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Completed

NCT Number: NCT01881607

An Integrated Intervention to Reduce Secondhandsmoke in Children

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).

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Key information

Age range

12 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catalan Institute of Oncology

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all schoolchildren attending the school at the day of interview

Exclusion criteria

  • absence of school
  • language problems with questionnaire

Treatment and study plan

RESPIRNET Program

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Prevalence of current smokers

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Institut Català d'Oncologia

Other

Collaborators

  • Fundació La Marató de TV3
  • Institut Municipal d'Investigació Mèdica
  • Public Health Agency of Barcelona

Registry information

Official study title

Respiratory Symptoms, Asthma and Passive Smoking in Children: Effectiveness of an Integrated Individual, Family, and School-based Intervention

Acronym: RESPIR·NET

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jun 19, 2013
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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