Feasibility, Acceptability, and Preliminary Effectiveness of a WeChat Quit Coach Smoking Cessation Intervention: A Pilot, Open-labeled, Randomized Controlled Trial Among Chinese Immigrant Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- WeChat Program Participant Satisfaction Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •Current participation in other smoking cessation treatment program(s)
- •Be pregnant or breastfeeding
- •Current participation in other smoking cessation treatment program(s)
- •Be pregnant or breastfeeding
- •Having a household member who has enrolled in this study
研究组 & 干预措施
Intervention Group A
Participants will be assigned to a 6-week intervention period.
干预措施: WeChat Quit Coach (Behavioral)
Intervention Group B
Participants will be assigned to a 12-week intervention period.
干预措施: WeChat Quit Coach (Behavioral)
Intervention Group B
Participants will be assigned to a 12-week intervention period.
干预措施: Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges (Drug)
Control Group
干预措施: Leaflet (Behavioral)
Control Group
干预措施: Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges (Drug)
Intervention Group A
Participants will be assigned to a 6-week intervention period.
干预措施: Optional Nicotine Replacement Therapy (NRT) Patches or Lozenges (Drug)
结局指标
主要结局
WeChat Program Participant Satisfaction Score
时间窗: 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.
Number of Participants Who Ask Self-Composed Questions
时间窗: Up to Week 6 Follow-Up
Measure of engagement. Measured among Aim 2 participants only.
Number of Participants Who Respond to Daily Text Questions
时间窗: Up to Week 6 Follow-Up
Measure of engagement. Measured among Aim 2 participants only.
Self-Reported 7-Day Point Prevalence Abstinence Rate at Month 6
时间窗: Month 6 Follow-Up
Participants are asked whether they smoked cigarettes in the past 7 days. Measured among Aim 3 participants only.
Number of Participants Who Asked Self-Composed Questions
时间窗: Up to Week 6 Follow-Up
Measure of engagement. Measured among Aim 2 participants only.
Number of Satisfied Participants Per WeChat Program Participant Satisfaction Score
时间窗: 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.
次要结局
- Number of Quit Attempts at Week 6(Week 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)
- Biochemically-Confirmed 7-Day Point Prevalence Abstinence Rate at Week 6(Week 6 Follow-Up)
- Self-Efficacy for Quitting Smoking Score at Week 12(Week 12 Follow-Up)
- Number of Participants With Progression on Stage of Change for Smoking Cessation at Week 12(Week 12 Follow-Up)
- Number of Participants With Progression on Stage of Change for Smoking Cessation at Month 6(Month 6 Follow-Up)
- Average Daily Cigarette Consumption at Month 6(Month 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)
- Self-Reported 7-Day Point Prevalence Abstinence Rate at Week 6(Week 6 Follow-Up)
- Self-Reported 7-Day Point Prevalence Abstinence Rate at Week 12(Week 12 Follow-Up)
- Self-Reported 7-Day Point Prevalence Abstinence Rate at Month 6 - Aim 2(Month 6 Follow-Up)
- Biochemically-Confirmed 7-Day Point Prevalence Abstinence Rate at Week 12(Week 12 Follow-Up)
- Number of Participants With Progression on Stage of Change for Smoking Cessation at Week 6(Week 6 Follow-Up)
- Average Score or Knowledge About Harms of Smoking at Week 6(Week 6 Follow-Up)
- Average Score or Knowledge About Harms of Smoking at Week 12(Week 12 Follow-Up)
- Self-Efficacy for Quitting Smoking Score at Week 6(Week 6 Follow-Up)
- Number of Participants who Report NRT Use During Intervention Period at Week 6(Week 6 Follow-Up)
- Number of Participants who Report NRT Use During Intervention Period at Week 12(Week 12 Follow-Up)
- Number of Participants who Report NRT Use During Intervention Period at Month 6(Month 6 Follow-Up)
- Percentage of Participants With Quit Attempts at Week 12(Week 12 Follow-Up)
- Biochemically-Confirmed 7-Day Point Prevalence Abstinence Rate at Month 6(Month 6 Follow-Up)
- Self-Efficacy for Quitting Smoking Score at Month 6(Month 6 Follow-Up)
- Percentage of Participants With Quit Attempts at Week 6(Week 6 Follow-Up)
- Percentage of Participants With Quit Attempts at Month 6(Month 6 Follow-Up)
- Change in Average Daily Cigarette Consumption at Week 12(Baseline, Week 12 Follow-Up)
- Change in Average Daily Cigarette Consumption at Month 6(Baseline, Month 6 Follow-Up)
- Self-Reported 7-Day Point Prevalence Abstinence Rate at Month 6(Month 6 Follow-Up)
- Percentage of Participants With Progression on Stage of Change for Smoking Cessation at Week 6(Week 6 Follow-Up)
- Percentage of Participants With Progression on Stage of Change for Smoking Cessation at Week 12(Week 12 Follow-Up)
- Percentage of Participants Who Report NRT Use During Intervention Period at Week 6(Week 6 Follow-Up)
- Number of Participants Who Report NRT Use During Intervention Period at Week 12(Week 12 Follow-Up)
- Number of Participants Who Report NRT Use During Intervention Period at Month 6(Month 6 Follow-Up)