A Family-Based Approach To Reduce Smoking in Vietnamese Men

NCT ID: NCT02007707

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-10-31

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

Conditions

Tobacco Use Cessation; Healthy Eating

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Tobacco LHW

Quit Smoking For a Healthy Family - family-based psycho-education intervention using lay health worker (LHW) outreach.

Group Type: EXPERIMENTAL

Tobacco LHW

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Healthy Eating

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janice Y Tsoh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Vietnamese Voluntary Foundation

San Jose, California, United States

Immigrant Resettlement & Cultural Center (IRCC)

Santa Clara, California, United States

Countries

United States

Other Identifiers

TRDRP 22RT-0089

Identifier Type: -

Identifier Source: org_study_id