Healthy Family Project: Tobacco Use and Smoke Exposure in Asian American Communities
NCT ID: NCT07049757
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
760 participants
INTERVENTIONAL
2025-06-11
2027-12-31
Brief Summary
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Detailed Description
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I. Integrate the original "Quit Smoking for a Healthy Family" (QS) curriculum with the third-hand smoke education and cleaning intervention (THS) into a new intervention titled "Smokefree Family Living" (SFL) for Chinese immigrant families and household members.
II. Examine the efficacy of SFL by measuring smoking cessation rates at six months and the reduction in third-hand smoke exposure among smokers and nonsmoking household member participants, respectively, using a 2-arm randomized trial targeting 320 smoker-household member dyads from the Chinese American communities.
SECONDARY OBJECTIVE:
I. Examine individual and social pathways mediating the outcomes for cessation attempts, abstinence, and tobacco smoke exposure.
EXPLORATORY OBJECTIVES:
I. Explore the long-term impacts of the THS education and the timing of the accessibility of the THS intervention by examining time to first 30-day quit attempts and duration of quit attempts after exposure to THS intervention in both intervention groups of a subsample available for 12-month follow-up.
II. To compare the long-term efficacy of the SFL and QS interventions in sustaining smoking cessation and reducing tobacco smoke exposure.
III. To evaluate the feasibility and effectiveness of using silicone wristbands to measure third-hand smoke (THS) exposure among non-smoking household members of Chinese American smokers participating in the study.
IV. Assess the behavioral changes related to smoking and smoke exposure, as well as the psychosocial impact of the interventions on participants and their household members.
OUTLINE:
A family-based intervention development phase prior to the randomized study will integrate the original "Quit Smoking for a Healthy Family" (QS) curriculum of the Healthy Family Project with the third-hand smoke education and cleaning intervention (THS) into a newly integrated intervention named "Smokefree Family Living" (SFL) for Chinese immigrant families and household members. Information collected from this group will be used to refine and develop the final SFL intervention used in the subsequent clinical trial. These participants will not be included in final study analyses.
Participants enrolled after the focus group data has been evaluated for implementation will be randomized to 1 of 2 arms.
ARM I: Participants attend two QS educational sessions over 45-60 minutes one month apart and receive two follow-up phone calls over 15-30 minutes 1-2 weeks after each session over 6 weeks. Participants also receive a Healthy Family Action Plan as well as a smoking cessation resource guide and set goals on study. Participants then receive THS education and cleaning strategies at 6 months. Additionally, participants undergo urine sample collection throughout the study.
ARM II: Participants attend two QS educational sessions over 45-60 minutes one month apart and receive two follow-up phone calls over 15-30 minutes 1-2 weeks after each session over 6 weeks. During the second QS educational session, participants receive THS education and cleaning strategies. Participants also receive a Healthy Family Action Plan as well as a smoking cessation resource guide and set goals on study. Additionally, participants undergo urine sample collection throughout the study.
After completion of study intervention, participants are followed up at 6 and 12 months.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Intervention Development (Focus group + Interview)
To achieve information gathering and preliminary adaptation design to prepare for the randomized clinical trial, focus groups and individual interviews with 24 participants (6 Chinese current smokers; 6 former smokers who have stopped smoking within the past 2 years; and 12 family/household members living with a current/former smoker) to review the newly developed or updated intervention materials. The Community Advisory Board (CAB) will also be involved in providing input.
Focus Group
Participants will review and comment on materials under development to be used in randomized clinical trial.
Arm I: Quit Smoking for a Healthy Family Group (QS)
Participants attend two QS educational sessions over 45-60 minutes one month apart and receive two follow-up phone calls over 15-30 minutes 1-2 weeks after each session over 6 weeks. Participants also receive a Healthy Family Action Plan as well as a smoking cessation resource guide and set goals on study. Participants then receive THS education and cleaning strategies at 6 months after the initial QS curriculum. Additionally, participants undergo urine sample collection throughout the study and non-smoking family/household members will wear a silicone wristband for 2 days at each assessment.
Smoking cessation education
Quit Smoking for a Healthy Family (QS) and Smokefree Family Living (SFL) education sessions to promote smoking cessation and reduce tobacco smoke exposure.
Survey Administration
Administered for ancillary studies
Telephone-Based Intervention
Participants will receive follow-up calls
Urine Specimen Collection
Undergo urine sample collection at baseline
Silicone Wrist Band
Non-smoking family/household members will wear a silicone wristband for 2 days at each assessment for ancillary studies
Interview
Selected participants will take part in an interview for ancillary studies
Arm II: Smokefree Family Living Group (SFL)
Participants attend two QS educational sessions over 45-60 minutes one month apart and receive two follow-up phone calls over 15-30 minutes 1-2 weeks after each session over 6 weeks. During the second QS educational session, participants receive THS education and cleaning strategies. Participants also receive a Healthy Family Action Plan as well as a smoking cessation resource guide and set goals on study. Additionally, participants undergo urine sample collection throughout the study and non-smoking family/household members will wear a silicone wristband for 2 days at each assessment.
Smoking cessation education
Quit Smoking for a Healthy Family (QS) and Smokefree Family Living (SFL) education sessions to promote smoking cessation and reduce tobacco smoke exposure.
Survey Administration
Administered for ancillary studies
Telephone-Based Intervention
Participants will receive follow-up calls
Urine Specimen Collection
Undergo urine sample collection at baseline
Silicone Wrist Band
Non-smoking family/household members will wear a silicone wristband for 2 days at each assessment for ancillary studies
Interview
Selected participants will take part in an interview for ancillary studies
Interventions
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Smoking cessation education
Quit Smoking for a Healthy Family (QS) and Smokefree Family Living (SFL) education sessions to promote smoking cessation and reduce tobacco smoke exposure.
Survey Administration
Administered for ancillary studies
Telephone-Based Intervention
Participants will receive follow-up calls
Urine Specimen Collection
Undergo urine sample collection at baseline
Silicone Wrist Band
Non-smoking family/household members will wear a silicone wristband for 2 days at each assessment for ancillary studies
Interview
Selected participants will take part in an interview for ancillary studies
Focus Group
Participants will review and comment on materials under development to be used in randomized clinical trial.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Must be 18 years of age or older.
2. Must self-identify as Chinese or of Chinese descent (ethnic or cultural identification, not national origin).
3. Must be able to understand in spoken Chinese (Cantonese and/or Mandarin) or English.
4. Able to attend educational sessions in person or via video conferencing.
5. Ability to understand and the willingness to sign a written informed consent document.
Lay Health Workers:
1. Must have experience or interest in community outreach and education.
2. Must demonstrate proficiency in language (Cantonese and/or Mandarin or English) sufficient to deliver study materials and interact with participants.
3. Must be affiliated with the Chinese Community Health Resource Center (CCHRC) or recruited through community networks.
4. Must agree to participate in training and intervention delivery activities as outlined in the study protocol.
Smokers (Participants who are current smokers):
1. Must have smoked within the past 30 days, either daily or occasionally.
2. Must have a non-smoking household member.
Family Participants (Non-smoking family/household members):
1. Must live in the same household as the smoker participant.
2. Must not have used any tobacco products in the past 30 days.
Post-Trial Household Member Group Interview Participants:
1\. Living in the same household with the smoker-household member dyad participant being interviewed or considered as a household member.
Exclusion Criteria
1. Currently participating in another smoking cessation program.
2. Non-residents of California.
3. Participants unwilling to provide follow-up contact for assessments at 6 and 12 months.
Lay Health Workers:
1. Lack of willingness or ability to complete training or deliver intervention sessions as required by the study protocol.
2. Inability to maintain confidentiality and professionalism during interactions with study participants.
3. Active participation in conflicting research studies or programs.
18 Years
ALL
Yes
Sponsors
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Tobacco Related Disease Research Program
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Janice Tsoh, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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NCI-2025-00206
Identifier Type: REGISTRY
Identifier Source: secondary_id
24634
Identifier Type: -
Identifier Source: org_study_id
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