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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02007707
First received: November 25, 2013
Last updated: April 14, 2014
Last verified: April 2014
  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: family-based lay health worker intervention for smoking cessation
Behavioral: family-based lay health worker intervention for healthy eating

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    report making at least one 24-hour quit attempt at 6-month post baseline

  • resource utilization [ Time Frame: 6-month ] [ Designated as safety issue: No ]
    report using a recommended evidence-based smoking cessation resource (quitline, FDA-approved smoking cessation medications, advice from health professionals) at 6-month post baseline


Estimated Enrollment: 216
Study Start Date: April 2014
Estimated Study Completion Date: August 2016
Estimated 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 - 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.
Behavioral: family-based lay health worker intervention for smoking cessation
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. 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.
Behavioral: family-based lay health worker intervention for healthy eating

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007707

Contacts
Contact: Janice Y Tsoh, PhD 415-502-8438 jtsoh@lppi.ucsf.edu

Locations
United States, California
Janice Tsoh Recruiting
San Francisco, California, United States, 94143
Contact: Janice Y Tsoh, PhD    415-502-8438    jtsoh@lppi.ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Janice Y Tsoh, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02007707     History of Changes
Other Study ID Numbers: TRDRP 22RT-0089
Study First Received: November 25, 2013
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Asian American
Vietnamese American
Smoking cessation
Community Health Worker
Lay Health Worker Outreach
Family Intervention

ClinicalTrials.gov processed this record on September 22, 2014