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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
- To what extent is an advocacy coalition related to smoking prevention implementable in school's routine ?
- 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
- Improve the implementation of tobacco-free school policies (TFSP, that is, prohibition of smoking for everyone, anytime, anywhere on the school grounds)
- Make these TFSP part of school's routine practice
- 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:
- To what extent is an advocacy coalition related to smoking prevention implementable in school's routine ?
- Is an advocacy coalition an effective way to prevent smoking among adolescents and shift smoking norms in school?
To answer these questions:
- We will make an audit on the state of the school policy regarding smoking and tobacco products.
- 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.
- 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).
- Conditions
- Smoking, Adolescent Behavior
- 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 group | Role | What they receive |
|---|---|---|
| Advocacy coalition | Experimental | Feedback + advocacy coalition Receives: Behavioral: Advocacy coalition; Behavioral: Feedback |
| Control | Active comparator | Only feedback Receives: Behavioral: Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking prevalence
Impact of the advocacy coalition on smoking prevalence and smoking initiation
Measured: 2 years
Secondary outcomes (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.
- First posted23 Oct 2024
- Study start25 Apr 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- FARES (Fonds des affections respiratoires asbl), Observatoire de la santé du Hainaut, SEPT (Service d'Etude et de Prévention du Tabagisme)
- Responsible party
- Sponsor
- Investigators
- Vincent Lorant, Professor, Principal investigator, Université Catholique de Louvain
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decent and Healthy Air for Everyone (ADHAirE) : a Randomized Controlled Trial to Improve the Implementation of Tobacco-free School Policies
- ClinicalTrials.gov ID
- NCT06655038
- Acronym / sponsor ID
- ADHAIRE
- Conditions
- Smoking, Adolescent Behavior
- Keywords
- School, Prevention, Advocacy coalition, Social norms
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- FARES (Fonds des affections respiratoires asbl), Observatoire de la santé du Hainaut, SEPT (Service d'Etude et de Prévention du Tabagisme)
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To what extent is an advocacy coalition related to smoking prevention implementable in school's routine ?
- 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.
Detailed description
The ADHAirE project is an experimental study to prevent adolescent smoking.
Its objectives are to
- Improve the implementation of tobacco-free school policies (TFSP, that is, prohibition of smoking for everyone, anytime, anywhere on the school grounds)
- Make these TFSP part of school's routine practice
- 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:
- To what extent is an advocacy coalition related to smoking prevention implementable in school's routine ?
- Is an advocacy coalition an effective way to prevent smoking among adolescents and shift smoking norms in school?
To answer these questions:
- We will make an audit on the state of the school policy regarding smoking and tobacco products.
- 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.
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Advocacy coalition | Experimental | Behavioral: Advocacy coalition, Behavioral: FeedbackFeedback + advocacy coalition |
| Control | Active comparator | Behavioral: FeedbackOnly feedback |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- student at a secondary school participating in the study
- student of the 3rd and 4th grade
Key exclusion criteria (2 listed)
- student at a secondary school not participating in the study
- student of another grade than 3rd and 4th grade
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advocacy coalition* 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. | Behavioural | Advocacy coalition |
| FeedbackFeedback on the basis of the audit and the surveys | Behavioural | Advocacy coalition, Control |
Primary outcome
Smoking prevalence
Time frame: 2 years
Impact of the advocacy coalition on smoking prevalence and smoking initiation
1 secondary outcome
Smoking norm
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 40130233Laloux 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.
- Link to the funders' websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent Lorant, Professor principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
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.