A Family-Based Approach To Reduce Smoking in Vietnamese Men

Tobacco Use Cessation Clinical Trial

— Tobacco LHW  

Official title:

A Family-Based Approach To Reduce Smoking in Vietnamese Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007707
• Other study ID #: TRDRP 22RT-0089
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: October 2018

Study information

• Verified date: August 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goals of the study are to develop smoking cessation intervention using lay health worker (LHW) outreach and family involvement targeting Vietnamese Americans ages 18 and above in Santa Clara County, CA, to evaluate efficacy of the proposed intervention. The study is a two-arm randomized controlled trial targeting a total of 18 lay health workers (LHW) and 108 dyads of a smoker and a family member from the same household. The hypotheses are:

H. At 6-month post initiation of the intervention, Vietnamese male daily smokers who receive the proposed ―Quit Smoking For a Healthy Family Intervention, a Family-based Intervention (FI), will be more likely to achieve biochemically verified 7-day point prevalence of smoking abstinence when compared to those receiving an attention control intervention (CI).

H2. At 6-month, FI participants we be more likely to report making at least one 24-hour quit attempt than those in CI.

H3. At 6-month, FI participants will be more likely to report using a recommended evidence-based smoking cessation resource (quitline, FDA-approved smoking cessation medications, advice from health professionals) than those in CI

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: October 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• self-identified as Vietnamese, Vietnamese-American, or Vietnamese-Chinese;

• Vietnamese speaking;

• reside in the Santa Clara County, California

• plan to stay in the area (Santa Clara County, California) for the next 6 months

• for the smoker participants, they must be male and have smoked at least 1 cigarette daily in the past 7 days.

• for family member participants, the participant must live in the same household as the smoker participant to form a dyad.

• provide a valid contact telephone number for pre- and post-intervention assessments.

Exclusion Criteria:

• For smoker participants, currently engaging in assisted smoking cessation efforts

Related Conditions & MeSH terms

• Healthy Eating
• Tobacco Use Cessation

Intervention

Behavioral:
• Tobacco LHW
Quit Smoking For a Healthy Family - This is a family-based psycho-education intervention using lay health worker (LHW) outreach. LHW will be trained to recruit smoke-family dyads and provide education and information about tobacco and health, and smoking cessation resources through 2 small-group education sessions and 2 individual phone calls over a 2-month period.
• Healthy Eating
Eating Healthy and Physically Active for You and Your Family - This is a attention-control comparison group using a family-based psycho-education intervention delivered through lay health worker (LHW) outreach. LHW will be trained to recruit smoke-family dyads and provide education and information about healthy eating and physical activity through 2 small-group education sessions and 2 individual phone calls over a 2-month period. Participants will receive writing information about smoking cessation resources.

Locations

Country	Name	City	State
United States	Vietnamese Voluntary Foundation	San Jose	California
United States	Immigrant Resettlement & Cultural Center (IRCC)	Santa Clara	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking abstinence	biochemically verified 7-day point prevalence of smoking abstinence at 6-month post baseline (initiation of intervention)	6-month
Secondary	24-hour quit attempt	report making at least one 24-hour quit attempt at 6-month post baseline	6-month
Secondary	resource utilization	report using a recommended evidence-based smoking cessation resource (quitline, FDA-approved smoking cessation medications, advice from health professionals) at 6-month post baseline	6-month