Clinical trial NCT05130788: WeChat Quit Coach Pilot Study
Official title: Feasibility, Acceptability, and Preliminary Effectiveness of a WeChat Quit Coach Smoking Cessation Intervention: A Pilot, Open-labeled, Randomized Controlled Trial Among Chinese Immigrant Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Asian Americans for Equality
name: Chinese American Planning Council
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2021-11-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study team will develop and assess the feasibility and acceptability of a WeChat-based peer-group mobile messaging smoking cessation intervention targeting Chinese immigrant smokers in New York City (NYC). For Aim 1, the study team will develop a message library for the WeChat Quit Coach smoking cessation program and conduct in-depth interviews with 20 Chinese immigrant smokers in person to assess content relevance. For Aim 2, a two-arm, open-labeled, pilot randomized controlled trial (RCT) will be conducted to test the feasibility and acceptability of the WeChat Quit Coach intervention among 60 Chinese immigrant smokers. Participants will be randomized to intervention (n=40) or control group (n=20). Participants in the intervention group will receive a 6-week WeChat Quit Coach intervention through WeChat private group. Participants in the control group will receive a leaflet with information about existing smoking cessation programs that focus on Chinese American smokers. All the 60 participants will be offered a 4-week supple of nicotine replacement therapy (NRT) patches and/or lozenges. Participants will complete a baseline in-person survey at enrollment, a 6-week follow-up phone survey immediately after the intervention, and a 6-month follow-up phone survey. Biochemical test (exhaled carbon monoxide test) will be conducted to confirm abstinence among those who report no smoking in past 7-day at 6-week and 6-month follow-up surveys. Post-test in-depth interviews will be conducted with at least 20 participants in person from the intervention group at 6-week follow-up to obtain more information about the usability and perceptions about the WeChat Quit Coach program. For Aim 3, the investigators will conduct an open-labeled, 3-arm pilot RCT to test the preliminary effectiveness of the WeChat Quit Coach intervention with 90 Chinese immigrant smokers. Participants will be randomized to one of the three groups, including a 6-week intervention group A (IA; n = 30), a 12-week intervention group B (IB; n = 30), and a control group (n = 30). Participants in the intervention groups will either receive a 6-week (IA) or 12-week (IB) WeChat Quit Coach intervention through WeChat private groups. Participants in the control group will receive a leaflet with information of existing smoking cessation programs targeting Chinese American smokers. All 90 participants will be offered a 4-week free supply of NRT patches and/or lozenges. Participants will complete a baseline phone survey at enrollment, 12-week and 6-month follow-up phone surveys. A remote biochemical validation (saliva cotinine test) will be conducted at 12-week and 6-month follow-up to confirm smoking abstinence among those who self-report no smoking in the past 7 days. Post-test in-depth phone interviews will be conducted with up to 30 intervention participants to obtain more information about their perceptions and experience with the WeChat Quit Coach program.


Eligibility criteria: Inclusion Criteria:

Aim 2:

* Age 18-80 years
* Chinese immigrant
* Have smoked at least 100 cigarettes in a lifetime
* Smoke ≥3 days per week
* Be somewhat interested in quitting smoking
* Has a Smartphone
* Current WeChat user who uses WeChat on ≥3 days per week
* Live in NYC
* Can read and speak Chinese
* Be able to provide consent

Aim 3:

* Age 18 years or above
* Chinese immigrant
* Have smoked at least 100 cigarettes in a lifetime
* Smoke ≥1 days per week
* Current WeChat user who uses WeChat on ≥3 days per week
* Can read and speak Chinese

Exclusion Criteria:

Aim 2:

* Current participation in other smoking cessation treatment program(s)
* Be pregnant or breastfeeding

Aim 3:

* Current participation in other smoking cessation treatment program(s)
* Be pregnant or breastfeeding
* Having a household member who has enrolled in this study

Primary outcomes:
measure: Number of Participants Who Respond to Daily Text Questions
timeFrame: Up to Week 6 Follow-Up
measure: Number of Participants Who Ask Self-Composed Questions
timeFrame: Up to Week 6 Follow-Up
measure: WeChat Program Participant Satisfaction Score
timeFrame: Up to Week 6 Follow-Up
measure: Self-Reported 7-Day Point Prevalence Abstinence Rate at Month 6
timeFrame: Month 6 Follow-Up
Secondary outcomes:
measure: Number of Quit Attempts at Week 6
timeFrame: Week 6 Follow-Up
measure: Number of Quit Attempts at Week 12
timeFrame: Week 12 Follow-Up
measure: Number of Quit Attempts at Month 6
timeFrame: Month 6 Follow-Up
measure: Average Daily Cigarette Consumption at Week 6
timeFrame: Week 6 Follow-Up
measure: Average Daily Cigarette Consumption at Week 12
timeFrame: Week 12 Follow-Up
measure: Average Daily Cigarette Consumption at Month 6
timeFrame: Month 6 Follow-Up
measure: Self-Reported 7-Day Point Prevalence Abstinence Rate at Week 6
timeFrame: Week 6 Follow-Up
measure: Self-Reported 7-Day Point Prevalence Abstinence Rate at Week 12
timeFrame: Week 12 Follow-Up
measure: Self-Reported 7-Day Point Prevalence Abstinence Rate at Month 6 - Aim 2
timeFrame: Month 6 Follow-Up
measure: Biochemically-Confirmed 7-Day Point Prevalence Abstinence Rate at Week 6
timeFrame: Week 6 Follow-Up
measure: Biochemically-Confirmed 7-Day Point Prevalence Abstinence Rate at Week 12
timeFrame: Week 12 Follow-Up
measure: Biochemically-Confirmed 7-Day Point Prevalence Abstinence Rate at Month 6
timeFrame: Month 6 Follow-Up
measure: Average Score or Knowledge About Harms of Smoking at Week 6
timeFrame: Week 6 Follow-Up
measure: Average Score or Knowledge About Harms of Smoking at Week 12
timeFrame: Week 12 Follow-Up
measure: Self-Efficacy for Quitting Smoking Score at Week 6
timeFrame: Week 6 Follow-Up
measure: Self-Efficacy for Quitting Smoking Score at Week 12
timeFrame: Week 12 Follow-Up
measure: Self-Efficacy for Quitting Smoking Score at Month 6
timeFrame: Month 6 Follow-Up
measure: Number of Participants With Progression on Stage of Change for Smoking Cessation at Week 6
timeFrame: Week 6 Follow-Up
measure: Number of Participants With Progression on Stage of Change for Smoking Cessation at Week 12
timeFrame: Week 12 Follow-Up
measure: Number of Participants With Progression on Stage of Change for Smoking Cessation at Month 6
timeFrame: Month 6 Follow-Up
measure: Number of Participants who Report NRT Use During Intervention Period at Week 6
timeFrame: Week 6 Follow-Up
measure: Number of Participants who Report NRT Use During Intervention Period at Week 12
timeFrame: Week 12 Follow-Up
measure: Number of Participants who Report NRT Use During Intervention Period at Month 6
timeFrame: Month 6 Follow-Up
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nan Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: