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.|
|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6000 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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|
|No Intervention: 1|
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
- exposure to environmental tobacco smoke [ Time Frame: 6 months ]
- smoking behaviour [ Time Frame: 6 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00647413
|Contact: Ulrich John, Prof. Dr.||+49383486 ext firstname.lastname@example.org|
|Contact: Jochen René Thyrian, PhD||+49383486 ext email@example.com|
|Institut für Epidemiologie und Sozialmedizin||Not yet recruiting|
|Greifswald, MV, Germany, 17489|
|Contact: Ulrich John, Prof. PhD +49383486 ext 7701 firstname.lastname@example.org|
|Contact: Jochen René Thyrian, PhD +49383486 ext 7715 email@example.com|
|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|