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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Nancy
Central Hospital, Nancy, France
Information provided by:
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00973570
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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 Intervention
Tobacco Use
Behavioral: TABADO program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of a Smoking Cessation Program Among ADOlescents in Vocational Training Centers

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall prevalence of tobacco use in the institutions concerned at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Students' motivation to quit smoking (motivational score) and frequency of attempts to quit within the 12 months after the intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of withdrawal from the program among the volunteers after 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: February 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years to 20 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Institut National de la Santé Et de la Recherche Médicale, France

Additional 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
Study First Received: September 8, 2009
Last Updated: September 8, 2009
Health Authority: France: French Data Protection Authority

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

ClinicalTrials.gov processed this record on October 23, 2014