Secondhand Smoke Exposure Reduction Study

Secondhand Smoking Clinical Trial

Official title:

Reducing Secondhand Smoke Exposure Among Young Children in Shanghai, China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145794
• Other study ID #: China-SHARE
• Status: Completed
• Phase: N/A
• First received: June 15, 2010
• Last updated: June 23, 2011
• Start date: October 2008
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Secondhand Smoking

Intervention

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).

Locations

Country	Name	City	State
China	Fu Hua	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	Flight Attendant Medical Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No