Smoking Cessation Program Among Adolescents in Vocational Training Centers

Tobacco Use Clinical Trial

— TABADO  

Official title:

Evaluation of a Smoking Cessation Program Among ADOlescents in Vocational Training Centers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00973570
• Other study ID #: C07-43
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2009
• Last updated: September 8, 2009
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2009
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Laetitia MINARY, MSc
• Email: l.minary[@]chu-nancy.fr
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 20 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Behavioral:
• TABADO program
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).

Locations

Country	Name	City	State
France	CHU Nancy	Nancy	Lorraine
France	CHU Nancy	Nancy	Lorraine

Sponsors (3)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Central Hospital, Nancy, France, University of Nancy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months	No
Secondary	Overall prevalence of tobacco use in the institutions concerned at 12 months.		12 months	No
Secondary	Students' motivation to quit smoking (motivational score) and frequency of attempts to quit within the 12 months after the intervention		12 months	No
Secondary	Rate of withdrawal from the program among the volunteers after 12 months.		12 months	No