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Smoking Cessation Program Among Adolescents in Vocational Training Centers (TABADO)

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ClinicalTrials.gov Identifier: NCT00973570
Recruitment Status : Unknown
Verified September 2009 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : September 9, 2009
Last Update Posted : September 9, 2009
Sponsor:
Collaborators:
University of Nancy
Central Hospital, Nancy, France
Information provided by:
Institut National de la Santé Et de la Recherche Médicale, France

Brief 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.


Condition or disease Intervention/treatment Phase
Tobacco Use Behavioral: TABADO program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of a Smoking Cessation Program Among ADOlescents in Vocational Training Centers
Study Start Date : February 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: "Intervention" group
The "intervention" group benefits from the TABADO program
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).
No Intervention: "Control" group
The "control" group not benefit from any specific intervention other than the treatment and education usually available



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Overall prevalence of tobacco use in the institutions concerned at 12 months. [ Time Frame: 12 months ]
  2. Students' motivation to quit smoking (motivational score) and frequency of attempts to quit within the 12 months after the intervention [ Time Frame: 12 months ]
  3. Rate of withdrawal from the program among the volunteers after 12 months. [ Time Frame: 12 months ]


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Ages Eligible for Study:   15 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973570


Contacts
Contact: Laetitia MINARY, MSc l.minary@chu-nancy.fr
Contact: François ALLA, MD/ PhD f.alla@chu-nancy.fr

Locations
France
CHU Nancy Recruiting
Nancy, Lorraine, France, 54000
Contact: Laetitia MINARY, MSc       l.minary@chu-nancy.fr   
Principal Investigator: François ALLA, MD/ PhD         
Principal Investigator: Denis Zmirou-Navier, MD/ PhD         
Sub-Investigator: Yves MARTINET, MD/ PhD         
CHU Nancy Recruiting
Nancy, Lorraine, France, 54000
Contact: Laetitia MINARY, MSc       l.minary@chu-nancy.fr   
Contact: François ALLA, MD/PhD       f.alla@chu-nancy.fr   
Principal Investigator: François ALLA, MD/ PhD         
Principal Investigator: Denis Zmirou-Navier, MD/ PhD         
Sub-Investigator: Yves MARTINET, MD/ PhD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
University of Nancy
Central Hospital, Nancy, France
Investigators
Principal Investigator: François ALLA, MD/ PhD Institut National de la Santé Et de la Recherche Médicale, France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: François ALLA MD/ PhD, INSERM
ClinicalTrials.gov Identifier: NCT00973570     History of Changes
Other Study ID Numbers: C07-43
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: September 9, 2009
Last Verified: September 2009

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
tobacco cessation
evaluation
epidémiology
adolescent
apprentices