- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01592682
Creating Smokefree Living Together for Chinese Household Pairs
June 1, 2015 updated by: University of California, Davis
"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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
410
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94133
- Chinatown Public Health Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Self-identified Chinese Americans who primarily speak Chinese
- Self-identified current smoker men and nonsmoker women
- Pair lives in same household
Exclusion Criteria:
- Current smoker women
- Nonsmoker men
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual care
Household pairs that are assessment only and receive usual care of local in-language smoking cessation resource referral including quitline.
|
|
|
Experimental: Smokefree counseling
Household pairs assigned to smokefree counseling intervention, consisting of group education sessions, tobacco exposure lab report, individual follow-up phone calls.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking cessation
Time Frame: 12 months
|
12 months
|
|
|
Elimination of secondhand smoke exposure
Time Frame: 12 months
|
Nonsmoker
|
12 months
|
|
Urine NNAL (4-(Methylnitrosamine)-1-(3-pyridyl)-1-butanol)
Time Frame: 12 months
|
Smoker and nonsmoker; NNAL is a tobacco-specific carcinogen
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cigarette consumption
Time Frame: 12 months
|
Smoker
|
12 months
|
|
Rule for no smoking in home
Time Frame: 12 months
|
Smoker and nonsmoker
|
12 months
|
|
Reduction in secondhand smoke exposure
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elisa K Tong, MD, MA, University of California, Davis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
April 26, 2012
First Submitted That Met QC Criteria
May 3, 2012
First Posted (Estimate)
May 7, 2012
Study Record Updates
Last Update Posted (Estimate)
June 3, 2015
Last Update Submitted That Met QC Criteria
June 1, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 261778
- RSGT-10-114-01-CPPB (Other Grant/Funding Number: American Cancer Society)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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