Smoking CessationNCT06187142
Mobile Phone-Based Smoking-Cessation Intervention for Chronic Patients
A study testing Initial phase: Personalized Chat Support (PCS), Second phase: Multi-component Optional Support (MOS) and Initial phase: Group Chat Support (GCS) in people with Smoking Cessation, run by Beijing Normal University at 1 site in China.
Trial summary
The study aims to facilitate mobile phone-based cessation support for chronic patients using a sequential multiple assignment randomized trial (SMART) , and combines different effective treatments to enhance engagement and determine the most effective adaptive interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Initial phase: Personalized Chat Support (PCS), Second phase: Multi-component Optional Support (MOS) and Initial phase: Group Chat Support (GCS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 15 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 or above, reside in Zhuhai for next 6 months;
- smoke at least 1 cigarette or use e-cigarettes daily;
- having a smartphone and a WeChat account, being able to use WeChat skillfully;
- having a diagnosis of at least one chronic disease related to smoking;
- intent to quit / reduce smoking.
Who cannot join
- smokers who have communication barrier (either physically or cognitively)
- having participation in other smoking cessation programmes or services
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile Phone-Based Smoking-Cessation Intervention for Chronic Patients: a Sequential, Multiple Assignment, Randomized Trial (SMART)
The study aims to facilitate mobile phone-based cessation support for chronic patients using a sequential multiple assignment randomized trial (SMART) , and combines different effective treatments to enhance engagement and determine the most effective adaptive interventions.
Read the detailed description
Noncommunicable diseases (NCDs) , also known as chronic diseases, affect of a large of number of people and cause 41 million death each year, equivalent to 74% of globally mortality. In China, NCDs have caused 86% of deaths in the past three decades.
Tobacco use is a type of modifiable behavioural risk factor for the development of noncommunicable disease and death. It not only increases the risk of developing NCDs, but also exacerbates their severity and complications. Tobacco causes over 8 million deaths annually. China has the world's largest population of smokers, more than 300 million. Tobacco related deaths in China are 1 million per year. Smoking cessation is one of the most effective and cost-efficient measures for the prevention and control of NCDs. It can reduce the morbidity and mortality rates of NCDs and improve the health and quality of life of patients.
Meanwhile, among current smokers in China, the prevalence of tobacco dependence was 49.7%, smoking cessation services are extremely limited in China, with only 366 clinics nationwide. For smokers with NCDs, hospitalization or outpatient treatment due to health problems can be a 'teachable moment' for quit smoking. Most physicians are unable to provide comprehensive cessation advice due to time and resource constraints, and chronic patients face many relapse triggers after leaving the hospital. Therefore, it is necessary to implement staged and personalized smoking cessation interventions for chronic patients.
To facilitate smoking cessation among chronic patients, we propose to use a sequential multiple assignment randomized trial (SMART) design. This adaptive approach is a concept of stepped treatment that aims to address the unmet needs of chronic patients and enhance smoking cessation outcomes.
The study aims to facilitate mobile phone-based cessation support for chronic patients using a sequential multiple assignment randomized trial (SMART) , and combines different effective treatments to enhance engagement and determine the most effective adaptive interventions.
- Conditions
- Smoking Cessation
- Being tested
- Initial phase: Personalized Chat Support (PCS), Second phase: Multi-component Optional Support (MOS), Initial phase: Group Chat Support (GCS), Second phase: Personalized Chat Support (PCS), 5A's / 5R's advice
- Keywords
- Smoking cessation, Chronic patients, SMART design
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial phase: Personalized Chat Support (PCS)Behavioural
Participants will receive three months of personalized chat support through WeChat. A total of 24 pre-set messages will be sent with the schedule of 3 times a week for 2 weeks, twice a week for the next 8 weeks and once a week for the last 2 weeks. These messages cover generic information about the benefits of quitting, methods to avoid/ manage craving or withdrawal symptoms, and hazards of smoking for chronic diseases experienced by different participants. Counsellors will respond to the participants' messages instantly. At the end of the initial phase (1-month), complete responders (quitters) will continue to receive PCS (subgroup PCS-1). Incomplete responders (smokers) will be randomly assigned to continue PCS (subgroup PCS-2) or receive PCS and MOS (subgroup PCS-3).
Second phase: Multi-component Optional Support (MOS)Behavioural
For incomplete responders (subgroup PCS-3) randomized to MOS, the available intervention options include phone counseling, family/peer support group and financial incentive for nicotine replacement therapy. Participants will be guided by cessation counsellors at 1-month follow-up to choose any combination of MOS based on their prefer choice or combination of MOS. If MOS participants cannot be followed up at 1-month, they will continue PCS by default.
Initial phase: Group Chat Support (GCS)Behavioural
Participant will receive three months of group chat support through WeChat. In this group, participants can send 'No Smoking' and the smart quit-smoking assistant will record it. A smoking cessation clinic doctor in the group will respond to participants' questions about smoking cessation. At the end of the initial phase (1-month), complete responders (quitters) will continue to receive GCS (subgroup GCS-1). Incomplete responders (smokers) will be randomly assigned to continue GCS (subgroup GCS-2) or receive GCS and PCS (subgroup GCS-3).
Second phase: Personalized Chat Support (PCS)Behavioural
For incomplete responders (subgroup GCS-3) randomized to PCS, participants will receive the same intervention as Group PCS delivered at the initial stage. Participants will receive two months of personalized messages through WeChat. Please refer to Intervention Group 'Initial phase: Personalized Chat Support (PCS) for details.
5A's / 5R's adviceBehavioural
5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.
health warning leafletBehavioural
The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.
Self-help bookletBehavioural
The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Group PCS, subgroup PCS-1+PCS-2+PCS-3) | Experimental | Personalized Chat Support (PCS) + Multi-component Optional Support (MOS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet Receives: Behavioral: Initial phase: Personalized Chat Support (PCS); Behavioral: Second phase: Multi-component Optional Support (MOS); Behavioral: 5A's / 5R's advice; Behavioral: health warning leaflet; Behavioral: Self-help booklet |
| Control Group (Group GCS, subgroup GCS-1+GCS-2+GCS-3) | Experimental | Group Chat Support (GCS) + Personalized Chat Support (PCS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet Receives: Behavioral: Initial phase: Group Chat Support (GCS); Behavioral: Second phase: Personalized Chat Support (PCS); Behavioral: 5A's / 5R's advice; Behavioral: health warning leaflet; Behavioral: Self-help booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate of eligible smokers (Feasibility)
The percentage of eligible smokers who agree to participate in the intervention
Measured: Baseline
Secondary outcomes (8)
Validated and self-reported abstinence of PCS vs. GCS
PCS (subgroup 1+2+3) vs. GCS(subgroup 1+2+3) on validated abstinence (salivary cotinine < 10 ng/ml) and self-reported abstinence.
Measured: 3- and 6-month follow-up
Validated and self-reported abstinence of PCS-3 vs. GCS-2
PCS-3 (add MOS) vs. GCS-2 (participants who are still smoking with 1-month) on validated abstinence (salivary cotinine < 10 ng/ml) and self-reported abstinence.
Measured: 3- and 6-month follow-up
Validated and self-reported abstinence of PCS-3 vs. PCS-2
PCS-3 (add MOS) vs. PCS-2 (participants who are still smoking with 1-month) on validated abstinence (salivary cotinine < 10 ng/ml) and self-reported abstinence.
Measured: 3- and 6-month follow-up
Validated and self-reported abstinence of GCS-3 vs. GCS-2
GCS-3 (add PCS) vs. GCS-2 (participants who are still smoking with 1-month) on validated abstinence (salivary cotinine < 10 ng/ml) and self-reported abstinence.
Measured: 3- and 6-month follow-up
Validated and self-reported abstinence of PCS-1+2 vs. GCS-1+2
PCS-1+2 vs. GCS-1+2 on validated abstinence (salivary cotinine < 10 ng/ml) and self-reported abstinence.
Measured: 3- and 6-month follow-up
Smoking reduction rate
Rate of smoking reduction by at least half of baseline amount in different groups.
Measured: 3- and 6-months follow-up
Engagement in PCS / GCS intervention
Self-reported engagement in PCS / GCS intervention in the different groups.
Measured: 3- and 6-months follow-up
Validated abstinence and self-reported of PCS-3 vs. GCS-3
Among non-responders to the initial treatments (PCS vs. GCS), compare the two augments treatments: MOS and PCS.
Measured: 3- and 6-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Jan 2024
- Primary completion15 Jul 2024
- Study completion15 Dec 2024 (estimated)
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 Smoking CessationStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187142
- Sponsor's protocol ID
- mCessation in Chronic Patients
- Status last verified
- Dec 2023
- First submitted
- 16 Dec 2023
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weng X, Song C, Liu K, Zhao S, Yang H, Wang MP. Mobile Phone-Based Smoking-Cessation Intervention in Patients With Chronic Diseases in China: A Sequential Multiple Assignment Randomized Trial. Nicotine Tob Res. 2025 Feb 24;27(3):502-510. doi: 10.1093/ntr/ntae230.
PubMed 39324617
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone-Based Smoking-Cessation Intervention for Chronic Patients: a Sequential, Multiple Assignment, Randomized Trial (SMART)
- ClinicalTrials.gov ID
- NCT06187142
- Acronym / sponsor ID
- mCessation in Chronic Patients
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Chronic patients, SMART design
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Beijing Normal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 2 Jan 2024 (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.
The study aims to facilitate mobile phone-based cessation support for chronic patients using a sequential multiple assignment randomized trial (SMART) , and combines different effective treatments to enhance engagement and determine the most effective adaptive interventions.
Detailed description
Noncommunicable diseases (NCDs) , also known as chronic diseases, affect of a large of number of people and cause 41 million death each year, equivalent to 74% of globally mortality. In China, NCDs have caused 86% of deaths in the past three decades.
Tobacco use is a type of modifiable behavioural risk factor for the development of noncommunicable disease and death. It not only increases the risk of developing NCDs, but also exacerbates their severity and complications. Tobacco causes over 8 million deaths annually. China has the world's largest population of smokers, more than 300 million. Tobacco related deaths in China are 1 million per year. Smoking cessation is one of the most effective and cost-efficient measures for the prevention and control of NCDs. It can reduce the morbidity and mortality rates of NCDs and improve the health and quality of life of patients.
Meanwhile, among current smokers in China, the prevalence of tobacco dependence was 49.7%, smoking cessation services are extremely limited in China, with only 366 clinics nationwide. For smokers with NCDs, hospitalization or outpatient treatment due to health problems can be a 'teachable moment' for quit smoking. Most physicians are unable to provide comprehensive cessation advice due to time and resource constraints, and chronic patients face many relapse triggers after leaving the hospital. Therefore, it is necessary to implement staged and personalized smoking cessation interventions for chronic patients.
To facilitate smoking cessation among chronic patients, we propose to use a sequential multiple assignment randomized trial (SMART) design. This adaptive approach is a concept of stepped treatment that aims to address the unmet needs of chronic patients and enhance smoking cessation outcomes.
The study aims to facilitate mobile phone-based cessation support for chronic patients using a sequential multiple assignment randomized trial (SMART) , and combines different effective treatments to enhance engagement and determine the most effective adaptive interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Group PCS, subgroup PCS-1+PCS-2+PCS-3) | Experimental | Behavioral: Initial phase: Personalized Chat Support (PCS), Behavioral: Second phase: Multi-component Optional Support (MOS), Behavioral: 5A's / 5R's advice, Behavioral: health warning leaflet, Behavioral: Self-help bookletPersonalized Chat Support (PCS) + Multi-component Optional Support (MOS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet |
| Control Group (Group GCS, subgroup GCS-1+GCS-2+GCS-3) | Experimental | Behavioral: Initial phase: Group Chat Support (GCS), Behavioral: Second phase: Personalized Chat Support (PCS), Behavioral: 5A's / 5R's advice, Behavioral: health warning leaflet, Behavioral: Self-help bookletGroup Chat Support (GCS) + Personalized Chat Support (PCS) + 5A's / 5R's advice + health warning leaflet +Self-help booklet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 or above, reside in Zhuhai for next 6 months;
- smoke at least 1 cigarette or use e-cigarettes daily;
- having a smartphone and a WeChat account, being able to use WeChat skillfully;
- having a diagnosis of at least one chronic disease related to smoking;
- intent to quit / reduce smoking.
Key exclusion criteria (2 listed)
- smokers who have communication barrier (either physically or cognitively)
- having participation in other smoking cessation programmes or services
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 |
|---|---|---|
| Initial phase: Personalized Chat Support (PCS)Participants will receive three months of personalized chat support through WeChat. A total of 24 pre-set messages will be sent with the schedule of 3 times a week for 2 weeks, twice a week for the next 8 weeks and once a week for the last 2 weeks. These messages cover generic information about the benefits of quitting, methods to avoid/ manage craving or withdrawal symptoms, and hazards of smoking for chronic diseases experienced by different participants. Counsellors will respond to the participants' messages instantly. At the end of the initial phase (1-month), complete responders (quitters) will continue to receive PCS (subgroup PCS-1). Incomplete responders (smokers) will be randomly assigned to continue PCS (subgroup PCS-2) or receive PCS and MOS (subgroup PCS-3). | Behavioural | Intervention Group (Group PCS, subgroup PCS-1+PCS-2+PCS-3) |
| Second phase: Multi-component Optional Support (MOS)For incomplete responders (subgroup PCS-3) randomized to MOS, the available intervention options include phone counseling, family/peer support group and financial incentive for nicotine replacement therapy. Participants will be guided by cessation counsellors at 1-month follow-up to choose any combination of MOS based on their prefer choice or combination of MOS. If MOS participants cannot be followed up at 1-month, they will continue PCS by default. | Behavioural | Intervention Group (Group PCS, subgroup PCS-1+PCS-2+PCS-3) |
| Initial phase: Group Chat Support (GCS)Participant will receive three months of group chat support through WeChat. In this group, participants can send 'No Smoking' and the smart quit-smoking assistant will record it. A smoking cessation clinic doctor in the group will respond to participants' questions about smoking cessation. At the end of the initial phase (1-month), complete responders (quitters) will continue to receive GCS (subgroup GCS-1). Incomplete responders (smokers) will be randomly assigned to continue GCS (subgroup GCS-2) or receive GCS and PCS (subgroup GCS-3). | Behavioural | Control Group (Group GCS, subgroup GCS-1+GCS-2+GCS-3) |
| Second phase: Personalized Chat Support (PCS)For incomplete responders (subgroup GCS-3) randomized to PCS, participants will receive the same intervention as Group PCS delivered at the initial stage. Participants will receive two months of personalized messages through WeChat. Please refer to Intervention Group 'Initial phase: Personalized Chat Support (PCS) for details. | Behavioural | Control Group (Group GCS, subgroup GCS-1+GCS-2+GCS-3) |
| 5A's / 5R's advice5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit. | Behavioural | Control Group (Group GCS, subgroup GCS-1+GCS-2+GCS-3), Intervention Group (Group PCS, subgroup PCS-1+PCS-2+PCS-3) |
| health warning leafletThe contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting. | Behavioural | Control Group (Group GCS, subgroup GCS-1+GCS-2+GCS-3), Intervention Group (Group PCS, subgroup PCS-1+PCS-2+PCS-3) |
| Self-help bookletThe contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc. | Behavioural | Control Group (Group GCS, subgroup GCS-1+GCS-2+GCS-3), Intervention Group (Group PCS, subgroup PCS-1+PCS-2+PCS-3) |
Primary outcome
Participation rate of eligible smokers (Feasibility)
Time frame: Baseline
The percentage of eligible smokers who agree to participate in the intervention
8 secondary outcomes
Validated and self-reported abstinence of PCS vs. GCS
Time frame: 3- and 6-month follow-up
Validated and self-reported abstinence of PCS-3 vs. GCS-2
Time frame: 3- and 6-month follow-up
Validated and self-reported abstinence of PCS-3 vs. PCS-2
Time frame: 3- and 6-month follow-up
Validated and self-reported abstinence of GCS-3 vs. GCS-2
Time frame: 3- and 6-month follow-up
Validated and self-reported abstinence of PCS-1+2 vs. GCS-1+2
Time frame: 3- and 6-month follow-up
Smoking reduction rate
Time frame: 3- and 6-months follow-up
Engagement in PCS / GCS intervention
Time frame: 3- and 6-months follow-up
Validated abstinence and self-reported of PCS-3 vs. GCS-3
Time frame: 3- and 6-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Derived from this study: PubMed 39324617Weng X, Song C, Liu K, Zhao S, Yang H, Wang MP. Mobile Phone-Based Smoking-Cessation Intervention in Patients With Chronic Diseases in China: A Sequential Multiple Assignment Randomized Trial. Nicotine Tob Res. 2025 Feb 24;27(3):502-510. doi: 10.1093/ntr/ntae230.
- Individual participant dataSharing planned: No
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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 Initial phase: Personalized Chat Support (PCS), Second phase: Multi-component Optional Support (MOS) and Initial phase: Group Chat Support (GCS) in people with Smoking Cessation, run by Beijing Normal University 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Aug 2024. 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?
Results are not available in the source record.
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?
Participation rate of eligible smokers (Feasibility) (time frame: Baseline). 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 NCT06187142, 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 19 Aug 2024.