Effectiveness of Intervention on Reducing the Prevalence of Smoking Among Adolescents (ITACA)
This study is currently recruiting participants.
Verified May 2012 by Fundació d'investigació Sanitària de les Illes Balears
Sponsor:
Fundació d'investigació Sanitària de les Illes Balears
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Fundació d'investigació Sanitària de les Illes Balears
ClinicalTrials.gov Identifier:
NCT01602796
First received: May 18, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
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Purpose
In this multicenter cluster randomized controlled trial stratified by school baseline prevalence of smoking will be randomly allocated to the control or intervention group. Control schools will receive normal smoking education and intrvention schools will receive a four year class-based curriculum intervention (22 Classroom lessons), reinforcement of smoke-free school policy, smoking cessation in parents, pupils, and teachers and information and annual meeting with parents.
Study participants will be children aged 12 to 15 years old ; they will be followed to 2 years after high school. External evaluator and analyst will be blinded to school allocation.
The aim of this study is to analyze the effectiveness of a complex intervention to reduce the prevalence of smoking at 3º ESO (14-15 yrs-old) and 2 years after high school (17-18 yrs-old) .
| Condition | Intervention |
|---|---|
|
Smoking |
Behavioral: School intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effectiveness of a Complex Intervention on Reducing the Prevalence of Smoking Among Adolescents: a Cluster Randomized Control Trial |
Resource links provided by NLM:
Further study details as provided by Fundació d'investigació Sanitària de les Illes Balears:
Primary Outcome Measures:
- Smoking prevalence of adolescents in each group [ Time Frame: six years ] [ Designated as safety issue: No ]We will compare the smoking prevalence of adolescents in each group at six years against the usual null hypothesis of no difference between groups. We will use the Chi-squared test, taking into account the "variance inflation factor" of the adolescent cluster and intraclass correlation coefficient.
| Estimated Enrollment: | 2226 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: School-based intervention |
Behavioral: School intervention
The ITACA intervention is a cognitive and social-influences approach to prevent tobacco consumption. The intervention is integrated in the curricula of the school, also schools are reinforced to follow a smoke-free school and strictly follow legislation about smoking in schools. The community component include annual meeting with adolescents parents and parents and teachers intensive group for smoking cessation.
|
| No Intervention: Control |
Eligibility| Ages Eligible for Study: | 11 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Children at first of Secondary education.
- Adolescents and parents accept and sign informed consent
Exclusion Criteria:
- None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602796
Contacts
| Contact: Aina M Yañez, phD | 656612192 | aina.yanez@caubet-cimera.es |
Locations
| Spain | |
| IES Josep Miquel Guardia | Recruiting |
| Alaior, Baleares, Spain, 07340 | |
| IES Alcudia | Recruiting |
| Alcudia, Baleares, Spain, 07410 | |
| IES Baltasar Porcel | Recruiting |
| Andraxt, Baleares, Spain, 07150 | |
| IES Llorenç Garcias i Font | Recruiting |
| Artà, Baleares, Spain, 07057 | |
| IES Son Ferrer | Recruiting |
| Calvia, Baleares, Spain, 07181 | |
| IES Capdepera | Recruiting |
| Capdepera, Baleares, Spain, 07580 | |
| IES Maria Angels Cardona | Recruiting |
| Ciudadela, Baleares, Spain, 07760 | |
| IES Josep Font i Trias | Recruiting |
| Esporlas, Baleares, Spain, 07190 | |
| IES Biel Martí | Recruiting |
| Ferreries, Baleares, Spain, 07200 | |
| IES La Ribera | Recruiting |
| Palma, Baleares, Spain, 07610 | |
| IES Porreres | Recruiting |
| Porreras, Baleares, Spain, 07260 | |
| IES Can Peu Blanc | Recruiting |
| Sa Pobla, Baleares, Spain, 07420 | |
| IES Santa Margalida | Recruiting |
| Santa Margarita, Baleares, Spain, 07450 | |
| IES Santanyi | Recruiting |
| Santanyi, Baleares, Spain, 07469 | |
| IES Sineu | Recruiting |
| Sineu, Baleares, Spain, 07510 | |
| IES Guillem Colom Casasnoves | Recruiting |
| Soller, Baleares, Spain, 07470 | |
| IES Puig de Sa Font | Recruiting |
| Son Servera, Baleares, Spain, 07550 | |
| IES Albuhaira | Recruiting |
| Muro, Baleare, Spain, 07440 | |
| IES Pasqual Calbó i Caldes | Recruiting |
| Mao, Balears, Spain, 07703 | |
| IES Guillem Cifre de Colonya | Recruiting |
| Baleares, Spain, 07460 | |
Sponsors and Collaborators
Fundació d'investigació Sanitària de les Illes Balears
Instituto de Salud Carlos III
More Information
No publications provided
| Responsible Party: | Fundació d'investigació Sanitària de les Illes Balears |
| ClinicalTrials.gov Identifier: | NCT01602796 History of Changes |
| Other Study ID Numbers: | FI-01 |
| Study First Received: | May 18, 2012 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Spain: Ministry of Health |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 21, 2013