NCT04079569

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

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

August 19, 2019

Completed
15 days 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
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

September 3, 2019

Last Update Submit

April 5, 2021

Conditions

Smoking CessationLifestyle Risk Reduction

Keywords

tobaccosmoking cessationAsian Americans

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Number of Quit attempts

    3 months

Study Arms (2)

Tobacco

EXPERIMENTAL

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

Healthy Living

ACTIVE COMPARATOR

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

Interventions

TobaccoBEHAVIORAL

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
Healthy LivingBEHAVIORAL

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.

Healthy Living

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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

MeSH Terms

Conditions

Smoking CessationRisk Reduction Behavior

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Janice Y Tsoh, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 6, 2019

Study Start

August 19, 2019

Primary Completion

December 20, 2020

Study Completion

March 31, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)