Secondhand SmokingNCT01145794
Secondhand Smoke Exposure Reduction Study
A study testing smoking hygiene intervention in people with Secondhand Smoking, run by Boston University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Secondhand Smoking
- What is being tested?
- smoking hygiene intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 348 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Secondhand Smoke Exposure Among Young Children in Shanghai, China
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.
- Conditions
- Secondhand Smoking
- Being tested
- smoking hygiene intervention
- Keywords
- SHS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking hygiene interventionBehavioural
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startOct 2008
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondhand SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Flight Attendant Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145794
- Sponsor's protocol ID
- China-SHARE
- Status last verified
- Jun 2011
- First submitted
- 15 Jun 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Secondhand Smoke Exposure Among Young Children in Shanghai, China
- ClinicalTrials.gov ID
- NCT01145794
- Acronym / sponsor ID
- China-SHARE
- Conditions
- Secondhand Smoking
- Keywords
- SHS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Flight Attendant Medical Research Institute
- Study start
- Oct 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smoking hygiene interventionThe 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). | Behavioural | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smoking hygiene intervention in people with Secondhand Smoking, run by Boston University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of smoking hygiene practices within the household as reported by the subjects (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.