Smoking in AdolescentsTAB_esNCT01048489
Evaluation of a Program to Reduce Smoking in High School Students
A study testing Health education in the high school in people with Smoking in Adolescents, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking in Adolescents
- What is being tested?
- Health education in the high school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,256 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2008to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students in high school
- Male and female
- Ages 12 to 16 years old
Who cannot join
- No Spanish speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Smoking in Adolescents
- Being tested
- Health education in the high school
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education in the high schoolBehavioural
(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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Other | Not described Receives: Behavioral: Health education in the high school |
| No counseling | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: January 2007 at June 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking in AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Institut Catala de Salut
- Investigators
- Empar Valdivieso, RN, MSN, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048489
- Sponsor's protocol ID
- PI070937
- Acronym
- TAB_es
- Status last verified
- Dec 2009
- First submitted
- 12 Jan 2010
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Community Integrated Program to Reduce Smoking Incidence in High School Students
- ClinicalTrials.gov ID
- NCT01048489
- Acronym / sponsor ID
- TAB_es / PI070937
- Conditions
- Smoking in Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,256 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Institut Catala de Salut
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2010 (estimated)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Other | Behavioral: Health education in the high school |
| No counseling | No intervention | – |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Students in high school
- Male and female
- Ages 12 to 16 years old
Key exclusion criteria (1 listed)
- No Spanish speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education in the high school(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. | Behavioural | Lifestyle counseling |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- BackgroundValdivieso 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Empar Valdivieso, RN, MSN principal investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education in the high school in people with Smoking in Adolescents, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01048489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010.