An Integrated Intervention to Reduce Secondhandsmoke in Children

Smoking Status Clinical Trial

— RESPIR·NET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881607
• Other study ID #: 040830
• Secondary ID: 64/04
• Status: Completed
• Phase: N/A
• First received: June 5, 2013
• Last updated: June 18, 2013
• Start date: May 2006
• Est. completion date: September 2008

Study information

• Verified date: June 2013
• Source: Institut Català d'Oncologia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical 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). 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1779
• Est. completion date: September 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 14 Years

Eligibility

Inclusion Criteria:

• all schoolchildren attending the school at the day of interview

Exclusion Criteria:

• absence of school

• language problems with questionnaire

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Secondhand Exposure
• Smoking Status

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Catalan Institute of Oncology	L'Hospitalet de Llobregat	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Institut Català d'Oncologia	Agència de Salut Pública de Barcelona, Fundació La Marató de TV3, Institut Municipal d'Investigació Mèdica

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Martín-Pujol A, Fernández E, Schiaffino A, Moncada A, Ariza C, Blanch C, Martínez-Sánchez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	1 year	No