Smoking CessationNCT02307734
A Family-Focused Intervention for Asian American Male Smokers
A study testing Quit Smoking for a Healthy Family and Healthy Living in people with Smoking Cessation and Family, run by University of California, San Francisco at 3 sites in United States.
Trial summary
This project proposes two aims. The first aim is to evaluate the efficacy of a family-focused intervention in promoting smoking cessation in Chinese and Vietnamese male smokers using a 2-arm cluster randomized controlled trial with assessments at baseline, 6, and 12 months targeting 360 smoker-family dyads. 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, Family, Health Behavior
- What is being tested?
- Quit Smoking for a Healthy Family and Healthy Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2015to 31 Mar 2020
- 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
- Chinese or Vietnamese males
- Age > 18
- Speak Cantonese or Mandarin (major Chinese dialects) or Vietnamese
- Have smoked at least 1 cigarette daily during the past 7 days, have a family member in the household with whom he will participate in the study, plan to stay in the area for the next 3 months (to complete all intervention activities) and can provide a valid phone number and a mailing address (for follow-up assessments and for sending saliva sample collection kits and payments).
- Family members (male or female) of an eligible smoker
- Age > 18
- Speak Cantonese or Mandarin (major Chinese dialects) or Vietnamese
- Have never smoked or have formerly smoked but have not had any cigarette in the year prior to participation
Who cannot join
- Those who are currently in a smoking cessation program or trying to quit smoking with assistance will be excluded.
- Only one smoker-family dyad from a household may participate.
- They must not live in the same household as their own LHW (or another LHW) or have participated in the study at any time (e.g., focus groups not directly related to the intervention implementation)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Southeast Asian Community Center (SEACC)
San Francisco, California, 94109
Chinese Community Health Resource Center
San Francisco, California, 94133
Vietnamese Voluntary Foundation
San Jose, California, 95122
About this study
This project proposes two aims. The first aim is to evaluate the efficacy of a family-focused intervention in promoting smoking cessation in Chinese and Vietnamese male smokers using a 2-arm cluster randomized controlled trial with assessments at baseline, 6, and 12 months targeting 360 smoker-family dyads. Half of the participants will be assigned to the proposed intervention, and the remaining half will be assigned to an attention-control condition where they will receive education on healthy eating and physical activity. The second aim is to explore mediators to identify key psychosocial and behavioral processes that underlie how the intervention affects the processes of quitting and maintaining abstinence in Chinese and Vietnamese smokers.
Read the detailed description
Smoking prevalence remains high in subgroups of Asian American men, particularly among those with low English proficiency (LEP) and immigrants from cultures where smoking prevalence is high, including Chinese and Vietnamese. The 2011-12 California Health Interview Survey estimates that nearly half (46%) of all Asian male smokers in California are either Chinese or Vietnamese. The smoking prevalences among LEP Chinese and Vietnamese men were 32% and 43%, respectively, compared to 16% of the general California male population. The investigators developed a family-focused intervention utilizing lay health worker (LWH) outreach that integrates formative qualitative research and selected constructs from Social Network Theory, Social Cognitive Theory, and the Transtheoretical Model. The intervention involves 2 small group education sessions with dyads of smokers and family members, and 2 follow-up individual telephone calls delivered by LHWs over 2 months. Our single-group pilot trial with 96 dyads of Chinese and Vietnamese male daily smokers and their family members showed a high feasibility of recruiting unmotivated smokers (42% were at "precontemplation"), and a promising 7-day point prevalence abstinence rate of 30% at 3 months with independent corroboration from family members. The first aim of the study is to evaluate the efficacy of the family-focused intervention in promoting smoking cessation in Chinese and Vietnamese male smokers. The second aim is to explore mediators to identify key psychosocial and behavioral processes that underlie how the intervention affects the processes of quitting and maintaining abstinence. The investigators will conduct a 2-arm cluster randomized controlled trial (RCT) with assessments at baseline, 6 and 12 months following intervention initiation. The RCT involves 60 lay health workers (LHWs); each recruits and delivers interventions to 6 dyads of one male daily smoker and one family member from his household, for a total 360 smoker-family dyads. Half of the LHWs, stratified by Asian subgroup and smoking history, will be randomized to the family-focused intervention group and the other half will be assigned to an attention control condition receiving education on healthy eating. All participants will receive written information on smoking cessation resources. The investigators hypothesize that, at 6 and 12 month follow-up, the intervention smokers will be more likely to achieve biochemically verified smoking abstinence (7-day point prevalence), to report having made at least one 24-hour quit attempt, and to report using at least one evidence-based smoking cessation resource (telephone counseling or Quitline, medication, health professional advice) than smokers in the control condition. Using prospective quantitative data obtained from the RCT, and post-trial dyadic and individual interviews of 12 smokers and 12 family members selected based on abstinence experiences, the investigators will explore mediators at individual, family and social network levels that explain how the intervention affects quitting and maintaining abstinence. The long-term goal is to understand effective ways to utilize family-based and social outreach strategies to reduce tobacco use disparities in hard-to-reach populations.
- Conditions
- Smoking Cessation, Family, Health Behavior
- Being tested
- Quit Smoking for a Healthy Family, Healthy Living
- Keywords
- Lay Health Workers, Chinese, Vietnamese, Tobacco Use, Intervention, Behavior Change, Social Networks, Asians
- Medical subject headings
- Smoking Cessation, Health Behavior, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quit Smoking for a Healthy FamilyBehavioural
The experimental/intervention study arm focuses on providing smoking cessation education and support through 2 LHW outreach small group educational sessions (4-5 weeks apart) and 2 individual follow-up telephone calls to smoker and family participants separately at 2-3 weeks after each group session for a total of 4 intervention contacts over 2 months. The LHW and dyads will choose the site of sessions, such as the LHW's or a participant's home, or LHW Agency's office. Each small group session will last 90 minutes, be interactive, and involve sharing personal stories, learning using a flip chart, and setting individual goals. Each telephone call will be 15- 20 minutes to reinforce progress and provide support.
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 |
|---|---|---|
| Quit Smoking for a Healthy Family | Experimental | The experimental/intervention study arm focuses on providing smoking cessation education and support through 2 LHW outreach small group educational sessions (4-5 weeks apart) and 2 individual follow-up telephone calls to smoker and family participants separately. Receives: Behavioral: Quit Smoking for a Healthy Family |
| Healthy Living | Active comparator | 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. Receives: Behavioral: Healthy Living |
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term 7-day point prevalence smoking abstinence (smoker participants)
Salivary cotinine will be obtained to provide biochemical verification for participants who report abstinence. A cotinine level of < 12 ng/mL will be considered to verify abstinence. Since nicotine replacement therapy (NRT) use will also produce positive cotinine assays, for participants reporting concurrent NRT use, we will use independent corroboration from family member in lieu of salivary cotinine verification. At Month 12, salivary cotinine will be used for biochemical validation of all smokers reporting abstinence.
Measured: 12 months
number of 24-hour quit attempts (smoker participants)
self-report of making quit attempts that lasted at least for 24 hours since baseline
Measured: 12 months
use of smoking cessation resources since program initiation (smoker participants)
Use of evidence-based smoking cessation resources since program initiation
Measured: 12 months
at least 50% reduction of the amount of cigarettes smoked per day from baseline
smoking reduction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study start1 May 2015
- Primary completion30 Apr 2019
- Study completion31 Mar 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, Chinese Community Health Resource Center, Immigrant Resettlement & Cultural Center, Vietnamese Voluntary Foundation, Inc., Southeast Asian Community Center, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Janice Y Tsoh, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307734
- Sponsor's protocol ID
- R01DA036749
- Other IDs
- R01DA036749
- Status last verified
- Aug 2021
- First submitted
- 24 Nov 2014
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family-Focused Intervention for Asian American Male Smokers
- ClinicalTrials.gov ID
- NCT02307734
- Acronym / sponsor ID
- R01DA036749
- Conditions
- Smoking Cessation, Family, Health Behavior
- Keywords
- Lay Health Workers, Chinese, Vietnamese, Tobacco Use, Intervention, Behavior Change, Social Networks, Asians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Davis, Chinese Community Health Resource Center, Immigrant Resettlement & Cultural Center, Vietnamese Voluntary Foundation, Inc., Southeast Asian Community Center, National Institute on Drug Abuse (NIDA)
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 4 Dec 2014 (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.
This project proposes two aims. The first aim is to evaluate the efficacy of a family-focused intervention in promoting smoking cessation in Chinese and Vietnamese male smokers using a 2-arm cluster randomized controlled trial with assessments at baseline, 6, and 12 months targeting 360 smoker-family dyads. Half of the participants will be assigned to the proposed intervention, and the remaining half will be assigned to an attention-control condition where they will receive education on healthy eating and physical activity. The second aim is to explore mediators to identify key psychosocial and behavioral processes that underlie how the intervention affects the processes of quitting and maintaining abstinence in Chinese and Vietnamese smokers.
Detailed description
Smoking prevalence remains high in subgroups of Asian American men, particularly among those with low English proficiency (LEP) and immigrants from cultures where smoking prevalence is high, including Chinese and Vietnamese. The 2011-12 California Health Interview Survey estimates that nearly half (46%) of all Asian male smokers in California are either Chinese or Vietnamese. The smoking prevalences among LEP Chinese and Vietnamese men were 32% and 43%, respectively, compared to 16% of the general California male population. The investigators developed a family-focused intervention utilizing lay health worker (LWH) outreach that integrates formative qualitative research and selected constructs from Social Network Theory, Social Cognitive Theory, and the Transtheoretical Model. The intervention involves 2 small group education sessions with dyads of smokers and family members, and 2 follow-up individual telephone calls delivered by LHWs over 2 months. Our single-group pilot trial with 96 dyads of Chinese and Vietnamese male daily smokers and their family members showed a high feasibility of recruiting unmotivated smokers (42% were at "precontemplation"), and a promising 7-day point prevalence abstinence rate of 30% at 3 months with independent corroboration from family members. The first aim of the study is to evaluate the efficacy of the family-focused intervention in promoting smoking cessation in Chinese and Vietnamese male smokers. The second aim is to explore mediators to identify key psychosocial and behavioral processes that underlie how the intervention affects the processes of quitting and maintaining abstinence. The investigators will conduct a 2-arm cluster randomized controlled trial (RCT) with assessments at baseline, 6 and 12 months following intervention initiation. The RCT involves 60 lay health workers (LHWs); each recruits and delivers interventions to 6 dyads of one male daily smoker and one family member from his household, for a total 360 smoker-family dyads. Half of the LHWs, stratified by Asian subgroup and smoking history, will be randomized to the family-focused intervention group and the other half will be assigned to an attention control condition receiving education on healthy eating. All participants will receive written information on smoking cessation resources. The investigators hypothesize that, at 6 and 12 month follow-up, the intervention smokers will be more likely to achieve biochemically verified smoking abstinence (7-day point prevalence), to report having made at least one 24-hour quit attempt, and to report using at least one evidence-based smoking cessation resource (telephone counseling or Quitline, medication, health professional advice) than smokers in the control condition. Using prospective quantitative data obtained from the RCT, and post-trial dyadic and individual interviews of 12 smokers and 12 family members selected based on abstinence experiences, the investigators will explore mediators at individual, family and social network levels that explain how the intervention affects quitting and maintaining abstinence. The long-term goal is to understand effective ways to utilize family-based and social outreach strategies to reduce tobacco use disparities in hard-to-reach populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quit Smoking for a Healthy Family | Experimental | Behavioral: Quit Smoking for a Healthy FamilyThe experimental/intervention study arm focuses on providing smoking cessation education and support through 2 LHW outreach small group educational sessions (4-5 weeks apart) and 2 individual follow-up telephone calls to smoker and family participants separately. |
| Healthy Living | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Chinese or Vietnamese males
- Age > 18
- Speak Cantonese or Mandarin (major Chinese dialects) or Vietnamese
- Have smoked at least 1 cigarette daily during the past 7 days, have a family member in the household with whom he will participate in the study, plan to stay in the area for the next 3 months (to complete all intervention activities) and can provide a valid phone number and a mailing address (for follow-up assessments and for sending saliva sample collection kits and payments).
- Family members (male or female) of an eligible smoker
Key exclusion criteria (3 listed)
- Those who are currently in a smoking cessation program or trying to quit smoking with assistance will be excluded.
- Only one smoker-family dyad from a household may participate.
- They must not live in the same household as their own LHW (or another LHW) or have participated in the study at any time (e.g., focus groups not directly related to the intervention implementation)
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 |
|---|---|---|
| Quit Smoking for a Healthy FamilyThe experimental/intervention study arm focuses on providing smoking cessation education and support through 2 LHW outreach small group educational sessions (4-5 weeks apart) and 2 individual follow-up telephone calls to smoker and family participants separately at 2-3 weeks after each group session for a total of 4 intervention contacts over 2 months. The LHW and dyads will choose the site of sessions, such as the LHW's or a participant's home, or LHW Agency's office. Each small group session will last 90 minutes, be interactive, and involve sharing personal stories, learning using a flip chart, and setting individual goals. Each telephone call will be 15- 20 minutes to reinforce progress and provide support. | Behavioural | Quit Smoking for a Healthy Family |
| 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
long-term 7-day point prevalence smoking abstinence (smoker participants)
Time frame: 12 months
Salivary cotinine will be obtained to provide biochemical verification for participants who report abstinence. A cotinine level of < 12 ng/mL will be considered to verify abstinence. Since nicotine replacement therapy (NRT) use will also produce positive cotinine assays, for participants reporting concurrent NRT use, we will use independent corroboration from family member in lieu of salivary cotinine verification. At Month 12, salivary cotinine will be used for biochemical validation of all smokers reporting abstinence.
number of 24-hour quit attempts (smoker participants)
Time frame: 12 months
self-report of making quit attempts that lasted at least for 24 hours since baseline
use of smoking cessation resources since program initiation (smoker participants)
Time frame: 12 months
Use of evidence-based smoking cessation resources since program initiation
at least 50% reduction of the amount of cigarettes smoked per day from baseline
Time frame: 12 months
smoking reduction
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 5 Sep 2021.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quit Smoking for a Healthy Family and Healthy Living in people with Smoking Cessation and Family, run by University of California, San Francisco at 3 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 8 inclusion and 3 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
long-term 7-day point prevalence smoking abstinence (smoker participants) (time frame: 12 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 5 Sep 2021.