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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00647413
Recruitment Status : Unknown
Verified March 2008 by University Medicine Greifswald.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2008
Last Update Posted : March 31, 2008
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:
University Medicine Greifswald

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Passive Smoking Exposure to Environmental Smoke Behavioral: bio-chemical feedback and expert system intervention ETS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cancer Prevention by Reducing Exposure to Environmental Tobacco Smoke at Home
Study Start Date : May 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
No Intervention: 1
Experimental: 2
expert system intervention on smoking behaviour + feedback of a biomarker
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

Other Names:
  • motivational interviewing
  • expert system intervention
  • tailored feedback

Primary Outcome Measures :
  1. exposure to environmental tobacco smoke [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. smoking behaviour [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00647413

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Contact: Ulrich John, Prof. Dr. +49383486 ext 7700
Contact: Jochen René Thyrian, PhD +49383486 ext 7715

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Institut für Epidemiologie und Sozialmedizin Not yet recruiting
Greifswald, MV, Germany, 17489
Contact: Ulrich John, Prof. PhD    +49383486 ext 7701   
Contact: Jochen René Thyrian, PhD    +49383486 ext 7715   
Sponsors and Collaborators
University Medicine Greifswald
Deutsche Krebshilfe e.V., Bonn (Germany)
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Study Director: Ulrich John, Prof. Dr. Institut für Epidemiologie und Sozialmedizin, University of Greifswald
Principal Investigator: Jochen René Thyrian, PhD Institut für Epidemiologie und Sozialmedizin

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Deutsche Krebshilfe e.V., Bonn (Germany), Dr. Kohlhuber Identifier: NCT00647413     History of Changes
Other Study ID Numbers: Krebshilfe-107539
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: March 31, 2008
Last Verified: March 2008

Keywords provided by University Medicine Greifswald:
passive smoking
exposure to environmental smoke
home smoking ban
urinary cotinine