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Secondhand Smoke Exposure Reduction Study

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ClinicalTrials.gov Identifier: NCT01145794
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : June 27, 2011
Sponsor:
Collaborator:
Flight Attendant Medical Research Institute
Information provided by:
Boston University

Brief Summary:
The high prevalence of smoking in adults in many developing countries (e.g. in China, 61% among men and 7% among women) results in many children being exposed to secondhand smoke (SHS). Although in 2001 the American Academy of Pediatrics recommended the promotion of proper smoking hygiene, (i.e. smoking away from the immediate environment of infants and children), similar recommendations in many developing countries are either scarce or non-existent. We hypothesize that implementation of a package of smoking hygiene intervention measures delivered by community health workers (CHWs) will reduce Chinese children's exposure to SHS and improve their respiratory health.

Condition or disease Intervention/treatment
Secondhand Smoking Behavioral: smoking hygiene intervention

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Secondhand Smoke Exposure Among Young Children in Shanghai, China
Study Start Date : October 2008
Primary Completion Date : May 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources


Intervention Details:
    Behavioral: smoking hygiene intervention
    The intervention, SHI, will address SHS and quitting. It will include behavioral counseling to address health hazards of SHS for children, brief advice to quit and to adopt a no smoking policy around children and self-help materials (related to second hand smoking).


Primary Outcome Measures :
  1. improvement of smoking hygiene practices within the household as reported by the subjects [ Time Frame: at 6 months ]
    The main outcome measures are: 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) and reduction in children's cotinine concentrations in urine at 6- month follow up.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
  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; and
  6. not able to communicate in Mandarin Chinese or Shanghai dialect.

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): NCT01145794


Locations
China
Fu Hua
Shanghai, China
Sponsors and Collaborators
Boston University
Flight Attendant Medical Research Institute

Responsible Party: Abu Abdullah/Associate Professor, Boston University School of Public Health
ClinicalTrials.gov Identifier: NCT01145794     History of Changes
Other Study ID Numbers: China-SHARE
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Boston University:
SHS