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OpenTrials
Completed

NCT Number: NCT04079569

Empower Korean Families to End Tobacco Use & Smoking Exposure

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?

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Lifestyle Risk Reduction Risk Reduction Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korean Community Center of the East Bay

San Leandro, California, 94577, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tobacco

Behavioral

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.

Healthy Living

Behavioral

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 outcomes

  1. Abstinence

    Time frame: 3 months

    Biochemically verified 7-day point prevalence of cigarette abstinence at 3-month post baseline assessment (initiation of intervention)

  2. Secondhand smoke (SHS) exposure of non-smokers

    Time frame: 3 months

    Biochemically verified 7-day point prevalence of SHS exposure at 3-month post baseline assessment (initiation of intervention)

  3. Percent attendance

    Time frame: 3-month

    Percent of participants who attend at least 3 out of 4 planned contacts

  4. Percentage of participants who rate the intervention as helpful

    Time frame: 3 months

    Participants will rate their perception as to whether or not they found the intervention to be helpful at the 3 month assessment

Secondary outcomes

  1. Number of Quit attempts

    Time frame: 3 months

    Self-report number participants making a quit attempt(s) that lasted at least for 24 hours since baseline

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Korean Community Center of the East Bay

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 6, 2019
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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