A Family-Focused Intervention for Asian American Male Smokers

August 30, 2021 updated by: University of California, San Francisco
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
680

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94133
        • Chinese Community Health Resource Center
      • San Francisco, California, United States, 94109
        • Southeast Asian Community Center (SEACC)
      • San Jose, California, United States, 95122
        • Vietnamese Voluntary Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria (for smoker participants):

  • 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).

Exclusion Criteria (for smoker participants):

  • Those who are currently in a smoking cessation program or trying to quit smoking with assistance will be excluded.

Inclusion Criteria (for family participants):

  • 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

Exclusion Criteria (for family participants):

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Quit Smoking for a Healthy Family
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.
Behavioral: Quit Smoking for a Healthy Family
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.
Active Comparator: Healthy Living
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.
Behavioral: Healthy Living
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months
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
12 months
use of smoking cessation resources since program initiation (smoker participants)
Time Frame: 12 months
Use of evidence-based smoking cessation resources since program initiation
12 months
at least 50% reduction of the amount of cigarettes smoked per day from baseline
Time Frame: 12 months
smoking reduction
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
University of California, Davis
Chinese Community Health Resource Center
Immigrant Resettlement & Cultural Center
Vietnamese Voluntary Foundation, Inc.
Southeast Asian Community Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Janice Y Tsoh, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01DA036749 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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