NCT00973570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

March 28, 2025

Status Verified

September 1, 2009

Enrollment Period

1.9 years

First QC Date

September 8, 2009

Last Update Submit

March 25, 2025

Conditions

Keywords

tobacco cessationevaluationepidémiologyadolescentapprentices

Outcome Measures

Primary Outcomes (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.

    12 months

Secondary Outcomes (3)

  • Overall prevalence of tobacco use in the institutions concerned at 12 months.

    12 months

  • Students' motivation to quit smoking (motivational score) and frequency of attempts to quit within the 12 months after the intervention

    12 months

  • Rate of withdrawal from the program among the volunteers after 12 months.

    12 months

Study Arms (2)

"Intervention" group

EXPERIMENTAL

The "intervention" group benefits from the TABADO program

Behavioral: TABADO program

"Control" group

NO INTERVENTION

The "control" group not benefit from any specific intervention other than the treatment and education usually available

Interventions

TABADO programBEHAVIORAL

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).

"Intervention" group

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All students, males and females, registered in the VTC for at least a 2-year training period
  • Aged from 15 to 20 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nancy

Nancy, Lorraine, 54000, France

Location

Related Publications (1)

  • Minary L, Martini H, Wirth N, Thouvenot F, Acouetey DS, Martinet Y, Bohadana A, Zmirou-Navier D, Alla F. TABADO: "evaluation of a smoking cessation program among adolescents in vocational training centers": study protocol. BMC Public Health. 2009 Nov 13;9:411. doi: 10.1186/1471-2458-9-411.

    PMID: 19912627BACKGROUND

MeSH Terms

Conditions

Tobacco UseTobacco Use Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • François ALLA, MD/ PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

February 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 28, 2025

Record last verified: 2009-09

Locations