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

October 22, 2024 updated by: Université Catholique de Louvain

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:

  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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • UCLouvain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

These criteria concern adolescents who will take part in the surveys.

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Advocacy coalition
Feedback + advocacy coalition
Behavioral: 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.
Behavioral: Feedback
Feedback on the basis of the audit and the surveys
Active Comparator: Control
Only feedback
Behavioral: Feedback
Feedback on the basis of the audit and the surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking prevalence
Time Frame: 2 years
Impact of the advocacy coalition on smoking prevalence and smoking initiation
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking norm
Time Frame: 2 years
Impact of the advocacy coalition on social norms about smoking among adolescents
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Catholique de Louvain

Collaborators

FARES (Fonds des affections respiratoires asbl)
Observatoire de la santé du Hainaut
SEPT (Service d'Etude et de Prévention du Tabagisme)

Investigators

  • Principal Investigator: Vincent Lorant, Professor, Université Catholique de Louvain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ADHAIRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking

Clinical Trials on Advocacy coalition

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe