- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01048489
Evaluation of a Program to Reduce Smoking in High School Students (TAB_es)
Effectiveness of a Community Integrated Program to Reduce Smoking Incidence in High School Students
Effectiveness of health education regarding the smoking habit is under discussion . Nevertheless, according to the literature, some personal, familiar, cultural, and social factors are considered risk factors for students to become smokers. Probably, a health education intervention integrated in the school program will show a higher rate of effectiveness regarding incidence and prevalence of smoking habit in this age-group .
OBJECTIVE: To evaluate the effectiveness of a health education program to reduce the smoking habit in students.
METHODOLOGY: Quasi-experimental design including all the junior high school students in an educational district in Tarragona (Spain). The sampled schools will be randomised into two groups (experimental and control). All the included students will be monitored for three years.
The health education program will be divided in three interventions: role games and debates (1st year), workshops regarding the family and the social role of smoking (2nd year) , and the analysis of smoking advertising (3rd year). The incidence and prevalence rates will be compared on the experimental and control group, before de beginning of the intervention and at the beginning of each year.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Tarragona, Spain, 43001
- Institut Català de la Salut
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Students in high school
- Male and female
- Ages 12 to 16 years old
Exclusion Criteria:
- No Spanish speakers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Lifestyle counseling
|
(12- 13 years old): 1.Questionnaire and measuring of carbon monoxide in air. 2.Role Games.3.Build a machine that simulates a cigarette. (13-14 years old):1.Questionnaire and measuring of carbon monoxide in air.2. Workshop dealing with current television series broadcast in Spain in which tobacco is constantly present.3.Workshop dedicated to make young people and their families stop smoking.A competition is performed between all the schools in order to reward the bookmark with the best motto asking any close person to stop smoking or thanking them for having quit. (14-15 years old):1.Questionnaire and measuring of carbon monoxide in air. 2. Workshop to go into depth about tobacco effects,by searching in the internet, aiming for the creation of an anti-tobacco pressure group in social networks such like Facebook.3.Workshop to create an advertising campaign to encourage non-consumption by mobile messages,use of internet..coinciding with the international day without tobacco. |
No Intervention: No counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence and incidence of smoking is measured annually at the beginning and end of each school year by the use of a validated questionnaire and by the monitoring of carbon monoxide in expired air
Time Frame: January 2007 at June 2010
|
January 2007 at June 2010
|
Collaborators and Investigators
Investigators
- Principal Investigator: Empar Valdivieso, RN, MSN, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Publications and helpful links
General Publications
- Valdivieso López A, Ledo Garcia J, Barrera Uriarte M, Rivera Bosch G, Fuentes Bellido CM. Muniain Diaz de Cerio MP. Efectividad de un programa comunitario integrado en la escuela para reducir la incidencia de tabaquismo entre los escolares de ESO. Nure Investigación 2005;14. available at: http://www.fuden.es/proyectos_detalle.cfm?ID_INV_NURE=37&FilaInicio=21
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PI070937
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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