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

NCT00647413 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2008-03-31

No results posted yet for this study

Summary

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.

Conditions

  • Smoking
  • Passive Smoking
  • Exposure to Environmental Smoke

Interventions

BEHAVIORAL

bio-chemical feedback and expert system intervention ETS

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

Sponsors & Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

    collaborator OTHER

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Ulrich John, Prof. Dr. · Institut für Epidemiologie und Sozialmedizin, University of Greifswald

  • Jochen René Thyrian, PhD · Institut für Epidemiologie und Sozialmedizin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-06-30
Completion
2010-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00647413 on ClinicalTrials.gov