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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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

Condition or disease	Intervention/treatment	Phase
Tobacco Use Cessation; Healthy Eating	Behavioral: Tobacco LHW; Behavioral: Healthy Eating	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	214 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	A Family-Based Approach To Reduce Smoking in Vietnamese Men
Actual Study Start Date :	April 2014
Actual Primary Completion Date :	June 2016
Actual Study Completion Date :	January 2017

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. smoking abstinence [ Time Frame: 6-month ]
   biochemically verified 7-day point prevalence of smoking abstinence at 6-month post baseline (initiation of intervention)

Secondary Outcome Measures :

1. 24-hour quit attempt [ Time Frame: 6-month ]
   report making at least one 24-hour quit attempt at 6-month post baseline
2. resource utilization [ Time Frame: 6-month ]
   report using a recommended evidence-based smoking cessation resource (quitline, FDA-approved smoking cessation medications, advice from health professionals) at 6-month post baseline

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of California, San Francisco

Investigators

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

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT02007707 History of Changes
Other Study ID Numbers:	TRDRP 22RT-0089
First Posted:	December 11, 2013
Last Update Posted:	May 9, 2017
Last Verified:	May 2017

Keywords provided by University of California, San Francisco:

Asian American; Vietnamese American; Smoking cessation	Community Health Worker; Lay Health Worker Outreach; Family Intervention