Secondhand Smoke Exposure Reduction Study

This study has been completed.
Sponsor:
Collaborator:
Flight Attendant Medical Research Institute
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT01145794
First received: June 15, 2010
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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 Intervention
Secondhand Smoking
Behavioral: smoking hygiene intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Secondhand Smoke Exposure Among Young Children in Shanghai, China

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • improvement of smoking hygiene practices within the household as reported by the subjects [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 348
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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).
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01145794

Locations
China
Fu Hua
Shanghai, China
Sponsors and Collaborators
Boston University
Flight Attendant Medical Research Institute
  More Information

No publications provided

Responsible Party: Abu Abdullah/Associate Professor, Boston University School of Public Health
ClinicalTrials.gov Identifier: NCT01145794     History of Changes
Other Study ID Numbers: China-SHARE
Study First Received: June 15, 2010
Last Updated: June 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
SHS

ClinicalTrials.gov processed this record on August 28, 2014