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?

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Lifestyle Risk Reduction
• Intervention / Treatment: Behavioral: Healthy Living; Behavioral: Tobacco

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Leandro, California, United States, 94577
      • Korean Community Center of the East Bay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abstinence	Biochemically verified 7-day point prevalence of cigarette abstinence at 3-month post baseline assessment (initiation of intervention)	3 months
Secondhand smoke (SHS) exposure of non-smokers	Biochemically verified 7-day point prevalence of SHS exposure at 3-month post baseline assessment (initiation of intervention)	3 months
Percent attendance	Percent of participants who attend at least 3 out of 4 planned contacts	3-month
Percentage of participants who rate the intervention as helpful	Participants will rate their perception as to whether or not they found the intervention to be helpful at the 3 month assessment	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Quit attempts	Self-report number participants making a quit attempt(s) that lasted at least for 24 hours since baseline	3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Korean Community Center of the East Bay
• Investigators: Principal Investigator: Janice Y Tsoh, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: smoking cessation; tobacco; Asian Americans
• Other Study ID Numbers: TRDRP 26IP-0037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No