A Family-Based Approach To Reduce Smoking in Vietnamese Men (Tobacco LHW)

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

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation; Healthy Eating
• Intervention / Treatment: Behavioral: Tobacco LHW; Behavioral: Healthy Eating

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95122
      • Vietnamese Voluntary Foundation
    • Santa Clara, California, United States, 95112
      • Immigrant Resettlement & Cultural Center (IRCC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tobacco LHW; Quit Smoking For a Healthy Family - family-based psycho-education intervention using lay health worker (LHW) outreach.	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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
smoking abstinence	biochemically verified 7-day point prevalence of smoking abstinence at 6-month post baseline (initiation of intervention)	6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour quit attempt	report making at least one 24-hour quit attempt at 6-month post baseline	6-month
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Janice Y Tsoh, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Smoking cessation; Family Intervention; Community Health Worker; Asian American; Vietnamese American; Lay Health Worker Outreach
• Other Study ID Numbers: TRDRP 22RT-0089