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SmokingNCT06655038

ADHAirE : a Randomized Controlled Trial to Improve the Implementation of Tobacco-free School Policies

A study testing Advocacy coalition and Feedback in people with Smoking and Adolescent Behavior, run by Université Catholique de Louvain at 1 site in Belgium.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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: 1. Read more about this study

Who is it for?
Ages 13 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Smoking, Adolescent Behavior
What is being tested?
Advocacy coalition and Feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBelgium
Study dates
25 Apr 2024to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium1 site
  • UCLouvain

    Brussels, 1200

Other trials in Belgium

About this study

Official title: A Decent and Healthy Air for Everyone (ADHAirE) : a Randomized Controlled Trial to Improve the Implementation of Tobacco-free School Policies

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:

Read more
  1. To what extent is an advocacy coalition related to smoking prevention implementable in school's routine ?
  2. Is an advocacy coalition an effective way to prevent smoking among adolescents and shift smoking norms in school?

Schools in the intervention arm will be compared to schools in the control arm, to test the effectiness of the advocacy coalition to improve the implementation of TFSP.

Schools in the intervention arm will put in place an advocacy coalition, that is

  • 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.

Read the detailed description

The ADHAirE project is an experimental study to prevent adolescent smoking.

Its objectives are to

  1. Improve the implementation of tobacco-free school policies (TFSP, that is, prohibition of smoking for everyone, anytime, anywhere on the school grounds)
  2. Make these TFSP part of school's routine practice
  3. Decrease adolescents initiating or reporting smoking

To achieve those goals, schools will put an advocacy coalition in place, that is:

  • They wil 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.
  • They will share their good practices regarding implementation with the other schools of the intervention arm through a sharing platform and two annual meetings.
  • They will be supported to reffer nicotine-dependant students and staff members to smoking cessation programs.
  • They will also be supported in the implementation of TFSP and in getting all school actors on board, by the research team, but also by local health promotion partners.

The intervention will be carry out during two years in secondary schools in the Hainaut province, Belgium. This province has one of the highest smoking prevalence in the country and the lowest income level.

A cluster randomized controlled trial will test the effectiveness of the advocacy coalition to improve the implementation of TFSP.

Schools (the clusters) are randomly assigned either to the intervention arm (and set up the advocacy coalition) or to the control arm (and try to achieve the objectives without the advocacy coalition). Randomization will be cross-stratified on the basis of their geographical location (to avoid contamination biases) and social-economic status.

The main questions this study aims to answer are:

  1. To what extent is an advocacy coalition related to smoking prevention implementable in school's routine ?
  2. Is an advocacy coalition an effective way to prevent smoking among adolescents and shift smoking norms in school?

To answer these questions:

  1. We will make an audit on the state of the school policy regarding smoking and tobacco products.
  2. A survey will be carried out among staff' members of the participating schools on their engagement in the project, their opinion about smoking prevention at school and their smoking status.
  3. A survey will be carried out among adolescents from the 3rd and 4th grade, following a repeated cross-sectional design. Questionnaires will focus on epidemiological indicators such as smoking status and initiation, but also on social norm features such as beliefs and perceptions adolescents hold about smoking.

These evaluations will occur at three times: at baseline, at one year of follow-up and at two years of follow-up. Results of these evaluations will serve to give a feedback to the schools on their situation regarding smoking (regardless to treatment arm to which the school is assigned).

Being tested
Advocacy coalition, Feedback
Keywords
School, Prevention, Advocacy coalition, Social norms
Medical subject headings
Smoking, Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advocacy coalitionBehavioural

    • 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.
  • FeedbackBehavioural

    Feedback on the basis of the audit and the surveys

Study groups in NCT06655038
Study groupRoleWhat they receive
Advocacy coalitionExperimentalFeedback + advocacy coalition
Receives: Behavioral: Advocacy coalition; Behavioral: Feedback
ControlActive comparatorOnly feedback
Receives: Behavioral: Feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking prevalence

    Impact of the advocacy coalition on smoking prevalence and smoking initiation

    Measured: 2 years

Secondary outcomes (1)
  1. Smoking norm

    Impact of the advocacy coalition on social norms about smoking among adolescents

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2024
  2. Study start25 Apr 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06655038
Sponsor's protocol ID
ADHAIRE
Status last verified
Oct 2024
First submitted
22 Oct 2024
Last updated
23 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40130233

Questions about this trial

What is this clinical trial studying?

A study testing Advocacy coalition and Feedback in people with Smoking and Adolescent Behavior, run by Université Catholique de Louvain at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking prevalence (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06655038, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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