Secondhand Smoke Exposure Reduction Study

• ClinicalTrials.gov Identifier: NCT01145794
• Recruitment Status: Completed
• First Posted: June 17, 2010
• Last Update Posted: June 27, 2011
• Sponsor: Boston University
• Collaborator: Flight Attendant Medical Research Institute
• Information provided by: Boston University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Secondhand Smoking	Behavioral: smoking hygiene intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 348 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Reducing Secondhand Smoke Exposure Among Young Children in Shanghai, China
• Study Start Date: October 2008
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: June 2011

Arms and Interventions

Intervention Details:

• 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).

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China

Fu Hua

Shanghai, China

Sponsors and Collaborators

Boston University

Flight Attendant Medical Research Institute

More Information

• Responsible Party: Abu Abdullah/Associate Professor, Boston University School of Public Health
• ClinicalTrials.gov Identifier: NCT01145794
• Other Study ID Numbers: China-SHARE
• First Posted: June 17, 2010
• Last Update Posted: June 27, 2011
• Last Verified: June 2011

Keywords provided by Boston University:

SHS