Secondhand Smoke ExposureChina SHARENCT00995254
Secondhand Smoke Exposure Reduction Among Young Children in China
A study testing SHI counseling in people with Secondhand Smoke Exposure and Respiratory Illness, run by Boston University at 1 site in China.
Trial summary
Second hand smoking (SHS) is a health hazard to infants and children, in whom it is associated with lower respiratory tract infections, wheezing, cough, middle ear infections and sudden infant death syndrome. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Secondhand Smoke Exposure, Respiratory Illness, Smoking Cessation
- What is being tested?
- SHI counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Sep 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 85 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; AND
- 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; OR
- 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
Second hand smoking (SHS) is a health hazard to infants and children, in whom it is associated with lower respiratory tract infections, wheezing, cough, middle ear infections and sudden infant death syndrome. Evidence from developed nations suggests that measures to reduce exposure to SHS can improve children's health outcomes; this has not been systematically studied in a developing country setting. The investigators 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.
To test this hypothesis, the investigators have identified three specific aims: (1) to obtain baseline data on second hand tobacco exposure among young children, health status of young children and smoking status of parents and other household members, (2) to generate preliminary effectiveness data for CHW-delivered SHI, and (3) to develop culturally appropriate biochemical measures to assess children's exposure to household SHS. The investigators propose to conduct this study in an urban district in Shanghai, China. After an initial assessment, the investigators will conduct a randomized controlled trial of households in a community, selected based on important study criteria, within the district. The investigators selected this design because it is most likely to produce a scientifically valid answer to our primary study question. All eligible smokers in the intervention group will receive behavioral counseling to address health hazards of SHS towards children, brief advice to quit or to adopt a no smoking policy around children, and educational pamphlets on the hazards of SHS, from a trained CHW in their community. A questionnaire will be used for data collection at the start and at 2 and 6 months. To assess the extent of total SHS exposure, children's urine cotinine (the indicator of nicotine) level will be measured at the first contact and at 2-and 6- months. To validate household members reported level of smoking the investigators will measure air nicotine levels of a sub-sample (10%) of households via passive monitors. The results of this study will provide clinical evidence for the development of CHW-delivered interventions designed to reduce exposure to SHS and improve the respiratory health of children in a resource-poor community. If successful, the program can serve as a model for implementation in other developing country settings. Furthermore, successful results could also be used to draft guidelines for health promotion interventions, which could be implemented as a policy for all primary health care settings. Finally, the study, which would be the first of its type in a developing country setting, will form the basis for future research and program development in the area of SHS.
- Being tested
- SHI counseling
- Keywords
- secondhand smoke, children, Chinese, respiratory symptoms, household smoking policy, Respiratory illnesses among children
- Medical subject headings
- Smoking Cessation, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHI counselingBehavioural
The SHI will be delivered in three different individualized counseling sessions: the initial in person counseling (30-45 minutes), at 1 week in person or telephone counseling (15-30 minutes) and at 1 month in person counseling (15-30 minutes). During the initial counseling, CHWs will emphasize the health hazards of SHS exposure towards young children and its possible illness outcomes. Then subjects will be asked to assess the SHS exposure of children in the household (e.g., estimating the number of hours for SHS exposure on the child per week or day) and the source of SHS. The concept of smoking hygiene and non-smoking household policy will be discussed and any potential barriers ascertained. Furthermore, the CHWs will use the transtheoretical model of Prochaska to assess the stage of readiness of the household member to change smoking behavior existing in the household. Individuals who wish to quit smoking will receive a brief advice on quitting smoking.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group will ONLY receive SHI after completion of the study |
| Intervention group | Experimental | Intervention group will receive smoking hygiene intervention (SHI) at three individualized contacts. Receives: Behavioral: SHI counseling |
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 (i.e. reduction in the number of cigarettes smoked indoors at home while a child was present during the previous week)
Measured: at 6 month follow up
Secondary outcomes (2)
reduction of respiratory illness incidence among young children as reported by key household members
Measured: at 6 month follow up
reduction of reported health care utilization due to respiratory disease
Measured: at 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startSep 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 Smoke ExposureStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995254
- Sponsor's protocol ID
- 072223_CIA
- Acronym
- China SHARE
- Status last verified
- Jun 2011
- First submitted
- 14 Oct 2009
- 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
- ClinicalTrials.gov ID
- NCT00995254
- Acronym / sponsor ID
- China SHARE / 072223_CIA
- Keywords
- secondhand smoke, children, Chinese, respiratory symptoms, household smoking policy, Respiratory illnesses among children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- Sep 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Oct 2009 (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.
Second hand smoking (SHS) is a health hazard to infants and children, in whom it is associated with lower respiratory tract infections, wheezing, cough, middle ear infections and sudden infant death syndrome. Evidence from developed nations suggests that measures to reduce exposure to SHS can improve children's health outcomes; this has not been systematically studied in a developing country setting. The investigators 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.
To test this hypothesis, the investigators have identified three specific aims: (1) to obtain baseline data on second hand tobacco exposure among young children, health status of young children and smoking status of parents and other household members, (2) to generate preliminary effectiveness data for CHW-delivered SHI, and (3) to develop culturally appropriate biochemical measures to assess children's exposure to household SHS. The investigators propose to conduct this study in an urban district in Shanghai, China. After an initial assessment, the investigators will conduct a randomized controlled trial of households in a community, selected based on important study criteria, within the district. The investigators selected this design because it is most likely to produce a scientifically valid answer to our primary study question. All eligible smokers in the intervention group will receive behavioral counseling to address health hazards of SHS towards children, brief advice to quit or to adopt a no smoking policy around children, and educational pamphlets on the hazards of SHS, from a trained CHW in their community. A questionnaire will be used for data collection at the start and at 2 and 6 months. To assess the extent of total SHS exposure, children's urine cotinine (the indicator of nicotine) level will be measured at the first contact and at 2-and 6- months. To validate household members reported level of smoking the investigators will measure air nicotine levels of a sub-sample (10%) of households via passive monitors. The results of this study will provide clinical evidence for the development of CHW-delivered interventions designed to reduce exposure to SHS and improve the respiratory health of children in a resource-poor community. If successful, the program can serve as a model for implementation in other developing country settings. Furthermore, successful results could also be used to draft guidelines for health promotion interventions, which could be implemented as a policy for all primary health care settings. Finally, the study, which would be the first of its type in a developing country setting, will form the basis for future research and program development in the area of SHS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group will ONLY receive SHI after completion of the study |
| Intervention group | Experimental | Behavioral: SHI counselingIntervention group will receive smoking hygiene intervention (SHI) at three individualized contacts. |
Who may qualify
- Ages
- 18 to 85 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; AND
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; OR
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 |
|---|---|---|
| SHI counselingThe SHI will be delivered in three different individualized counseling sessions: the initial in person counseling (30-45 minutes), at 1 week in person or telephone counseling (15-30 minutes) and at 1 month in person counseling (15-30 minutes). During the initial counseling, CHWs will emphasize the health hazards of SHS exposure towards young children and its possible illness outcomes. Then subjects will be asked to assess the SHS exposure of children in the household (e.g., estimating the number of hours for SHS exposure on the child per week or day) and the source of SHS. The concept of smoking hygiene and non-smoking household policy will be discussed and any potential barriers ascertained. Furthermore, the CHWs will use the transtheoretical model of Prochaska to assess the stage of readiness of the household member to change smoking behavior existing in the household. Individuals who wish to quit smoking will receive a brief advice on quitting smoking. | Behavioural | Intervention group |
Primary outcome
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)
Time frame: at 6 month follow up
2 secondary outcomes
reduction of respiratory illness incidence among young children as reported by key household members
Time frame: at 6 month follow up
reduction of reported health care utilization due to respiratory disease
Time frame: at 6 months 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 SHI counseling in people with Secondhand Smoke Exposure and Respiratory Illness, 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 (i.e. reduction in the number of cigarettes smoked indoors at home while a child was present during the previous week) (time frame: at 6 month follow up). 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.