NCT04079556

Brief Summary

The goals of the study are to develop a culturally and linguistically appropriate intervention to reduce SHS exposure for LEP Korean women using a family-focused 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 single group feasibility trial targeting a total of 4 lay health workers (LHW) and 24 dyads of LEP Korean women with self-reported SHS exposure at home and a male household smoker. The hypothesis is: H. Can a family-based intervention approach reduce SHS exposure among Korean American women who live with a current smoker?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

September 3, 2019

Last Update Submit

March 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • SHS exposure of non-smokers

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

    3-month

Secondary Outcomes (3)

  • Smoker's adoption of smoke-free rules

    3-month

  • Smoker's Utilization of smoking cessation resources

    3-month

  • Smoking Abstinence

    3-month

Study Arms (1)

Tobacco LHW

EXPERIMENTAL

Quit Smoking For a Healthy Family - family-based psycho-education intervention using lay health worker (LHW) outreach.

Behavioral: Tobacco LHW

Interventions

Tobacco LHWBEHAVIORAL

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.

Tobacco LHW

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsRecruiting for male smokers and female household partner.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • self-identified as Korean or Korean American;
  • Korean speaking;
  • reside in the San Francisco Bay Area
  • plan to stay in the area for the next 3 months
  • for women participants, the participant must report having SHS exposure at home at least 1 day in the past 7 days and live in the same household as the smoker participant to form a dyad.
  • for the smoker participants, they must be male and have smoked at least 1 cigarette daily in the past 7 days.
  • provide a valid contact telephone number for pre- and post-intervention assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korean Community Center of the East Bay

San Leandro, California, 94577, United States

Location

Study Officials

  • Janice Y Tsoh, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 6, 2019

Study Start

March 16, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations