Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-03 @ 4:04 PM
Study NCT ID:
NCT02307734
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2014-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Family-Focused Intervention for Asian American Male Smokers
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
A Family-Focused Intervention for Asian American Male Smokers
Status:
COMPLETED
Status Verified Date:
2021-08
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 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|---|
| R01DA036749 | NIH | None | https://reporter.nih.gov/quic… | View |