SmokingNCT01592682
Creating Smokefree Living Together for Chinese Household Pairs
A study testing Smokefree counseling in people with Smoking and Smoke Exposure, run by University of California, Davis at 1 site in United States.
Trial summary
This is a trial of household pairs of a Chinese smoker and nonsmoker randomized either to a smoke-free educational intervention or self-help control group. The smokefree educational intervention includes group education about smokefree environments and smoking cessation, follow-up phone calls, and tobacco exposure lab… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoke Exposure
- What is being tested?
- Smokefree counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to May 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified Chinese Americans who primarily speak Chinese
- Self-identified current smoker men and nonsmoker women
- Pair lives in same household
Who cannot join
- Current smoker women
- Nonsmoker men
Trial locations and contacts
1 site in 1 country.
United States1 site
Chinatown Public Health Center
San Francisco, California, 94133
About this study
Official title: "Creating Smokefree Living Together": Smokefree Counseling Intervention for Chinese Smokers and Household Nonsmokers
This is a trial of household pairs of a Chinese smoker and nonsmoker randomized either to a smoke-free educational intervention or self-help control group. The smokefree educational intervention includes group education about smokefree environments and smoking cessation, follow-up phone calls, and tobacco exposure lab reports. The control group is referred to usual care with local in-language smoking cessation classes or quitline, and is otherwise assessment only. The investigators hypothesize that pairs in the intervention group will have higher rates of tobacco cessation and elimination of smoke exposure, compared to the control group.
- Conditions
- Smoking, Smoke Exposure
- Being tested
- Smokefree counseling
- Keywords
- tobacco, secondhand smoke, Chinese, NNAL
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smokefree counselingBehavioural
Smokefree counseling intervention involves group education sessions, follow-up phone calls, tobacco exposure lab report. Comparison is usual care with referral to local in-language smoking cessation services including quitline.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Household pairs that are assessment only and receive usual care of local in-language smoking cessation resource referral including quitline. |
| Smokefree counseling | Experimental | Household pairs assigned to smokefree counseling intervention, consisting of group education sessions, tobacco exposure lab report, individual follow-up phone calls. Receives: Behavioral: Smokefree counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Measured: 12 months
Elimination of secondhand smoke exposure
Nonsmoker
Measured: 12 months
Urine NNAL (4-(Methylnitrosamine)-1-(3-pyridyl)-1-butanol)
Smoker and nonsmoker; NNAL is a tobacco-specific carcinogen
Measured: 12 months
Secondary outcomes (3)
Cigarette consumption
Smoker
Measured: 12 months
Rule for no smoking in home
Smoker and nonsmoker
Measured: 12 months
Reduction in secondhand smoke exposure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Elisa K Tong, MD, MA, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592682
- Sponsor's protocol ID
- 261778
- Other IDs
- RSGT-10-114-01-CPPB
- Status last verified
- Jun 2015
- First submitted
- 26 Apr 2012
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chang E, Dove M, Saw A, Tsoh JY, Fung LC, Tong EK. Home Smoking Bans and Urinary NNAL Levels to Measure Tobacco Smoke Exposure in Chinese American Household Pairs. Int J Environ Res Public Health. 2021 Jul 20;18(14):7682. doi: 10.3390/ijerph18147682.
PubMed 34300133
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Creating Smokefree Living Together": Smokefree Counseling Intervention for Chinese Smokers and Household Nonsmokers
- ClinicalTrials.gov ID
- NCT01592682
- Acronym / sponsor ID
- 261778
- Conditions
- Smoking, Smoke Exposure
- Keywords
- tobacco, secondhand smoke, Chinese, NNAL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Apr 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 May 2012 (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.
This is a trial of household pairs of a Chinese smoker and nonsmoker randomized either to a smoke-free educational intervention or self-help control group. The smokefree educational intervention includes group education about smokefree environments and smoking cessation, follow-up phone calls, and tobacco exposure lab reports. The control group is referred to usual care with local in-language smoking cessation classes or quitline, and is otherwise assessment only. The investigators hypothesize that pairs in the intervention group will have higher rates of tobacco cessation and elimination of smoke exposure, compared to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Household pairs that are assessment only and receive usual care of local in-language smoking cessation resource referral including quitline. |
| Smokefree counseling | Experimental | Behavioral: Smokefree counselingHousehold pairs assigned to smokefree counseling intervention, consisting of group education sessions, tobacco exposure lab report, individual follow-up phone calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identified Chinese Americans who primarily speak Chinese
- Self-identified current smoker men and nonsmoker women
- Pair lives in same household
Key exclusion criteria (2 listed)
- Current smoker women
- Nonsmoker men
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 |
|---|---|---|
| Smokefree counselingSmokefree counseling intervention involves group education sessions, follow-up phone calls, tobacco exposure lab report. Comparison is usual care with referral to local in-language smoking cessation services including quitline. | Behavioural | Smokefree counseling |
Primary outcome
Smoking cessation
Time frame: 12 months
Elimination of secondhand smoke exposure
Time frame: 12 months
Nonsmoker
Urine NNAL (4-(Methylnitrosamine)-1-(3-pyridyl)-1-butanol)
Time frame: 12 months
Smoker and nonsmoker; NNAL is a tobacco-specific carcinogen
3 secondary outcomes
Cigarette consumption
Time frame: 12 months
Rule for no smoking in home
Time frame: 12 months
Reduction in secondhand smoke exposure
Time frame: 12 months
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 3 Jun 2015.
- Derived from this study: PubMed 34300133Chang E, Dove M, Saw A, Tsoh JY, Fung LC, Tong EK. Home Smoking Bans and Urinary NNAL Levels to Measure Tobacco Smoke Exposure in Chinese American Household Pairs. Int J Environ Res Public Health. 2021 Jul 20;18(14):7682. doi: 10.3390/ijerph18147682.
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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.
Elisa K Tong, MD, MA principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smokefree counseling in people with Smoking and Smoke Exposure, run by University of California, Davis at 1 site in United States.
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 3 inclusion and 2 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 3 Jun 2015. 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 United States. 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?
Smoking cessation (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01592682, which also lists 1 linked publication.
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 3 Jun 2015.