Prevent Exposure to Tobacco Smoke at Home [Gesunde Atemluft zu Hause]

Study Overview
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Brief Summary
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Background: Infants are at risk for tobacco-attributable diseases by being exposed to environmental tobacco smoke (ETS). International literature has shown that a home smoking ban can reduce ETS. The purpose of this study is to examine whether a brief feedback about urinary cotinine in infants and a counselling session about the consequences of ETS leads to a reduction of ETS. All families with children up to an age of three years in the study region will be contacted by mail and asked for participation in this study. They will be randomised into an intervention and one control group. The intervention group will receive a ETS counselling session and detailed analysis of urinary cotinine (a biomarker of ETS) at their home. They will further receive written feedback approx. 2 weeks later. The control group will be visited and will answer a questionnaire and will receive brochures about ETS. They will receive a standard analysis feedback of urinary cotinine. There will be oine further assessment/ visit 12 months later. The outcome of this study is an anlysis of urinary cotinine and smoking behaviour and changes in cotinine and smoking behaviour.

Official Title
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Cancer Prevention by Reducing Exposure to Environmental Tobacco Smoke at Home

Conditions
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Smoking, Passive Smoking, Exposure to Environmental Smoke

Intervention / Treatment
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* Behavioral: bio-chemical feedback and expert system intervention ETS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: born in 2005, 2006 or 2007, being exposed to environmental tobacco smoke at home by at least one parent, living in the study region of west pommerania Exclusion Criteria:

Ages Eligible for Study
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Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | |
| Experimental: 2<br>expert system intervention on smoking behaviour + feedback of a biomarker | Behavioral: bio-chemical feedback and expert system intervention ETS<br>* Urinary cotinien will be measured using urine collected from the infants diaper. It will be analysed and the result will be explained to the participant in a written letter approximately 2 weeks after the intervention. The intervention will also be a counselling session about the consequences of ETS to the infant. The counselling will be guided by the principles of motivational intervieweing and an expert system letter tailored to the data assessed will be send to the participants<br>* Other names: tailored feedback;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exposure to environmental tobacco smoke |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking behaviour |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, passive smoking, exposure to environmental smoke, home smoking ban, urinary cotinine