Cigarette SmokingNCT03169686
'WeChat WeQuit' Smoking Cessation Program
A study testing Cognitive and Behavioral Intervention in people with Cigarette Smoking and Smoking Cessation, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Smoking Cessation
- What is being tested?
- Cognitive and Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2020to 16 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Nonsmokers.
- Smokers without attempt to quit.
- Below 18 years old.
- Unable to use smartphone and WeChat.
- Unable to read and write in Chinese.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cigarette Smoking, Smoking Cessation
- Being tested
- Cognitive and Behavioral Intervention
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and Behavioral InterventionBehavioural
Participants who allocate to the intervention group will receive regular smoking cessation related information by professional team.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Cognitive and Behavioral Intervention |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically Validated Continuously Abstinence
The primary outcome will be biochemical validation of self-reported 26-week continuous smoking abstinence
Measured: 26 weeks
Secondary outcomes (2)
Self-reported 7-day Point Abstinence
Self-reported 7-day point-prevalence abstinence at week 1, 4, 8, 12, 16, 20 and 26 after quit date.
Measured: 26 weeks
Self-reported Continuous Abstinence
Self-reported continuous smoking abstinence rate at weeks 4, 8, 12, 16, 20, and 26 after the quit date.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start19 Mar 2020
- Primary completion16 Nov 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhui Liao, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169686
- Sponsor's protocol ID
- 2017S015
- Status last verified
- Nov 2022
- First submitted
- 25 May 2017
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (without personal information) will be included in submission and will be available to other researchers.
Publications
Tang J, Yang J, Liu Y, Liu X, Li L, Sun Y, Jin J, Fang Y, Zhou Z, Wang Y, Liu Y, Chen W, McNeill A, Kelly BC, Cohen JE, Liao Y. Efficacy of WeChat-based online smoking cessation intervention ('WeChat WeQuit') in China: a randomised controlled trial. EClinicalMedicine. 2023 May 18;60:102009. doi: 10.1016/j.eclinm.2023.102009. eCollection 2023 Jun.
PubMed 37251625
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of WeChat Based Interventions ('WeChat WeQuit' Program) for Smoking Cessation in China: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03169686
- Acronym / sponsor ID
- 2017S015
- Conditions
- Cigarette Smoking, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Cognitive and Behavioral InterventionParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Nonsmokers.
- Smokers without attempt to quit.
- Below 18 years old.
- Unable to use smartphone and WeChat.
- Unable to read and write in Chinese.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive and Behavioral InterventionParticipants who allocate to the intervention group will receive regular smoking cessation related information by professional team. | Behavioural | Intervention Group |
Primary outcome
Biochemically Validated Continuously Abstinence
Time frame: 26 weeks
The primary outcome will be biochemical validation of self-reported 26-week continuous smoking abstinence
2 secondary outcomes
Self-reported 7-day Point Abstinence
Time frame: 26 weeks
Self-reported Continuous Abstinence
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Derived from this study: PubMed 37251625Tang J, Yang J, Liu Y, Liu X, Li L, Sun Y, Jin J, Fang Y, Zhou Z, Wang Y, Liu Y, Chen W, McNeill A, Kelly BC, Cohen JE, Liao Y. Efficacy of WeChat-based online smoking cessation intervention ('WeChat WeQuit') in China: a randomised controlled trial. EClinicalMedicine. 2023 May 18;60:102009. doi: 10.1016/j.eclinm.2023.102009. eCollection 2023 Jun.
- Individual participant dataSharing planned: Yes. All individual participant data (without personal information) will be included in submission and will be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive and Behavioral Intervention in people with Cigarette Smoking and Smoking Cessation, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically Validated Continuously Abstinence (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03169686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.