Effectiveness of Intervention on Reducing the Prevalence of Smoking Among Adolescents

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Behavioral: School intervention

• Registration Number: NCT01602796
• Lead Sponsor: Fundació d'investigació Sanitària de les Illes Balears

Brief 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) .

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-05-18
• Study First Submitted QC: 2012-05-18
• Study First Posted: 2012-05-21
• Status Verified: 2018-12
• Primary Completion: 2019-09
• Study Completion: 2020-09
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2226

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
School-based intervention	School intervention	-

Primary Outcome Measures

Name	Time	Method
Smoking prevalence of adolescents in each group	six years	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.

Trial Locations

Locations (20)

IES Josep Miquel Guardia; 🇪🇸 Alaior, Baleares, Spain

IES Alcudia; 🇪🇸 Alcudia, 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 La Ribera; 🇪🇸 Palma, Baleares, Spain

IES Guillem Cifre de Colonya; 🇪🇸 Pollença, Baleares, Spain

IES Can Peu Blanc; 🇪🇸 Sa Pobla, Baleares, Spain

IES Porreres; 🇪🇸 Porreras, Baleares, Spain

IES Santa Margalida; 🇪🇸 Santa Margarita, Baleares, Spain

IES Santanyi; 🇪🇸 Santanyi, Baleares, Spain

IES Sineu; 🇪🇸 Sineu, Baleares, Spain

IES Albuhaira; 🇪🇸 Muro, Baleare, Spain

IES Baltasar Porcel; 🇪🇸 Andratx, Baleares, Spain

IES Biel Martí; 🇪🇸 Ferreries, Baleares, Spain

IES Guillem Colom Casasnoves; 🇪🇸 Soller, Baleares, Spain

IES Puig de Sa Font; 🇪🇸 Son Servera, Baleares, Spain

IES Pasqual Calbó i Caldes; 🇪🇸 Mao, Balears, Spain