HealthyNCT00960596
Preventive Medicine Study of Childhood Atopic Diseases
A study testing Health promotion and health education for smoking habits in people with Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Under environmental intervention programs, to explore the associations between Environmental Tobacco Smoke (ETS) and changes of pulmonary function, cytokines and new-onset asthma between different groups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Health promotion and health education for smoking habits
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2009to Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Only one smokers living in the same household
- Having smoking exposure during the past 12 months while questionnaire surveying
- Child without smoking habit
Who cannot join
- None of above
Trial locations and contacts
1 site in 1 country.
About this study
Under environmental intervention programs, to explore the associations between Environmental Tobacco Smoke (ETS) and changes of pulmonary function, cytokines and new-onset asthma between different groups.
Read the detailed description
Environmental intervention programs:
We will both interview by telephone and mail the health education leaflets, in order to achieve the following aims:
-Smokers living with the children will change where smoking takes place for reducing the children's ETS exposure.
Data collection:
We will contact participants individually to get informed consent before data collection. No matter what intervention, non-intervention or reference group, all participants will test as follows:
- Blood sample collection: We will test the total IgE, specific IgE, cytokines, such as IL-4, IL-13, TNF-α, ECP and EOS.
- Questionnaire collection
- Pulmonary function test
After intervention programs applied, all participants will test pulmonary function, and total IgE, specific IgE and cytokines by blood sample after six months by school approaches. Then, we can compare the pulmonary function, total IgE, specific IgE and cytokines before and after intervention programs.
- Conditions
- Healthy
- Being tested
- Health promotion and health education for smoking habits
- Keywords
- educational intervention, asthma, Environmental Tobacco Smoke(ETS), children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promotion and health education for smoking habitsBehavioural
We provide the education to intervention group.
What is being measured
The primary outcome is the main question the study is designed to answer.
urine cotinine level
Measured: six months, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- YungLing Lee, Dr., Principal investigator, Institute of Preventive Medicine, College of Public Health, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960596
- Sponsor's protocol ID
- 200902042R
- Status last verified
- Aug 2009
- First submitted
- 16 Aug 2009
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Medicine Study of Childhood Atopic Diseases
- ClinicalTrials.gov ID
- NCT00960596
- Acronym / sponsor ID
- 200902042R
- Conditions
- Healthy
- Keywords
- educational intervention, asthma, Environmental Tobacco Smoke(ETS), children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 18 Aug 2009 (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.
Under environmental intervention programs, to explore the associations between Environmental Tobacco Smoke (ETS) and changes of pulmonary function, cytokines and new-onset asthma between different groups.
Detailed description
Environmental intervention programs:
We will both interview by telephone and mail the health education leaflets, in order to achieve the following aims:
-Smokers living with the children will change where smoking takes place for reducing the children's ETS exposure.
Data collection:
We will contact participants individually to get informed consent before data collection. No matter what intervention, non-intervention or reference group, all participants will test as follows:
- Blood sample collection: We will test the total IgE, specific IgE, cytokines, such as IL-4, IL-13, TNF-α, ECP and EOS.
- Questionnaire collection
- Pulmonary function test
After intervention programs applied, all participants will test pulmonary function, and total IgE, specific IgE and cytokines by blood sample after six months by school approaches. Then, we can compare the pulmonary function, total IgE, specific IgE and cytokines before and after intervention programs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Only one smokers living in the same household
- Having smoking exposure during the past 12 months while questionnaire surveying
- Child without smoking habit
Key exclusion criteria (1 listed)
- None of above
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 |
|---|---|---|
| Health promotion and health education for smoking habitsWe provide the education to intervention group. | Behavioural | – |
Primary outcome
urine cotinine level
Time frame: six months, one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
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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.
YungLing Lee, Dr. principal investigator
Institute of Preventive Medicine, College of Public Health, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health promotion and health education for smoking habits in people with Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 1 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 25 Aug 2009. 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urine cotinine level (time frame: six months, one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2009.