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Completed

NCT Number: NCT01145794

Secondhand Smoke Exposure Reduction Study

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.

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Key information

Conditions

Secondhand Smoking

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fu Hua

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Smoking hygiene intervention

Behavioral

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).

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Flight Attendant Medical Research Institute

Registry information

Official study title

Reducing Secondhand Smoke Exposure Among Young Children in Shanghai, China

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2010
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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