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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by University Medicine Greifswald.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00647413
First received: March 26, 2008
Last updated: March 28, 2008
Last verified: March 2008

March 26, 2008
March 28, 2008
May 2008
June 2010   (final data collection date for primary outcome measure)
exposure to environmental tobacco smoke [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00647413 on ClinicalTrials.gov Archive Site
smoking behaviour [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prevent Exposure to Tobacco Smoke at Home [Gesunde Atemluft zu Hause]
Cancer Prevention by Reducing Exposure to Environmental Tobacco Smoke at Home

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Smoking
  • Passive Smoking
  • Exposure to Environmental Smoke
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
  • No Intervention: 1
  • Experimental: 2
    expert system intervention on smoking behaviour + feedback of a biomarker
    Intervention: Behavioral: bio-chemical feedback and expert system intervention ETS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
6000
December 2010
June 2010   (final data collection date for primary outcome measure)

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:

Both
up to 3 Years
Yes
Contact: Ulrich John, Prof. Dr. +49383486 ext 7700 ujohn@uni-greifswald.de
Contact: Jochen René Thyrian, PhD +49383486 ext 7715 thyrian@uni-greifswald.de
Germany
 
NCT00647413
Krebshilfe-107539, DM8-IESO02
No
Deutsche Krebshilfe e.V., Bonn (Germany), Dr. Kohlhuber
University Medicine Greifswald
Deutsche Krebshilfe e.V., Bonn (Germany)
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
University Medicine Greifswald
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP