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Empower Korean Families to End Tobacco Use & Smoking Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04079569
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : May 6, 2020
Sponsor:
Collaborator:
Korean Community Center of the East Bay
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The goals of the study are to develop a culturally and linguistically appropriate intervention to promote smoking cessation and reduce secondhand smoke exposure for Korean Americans using a family-based intervention approach targeting Korean Americans ages 18 and above in the greater San Francisco Bay Area, CA, and to evaluate efficacy of the proposed intervention. The study is a randomized control trial targeting a total of 8 lay health workers (LHW) and 48 dyads of a daily smoker and a partner who will attend intervention sessions together. The research question is: Can a family-based lay health worker outreach intervention promote smoking cessation and reduce SHS exposure among Korean Americans?

Condition or disease Intervention/treatment Phase
Smoking Cessation Lifestyle Risk Reduction Behavioral: Tobacco Behavioral: Healthy Living Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Empower Korean Families to End Tobacco Use & Smoking Exposure
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tobacco
Participants will receive education delivered by a lay health worker on "Quit Smoking For a Healthy Family." Participants will receive written information on nutrition and physical activity.
Behavioral: Tobacco
Quit Smoking For a Healthy Family - This is a family-based psycho-education intervention using lay health worker (LHW) outreach. LHW will be trained to recruit smoke-family dyads and provide education and information about tobacco and health, and smoking cessation resources through 2 small-group education sessions and 2 individual phone calls over a 2-month period.

Active Comparator: Healthy Living
In this comparison arm, participants will receive education delivered by the lay health worker about "Healthy Living" focusing on nutrition and physical activity education. Participants will also receive the Smoking Cessation Resource Handout.
Behavioral: Healthy Living
In this comparison arm, participants will receive the same number of contacts on the same schedule and in the same format (2 small group sessions and 2 telephone calls). The comparison LHWs will receive training about "Healthy Living" focusing on nutrition and physical activity education. Participants will also receive the Smoking Cessation Resource Handout.




Primary Outcome Measures :
  1. Abstinence [ Time Frame: 3-month ]
    biochemically verified 7-day point prevalence of cigarette abstinence at 3-month post baseline (initiation of intervention)

  2. Secondhand smoke exposure of non-smokers [ Time Frame: 3-month ]
    biochemically verified 7-day point prevalence of SHS exposure at 3-month post baseline (initiation of intervention)

  3. Treatment attendance [ Time Frame: 3-month ]
    Percent of participants who attend at least 3 out of 4 planned contacts

  4. Perceived helpfulness [ Time Frame: 3-month ]
    Percent of participants who rate the intervention as helpful assessment


Secondary Outcome Measures :
  1. Quit attempts [ Time Frame: 3-month ]
    Self-report of making quit attempts that lasted at least for 24 hours since baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • reside in California, United States
  • for the smoker participants, they must have smoked at least 1 cigarette in the past 30 days, and have smoked either at least 1 cigarette and/or used e-cigarettes in the past 7 days, and self-identified as Korean or Korean American
  • for partner participants, they must be willing to attend intervention session together with a smoker participant
  • provide a valid contact telephone number and email address for pre- and post-intervention assessments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079569


Contacts
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Contact: Janice Y Tsoh, PhD 415-502-8438 janice.tsoh@ucsf.edu

Locations
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United States, California
Korean Community Center of the East Bay Recruiting
San Leandro, California, United States, 94577
Contact: June Lee, MS    844-828-2254    junelee@kcceb.org   
Sponsors and Collaborators
University of California, San Francisco
Korean Community Center of the East Bay
Investigators
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Principal Investigator: Janice Y Tsoh, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04079569    
Other Study ID Numbers: TRDRP 26IP-0037
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
tobacco
smoking cessation
Asian Americans