A Family-Focused Intervention for Asian American Male Smokers

NCT02307734 | Completed DMC

• 1 other identifier: R01DA036749
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 3

Brief Summary

This project proposes two aims. The first aim is to evaluate the efficacy of a family-focused intervention in promoting smoking cessation in Chinese and Vietnamese male smokers using a 2-arm cluster randomized controlled trial with assessments at baseline, 6, and 12 months targeting 360 smoker-family dyads. Half of the participants will be assigned to the proposed intervention, and the remaining half will be assigned to an attention-control condition where they will receive education on healthy eating and physical activity. The second aim is to explore mediators to identify key psychosocial and behavioral processes that underlie how the intervention affects the processes of quitting and maintaining abstinence in Chinese and Vietnamese smokers.

Conditions

Smoking Cessation; Family; Health Behavior

Keywords

Lay Health Workers; Chinese; Vietnamese; Tobacco Use; Intervention; Behavior Change; Social Networks; Asians

Outcome Measures

Primary Outcomes (4)

• long-term 7-day point prevalence smoking abstinence (smoker participants)

  Salivary cotinine will be obtained to provide biochemical verification for participants who report abstinence. A cotinine level of \< 12 ng/mL will be considered to verify abstinence. Since nicotine replacement therapy (NRT) use will also produce positive cotinine assays, for participants reporting concurrent NRT use, we will use independent corroboration from family member in lieu of salivary cotinine verification. At Month 12, salivary cotinine will be used for biochemical validation of all smokers reporting abstinence.

  12 months

• number of 24-hour quit attempts (smoker participants)

  self-report of making quit attempts that lasted at least for 24 hours since baseline

  12 months

• use of smoking cessation resources since program initiation (smoker participants)

  Use of evidence-based smoking cessation resources since program initiation

  12 months

• at least 50% reduction of the amount of cigarettes smoked per day from baseline

  smoking reduction

  12 months

Study Arms (2)

Quit Smoking for a Healthy Family

EXPERIMENTAL

The experimental/intervention study arm focuses on providing smoking cessation education and support through 2 LHW outreach small group educational sessions (4-5 weeks apart) and 2 individual follow-up telephone calls to smoker and family participants separately.

Behavioral: Quit Smoking for a Healthy Family

Healthy Living

ACTIVE COMPARATOR

In this comparison arm, participants will receive the same number of contacts on the same schedule and in the same format (2 small group sessions and 2 telephone calls). The comparison LHWs will receive training about "Healthy Living" focusing on nutrition and physical activity education. Participants will also receive the Smoking Cessation Resource Handout.

Behavioral: Healthy Living

Interventions

Quit Smoking for a Healthy Family BEHAVIORAL

The experimental/intervention study arm focuses on providing smoking cessation education and support through 2 LHW outreach small group educational sessions (4-5 weeks apart) and 2 individual follow-up telephone calls to smoker and family participants separately at 2-3 weeks after each group session for a total of 4 intervention contacts over 2 months. The LHW and dyads will choose the site of sessions, such as the LHW's or a participant's home, or LHW Agency's office. Each small group session will last 90 minutes, be interactive, and involve sharing personal stories, learning using a flip chart, and setting individual goals. Each telephone call will be 15- 20 minutes to reinforce progress and provide support.

Quit Smoking for a Healthy Family

Healthy Living BEHAVIORAL

In this comparison arm, participants will receive the same number of contacts on the same schedule and in the same format (2 small group sessions and 2 telephone calls). The comparison LHWs will receive training about "Healthy Living" focusing on nutrition and physical activity education. Participants will also receive the Smoking Cessation Resource Handout.

Healthy Living

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese or Vietnamese males
• Age \> 18
• Speak Cantonese or Mandarin (major Chinese dialects) or Vietnamese
• Have smoked at least 1 cigarette daily during the past 7 days, have a family member in the household with whom he will participate in the study, plan to stay in the area for the next 3 months (to complete all intervention activities) and can provide a valid phone number and a mailing address (for follow-up assessments and for sending saliva sample collection kits and payments).

You may not qualify if:

• Those who are currently in a smoking cessation program or trying to quit smoking with assistance will be excluded.
• Family members (male or female) of an eligible smoker
• Age \> 18
• Speak Cantonese or Mandarin (major Chinese dialects) or Vietnamese
• Have never smoked or have formerly smoked but have not had any cigarette in the year prior to participation
• Only one smoker-family dyad from a household may participate.
• They must not live in the same household as their own LHW (or another LHW) or have participated in the study at any time (e.g., focus groups not directly related to the intervention implementation)

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Davis: collaborator
• Chinese Community Health Resource Center: collaborator
• Immigrant Resettlement & Cultural Center: collaborator
• Vietnamese Voluntary Foundation, Inc.: collaborator
• Southeast Asian Community Center: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Southeast Asian Community Center (SEACC)

San Francisco, California, 94109, United States

Location

Chinese Community Health Resource Center

San Francisco, California, 94133, United States

Location

Vietnamese Voluntary Foundation

San Jose, California, 95122, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Health Behavior; Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Janice Y Tsoh, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 4, 2014
• Study Start: May 1, 2015
• Primary Completion: April 30, 2019
• Study Completion: March 31, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

US (3)