Tobacco Smoke PollutionNCT05996029
A Joint Real-World Study of Digital Smoking Cessation Interventions
A study testing Digital Smoking Cessation in people with Tobacco Smoke Pollution and Passive Smoking, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
According to the "China Smoking Health Hazard Report 2020", the total number of smokers in China is estimated to be 350 million, of which 180 million are already addicted. In addition, more than 700 million nonsmokers are exposed to secondhand smoke and become passive smoking victims, among which the family is one of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Smoke Pollution, Passive Smoking, Secondhand Smoking
- What is being tested?
- Digital Smoking Cessation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,214 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Jun 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
- Pregnant women's inclusion criteria A. Adult females during gestation and within 42 days after delivery B. I do not smoke, but I self-reported secondhand smoke exposure problems
- Inclusion criteria for smoking quitters A. Adults over the age of 18 who smoke every day; B. I have a clear intention to quit smoking;
Who cannot join
- Maternal maternal exclusion criteria A. I am a smoker (pregnant women who are willing to quit smoking can join the smoking cessation group) B. Self-report had no risk of secondhand smoke exposure
- Exclusion criteria for smoking quitters A. Receiving other smoking cessation interventions; B. having a severe mental illness or psychological disorder C. No smart phone or not skilled to use WeChat mini program
Trial locations and contacts
1 site in 1 country.
China1 site
Department of ob gyn, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
According to the "China Smoking Health Hazard Report 2020", the total number of smokers in China is estimated to be 350 million, of which 180 million are already addicted. In addition, more than 700 million nonsmokers are exposed to secondhand smoke and become passive smoking victims, among which the family is one of the main places of secondhand smoke exposure, and mothers and children are the most affected group.
Passive smoking is a risk factor for spontaneous abortion in pregnant women and an important risk factor for the occurrence of gestational hypertension syndrome and pregnancy complications, and it also affects embryonic development with adverse pregnancy outcomes such as miscarriage, stillbirth, intrauterine growth retardation, preterm birth, immune deficiency, birth defects, and mental retardation.
Helping smokers quit is the fundamental solution to reducing secondhand smoke exposure. The accessibility and effectiveness of traditional offline smoking cessation intervention services do not meet the needs of society. With the development of mobile communication technology, digital cessation such as SMS cessation, WeChat cessation, and APP cessation have emerged, which combine clinical cessation guidelines with software technology and present rich product features and interactive design, providing a new solution to expand the accessibility of clinical cessation interventions and address the problem of secondhand smoke exposure.We hope to explore the impact of different digital cessation tools and their combinations on reducing smoking prevalence and maternal tobacco exposure.
Read the detailed description
This project is a two-arm, practical-utility randomized controlled trial.The study was designed to enroll 2214 quitters, and maternal cessation of enrollment after completion of the quitter enrollment.After self-reported exposure to secondhand smoke has been tested with a free cotinine urine test and the pregnant woman has signed an informed consent, she invites the smoker who is causing her secondhand smoke to quit, which may include her husband, family, friends, colleagues, neighbors, etc., or the pregnant woman herself.
Invited smokers will choose a quit day within two weeks of enrollment, use a cognitive behavioral therapy-based cessation package and online coaching from medical staff, as well as additional digital cessation tools, and receive a 12-week follow-up (smoking/quit status). Enrolled pregnant women will receive general education on maternal and child health management and the dangers of tobacco, and will be encouraged to provide psychological support and encouragement to invited quitters in the mini-program (provided both parties volunteer). The pregnant women will receive a 16-week follow-up (secondhand smoke exposure).
At the end of the study, all pregnant women and those who self-report successful cessation will receive a free cotinine test as an objective test of cessation effectiveness.
- Conditions
- Tobacco Smoke Pollution, Passive Smoking, Secondhand Smoking
- Being tested
- Digital Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Smoking CessationCombination product
The core technology of the study is a smoking cessation assistance practice service driven by a machine learning algorithm. The small programs used by the intervention group in this study included smoking cessation service packages based on cognitive behavioral therapy and online guidance from medical staff on staff, and more digital smoking cessation tools.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intensive intervention package "Quit with Love" (1 month)
1. Cognitive-behavioral (CBT) smoking cessation intervention
2. ACT cessation intervention with positive thinking
3. Online group smoking cessation intervention through live streaming
"Quit Assistant" intelligent support platform (3 months)
1. Quit smoking punch card toolkit
2. Machine learning algorithm-driven cessation assistance practice service Receives: Combination Product: Digital Smoking Cessation |
| control group | No intervention | Reduced functionality of the Love Quit applet Only a simple smoking punch card support function, mainly used to assist subjects to quit smoking on their own and collect follow-up information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biologically validated subject withdrawal rate
Urine cotinine concentrations was determined using a cotinine test kit (colloidal gold) at the end of follow-up.
Measured: through study completion, an average of 4 months
Biologically validated maternal environmental tobacco exposure rate
Urine cotinine concentration was determined using a cotinine test kit (colloidal gold method) at the end of enrollment and follow-up to determine the exposure of second-hand smoke.
Measured: through study completion, an average of 4 months
Secondary outcomes (3)
Engagement and adherence to digital smoking cessation interventions
Actual enrollment and enrollment of invited participants in the digital cessation population.
Proportion of subjects in the intervention group who completed a digital cessation intervention session.
Measured: through study completion, an average of 4 months
Self-reported abstinence rates for subjects at weeks 1, 2, 3, 4, 8, and 12 after quitting date
Measured: through study completion, an average of 4 months
Changes in maternal and smoking cessation subjects' respective psychological scale assessments at baseline and at the end of follow-up
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Smoke PollutionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Hangzhou Medisol Technology Co.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996029
- Sponsor's protocol ID
- K4011
- Status last verified
- May 2023
- First submitted
- 31 Jul 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Joint Real-World Study of Digital Smoking Cessation Interventions
- ClinicalTrials.gov ID
- NCT05996029
- Acronym / sponsor ID
- K4011
- Conditions
- Tobacco Smoke Pollution, Passive Smoking, Secondhand Smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,214 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Hangzhou Medisol Technology Co.
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 16 Aug 2023 (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.
According to the "China Smoking Health Hazard Report 2020", the total number of smokers in China is estimated to be 350 million, of which 180 million are already addicted. In addition, more than 700 million nonsmokers are exposed to secondhand smoke and become passive smoking victims, among which the family is one of the main places of secondhand smoke exposure, and mothers and children are the most affected group.
Passive smoking is a risk factor for spontaneous abortion in pregnant women and an important risk factor for the occurrence of gestational hypertension syndrome and pregnancy complications, and it also affects embryonic development with adverse pregnancy outcomes such as miscarriage, stillbirth, intrauterine growth retardation, preterm birth, immune deficiency, birth defects, and mental retardation.
Helping smokers quit is the fundamental solution to reducing secondhand smoke exposure. The accessibility and effectiveness of traditional offline smoking cessation intervention services do not meet the needs of society. With the development of mobile communication technology, digital cessation such as SMS cessation, WeChat cessation, and APP cessation have emerged, which combine clinical cessation guidelines with software technology and present rich product features and interactive design, providing a new solution to expand the accessibility of clinical cessation interventions and address the problem of secondhand smoke exposure.We hope to explore the impact of different digital cessation tools and their combinations on reducing smoking prevalence and maternal tobacco exposure.
Detailed description
This project is a two-arm, practical-utility randomized controlled trial.The study was designed to enroll 2214 quitters, and maternal cessation of enrollment after completion of the quitter enrollment.After self-reported exposure to secondhand smoke has been tested with a free cotinine urine test and the pregnant woman has signed an informed consent, she invites the smoker who is causing her secondhand smoke to quit, which may include her husband, family, friends, colleagues, neighbors, etc., or the pregnant woman herself.
Invited smokers will choose a quit day within two weeks of enrollment, use a cognitive behavioral therapy-based cessation package and online coaching from medical staff, as well as additional digital cessation tools, and receive a 12-week follow-up (smoking/quit status). Enrolled pregnant women will receive general education on maternal and child health management and the dangers of tobacco, and will be encouraged to provide psychological support and encouragement to invited quitters in the mini-program (provided both parties volunteer). The pregnant women will receive a 16-week follow-up (secondhand smoke exposure).
At the end of the study, all pregnant women and those who self-report successful cessation will receive a free cotinine test as an objective test of cessation effectiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Combination Product: Digital Smoking CessationIntensive intervention package "Quit with Love" (1 month) 1. Cognitive-behavioral (CBT) smoking cessation intervention 2. ACT cessation intervention with positive thinking 3. Online group smoking cessation intervention through live streaming "Quit Assistant" intelligent support platform (3 months) 1. Quit smoking punch card toolkit 2. Machine learning algorithm-driven cessation assistance practice service |
| control group | No intervention | –Reduced functionality of the Love Quit applet Only a simple smoking punch card support function, mainly used to assist subjects to quit smoking on their own and collect follow-up information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women's inclusion criteria A. Adult females during gestation and within 42 days after delivery B. I do not smoke, but I self-reported secondhand smoke exposure problems
- Inclusion criteria for smoking quitters A. Adults over the age of 18 who smoke every day; B. I have a clear intention to quit smoking;
Key exclusion criteria (2 listed)
- Maternal maternal exclusion criteria A. I am a smoker (pregnant women who are willing to quit smoking can join the smoking cessation group) B. Self-report had no risk of secondhand smoke exposure
- Exclusion criteria for smoking quitters A. Receiving other smoking cessation interventions; B. having a severe mental illness or psychological disorder C. No smart phone or not skilled to use WeChat mini program
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 |
|---|---|---|
| Digital Smoking CessationThe core technology of the study is a smoking cessation assistance practice service driven by a machine learning algorithm. The small programs used by the intervention group in this study included smoking cessation service packages based on cognitive behavioral therapy and online guidance from medical staff on staff, and more digital smoking cessation tools. | Combination product | Intervention group |
Primary outcome
Biologically validated subject withdrawal rate
Time frame: through study completion, an average of 4 months
Urine cotinine concentrations was determined using a cotinine test kit (colloidal gold) at the end of follow-up.
Biologically validated maternal environmental tobacco exposure rate
Time frame: through study completion, an average of 4 months
Urine cotinine concentration was determined using a cotinine test kit (colloidal gold method) at the end of enrollment and follow-up to determine the exposure of second-hand smoke.
3 secondary outcomes
Engagement and adherence to digital smoking cessation interventions
Time frame: through study completion, an average of 4 months
Self-reported abstinence rates for subjects at weeks 1, 2, 3, 4, 8, and 12 after quitting date
Time frame: through study completion, an average of 4 months
Changes in maternal and smoking cessation subjects' respective psychological scale assessments at baseline and at the end of follow-up
Time frame: through study completion, an average of 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- 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 Digital Smoking Cessation in people with Tobacco Smoke Pollution and Passive Smoking, run by Peking Union Medical College 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 2 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 16 Aug 2023. 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?
Biologically validated subject withdrawal rate (time frame: through study completion, an average of 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2023.