NCT07049757

Brief Summary

This study evaluates whether the Smokefree Family Living (SFL) intervention improves quit rates (smoking cessation) and exposure to tobacco contamination that stays in items such as, carpets, walls, and furniture, even after the smoke has cleared (third-hand smoke (THS)) among Chinese American smokers and their non-smoking household members. Smoking remains high among Chinese American males with limited ability to speak English. This causes the non-smoking household members to be exposed to THS, which contains many of the same harmful components as smoking and becomes more toxic as it ages. SFL is tailored for Chinese Americans and combines the contents of the Quit Smoking for a Healthy Family (QS) intervention with additional THS education and cleaning strategies. QS focuses on smoking cessation through educational sessions and support. THS education and cleaning strategies provide information on THS and how to clean the home for THS. SFL may help Chinese American smokers and their non-smoking household members learn about the importance of quitting and the dangers of THS, this may improve smoking cessation and reduce THS exposure

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
760

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Jun 2025Dec 2027

Study Start

First participant enrolled

June 11, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

June 25, 2025

Last Update Submit

March 19, 2026

Conditions

Keywords

Third-hand Smoke

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants who have quit smoking at 6 months

    The smoking cessation rate is defined as the proportion of smokers who report quitting smoking, with biochemically verified 30-day point prevalent abstinence at the 6-month follow-up. Smoking rates will be reported by arm.

    6 months

Secondary Outcomes (2)

  • Change in levels of tobacco smoke biomarkers for second-(SHS)hand smoke exposure

    Up to 6 months

  • Proportion of participants who have quit smoking at 12 months

    Up to 12 months

Study Arms (3)

Intervention Development (Focus group + Interview)

EXPERIMENTAL

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.

Other: Focus Group

Arm I: Quit Smoking for a Healthy Family Group (QS)

ACTIVE COMPARATOR

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.

Other: Smoking cessation educationBehavioral: Survey AdministrationBehavioral: Telephone-Based InterventionProcedure: Urine Specimen CollectionOther: Silicone Wrist BandOther: Interview

Arm II: Smokefree Family Living Group (SFL)

EXPERIMENTAL

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.

Other: Smoking cessation educationBehavioral: Survey AdministrationBehavioral: Telephone-Based InterventionProcedure: Urine Specimen CollectionOther: Silicone Wrist BandOther: Interview

Interventions

Quit Smoking for a Healthy Family (QS) and Smokefree Family Living (SFL) education sessions to promote smoking cessation and reduce tobacco smoke exposure.

Also known as: Education for Intervention, Intervention by Education, Intervention through Education
Arm I: Quit Smoking for a Healthy Family Group (QS)Arm II: Smokefree Family Living Group (SFL)

Administered for ancillary studies

Also known as: Questionnaires
Arm I: Quit Smoking for a Healthy Family Group (QS)Arm II: Smokefree Family Living Group (SFL)

Participants will receive follow-up calls

Also known as: Telephone-Based Follow-up
Arm I: Quit Smoking for a Healthy Family Group (QS)Arm II: Smokefree Family Living Group (SFL)

Undergo urine sample collection at baseline

Also known as: Urine Sample
Arm I: Quit Smoking for a Healthy Family Group (QS)Arm II: Smokefree Family Living Group (SFL)

Non-smoking family/household members will wear a silicone wristband for 2 days at each assessment for ancillary studies

Arm I: Quit Smoking for a Healthy Family Group (QS)Arm II: Smokefree Family Living Group (SFL)

Selected participants will take part in an interview for ancillary studies

Also known as: In-depth interview
Arm I: Quit Smoking for a Healthy Family Group (QS)Arm II: Smokefree Family Living Group (SFL)

Participants will review and comment on materials under development to be used in randomized clinical trial.

Intervention Development (Focus group + Interview)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All Participants (Lay Health Workers, Smokers, Family Participants, and Post-Trial Household Member Group Interview Participants):
  • Must be 18 years of age or older.
  • Must self-identify as Chinese or of Chinese descent (ethnic or cultural identification, not national origin).
  • Must be able to understand in spoken Chinese (Cantonese and/or Mandarin) or English.
  • Able to attend educational sessions in person or via video conferencing.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Have a mobile phone that can receive Short Message Service (SMS) text messages, or an email address and a phone number where they can be reached by the study team.
  • Lay Health Workers:
  • Must have experience or interest in community outreach and education.
  • Must demonstrate proficiency in language (Cantonese and/or Mandarin or English) sufficient to deliver study materials and interact with participants.
  • Must be affiliated with the Chinese Community Health Resource Center (CCHRC) or recruited through community networks.
  • Must agree to participate in training and intervention delivery activities as outlined in the study protocol.
  • Smokers (Participants who are current smokers):
  • Must have smoked within the past 30 days, either daily or occasionally.
  • Must have a non-smoking household member.
  • +5 more criteria

You may not qualify if:

  • Lay Health Workers, Smokers (Participants who are current smokers) and Family Participants (Non-smoking Family/household members):
  • Currently participating in another smoking cessation program.
  • Non-residents of California.
  • Participants unwilling to provide follow-up contact for assessments at 6 and 12 months.
  • Lay Health Workers:
  • Lack of willingness or ability to complete training or deliver intervention sessions as required by the study protocol.
  • Inability to maintain confidentiality and professionalism during interactions with study participants.
  • Active participation in conflicting research studies or programs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94122, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Educational StatusMethodsSurveys and QuestionnairesUrine Specimen CollectionInterviews as TopicFocus Groups

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Janice Tsoh, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 3, 2025

Study Start

June 11, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations