NCT01881607

Brief 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). 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,779

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

May 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

1.6 years

First QC Date

June 5, 2013

Last Update Submit

June 18, 2013

Conditions

Keywords

tobacco smoke pollutionTobacco use

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • Prevalence of current smokers

    1 year

Study Arms (2)

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.

Behavioral: RESPIRNET Program

Interventions

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

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • all schoolchildren attending the school at the day of interview

You may not qualify if:

  • absence of school
  • language problems with questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catalan Institute of Oncology

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Related Publications (2)

  • 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.

    PMID: 23581609BACKGROUND
  • 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.

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Design

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

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 19, 2013

Study Start

May 1, 2006

Primary Completion

December 1, 2007

Study Completion

September 1, 2008

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations