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Preventive Medicine Study of Childhood Atopic Diseases

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by National Taiwan University Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00960596
First Posted: August 18, 2009
Last Update Posted: August 25, 2009
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.
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
  Purpose
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.

Condition Intervention
Healthy Behavioral: Health promotion and health education for smoking habits

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Preventive Medicine Study of Childhood Atopic Diseases

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • urine cotinine level [ Time Frame: six months, one year ]

Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Health promotion and health education for smoking habits
    We provide the education to intervention group.
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Only one smokers living in the same household
  • Having smoking exposure during the past 12 months while questionnaire surveying
  • Child without smoking habit

Exclusion Criteria:

  • None of above
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00960596


Locations
Taiwan
National Taiwan University
Taipei, Taiwan, 10020
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: YungLing Lee, Dr. Institute of Preventive Medicine, College of Public Health, National Taiwan University
  More Information

Responsible Party: YungLing Lee / Institute of Preventive Medicine, College of Public Health, National Taiwan University
ClinicalTrials.gov Identifier: NCT00960596     History of Changes
Other Study ID Numbers: 200902042R
First Submitted: August 16, 2009
First Posted: August 18, 2009
Last Update Posted: August 25, 2009
Last Verified: August 2009

Keywords provided by National Taiwan University Hospital:
educational intervention
asthma
Environmental Tobacco Smoke(ETS)
children