An Integrated Intervention to Reduce Secondhandsmoke in Children

NCT ID: NCT01881607

Last Updated: 2013-06-19

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

1779 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Secondhand Exposure Smoking Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type EXPERIMENTAL

RESPIRNET Program

Intervention Type BEHAVIORAL

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.

Interventions

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RESPIRNET Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* all schoolchildren attending the school at the day of interview

Exclusion Criteria

* absence of school
* language problems with questionnaire
Minimum Eligible Age

12 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Public Health Agency of Barcelona

OTHER

Sponsor Role collaborator

Institut Municipal d'Investigació Mèdica

UNKNOWN

Sponsor Role collaborator

Fundació La Marató de TV3

OTHER

Sponsor Role collaborator

Institut Català d'Oncologia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Catalan Institute of Oncology

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 23581609 (View on PubMed)

Blanch 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.

Reference Type DERIVED
PMID: 23933268 (View on PubMed)

Other Identifiers

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64/04

Identifier Type: OTHER

Identifier Source: secondary_id

040830

Identifier Type: -

Identifier Source: org_study_id

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