Effectiveness of Intervention on Reducing the Prevalence of Smoking Among Adolescents

NCT ID: NCT01602796

Last Updated: 2021-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2020-09-30

Brief Summary

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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

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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School-based intervention

Group Type EXPERIMENTAL

School intervention

Intervention Type BEHAVIORAL

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Fundació d'investigació Sanitària de les Illes Balears

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IES Albuhaira

Muro, Baleare, Spain

Site Status

IES Josep Miquel Guardia

Alaior, Balearic Islands, Spain

Site Status

IES Alcudia

Alcúdia, Balearic Islands, Spain

Site Status

IES Baltasar Porcel

Andratx, Balearic Islands, Spain

Site Status

IES Llorenç Garcias i Font

Artà, Balearic Islands, Spain

Site Status

IES Son Ferrer

Calvià, Balearic Islands, Spain

Site Status

IES Capdepera

Capdepera, Balearic Islands, Spain

Site Status

IES Maria Angels Cardona

Ciutadella, Balearic Islands, Spain

Site Status

IES Josep Font i Trias

Esporles, Balearic Islands, Spain

Site Status

IES Biel Martí

Ferreries, Balearic Islands, Spain

Site Status

IES Pasqual Calbó i Caldes

Mahon, Balearic Islands, Spain

Site Status

IES La Ribera

Palma, Balearic Islands, Spain

Site Status

IES Guillem Cifre de Colonya

Pollença, Balearic Islands, Spain

Site Status

IES Porreres

Porreres, Balearic Islands, Spain

Site Status

IES Can Peu Blanc

sa Pobla, Balearic Islands, Spain

Site Status

IES Santa Margalida

Santa Margalida, Balearic Islands, Spain

Site Status

IES Santanyi

Santanyí, Balearic Islands, Spain

Site Status

IES Sineu

Sineu, Balearic Islands, Spain

Site Status

IES Guillem Colom Casasnoves

Soller, Balearic Islands, Spain

Site Status

IES Puig de Sa Font

Son Servera, Balearic Islands, Spain

Site Status

Countries

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Spain

References

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Leiva A, Estela A, Bennasar-Veny M, Aguilo A, Llobera J, Yanez AM. Effectiveness of a complex intervention on smoking in adolescents: A cluster-randomized controlled trial. Prev Med. 2018 Sep;114:88-94. doi: 10.1016/j.ypmed.2018.06.009. Epub 2018 Jun 22.

Reference Type DERIVED
PMID: 29940292 (View on PubMed)

Leiva A, Estela A, Torrent M, Calafat A, Bennasar M, Yanez A. Effectiveness of a complex intervention in reducing the prevalence of smoking among adolescents: study design of a cluster-randomized controlled trial. BMC Public Health. 2014 Apr 16;14:373. doi: 10.1186/1471-2458-14-373.

Reference Type DERIVED
PMID: 24739452 (View on PubMed)

Other Identifiers

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FI-01

Identifier Type: -

Identifier Source: org_study_id

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