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Secondhand Smoke Exposure Reduction Among Young Children in China (China SHARE)

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ClinicalTrials.gov Identifier: NCT00995254
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : June 27, 2011
Sponsor:
Collaborator:
Fudan University
Information provided by:
Boston University

Tracking Information
First Submitted Date  ICMJE October 14, 2009
First Posted Date  ICMJE October 15, 2009
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE September 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00995254 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2009)
  • reduction of respiratory illness incidence among young children as reported by key household members [ Time Frame: at 6 month follow up ]
  • reduction of reported health care utilization due to respiratory disease [ Time Frame: at 6 months follow up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Secondhand Smoke Exposure Reduction Among Young Children in China
Official Title  ICMJE Reducing Secondhand Smoke Exposure Among Young Children
Brief Summary

Second hand smoking (SHS) is a health hazard to infants and children, in whom it is associated with lower respiratory tract infections, wheezing, cough, middle ear infections and sudden infant death syndrome. Evidence from developed nations suggests that measures to reduce exposure to SHS can improve children's health outcomes; this has not been systematically studied in a developing country setting. The investigators 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.

To test this hypothesis, the investigators have identified three specific aims: (1) to obtain baseline data on second hand tobacco exposure among young children, health status of young children and smoking status of parents and other household members, (2) to generate preliminary effectiveness data for CHW-delivered SHI, and (3) to develop culturally appropriate biochemical measures to assess children's exposure to household SHS. The investigators propose to conduct this study in an urban district in Shanghai, China. After an initial assessment, the investigators will conduct a randomized controlled trial of households in a community, selected based on important study criteria, within the district. The investigators selected this design because it is most likely to produce a scientifically valid answer to our primary study question. All eligible smokers in the intervention group will receive behavioral counseling to address health hazards of SHS towards children, brief advice to quit or to adopt a no smoking policy around children, and educational pamphlets on the hazards of SHS, from a trained CHW in their community. A questionnaire will be used for data collection at the start and at 2 and 6 months. To assess the extent of total SHS exposure, children's urine cotinine (the indicator of nicotine) level will be measured at the first contact and at 2-and 6- months. To validate household members reported level of smoking the investigators will measure air nicotine levels of a sub-sample (10%) of households via passive monitors. The results of this study will provide clinical evidence for the development of CHW-delivered interventions designed to reduce exposure to SHS and improve the respiratory health of children in a resource-poor community. If successful, the program can serve as a model for implementation in other developing country settings. Furthermore, successful results could also be used to draft guidelines for health promotion interventions, which could be implemented as a policy for all primary health care settings. Finally, the study, which would be the first of its type in a developing country setting, will form the basis for future research and program development in the area of SHS.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Secondhand Smoke Exposure
  • Respiratory Illness
  • Smoking Cessation
Intervention  ICMJE Behavioral: SHI counseling
The SHI will be delivered in three different individualized counseling sessions: the initial in person counseling (30-45 minutes), at 1 week in person or telephone counseling (15-30 minutes) and at 1 month in person counseling (15-30 minutes). During the initial counseling, CHWs will emphasize the health hazards of SHS exposure towards young children and its possible illness outcomes. Then subjects will be asked to assess the SHS exposure of children in the household (e.g., estimating the number of hours for SHS exposure on the child per week or day) and the source of SHS. The concept of smoking hygiene and non-smoking household policy will be discussed and any potential barriers ascertained. Furthermore, the CHWs will use the transtheoretical model of Prochaska to assess the stage of readiness of the household member to change smoking behavior existing in the household. Individuals who wish to quit smoking will receive a brief advice on quitting smoking.
Study Arms
  • No Intervention: Control group
    Control group will ONLY receive SHI after completion of the study
  • Experimental: Intervention group
    Intervention group will receive smoking hygiene intervention (SHI) at three individualized contacts.
    Intervention: Behavioral: SHI counseling
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: October 14, 2009)
400
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date 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; 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers 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 NCT00995254
Other Study ID Numbers  ICMJE 072223_CIA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abu S Abdullah, Boston University School of Public Health
Study Sponsor  ICMJE Boston University
Collaborators  ICMJE Fudan University
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