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Smoking CessationNCT05130788

WeChat Quit Coach Pilot Study

A study testing WeChat Quit Coach, Leaflet and Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges in people with Smoking Cessation, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Smoking Cessation
What is being tested?
WeChat Quit Coach, Leaflet and Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
10 Feb 2022to 15 Jan 2025
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • NYU Langone Health

    New York, New York, 10016

Other trials in United States

About this 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

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.

Being tested
WeChat Quit Coach, Leaflet, Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WeChat Quit CoachBehavioural

    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.

  • LeafletBehavioural

    Participants in the control group will receive a leaflet with information about existing smoking cessation programs targeting Chinese American smokers.

  • Optional Nicotine Replacement Therapy (NRT) Patches or LozengesDrug

    Also called Habitrol, Nicorette

    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.

Study groups in NCT05130788
Study groupRoleWhat they receive
Intervention Group AExperimentalParticipants will be assigned to a 6-week intervention period.
Receives: Behavioral: WeChat Quit Coach; Drug: Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges
Intervention Group BExperimentalParticipants will be assigned to a 12-week intervention period.
Receives: Behavioral: WeChat Quit Coach; Drug: Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges
Control GroupActive comparatorNot described
Receives: Behavioral: Leaflet; Drug: Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Respond to Daily Text Questions

    Measure of engagement. Measured among Aim 2 participants only.

    Measured: Up to Week 6 Follow-Up

  2. Number of Participants Who Asked Self-Composed Questions

    Measure of engagement. Measured among Aim 2 participants only.

    Measured: Up to Week 6 Follow-Up

  3. Number of Satisfied Participants Per WeChat Program Participant Satisfaction Score

    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.

    Measured: Up to Week 6 Follow-Up

  4. Self-Reported 7-Day Point Prevalence Abstinence Rate at Month 6

    Participants are asked whether they smoked cigarettes in the past 7 days. Measured among Aim 3 participants only.

    Measured: Month 6 Follow-Up

Secondary outcomes (23)
  1. Percentage of Participants With Quit Attempts at Week 6

    Measured among Aim 2 participants only.

    Measured: Week 6 Follow-Up

  2. Percentage of Participants With Quit Attempts at Week 12

    Measured among Aim 3 participants only.

    Measured: Week 12 Follow-Up

  3. Percentage of Participants With Quit Attempts at Month 6

    Measured among Aim 2 participants only.

    Measured: Month 6 Follow-Up

  4. Average Daily Cigarette Consumption at Week 6

    Measured among Aim 2 participants only.

    Measured: Week 6 Follow-Up

  5. Change in Average Daily Cigarette Consumption at Week 12

    Measured among Aim 3 participants only.

    Measured: Baseline, Week 12 Follow-Up

  6. Change in Average Daily Cigarette Consumption at Month 6

    Measured among Aim 3 participants only.

    Measured: Baseline, Month 6 Follow-Up

  7. Self-Reported 7-Day Point Prevalence Abstinence Rate at Week 6

    Participants are asked whether they smoked cigarettes in the past 7 days. Measured among Aim 2 participants only.

    Measured: Week 6 Follow-Up

  8. Self-Reported 7-Day Point Prevalence Abstinence Rate at Week 12

    Participants are asked whether they smoked cigarettes in the past 7 days. Measured among Aim 3 participants only.

    Measured: Week 12 Follow-Up

  9. Self-Reported 7-Day Point Prevalence Abstinence Rate at Month 6

    Participants are asked whether they smoked cigarettes in the past 7 days. Measured among Aim 2 participants only.

    Measured: Month 6 Follow-Up

  10. Biochemically-Confirmed 7-Day Point Prevalence Abstinence Rate at Week 6

    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.

    Measured: Week 6 Follow-Up

  11. Biochemically-Confirmed 7-Day Point Prevalence Abstinence Rate at Week 12

    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.

    Measured: Week 12 Follow-Up

  12. Biochemically-Confirmed 7-Day Point Prevalence Abstinence Rate at Month 6

    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.

    Measured: Month 6 Follow-Up

  13. Average Score or Knowledge About Harms of Smoking at Week 6

    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.

    Measured: Week 6 Follow-Up

  14. Average Score or Knowledge About Harms of Smoking at Week 12

    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.

    Measured: Week 12 Follow-Up

  15. Self-Efficacy for Quitting Smoking Score at Week 6

    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.

    Measured: Week 6 Follow-Up

  16. Self-Efficacy for Quitting Smoking Score at Week 12

    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.

    Measured: Week 12 Follow-Up

  17. Self-Efficacy for Quitting Smoking Score at Month 6

    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.

    Measured: Month 6 Follow-Up

  18. Percentage of Participants With Progression on Stage of Change for Smoking Cessation at Week 6

    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.

    Measured: Week 6 Follow-Up

  19. Percentage of Participants With Progression on Stage of Change for Smoking Cessation at Week 12

    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.

    Measured: Week 12 Follow-Up

  20. Number of Participants With Progression on Stage of Change for Smoking Cessation at Month 6

    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.

    Measured: Month 6 Follow-Up

  21. Percentage of Participants Who Report NRT Use During Intervention Period at Week 6

    Measured among Aim 2 participants only.

    Measured: Week 6 Follow-Up

  22. Number of Participants Who Report NRT Use During Intervention Period at Week 12

    Measured among Aim 3 participants only.

    Measured: Week 12 Follow-Up

  23. Number of Participants Who Report NRT Use During Intervention Period at Month 6

    Measured among aim 3 participants only.

    Measured: Month 6 Follow-Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2021
  2. Study start10 Feb 2022
  3. Primary completion15 Jan 2025
  4. Study completion15 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05130788
Sponsor's protocol ID
20-01959
Other IDs
K01MD014165
Status last verified
Jul 2026
First submitted
11 Nov 2021
Last updated
31 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Publications

  • Jiang N, Zhao A, Rogers ES, Cupertino AP, Zhao X, Cartujano-Barrera F, Siu K, Sherman SE. Feasibility and Preliminary Effects of a Social Media-Based Peer-Group Mobile Messaging Smoking Cessation Intervention Among Chinese Immigrants who Smoke: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jul 22;12:e59496. doi: 10.2196/59496.

    PubMed 39037756

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