Secondhand ExposureRESPIR·NETNCT01881607
An Integrated Intervention to Reduce Secondhandsmoke in Children
A study testing RESPIRNET Program in people with Secondhand Exposure and Smoking Status, run by Institut Català d'Oncologia at 1 site in Spain.
Trial summary
This is a community essay to assess the effectiveness of a multi-level (individual, family, and school) school-based intervention to prevent the exposure to secondhand smoke (SHS) in a population of 1,734 schoolchildren (12-14 years old) in Terrassa (Catalonia, Spain). Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Secondhand Exposure, Smoking Status
- What is being tested?
- RESPIRNET Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,779 participants
- Where
- 1 siteSpain
- Study dates
- May 2006to Sep 2008
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- all schoolchildren attending the school at the day of interview
Who cannot join
- absence of school
- language problems with questionnaire
Trial locations and contacts
1 site in 1 country.
Spain1 site
Catalan Institute of Oncology
L'Hospitalet de Llobregat, Barcelona, 08908
About this study
Official title: Respiratory Symptoms, Asthma and Passive Smoking in Children: Effectiveness of an Integrated Individual, Family, and School-based Intervention
This is a community essay to assess the effectiveness of a multi-level (individual, family, and school) school-based intervention to prevent the exposure to secondhand smoke (SHS) in a population of 1,734 schoolchildren (12-14 years old) in Terrassa (Catalonia, Spain). Schools were assigned to the intervention or the controlgroup at random. The investigators assessed SHS exposure in different settings (at school, at home, on transportation and leisure time) and tobacco consumption by means of a questionnaire before and one year after the intervention. Based on a previously evaluated intervention to prevent smoking initiation (PASE/ESFA program) the investigators designed a new intervention (the RESPIR•NET Program) including two new activities to prevent passive smoking to be applied at three levels: in the classroom (pupils), at the school (pupils, teachers, and parents), and in the family (pupils and parents).
- Conditions
- Secondhand Exposure, Smoking Status
- Being tested
- RESPIRNET Program
- Keywords
- tobacco smoke pollution, Tobacco use
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPIRNET ProgramBehavioural
The intervention at the classroom consisted of six sessions with the pupils of one hour each that were conducted by the teacher/tutor. We provided the teachers with a training session and a teachers' guide, and we gave each pupil a workbook with the activities. At the school level, the intervention consisted of four types of posters with specific messages directed to students, teachers, and parents, and the fourth poster type advertised the new smoking laws. we gave teachers and school managers the guide "Towards a Smoke-Free School" to facilitate the prevention and control of smoking (active and passive) in the school environment. Family level activities: Parents were required to complete the "My risk thermometer" activity at home with their children. Parents received a brochure with information on the risks of SHS exposure and recommendations to prevent SHS exposure, and a refrigerator magnet with the logo of the program.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Schoolchildren aged 12-13 years in the first year of Compulsory Secondary Education (Enseñanza Secundaria Obligatoria in the Spanish educational system) in the city of Terrassa. The CONTROL arm is formed by schoolchildren in schools that willnot receive the intervention and will continue with ongoing (usual) health education sessions. |
| Intervention | Experimental | The intervention at the classroom consisted of six sessions with the pupils of one hour each that were conducted by the teacher/tutor. We provided the teachers with a training session and a teachers' guide, and we gave each pupil a workbook with the activities. At the school level, the intervention consisted of four types of posters with specific messages directed to students, teachers, and parents, and the fourth poster type advertised the new smoking laws. we gave teachers and school managers the guide "Towards a Smoke-Free School" to facilitate the prevention and control of smoking (active and passive) in the school environment. Family level activities: Parents were required to complete the "My risk thermometer" activity at home with their children. Parents received a brochure with information on the risks of SHS exposure and recommendations to prevent SHS exposure, and a refrigerator magnet with the logo of the program. Receives: Behavioral: RESPIRNET Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of exposure to secondhand smoke
The prevalence of exposure to secondhand smoke is computed by dividing the number of children exposed / total number of children. Exposure to secondhand smoke is obtained using a questionnaire at baseline and one year later. The questionnaire was prepared from previously validated questionnaires on SHS.
Measured: 1 year
Secondary outcomes (1)
Prevalence of current smokers
The prevalence of smoking is computed by dividing the number of smoking children / total number of children. Smoker status is obtained using a questionnaire at baseline and one year later. The questionnaire has been previously validated in other investigations.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startMay 2006
- Primary completionDec 2007
- Study completionSep 2008
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 Secondhand ExposureStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Barcelona, Institut Municipal d'Investigació Mèdica, Fundació La Marató de TV3
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881607
- Sponsor's protocol ID
- 040830
- Other IDs
- 64/04
- Acronym
- RESPIR·NET
- Status last verified
- Jun 2013
- First submitted
- 5 Jun 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Martin-Pujol A, Fernandez E, Schiaffino A, Moncada A, Ariza C, Blanch C, Martinez-Sanchez JM; RESPIR.NET research group. Tobacco smoking, exposure to second-hand smoke, and asthma and wheezing in schoolchildren: a cross-sectional study. Acta Paediatr. 2013 Jul;102(7):e305-9. doi: 10.1111/apa.12232. Epub 2013 Apr 16.
PubMed 23581609Blanch C, Fernandez E, Martinez-Sanchez JM, Ariza C, Lopez MJ, Moncada A, Schiaffino A, Rajmil L, Salto E, Pascual JA, Nebot M; RESPIR.NET research group. Impact of a multi-level intervention to prevent secondhand smoke exposure in schoolchildren: a randomized cluster community trial. Prev Med. 2013 Nov;57(5):585-90. doi: 10.1016/j.ypmed.2013.07.018. Epub 2013 Aug 7.
PubMed 23933268
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Symptoms, Asthma and Passive Smoking in Children: Effectiveness of an Integrated Individual, Family, and School-based Intervention
- ClinicalTrials.gov ID
- NCT01881607
- Acronym / sponsor ID
- RESPIR·NET / 040830
- Conditions
- Secondhand Exposure, Smoking Status
- Keywords
- tobacco smoke pollution, Tobacco use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,779 participants (actual)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Collaborators
- Public Health Agency of Barcelona, Institut Municipal d'Investigació Mèdica, Fundació La Marató de TV3
- Study start
- May 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 19 Jun 2013 (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.
This is a community essay to assess the effectiveness of a multi-level (individual, family, and school) school-based intervention to prevent the exposure to secondhand smoke (SHS) in a population of 1,734 schoolchildren (12-14 years old) in Terrassa (Catalonia, Spain). Schools were assigned to the intervention or the controlgroup at random. The investigators assessed SHS exposure in different settings (at school, at home, on transportation and leisure time) and tobacco consumption by means of a questionnaire before and one year after the intervention. Based on a previously evaluated intervention to prevent smoking initiation (PASE/ESFA program) the investigators designed a new intervention (the RESPIR•NET Program) including two new activities to prevent passive smoking to be applied at three levels: in the classroom (pupils), at the school (pupils, teachers, and parents), and in the family (pupils and parents).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Schoolchildren aged 12-13 years in the first year of Compulsory Secondary Education (Enseñanza Secundaria Obligatoria in the Spanish educational system) in the city of Terrassa. The CONTROL arm is formed by schoolchildren in schools that willnot receive the intervention and will continue with ongoing (usual) health education sessions. |
| Intervention | Experimental | Behavioral: RESPIRNET ProgramThe intervention at the classroom consisted of six sessions with the pupils of one hour each that were conducted by the teacher/tutor. We provided the teachers with a training session and a teachers' guide, and we gave each pupil a workbook with the activities. At the school level, the intervention consisted of four types of posters with specific messages directed to students, teachers, and parents, and the fourth poster type advertised the new smoking laws. we gave teachers and school managers the guide "Towards a Smoke-Free School" to facilitate the prevention and control of smoking (active and passive) in the school environment. Family level activities: Parents were required to complete the "My risk thermometer" activity at home with their children. Parents received a brochure with information on the risks of SHS exposure and recommendations to prevent SHS exposure, and a refrigerator magnet with the logo of the program. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all schoolchildren attending the school at the day of interview
Key exclusion criteria (2 listed)
- absence of school
- language problems with questionnaire
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 |
|---|---|---|
| RESPIRNET ProgramThe intervention at the classroom consisted of six sessions with the pupils of one hour each that were conducted by the teacher/tutor. We provided the teachers with a training session and a teachers' guide, and we gave each pupil a workbook with the activities. At the school level, the intervention consisted of four types of posters with specific messages directed to students, teachers, and parents, and the fourth poster type advertised the new smoking laws. we gave teachers and school managers the guide "Towards a Smoke-Free School" to facilitate the prevention and control of smoking (active and passive) in the school environment. Family level activities: Parents were required to complete the "My risk thermometer" activity at home with their children. Parents received a brochure with information on the risks of SHS exposure and recommendations to prevent SHS exposure, and a refrigerator magnet with the logo of the program. | Behavioural | Intervention |
Primary outcome
Prevalence of exposure to secondhand smoke
Time frame: 1 year
The prevalence of exposure to secondhand smoke is computed by dividing the number of children exposed / total number of children. Exposure to secondhand smoke is obtained using a questionnaire at baseline and one year later. The questionnaire was prepared from previously validated questionnaires on SHS.
1 secondary outcome
Prevalence of current smokers
Time frame: 1 year
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 19 Jun 2013.
- Background: PubMed 23581609Martin-Pujol A, Fernandez E, Schiaffino A, Moncada A, Ariza C, Blanch C, Martinez-Sanchez JM; RESPIR.NET research group. Tobacco smoking, exposure to second-hand smoke, and asthma and wheezing in schoolchildren: a cross-sectional study. Acta Paediatr. 2013 Jul;102(7):e305-9. doi: 10.1111/apa.12232. Epub 2013 Apr 16.
- Derived from this study: PubMed 23933268Blanch C, Fernandez E, Martinez-Sanchez JM, Ariza C, Lopez MJ, Moncada A, Schiaffino A, Rajmil L, Salto E, Pascual JA, Nebot M; RESPIR.NET research group. Impact of a multi-level intervention to prevent secondhand smoke exposure in schoolchildren: a randomized cluster community trial. Prev Med. 2013 Nov;57(5):585-90. doi: 10.1016/j.ypmed.2013.07.018. Epub 2013 Aug 7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESPIRNET Program in people with Secondhand Exposure and Smoking Status, run by Institut Català d'Oncologia at 1 site 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 1 inclusion and 2 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 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Prevalence of exposure to secondhand smoke (time frame: 1 year). 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 NCT01881607, 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 19 Jun 2013.