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Secondhand Smoke Exposure Reduction Study

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.
 
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

Tracking Information
First Submitted Date  ICMJE June 15, 2010
First Posted Date  ICMJE June 17, 2010
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE October 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Secondhand Smoke Exposure Reduction Study
Official Title  ICMJE Reducing Secondhand Smoke Exposure Among Young Children in Shanghai, China
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Secondhand Smoking
Intervention  ICMJE 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).
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 16, 2010)
348
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01145794
Other Study ID Numbers  ICMJE China-SHARE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abu Abdullah/Associate Professor, Boston University School of Public Health
Study Sponsor  ICMJE Boston University
Collaborators  ICMJE Flight Attendant Medical Research Institute
Investigators  ICMJE Not Provided
PRS Account Boston University
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP