NCT01602796

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) .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2012

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 10, 2021

Status Verified

December 1, 2018

Enrollment Period

8 years

First QC Date

May 18, 2012

Last Update Submit

March 9, 2021

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

School-based intervention

EXPERIMENTAL
Behavioral: School intervention

Control

NO INTERVENTION

Interventions

School interventionBEHAVIORAL

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.

School-based intervention

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

IES Albuhaira

Muro, Baleare, 07440, Spain

Location

IES Josep Miquel Guardia

Alaior, Balearic Islands, 07340, Spain

Location

IES Alcudia

Alcúdia, Balearic Islands, 07410, Spain

Location

IES Baltasar Porcel

Andratx, Balearic Islands, 07150, Spain

Location

IES Llorenç Garcias i Font

Artà, Balearic Islands, 07057, Spain

Location

IES Son Ferrer

Calvià, Balearic Islands, 07181, Spain

Location

IES Capdepera

Capdepera, Balearic Islands, 07580, Spain

Location

IES Maria Angels Cardona

Ciutadella, Balearic Islands, 07760, Spain

Location

IES Josep Font i Trias

Esporles, Balearic Islands, 07190, Spain

Location

IES Biel Martí

Ferreries, Balearic Islands, 07200, Spain

Location

IES Pasqual Calbó i Caldes

Maó, Balearic Islands, 07703, Spain

Location

IES La Ribera

Palma, Balearic Islands, 07610, Spain

Location

IES Guillem Cifre de Colonya

Pollença, Balearic Islands, 07460, Spain

Location

IES Porreres

Porreres, Balearic Islands, 07260, Spain

Location

IES Can Peu Blanc

sa Pobla, Balearic Islands, 07420, Spain

Location

IES Santa Margalida

Santa Margalida, Balearic Islands, 07450, Spain

Location

IES Santanyi

Santanyí, Balearic Islands, 07469, Spain

Location

IES Sineu

Sineu, Balearic Islands, 07510, Spain

Location

IES Guillem Colom Casasnoves

Soller, Balearic Islands, 07470, Spain

Location

IES Puig de Sa Font

Son Servera, Balearic Islands, 07550, Spain

Location

Related Publications (2)

  • 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.

    PMID: 29940292DERIVED

  • 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.

    PMID: 24739452DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2012

First Posted

May 21, 2012

Study Start

September 1, 2011

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

March 10, 2021

Record last verified: 2018-12

Locations

ES(20)