Tobacco Use CessationTobacco LHWNCT02007707
A Family-Based Approach To Reduce Smoking in Vietnamese Men
A study testing Tobacco LHW and Healthy Eating in people with Tobacco Use Cessation and Healthy Eating, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The goals of the study are to develop smoking cessation intervention using lay health worker (LHW) outreach and family involvement targeting Vietnamese Americans ages 18 and above in Santa Clara County, CA, to evaluate efficacy of the proposed intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation, Healthy Eating
- What is being tested?
- Tobacco LHW and Healthy Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Oct 2018
- 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
- self-identified as Vietnamese, Vietnamese-American, or Vietnamese-Chinese;
- Vietnamese speaking;
- reside in the Santa Clara County, California
- plan to stay in the area (Santa Clara County, California) for the next 6 months
- for the smoker participants, they must be male and have smoked at least 1 cigarette daily in the past 7 days.
- for family member participants, the participant must live in the same household as the smoker participant to form a dyad.
- provide a valid contact telephone number for pre- and post-intervention assessments.
Who cannot join
- For smoker participants, currently engaging in assisted smoking cessation efforts
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vietnamese Voluntary Foundation
San Jose, California, 95122
Immigrant Resettlement & Cultural Center (IRCC)
Santa Clara, California, 95112
About this study
The goals of the study are to develop smoking cessation intervention using lay health worker (LHW) outreach and family involvement targeting Vietnamese Americans ages 18 and above in Santa Clara County, CA, to evaluate efficacy of the proposed intervention. The study is a two-arm randomized controlled trial targeting a total of 18 lay health workers (LHW) and 108 dyads of a smoker and a family member from the same household. The hypotheses are:
- At 6-month post initiation of the intervention, Vietnamese male daily smokers who receive the proposed -Quit Smoking For a Healthy Family Intervention, a Family-based Intervention (FI), will be more likely to achieve biochemically verified 7-day point prevalence of smoking abstinence when compared to those receiving an attention control intervention (CI).
Read more
H2. At 6-month, FI participants we be more likely to report making at least one 24-hour quit attempt than those in CI.
H3. At 6-month, FI participants will be more likely to report using a recommended evidence-based smoking cessation resource (quitline, FDA-approved smoking cessation medications, advice from health professionals) than those in CI
- Conditions
- Tobacco Use Cessation, Healthy Eating
- Being tested
- Tobacco LHW, Healthy Eating
- Keywords
- Asian American, Vietnamese American, Smoking cessation, Community Health Worker, Lay Health Worker Outreach, Family Intervention
- Medical subject headings
- Tobacco Use Cessation, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco LHWBehavioural
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 EatingBehavioural
Eating Healthy and Physically Active for You and Your Family - This is a attention-control comparison group using a family-based psycho-education intervention delivered through lay health worker (LHW) outreach. LHW will be trained to recruit smoke-family dyads and provide education and information about healthy eating and physical activity through 2 small-group education sessions and 2 individual phone calls over a 2-month period. Participants will receive writing information about smoking cessation resources.
| Study group | Role | What they receive |
|---|---|---|
| Tobacco LHW | Experimental | Quit Smoking For a Healthy Family - family-based psycho-education intervention using lay health worker (LHW) outreach. Receives: Behavioral: Tobacco LHW |
| Healthy Eating | Active comparator | Eating Healthy and Physically Active for You and Your Family - This is a attention-control comparison group using a family-based psycho-education intervention delivered through lay health worker (LHW) outreach. Receives: Behavioral: Healthy Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking abstinence
biochemically verified 7-day point prevalence of smoking abstinence at 6-month post baseline (initiation of intervention)
Measured: 6-month
Secondary outcomes (2)
24-hour quit attempt
report making at least one 24-hour quit attempt at 6-month post baseline
Measured: 6-month
resource utilization
report using a recommended evidence-based smoking cessation resource (quitline, FDA-approved smoking cessation medications, advice from health professionals) at 6-month post baseline
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startApr 2014
- Primary completionAug 2016
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use 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
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice Y Tsoh, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007707
- Sponsor's protocol ID
- TRDRP 22RT-0089
- Acronym
- Tobacco LHW
- Status last verified
- Aug 2019
- First submitted
- 25 Nov 2013
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family-Based Approach To Reduce Smoking in Vietnamese Men
- ClinicalTrials.gov ID
- NCT02007707
- Acronym / sponsor ID
- Tobacco LHW / TRDRP 22RT-0089
- Conditions
- Tobacco Use Cessation, Healthy Eating
- Keywords
- Asian American, Vietnamese American, Smoking cessation, Community Health Worker, Lay Health Worker Outreach, Family Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 11 Dec 2013 (estimated)
- 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 smoking cessation intervention using lay health worker (LHW) outreach and family involvement targeting Vietnamese Americans ages 18 and above in Santa Clara County, CA, to evaluate efficacy of the proposed intervention. The study is a two-arm randomized controlled trial targeting a total of 18 lay health workers (LHW) and 108 dyads of a smoker and a family member from the same household. The hypotheses are:
- At 6-month post initiation of the intervention, Vietnamese male daily smokers who receive the proposed -Quit Smoking For a Healthy Family Intervention, a Family-based Intervention (FI), will be more likely to achieve biochemically verified 7-day point prevalence of smoking abstinence when compared to those receiving an attention control intervention (CI).
H2. At 6-month, FI participants we be more likely to report making at least one 24-hour quit attempt than those in CI.
H3. At 6-month, FI participants will be more likely to report using a recommended evidence-based smoking cessation resource (quitline, FDA-approved smoking cessation medications, advice from health professionals) than those in CI
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobacco LHW | Experimental | Behavioral: Tobacco LHWQuit Smoking For a Healthy Family - family-based psycho-education intervention using lay health worker (LHW) outreach. |
| Healthy Eating | Active comparator | Behavioral: Healthy EatingEating Healthy and Physically Active for You and Your Family - This is a attention-control comparison group using a family-based psycho-education intervention delivered through lay health worker (LHW) outreach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- self-identified as Vietnamese, Vietnamese-American, or Vietnamese-Chinese;
- Vietnamese speaking;
- reside in the Santa Clara County, California
- plan to stay in the area (Santa Clara County, California) for the next 6 months
- for the smoker participants, they must be male and have smoked at least 1 cigarette daily in the past 7 days.
Key exclusion criteria (1 listed)
- For smoker participants, currently engaging in assisted smoking cessation efforts
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 |
|---|---|---|
| Tobacco LHWQuit 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 LHW |
| Healthy EatingEating Healthy and Physically Active for You and Your Family - This is a attention-control comparison group using a family-based psycho-education intervention delivered through lay health worker (LHW) outreach. LHW will be trained to recruit smoke-family dyads and provide education and information about healthy eating and physical activity through 2 small-group education sessions and 2 individual phone calls over a 2-month period. Participants will receive writing information about smoking cessation resources. | Behavioural | Healthy Eating |
Primary outcome
smoking abstinence
Time frame: 6-month
biochemically verified 7-day point prevalence of smoking abstinence at 6-month post baseline (initiation of intervention)
2 secondary outcomes
24-hour quit attempt
Time frame: 6-month
resource utilization
Time frame: 6-month
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 6 Aug 2019.
Related trials for Tobacco Use Cessation
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco LHW and Healthy Eating in people with Tobacco Use Cessation and Healthy Eating, run by University of California, San Francisco at 2 sites 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 7 inclusion and 1 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 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
smoking abstinence (time frame: 6-month). 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 6 Aug 2019.