.

Advocacy coalition
FeedbackBEHAVIORAL

Feedback on the basis of the audit and the surveys

Advocacy coalitionControl

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • student at a secondary school participating in the study
  • student of the 3rd and 4th grade

You may not qualify if:

  • student at a secondary school not participating in the study
  • student of another grade than 3rd and 4th grade

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLouvain

Brussels, 1200, Belgium

Location

Related Publications (1)

  • Laloux P, Melard N, Lorant V. Implementation of school tobacco policies: The advocacy coalition approach. Protocol of the ADHAirE study, a cluster randomized controlled trial. Tob Prev Cessat. 2025 Mar 24;11. doi: 10.18332/tpc/202392. eCollection 2025.

Related Links

MeSH Terms

Conditions

SmokingAdolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Vincent Lorant, Professor

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Schools will be the target of an intervention. The 20 participating schools will be randomly assigned either to the intervention arm or to the control arm.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2024

First Posted

October 23, 2024

Study Start

April 25, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

October 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations