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Completed

NCT Number: NCT02007707

A Family-Based Approach To Reduce Smoking in Vietnamese Men

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vietnamese Voluntary Foundation, San Jose, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: Tobacco LHW

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Dec 11, 2013
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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