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Creating Smokefree Living Together for Chinese Household Pairs

This study is currently recruiting participants.
Verified May 2012 by University of California, Davis
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01592682
First received: April 26, 2012
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Smoking
Smoke Exposure
 Behavioral: Smokefree counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: "Creating Smokefree Living Together": Smokefree Counseling Intervention for Chinese Smokers and Household Nonsmokers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Smoking cessation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Elimination of secondhand smoke exposure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Nonsmoker

  • Urine NNAL (4-(Methylnitrosamine)-1-(3-pyridyl)-1-butanol) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Smoker and nonsmoker; NNAL is a tobacco-specific carcinogen


Secondary Outcome Measures:
  • Cigarette consumption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Smoker

  • Rule for no smoking in home [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Smoker and nonsmoker

  • Reduction in secondhand smoke exposure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: April 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592682

Contacts
Contact: Elisa Tong, MD, MA 9167347005 elisa.tong@ucdmc.ucdavis.edu
Contact: Lei-Chun Fung, MSW, MPH 4153647908 lei_chun_fung@hotmail.com

Locations
United States, California
Chinatown Public Health Center Recruiting
San Francisco, California, United States, 94133
Contact: Lei-Chun Fung, MPH, MSW     415-364-7907     lei_chun_fung@hotmail.com    
Contact: Elisa Tong, MD, MA     9167347005     elisa.tong@ucdmc.ucdavis.edu    
Sub-Investigator: Lei-Chun Fung, MSW, MPH            
Sponsors and Collaborators
University of California, Davis
University of California, San Francisco
Investigators
Principal Investigator: Elisa K Tong, MD, MA University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01592682     History of Changes
Other Study ID Numbers: 261778, RSGT-10-114-01-CPPB
Study First Received: April 26, 2012
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
tobacco
secondhand smoke
Chinese
NNAL

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 22, 2013