SmokingGESANCT00647413
Prevent Exposure to Tobacco Smoke at Home [Gesunde Atemluft zu Hause]
A study testing bio-chemical feedback and expert system intervention ETS in people with Smoking and Passive Smoking, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Passive Smoking, Exposure to Environmental Smoke
- What is being tested?
- bio-chemical feedback and expert system intervention ETS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Epidemiologie und Sozialmedizin
Greifswald, Mecklenburg-Vorpommern, 17489
Ulrich John, Prof. PhD, +49383486 ext. 7701, ujohn@uni-greifswald.de
Jochen René Thyrian, PhD, +49383486 ext. 7715, thyrian@uni-greifswald.de
About this study
Official title: 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.
- Conditions
- Smoking, Passive Smoking, Exposure to Environmental Smoke
- Being tested
- bio-chemical feedback and expert system intervention ETS
- Keywords
- smoking, passive smoking, exposure to environmental smoke, home smoking ban, urinary cotinine
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bio-chemical feedback and expert system intervention ETSBehavioural
Also called motivational interviewing, expert system intervention, tailored feedback
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | expert system intervention on smoking behaviour + feedback of a biomarker Receives: Behavioral: bio-chemical feedback and expert system intervention ETS |
What is being measured
The primary outcome is the main question the study is designed to answer.
exposure to environmental tobacco smoke
Measured: 6 months
Secondary outcomes (1)
smoking behaviour
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Investigators
- Ulrich John, Prof. Dr., Study director, Institut für Epidemiologie und Sozialmedizin, University of GreifswaldJochen René Thyrian, PhD, Principal investigator, Institut für Epidemiologie und Sozialmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647413
- Sponsor's protocol ID
- Krebshilfe-107539
- Other IDs
- DM8-IESO02
- Acronym
- GESA
- Status last verified
- Mar 2008
- First submitted
- 26 Mar 2008
- Last updated
- 31 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Ulbricht S, Gross S, Meyer C, Hannover W, Nauck M, John U. Reducing tobacco smoke exposure in children aged below 4 years - a randomized controlled trial. Prev Med. 2014 Dec;69:208-13. doi: 10.1016/j.ypmed.2014.10.016. Epub 2014 Oct 18.
PubMed 25456808
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Prevention by Reducing Exposure to Environmental Tobacco Smoke at Home
- ClinicalTrials.gov ID
- NCT00647413
- Acronym / sponsor ID
- GESA / Krebshilfe-107539
- Conditions
- Smoking, Passive Smoking, Exposure to Environmental Smoke
- Keywords
- smoking, passive smoking, exposure to environmental smoke, home smoking ban, urinary cotinine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Study start
- May 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 31 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Behavioral: bio-chemical feedback and expert system intervention ETSexpert system intervention on smoking behaviour + feedback of a biomarker |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bio-chemical feedback and expert system intervention ETSAlso: motivational interviewing, expert system intervention, tailored feedbackUrinary 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 | Behavioural | 2 |
Primary outcome
exposure to environmental tobacco smoke
Time frame: 6 months
1 secondary outcome
smoking behaviour
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2008.
- Derived from this study: PubMed 25456808Ulbricht S, Gross S, Meyer C, Hannover W, Nauck M, John U. Reducing tobacco smoke exposure in children aged below 4 years - a randomized controlled trial. Prev Med. 2014 Dec;69:208-13. doi: 10.1016/j.ypmed.2014.10.016. Epub 2014 Oct 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich John, Prof. Dr. study director
Institut für Epidemiologie und Sozialmedizin, University of Greifswald
Jochen René Thyrian, PhD principal investigator
Institut für Epidemiologie und Sozialmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bio-chemical feedback and expert system intervention ETS in people with Smoking and Passive Smoking, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrich John, Prof. Dr. (+49383486 ext. 7700, ujohn@uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exposure to environmental tobacco smoke (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00647413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2008.