- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00973570
Smoking Cessation Program Among Adolescents in Vocational Training Centers (TABADO)
Evaluation of a Smoking Cessation Program Among ADOlescents in Vocational Training Centers
Background: Most of the efforts to fight against young people's tobacco addiction have focused on smoking prevention and little on smoking cessation. A smoking cessation program, associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable population (vocational trainees), was developed by a team of tobacco addiction specialist physicians. We developed a study to evaluate the efficacy of the program. Its main objective is to compare the efficacy of a smoking cessation program offered to all smokers in a population aged 15 to 20 years in Vocational Training Centers (VTC) with that in a control population. The objective of this paper is to present the TABADO study protocol and the results of the pilot study.
Methods: The study is quasi-experimental, prospective, evaluative and comparative and takes place during the 2 years of vocational training. The final population will be composed of 2000 trainees entering a VTC (in Lorraine, France): The intervention group (1000 trainees) benefited from the TABADO program while no specific intervention took place in the "control" group (1000 trainees) other than the treatment and education services usually available. Our primary outcome will be the tobacco abstinence rate at 12 months.
The pilot study is a descriptive monocentric cross-sectional study conducted among the whole group of students, completed by a longitudinal prospective study of smoker volunteers.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lorraine
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Nancy, Lorraine, France, 54000
- CHU Nancy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- All students, males and females, registered in the VTC for at least a 2-year training period
- Aged from 15 to 20 years
Exclusion criteria:
- Subjects with current serious psychiatric disorders or who may be susceptible to decompensation upon quitting smoking (major depression)
- Smokers who are involved in an ongoing attempt to quit, with medical monitoring.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: "Intervention" group
The "intervention" group benefits from the TABADO program
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The intervention takes place in 3 stages: (i) a general information session on tobacco consumption is delivered to all teenagers, both smokers and nonsmokers.
(ii) For smokers wishing to join the program, this session is followed by individualized consultations with a team of tobacco addiction physicians.
(iii) The volunteers then benefit from a small group approach, consisting of discussion sessions to share experiences, strengthen motivation, and prevent relapse.
There will be 4 sessions in total, comprising individual counseling and work in groups spread over 3 months (taking into account the availability of the trainees because of their alternate-week training schedule).
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|
No Intervention: "Control" group
The "control" group not benefit from any specific intervention other than the treatment and education usually available
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The primary outcome is the rate of smoking abstinence after 12 months, measured on the basis of the statements of the whole sample, not only among volunteers.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall prevalence of tobacco use in the institutions concerned at 12 months.
Time Frame: 12 months
|
12 months
|
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Students' motivation to quit smoking (motivational score) and frequency of attempts to quit within the 12 months after the intervention
Time Frame: 12 months
|
12 months
|
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Rate of withdrawal from the program among the volunteers after 12 months.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: François ALLA, MD/ PhD, Institut National de la Santé Et de la Recherche Médicale, France
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- C07-43
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