Effectiveness of Intervention on Reducing the Prevalence of Smoking Among Adolescents

Smoking Clinical Trial

— ITACA  

Official title:

Effectiveness of a Complex Intervention on Reducing the Prevalence of Smoking Among Adolescents: a Cluster Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602796
• Other study ID #: FI-01
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: September 2020

Study information

• Verified date: December 2018
• Source: Fundació d'investigació Sanitària de les Illes Balears
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2226
• Est. completion date: September 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

• Children at first of Secondary education.
• Adolescents and parents accept and sign informed consent

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Smoking

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.

Locations

Country	Name	City	State
Spain	IES Josep Miquel Guardia	Alaior	Baleares
Spain	IES Alcudia	Alcudia	Baleares
Spain	IES Baltasar Porcel	Andratx	Baleares
Spain	IES Llorenç Garcias i Font	Artà	Baleares
Spain	IES Son Ferrer	Calvia	Baleares
Spain	IES Capdepera	Capdepera	Baleares
Spain	IES Maria Angels Cardona	Ciudadela	Baleares
Spain	IES Josep Font i Trias	Esporles	Baleares
Spain	IES Biel Martí	Ferreries	Baleares
Spain	IES Pasqual Calbó i Caldes	Mao	Balears
Spain	IES Albuhaira	Muro	Baleare
Spain	IES La Ribera	Palma	Baleares
Spain	IES Guillem Cifre de Colonya	Pollença	Baleares
Spain	IES Porreres	Porreras	Baleares
Spain	IES Can Peu Blanc	Sa Pobla	Baleares
Spain	IES Santa Margalida	Santa Margarita	Baleares
Spain	IES Santanyi	Santanyi	Baleares
Spain	IES Sineu	Sineu	Baleares
Spain	IES Guillem Colom Casasnoves	Soller	Baleares
Spain	IES Puig de Sa Font	Son Servera	Baleares

Sponsors (2)

Lead Sponsor	Collaborator
Fundació d'investigació Sanitària de les Illes Balears	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking prevalence of adolescents in each group	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.	six years