Overview

This trial is active, not recruiting.

Conditions tobacco use cessation, healthy eating
Treatments tobacco lhw, healthy eating
Sponsor University of California, San Francisco
Start date April 2014
End date June 2016
Trial size 214 participants
Trial identifier NCT02007707, TRDRP 22RT-0089

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Quit Smoking For a Healthy Family - family-based psycho-education intervention using lay health worker (LHW) outreach.
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)
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.
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.

Primary Outcomes

Measure
smoking abstinence
time frame: 6-month

Secondary Outcomes

Measure
24-hour quit attempt
time frame: 6-month
resource utilization
time frame: 6-month

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Family-Based Approach To Reduce Smoking in Vietnamese Men
Principal investigator Janice Y Tsoh, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.