A Family-Based Approach To Reduce Smoking in Vietnamese Men

NCT02007707 | Completed DMC

• 1 other identifier: TRDRP 22RT-0089
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• smoking abstinence

  biochemically verified 7-day point prevalence of smoking abstinence at 6-month post baseline (initiation of intervention)

  6-month

Secondary Outcomes (2)

• 24-hour quit attempt

  6-month

• resource utilization

  6-month

Study Arms (2)

Tobacco LHW

EXPERIMENTAL

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

Behavioral: Tobacco LHW

Healthy Eating

ACTIVE COMPARATOR

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

Interventions

Tobacco LHW 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.

Tobacco LHW

Healthy Eating 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.

Healthy Eating

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

Vietnamese Voluntary Foundation

San Jose, California, 95122, United States

Location

Immigrant Resettlement & Cultural Center (IRCC)

Santa Clara, California, 95112, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Smoking Cessation

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Janice Y Tsoh, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 11, 2013
• Study Start: April 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2018
• Last Updated: August 6, 2019

Record last verified: 2019-08

Locations

US (2)