Empower Korean Families to End Tobacco Use & Smoking Exposure

Smoking Cessation Clinical Trial

Official title:

Empower Korean Families to End Tobacco Use & Smoking Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079569
• Other study ID #: TRDRP 26IP-0037
• Status: Completed
• Phase: N/A
• Start date: August 19, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 31, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lifestyle Risk Reduction
• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Korean Community Center of the East Bay	San Leandro	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Korean Community Center of the East Bay

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence	Biochemically verified 7-day point prevalence of cigarette abstinence at 3-month post baseline assessment (initiation of intervention)	3 months
Primary	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
Primary	Percent attendance	Percent of participants who attend at least 3 out of 4 planned contacts	3-month
Primary	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	Number of Quit attempts	Self-report number participants making a quit attempt(s) that lasted at least for 24 hours since baseline	3 months