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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00995254 |
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Date of registration:
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14/10/2009 |
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Primary sponsor: |
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Public title:
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Secondhand Smoke Exposure Reduction Among Young Children in China
China SHARE |
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Scientific title:
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Reducing Secondhand Smoke Exposure Among Young Children |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00995254 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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China
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. household member has smoked one or more cigarettes daily for the past 30 days as self reported;
2. household smoker smokes a total of at least 10 cigarettes per week at home in the presence of the child, as self reported;
3. smoker household member and the child are living together in the same household and will live together during the entire period of the study;
4. residents of the study community;
5. able to communicate in Mandarin Chinese or local Shanghai dialect; AND
6. has signed an informed consent form or given verbal consent (for those who cannot read and write).
Exclusion Criteria:
1. reported residential coal burning and confirmed by the interviewer;
2. households with breast-feeding child;
3. household members do not smoke at home;
4. smoker member does not live in the same household as the under 5 child;
5. non-local community resident; OR
6. not able to communicate in Mandarin Chinese or Shanghai dialect.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Respiratory Illness
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Secondhand Smoke Exposure
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Smoking Cessation
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Intervention(s)
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Behavioral: SHI counseling
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Primary Outcome(s)
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improvement of smoking hygiene practices within the household as reported by the subjects (i.e. reduction in the number of cigarettes smoked indoors at home while a child was present during the previous week)
[Time Frame: at 6 month follow up]
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Secondary Outcome(s)
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reduction of reported health care utilization due to respiratory disease
[Time Frame: at 6 months follow up]
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reduction of respiratory illness incidence among young children as reported by key household members
[Time Frame: at 6 month follow up]
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Secondary ID(s)
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072223_CIA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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