Smoking CessationNCT04079569
Empower Korean Families to End Tobacco Use & Smoking Exposure
A study testing Tobacco and Healthy Living in people with Smoking Cessation and Lifestyle Risk Reduction, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Lifestyle Risk Reduction
- What is being tested?
- Tobacco and Healthy Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Korean Community Center of the East Bay
San Leandro, California, 94577
About this study
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?
- Conditions
- Smoking Cessation, Lifestyle Risk Reduction
- Being tested
- Tobacco, Healthy Living
- Keywords
- tobacco, smoking cessation, Asian Americans
- Medical subject headings
- Smoking Cessation, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TobaccoBehavioural
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 LivingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Healthy Living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence
Biochemically verified 7-day point prevalence of cigarette abstinence at 3-month post baseline assessment (initiation of intervention)
Measured: 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)
Measured: 3 months
Percent attendance
Percent of participants who attend at least 3 out of 4 planned contacts
Measured: 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
Measured: 3 months
Secondary outcomes (1)
Number of Quit attempts
Self-report number participants making a quit attempt(s) that lasted at least for 24 hours since baseline
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start19 Aug 2019
- Primary completion20 Dec 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Community Center of the East Bay
- Responsible party
- Sponsor
- Investigators
- Janice Y Tsoh, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079569
- Sponsor's protocol ID
- TRDRP 26IP-0037
- Status last verified
- Apr 2021
- First submitted
- 3 Sep 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empower Korean Families to End Tobacco Use & Smoking Exposure
- ClinicalTrials.gov ID
- NCT04079569
- Acronym / sponsor ID
- TRDRP 26IP-0037
- Conditions
- Smoking Cessation, Lifestyle Risk Reduction
- Keywords
- tobacco, smoking cessation, Asian Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Korean Community Center of the East Bay
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobacco | Experimental | Behavioral: TobaccoParticipants 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. |
| Healthy Living | Active comparator | Behavioral: Healthy LivingIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TobaccoQuit 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. | Behavioural | Tobacco |
| Healthy LivingIn 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. | Behavioural | Healthy Living |
Primary outcome
Abstinence
Time frame: 3 months
Biochemically verified 7-day point prevalence of cigarette abstinence at 3-month post baseline assessment (initiation of intervention)
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)
Percent attendance
Time frame: 3-month
Percent of participants who attend at least 3 out of 4 planned contacts
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
1 secondary outcome
Number of Quit attempts
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Y Tsoh, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco and Healthy Living in people with Smoking Cessation and Lifestyle Risk Reduction, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.