- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05130788
WeChat Quit Coach Pilot Study
April 8, 2025 updated by: NYU Langone Health
Feasibility, Acceptability, and Preliminary Effectiveness of a WeChat Quit Coach Smoking Cessation Intervention: A Pilot, Open-labeled, Randomized Controlled Trial Among Chinese Immigrant Smokers
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
|
Participants in both groups will be offered a 4-week supply of NRT patches and lozenges but not forced to use the medications.
The medications are free to participants.
If participants want to try or use the medications, the study team will mail the patches and lozenges (with a Chinese version of the instruction) or deliver in person.
Other Names:
Participants in the control group will receive a leaflet with information about existing smoking cessation programs targeting Chinese American smokers.
|
|
Experimental: Intervention Group A
Participants will be assigned to a 6-week intervention period.
|
Participants in both groups will be offered a 4-week supply of NRT patches and lozenges but not forced to use the medications.
The medications are free to participants.
If participants want to try or use the medications, the study team will mail the patches and lozenges (with a Chinese version of the instruction) or deliver in person.
Other Names:
WeChat Quit Coach intervention will be delivered via WeChat private groups for 6-12 weeks (<30 seconds per day).
During the intervention period, participants will receive a text message at a fixed point of time every day (e.g., 8:00 am).
The messages are designed to build motivations and skillset to quit smoking.
Participants will also receive a daily group discussion question (e.g., "If you are to give one piece of advice to someone who has not made the decision to quit smoking, what would you say to his/her?"), and be encouraged to respond to the question.
Participants can comment on group members' responses and ask questions related to smoking and quitting either in group (so everyone in the group can see the message) or directly to the coach (so only the coach can see the message).
The coach will respond to the questions within 24 hours.
The PI and the RA will moderate group discussions.
|
|
Experimental: Intervention Group B
Participants will be assigned to a 12-week intervention period.
|
Participants in both groups will be offered a 4-week supply of NRT patches and lozenges but not forced to use the medications.
The medications are free to participants.
If participants want to try or use the medications, the study team will mail the patches and lozenges (with a Chinese version of the instruction) or deliver in person.
Other Names:
WeChat Quit Coach intervention will be delivered via WeChat private groups for 6-12 weeks (<30 seconds per day).
During the intervention period, participants will receive a text message at a fixed point of time every day (e.g., 8:00 am).
The messages are designed to build motivations and skillset to quit smoking.
Participants will also receive a daily group discussion question (e.g., "If you are to give one piece of advice to someone who has not made the decision to quit smoking, what would you say to his/her?"), and be encouraged to respond to the question.
Participants can comment on group members' responses and ask questions related to smoking and quitting either in group (so everyone in the group can see the message) or directly to the coach (so only the coach can see the message).
The coach will respond to the questions within 24 hours.
The PI and the RA will moderate group discussions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Respond to Daily Text Questions
Time Frame: Up to Week 6 Follow-Up
|
Measure of engagement.
Measured among Aim 2 participants only.
|
Up to Week 6 Follow-Up
|
|
Number of Participants Who Ask Self-Composed Questions
Time Frame: Up to Week 6 Follow-Up
|
Measure of engagement.
Measured among Aim 2 participants only.
|
Up to Week 6 Follow-Up
|
|
WeChat Program Participant Satisfaction Score
Time Frame: Up to Week 6 Follow-Up
|
A 5-point Likert scale will be used to report satisfaction.
The total range in score is 1-5; the higher the score, the higher the satisfaction.
Measured among Aim 2 participants only.
|
Up to Week 6 Follow-Up
|
|
Self-Reported 7-Day Point Prevalence Abstinence Rate at Month 6
Time Frame: Month 6 Follow-Up
|
Participants are asked whether they smoked cigarettes in the past 7 days.
Measured among Aim 3 participants only.
|
Month 6 Follow-Up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Daily Cigarette Consumption at Month 6
Time Frame: Month 6 Follow-Up
|
Month 6 Follow-Up
|
|
|
Biochemically-Confirmed 7-Day Point Prevalence Abstinence Rate at Month 6
Time Frame: Month 6 Follow-Up
|
Participants are asked whether they smoked cigarettes in the past 7 days.
Biochemical test (exhaled carbon monoxide test) will be conducted to confirm abstinence among those who report no smoking in past 7 days.
|
Month 6 Follow-Up
|
|
Number of Participants who Report NRT Use During Intervention Period at Month 6
Time Frame: Month 6 Follow-Up
|
Month 6 Follow-Up
|
|
|
Number of Quit Attempts at Week 6
Time Frame: Week 6 Follow-Up
|
Measured among Aim 2 participants only.
|
Week 6 Follow-Up
|
|
Number of Quit Attempts at Week 12
Time Frame: Week 12 Follow-Up
|
Measured among Aim 3 participants only.
|
Week 12 Follow-Up
|
|
Number of Quit Attempts at Month 6
Time Frame: Month 6 Follow-Up
|
Month 6 Follow-Up
|
|
|
Average Daily Cigarette Consumption at Week 6
Time Frame: Week 6 Follow-Up
|
Measured among Aim 2 participants only.
|
Week 6 Follow-Up
|
|
Average Daily Cigarette Consumption at Week 12
Time Frame: Week 12 Follow-Up
|
Measured among Aim 3 participants only.
|
Week 12 Follow-Up
|
|
Self-Reported 7-Day Point Prevalence Abstinence Rate at Week 6
Time Frame: Week 6 Follow-Up
|
Participants are asked whether they smoked cigarettes in the past 7 days.
Measured among Aim 2 participants only.
|
Week 6 Follow-Up
|
|
Self-Reported 7-Day Point Prevalence Abstinence Rate at Week 12
Time Frame: Week 12 Follow-Up
|
Participants are asked whether they smoked cigarettes in the past 7 days.
Measured among Aim 3 participants only.
|
Week 12 Follow-Up
|
|
Self-Reported 7-Day Point Prevalence Abstinence Rate at Month 6 - Aim 2
Time Frame: Month 6 Follow-Up
|
Participants are asked whether they smoked cigarettes in the past 7 days.
Measured Among Aim 2 participants only.
|
Month 6 Follow-Up
|
|
Biochemically-Confirmed 7-Day Point Prevalence Abstinence Rate at Week 6
Time Frame: Week 6 Follow-Up
|
Participants are asked whether they smoked cigarettes in the past 7 days.
Biochemical test (exhaled carbon monoxide test) will be conducted to confirm abstinence among those who report no smoking in past 7 days.
Measured among Aim 2 participants only.
|
Week 6 Follow-Up
|
|
Biochemically-Confirmed 7-Day Point Prevalence Abstinence Rate at Week 12
Time Frame: Week 12 Follow-Up
|
Participants are asked whether they smoked cigarettes in the past 7 days.
Biochemical test (exhaled carbon monoxide test) will be conducted to confirm abstinence among those who report no smoking in past 7 days.
Measured among Aim 3 participants only.
|
Week 12 Follow-Up
|
|
Average Score or Knowledge About Harms of Smoking at Week 6
Time Frame: Week 6 Follow-Up
|
Participants are asked 5 questions on knowledge of the harms of smoking.
The total range in the knowledge score is 0-5; the higher the score, the higher the knowledge level.
Measured among Aim 2 participants only.
|
Week 6 Follow-Up
|
|
Average Score or Knowledge About Harms of Smoking at Week 12
Time Frame: Week 12 Follow-Up
|
Participants are asked 5 questions on knowledge of the harms of smoking.
The total range in the knowledge score is 0-5; the higher the score, the higher the knowledge level.
Measured among Aim 3 participants only.
|
Week 12 Follow-Up
|
|
Self-Efficacy for Quitting Smoking Score at Week 6
Time Frame: Week 6 Follow-Up
|
12-item questionnaire asking participants to indicate to what extent that they are sure that they could refrain from smoking in certain situations.
Each item is ranked on a scale from 1 (Not at all sure) to 5 (Absolutely sure).
The total score ranges from 12-60; higher scores indicate greater self-efficacy in quitting smoking.
Measured among Aim 2 participants only.
|
Week 6 Follow-Up
|
|
Self-Efficacy for Quitting Smoking Score at Week 12
Time Frame: Week 12 Follow-Up
|
12-item questionnaire asking participants to indicate to what extent that they are sure that they could refrain from smoking in certain situations.
Each item is ranked on a scale from 1 (Not at all sure) to 5 (Absolutely sure).
The total score ranges from 12-60; higher scores indicate greater self-efficacy in quitting smoking.
Measured among Aim 3 participants only.
|
Week 12 Follow-Up
|
|
Self-Efficacy for Quitting Smoking Score at Month 6
Time Frame: Month 6 Follow-Up
|
12-item questionnaire asking participants to indicate to what extent that they are sure that they could refrain from smoking in certain situations.
Each item is ranked on a scale from 1 (Not at all sure) to 5 (Absolutely sure).
The total score ranges from 12-60; higher scores indicate greater self-efficacy in quitting smoking.
|
Month 6 Follow-Up
|
|
Number of Participants With Progression on Stage of Change for Smoking Cessation at Week 6
Time Frame: Week 6 Follow-Up
|
The 5 stages of change are: precontemplation, contemplation, preparation, action, and maintenance.
Progression defined as moving from an early stage to an advanced stage (e.g., from pre-contemplation to contemplation, or contemplation to preparation stage).
Measured among Aim 2 participants only.
|
Week 6 Follow-Up
|
|
Number of Participants With Progression on Stage of Change for Smoking Cessation at Week 12
Time Frame: Week 12 Follow-Up
|
The 5 stages of change are: precontemplation, contemplation, preparation, action, and maintenance.
Progression defined as moving from an early stage to an advanced stage (e.g., from pre-contemplation to contemplation, or contemplation to preparation stage).
Measured among Aim 3 participants only.
|
Week 12 Follow-Up
|
|
Number of Participants With Progression on Stage of Change for Smoking Cessation at Month 6
Time Frame: Month 6 Follow-Up
|
The 5 stages of change are: precontemplation, contemplation, preparation, action, and maintenance.
Progression defined as moving from an early stage to an advanced stage (e.g., from pre-contemplation to contemplation, or contemplation to preparation stage).
Measured among Aim 3 participants only.
|
Month 6 Follow-Up
|
|
Number of Participants who Report NRT Use During Intervention Period at Week 6
Time Frame: Week 6 Follow-Up
|
Measured among Aim 2 participants only.
|
Week 6 Follow-Up
|
|
Number of Participants who Report NRT Use During Intervention Period at Week 12
Time Frame: Week 12 Follow-Up
|
Measured among Aim 3 participants only.
|
Week 12 Follow-Up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nan Jiang, PhD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2022
Primary Completion (Actual)
January 15, 2025
Study Completion (Actual)
January 15, 2025
Study Registration Dates
First Submitted
November 11, 2021
First Submitted That Met QC Criteria
November 11, 2021
First Posted (Actual)
November 23, 2021
Study Record Updates
Last Update Posted (Actual)
April 9, 2025
Last Update Submitted That Met QC Criteria
April 8, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-01959
- K01MD014165 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request.
Requests should be directed to Nan.Jiang@nyulangone.org.
To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
National University of SingaporeRecruitingSmoking &Amp; Tobacco CessationSingapore
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedSmoking &Amp; Tobacco CessationUnited States
-
Sultan Qaboos UniversityCompletedSmoking Cessation | Tobacco Use Cessation | Smoking PreventionOman
-
The University of Hong KongCompletedSmoking Cessation Counseling Ability | Smoking Cessation Counseling PracticeHong Kong
Clinical Trials on Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges
-
Medical University of South CarolinaCompletedSmoking | Smoking Cessation | Tobacco Smoking | Cigarette SmokingUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Not yet recruitingSmoking CessationUnited States
-
University of California, San FranciscoTobacco Related Disease Research ProgramRecruitingTobacco Cessation | Tobacco Use | Tobacco Use Cessation | Tobacco Dependence | Tobacco AbstinenceUnited States
-
Medical University of South CarolinaEnrolling by invitationSmoking ( Cigarette)United States
-
Poitiers University HospitalNot yet recruitingNicotine Replacement Therapy | Healthcare Professionals | Tobacco Craving | Tabacco CessationFrance
-
University of OklahomaCompleted
-
Chiao-Chiao LiaoRecruitingMental Disorders | Anxiety | Tobacco Use Disorder | Nicotine Dependence | Nicotine WithdrawalTaiwan
-
Ottawa Hospital Research InstituteEnrolling by invitationSubstance Use | Mental Illness | Tobacco Dependence | COPD AsthmaCanada
-
University of HoustonUniversity of OklahomaNot yet recruitingESCAPE Intervention+NRT | quitSTART Intervention+NRT | CTRL+NRTUnited States
-
Duke UniversityNational Institute on Drug Abuse (NIDA)Recruiting