Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 2:58 AM
Study NCT ID:
NCT07049757
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Family Project: Tobacco Use and Smoke Exposure in Asian American Communities
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Healthy Family Project: Ending Tobacco Use and Smoke Exposure in Asian American Communities
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
PRIMARY OBJECTIVES:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-00206 | REGISTRY | NCI Clinical Trials Reporting Program (CTRP) | View |