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A Family-Based Approach To Reduce Smoking in Vietnamese Men (Tobacco LHW)
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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 |
- smoking abstinence [ Time Frame: 6-month ]biochemically verified 7-day point prevalence of smoking abstinence at 6-month post baseline (initiation of intervention)
- 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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02007707
| United States, California | |
| Vietnamese Voluntary Foundation | |
| San Jose, California, United States, 95122 | |
| Immigrant Resettlement & Cultural Center (IRCC) | |
| Santa Clara, California, United States, 95112 | |
| 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 |
| Study First Received: | November 25, 2013 |
| Last Updated: | May 5, 2017 |
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 August 18, 2017