NCT05130788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

2.9 years

First QC Date

November 11, 2021

Last Update Submit

April 8, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Number of Participants Who Respond to Daily Text Questions

    Measure of engagement. Measured among Aim 2 participants only.

    Up to Week 6 Follow-Up

  • Number of Participants Who Ask Self-Composed Questions

    Measure of engagement. Measured among Aim 2 participants only.

    Up to Week 6 Follow-Up

  • 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.

    Up to Week 6 Follow-Up

  • 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.

    Month 6 Follow-Up

Secondary Outcomes (23)

  • Number of Quit Attempts at Week 6

    Week 6 Follow-Up

  • Number of Quit Attempts at Week 12

    Week 12 Follow-Up

  • Number of Quit Attempts at Month 6

    Month 6 Follow-Up

  • Average Daily Cigarette Consumption at Week 6

    Week 6 Follow-Up

  • Average Daily Cigarette Consumption at Week 12

    Week 12 Follow-Up

  • +18 more secondary outcomes

Study Arms (3)

Intervention Group A

EXPERIMENTAL

Participants will be assigned to a 6-week intervention period.

Behavioral: WeChat Quit CoachDrug: Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges

Intervention Group B

EXPERIMENTAL

Participants will be assigned to a 12-week intervention period.

Behavioral: WeChat Quit CoachDrug: Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges

Control Group

ACTIVE COMPARATOR
Behavioral: LeafletDrug: Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges

Interventions

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.

Intervention Group AIntervention Group B
LeafletBEHAVIORAL

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

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.

Also known as: Habitrol, Nicorette
Control GroupIntervention Group AIntervention Group B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement TherapyTransdermal PatchNicotineNicotine Chewing Gum

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsEquipment and SuppliesSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingChewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTobacco Use Cessation DevicesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Nan Jiang, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 23, 2021

Study Start

February 10, 2022

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
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.
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.

Locations