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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02007707
First Posted: December 11, 2013
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose

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 Intervention
Tobacco Use Cessation Healthy Eating Behavioral: Tobacco LHW Behavioral: Healthy Eating

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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:
  • 24-hour quit attempt [ Time Frame: 6-month ]
    report making at least one 24-hour quit attempt at 6-month post baseline

  • 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


Enrollment: 214
Actual Study Start Date: April 2014
Study Completion Date: January 2017
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007707


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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02007707     History of Changes
Other Study ID Numbers: TRDRP 22RT-0089
First Submitted: November 25, 2013
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