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Preventive Medicine Study of Childhood Atopic Diseases

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00960596
First received: August 16, 2009
Last updated: August 24, 2009
Last verified: August 2009
History of Changes
  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 Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Preventive Medicine Study of Childhood Atopic Diseases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • urine cotinine level [ Time Frame: six months, one year ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 16, 2009
Last Updated: August 24, 2009
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on May 23, 2013