Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02307734 |
Other study ID # |
R01DA036749 |
Secondary ID |
R01DA036749 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2015 |
Est. completion date |
March 31, 2020 |
Study information
Verified date |
August 2021 |
Source |
University of California, San Francisco |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.