Secondhand Smoke Exposure Reduction Study
Reducing Secondhand Smoke Exposure Among Young Children in Shanghai, China
1 other identifier
interventional
348
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 15, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 27, 2011
June 1, 2011
2.6 years
June 15, 2010
June 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
improvement of smoking hygiene practices within the household as reported by the subjects
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.
at 6 months
Interventions
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).
Eligibility Criteria
You may qualify if:
- household member has smoked one or more cigarettes daily for the past 30 days as self reported;
- household smoker smokes a total of at least 10 cigarettes per week at home in the presence of the child, as self reported;
- smoker household member and the child are living together in the same household and will live together during the entire period of the study;
- residents of the study community;
- able to communicate in Mandarin Chinese or local Shanghai dialect;
- has signed an informed consent form or given verbal consent (for those who cannot read and write).
You may not qualify if:
- reported residential coal burning and confirmed by the interviewer;
- households with breast-feeding child;
- household members do not smoke at home;
- smoker member does not live in the same household as the under 5 child;
- non-local community resident; and
- not able to communicate in Mandarin Chinese or Shanghai dialect.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Universitylead
- Flight Attendant Medical Research Institutecollaborator
Study Sites (1)
Fu Hua
Shanghai, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 15, 2010
First Posted
June 17, 2010
Study Start
October 1, 2008
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
June 27, 2011
Record last verified: 2011-06