Clinical trial NCT01602796: Effectiveness of Intervention on Reducing the Prevalence of Smoking Among Adolescents
Official title: Effectiveness of a Complex Intervention on Reducing the Prevalence of Smoking Among Adolescents: a Cluster Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Fundació d'investigació Sanitària de les Illes Balears
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Salud Carlos III
First posted: 2012-05-21
Enrollment: 2226
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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) .


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Smoking prevalence of adolescents in each group
timeFrame: six years
Secondary outcomes:
Other outcomes:
Locations:
city: Alaior
country: Spain
facility: IES Josep Miquel Guardia
state: Baleares
city: Alcudia
country: Spain
facility: IES Alcudia
state: Baleares
city: Andratx
country: Spain
facility: IES Baltasar Porcel
state: Baleares
city: Artà
country: Spain
facility: IES Llorenç Garcias i Font
state: Baleares
city: Calvia
country: Spain
facility: IES Son Ferrer
state: Baleares
city: Capdepera
country: Spain
facility: IES Capdepera
state: Baleares
city: Ciudadela
country: Spain
facility: IES Maria Angels Cardona
state: Baleares
city: Esporles
country: Spain
facility: IES Josep Font i Trias
state: Baleares
city: Ferreries
country: Spain
facility: IES Biel Martí
state: Baleares
city: Palma
country: Spain
facility: IES La Ribera
state: Baleares
city: Pollença
country: Spain
facility: IES Guillem Cifre de Colonya
state: Baleares
city: Porreras
country: Spain
facility: IES Porreres
state: Baleares
city: Sa Pobla
country: Spain
facility: IES Can Peu Blanc
state: Baleares
city: Santa Margarita
country: Spain
facility: IES Santa Margalida
state: Baleares
city: Santanyi
country: Spain
facility: IES Santanyi
state: Baleares
city: Sineu
country: Spain
facility: IES Sineu
state: Baleares
city: Soller
country: Spain
facility: IES Guillem Colom Casasnoves
state: Baleares
city: Son Servera
country: Spain
facility: IES Puig de Sa Font
state: Baleares
city: Muro
country: Spain
facility: IES Albuhaira
state: Baleare
city: Mao
country: Spain
facility: IES Pasqual Calbó i Caldes
state: Balears
Study officials:
References:
citation: 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.
citation: 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.