SmokingITACANCT01602796
Effectiveness of Intervention on Reducing the Prevalence of Smoking Among Adolescents
A study testing School intervention in people with Smoking, run by Fundació d'investigació Sanitària de les Illes Balears at 20 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Smoking
- What is being tested?
- School intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,226 participants
- Where
- 20 sitesSpain
- Study dates
- Sep 2011to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children at first of Secondary education.
- Adolescents and parents accept and sign informed consent
Who cannot join
- None
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
IES Josep Miquel Guardia
Alaior, Balearic Islands, 07340
IES Alcudia
Alcúdia, Balearic Islands, 07410
IES Baltasar Porcel
Andratx, Balearic Islands, 07150
IES Llorenç Garcias i Font
Artà, Balearic Islands, 07057
IES Son Ferrer
Calvià, Balearic Islands, 07181
IES Capdepera
Capdepera, Balearic Islands, 07580
IES Maria Angels Cardona
Ciutadella, Balearic Islands, 07760
IES Josep Font i Trias
Esporles, Balearic Islands, 07190
IES Biel Martí
Ferreries, Balearic Islands, 07200
IES Pasqual Calbó i Caldes
Maó, Balearic Islands, 07703
IES Albuhaira
Muro, Baleare, 07440
IES La Ribera
Palma, Balearic Islands, 07610
IES Guillem Cifre de Colonya
Pollença, Balearic Islands, 07460
IES Porreres
Porreres, Balearic Islands, 07260
IES Can Peu Blanc
sa Pobla, Balearic Islands, 07420
IES Santa Margalida
Santa Margalida, Balearic Islands, 07450
IES Santanyi
Santanyí, Balearic Islands, 07469
IES Sineu
Sineu, Balearic Islands, 07510
IES Guillem Colom Casasnoves
Soller, Balearic Islands, 07470
IES Puig de Sa Font
Son Servera, Balearic Islands, 07550
About this study
Official title: Effectiveness of a Complex Intervention on Reducing the Prevalence of Smoking Among Adolescents: a Cluster Randomized Control Trial
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) .
- Conditions
- Smoking
- Being tested
- School intervention
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| School-based intervention | Experimental | Not described Receives: Behavioral: School intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2019
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602796
- Sponsor's protocol ID
- FI-01
- Acronym
- ITACA
- Status last verified
- Dec 2018
- First submitted
- 18 May 2012
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29940292Leiva 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.
PubMed 24739452
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Complex Intervention on Reducing the Prevalence of Smoking Among Adolescents: a Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01602796
- Acronym / sponsor ID
- ITACA / FI-01
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,226 participants (actual)
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes BalearsOther government
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Sep 2011
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 21 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School-based intervention | Experimental | Behavioral: School intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children at first of Secondary education.
- Adolescents and parents accept and sign informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School interventionThe 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. | Behavioural | School-based intervention |
Primary outcome
Smoking prevalence of adolescents in each group
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 29940292Leiva 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.
- Derived from this study: PubMed 24739452Leiva 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School intervention in people with Smoking, run by Fundació d'investigació Sanitària de les Illes Balears at 20 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking prevalence of adolescents in each group (time frame: six years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01602796, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.