Smoking Cessation Clinical Trial
Official title:
Reducing Secondhand Smoke Exposure Among Young Children
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.
n/a
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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