- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03169686
'WeChat WeQuit' Smoking Cessation Program
November 30, 2022 updated by: Yanhui Liao, Sir Run Run Shaw Hospital
The Efficacy of WeChat Based Interventions ('WeChat WeQuit' Program) for Smoking Cessation in China: a Randomized Trial
This proposed project is to assess whether WeChat-based smoking cessation interventions ('WeChat WeQuit' program) will be effective at helping people in China who smoke, to quit.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2000
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
-
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Zhejiang
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Hanzhou, Zhejiang, China, 360000
- Yanhui Liao
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Daily Chinese cigarette smokers.
- 18 years of age and older living.
- Being able to read and write in Chinese.
- Owning a smartphone and knowing how to use WeChat.
- Willing to make an attempt to quit smoking in the next month.
- Willing to provide informed consent to participate in the study.
Exclusion Criteria:
- Nonsmokers.
- Smokers without attempt to quit.
- Below 18 years old.
- Unable to use smartphone and WeChat.
- Unable to read and write in Chinese.
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants in the intervention group will receive the 'WeChat WeQuit' program from the WeChat subscription account.
The period for intervention was 14 weeks, including 2-week quiting preparation intervention and 12-week postquit intervention.
The number of messages/pictures/audios received by participants will gradually decrease (will be intensively sent to them during 2-week prequit and 4-week postquit, and less intensively during 5-week to 12-week postquit), and follow-up questionnaires were sent only once a month in 14-28 weeks (week 16, 20, and 26 after the quit date).
A WeChat group was created for answering questions from participants, and sharing the latest resources related to quitting smoking, and promoting communication between participants.
|
Participants who allocate to the intervention group will receive regular smoking cessation related information by professional team.
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|
No Intervention: Control Group
Control group participants will not receive any smoking cessation messages by professional team.
They will receive messages of thanking them for being in the study and reminding them of the time until their free month at the end of follow up.
In order to measure the main two outcomes (self-reported continuous smoking abstinence and point prevalence of abstinence), continuous smoking abstinence, point prevalence of abstinence, how many cigarettes per day during the last week if they are still smoking will be checked at week 1, 4, 8, 12, 16, 20 and 26 points.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biochemically Validated Continuously Abstinence
Time Frame: 26 weeks
|
The primary outcome will be biochemical validation of self-reported 26-week continuous smoking abstinence
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26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported 7-day Point Abstinence
Time Frame: 26 weeks
|
Self-reported 7-day point-prevalence abstinence at week 1, 4, 8, 12, 16, 20 and 26 after quit date.
|
26 weeks
|
|
Self-reported Continuous Abstinence
Time Frame: 26 weeks
|
Self-reported continuous smoking abstinence rate at weeks 4, 8, 12, 16, 20, and 26 after the quit date.
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26 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking Reduction and Participation
Time Frame: 26 weeks
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Reductions in number of cigarettes smoked per day and rates of participation in and completion of smoking-cessation programs.
|
26 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 19, 2020
Primary Completion (Actual)
November 16, 2022
Study Completion (Actual)
November 16, 2022
Study Registration Dates
First Submitted
May 25, 2017
First Submitted That Met QC Criteria
May 25, 2017
First Posted (Actual)
May 30, 2017
Study Record Updates
Last Update Posted (Actual)
December 2, 2022
Last Update Submitted That Met QC Criteria
November 30, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2017S015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
All individual participant data (without personal information) will be included in submission and will be available to other researchers.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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