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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01592682
Other study ID # 261778
Secondary ID RSGT-10-114-01-C
Status Completed
Phase N/A
First received April 26, 2012
Last updated June 1, 2015
Start date April 2012
Est. completion date May 2015

Study information

Verified date June 2015
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 410
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Smokefree counseling
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.

Locations

Country Name City State
United States Chinatown Public Health Center San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Davis University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking cessation 12 months No
Primary Elimination of secondhand smoke exposure Nonsmoker 12 months No
Primary Urine NNAL (4-(Methylnitrosamine)-1-(3-pyridyl)-1-butanol) Smoker and nonsmoker; NNAL is a tobacco-specific carcinogen 12 months No
Secondary Cigarette consumption Smoker 12 months No
Secondary Rule for no smoking in home Smoker and nonsmoker 12 months No
Secondary Reduction in secondhand smoke exposure 12 months No
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