Smoking CessationNCT04890223
Efficacy of Brief MI Delivered Via Mobile Instant Messaging to Help Unmotivated Smokers With Chronic Diseases to Quit
A study testing Brief MI intervention in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to examine the efficacy of brief MI delivered by mobile instant messaging tools in promoting smoking cessation among unmotivated smokers with chronic diseases. Participants in the intervention group will receive a brief MI intervention while the control group will receive a placebo intervention. 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?
- Brief MI intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 728 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2021to 17 Feb 2023
- 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
- Hong Kong Chinese over the age of 17
- Had smoked at least one cigarette per day over the previous three months
- Had been diagnosed with at least one chronic disease
- Able to speak Cantonese and read Chinese
- Willing to take action to improve their health but had no intention to quit smoking
- Had a smartphone and were able to use mobile instant messaging tools
- Willing to receive health promotion advice and communicate through mobile instant messaging
Who cannot join
- Participating in other smoking cessation programs or services
- With mental or cognitive impairment or communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Brief Motivational Interviewing Delivered Via Mobile Instant Messaging Tools to Promote Smoking Cessation Among Unmotivated Smokers With Chronic Diseases
This study aims to examine the efficacy of brief MI delivered by mobile instant messaging tools in promoting smoking cessation among unmotivated smokers with chronic diseases. Participants in the intervention group will receive a brief MI intervention while the control group will receive a placebo intervention.
Read the detailed description
Smoking plays a causal role in the development of chronic diseases and may increase the risk of disease progression or recurrence, elevate the risk of mortality, and reduce the efficacy of treatment for disease sufferers. However, a majority of smokers with chronic diseases are unmotivated, having no intention to quit. These characteristics underscore the critical need for appropriate and effective smoking cessation interventions targeting this population. Nevertheless, most existing smoking cessation services are generic, and none seems to target smokers suffering from chronic diseases. A systematic review indicated that no study had yet examined the efficacy of a smoking cessation intervention designed specifically for unmotivated smokers with chronic diseases. Though MI was effective in promoting smoking cessation among the general population, was not effective for smokers with chronic diseases, who as has been seen tend to be unmotivated smokers. Brief MI, accordingly, is better suited to reaching these smokers in clinical settings, but the application of this approach to smoking cessation contexts has not been well studied.
The proposed intervention will be designed to promote smoking cessation among unmotivated smokers with chronic diseases. To reduce the influence of the participants' baseline characteristics on the efficacy of the intervention, this study will be designed to motivate them to change a selected unfavourable behaviour as a means to reduce their resistance to the intervention. The foot-in-the-door technique served both to facilitate the recruitment for the study and to enhance the participants' compliance with the intervention, in the latter case by promoting change in their selected unfavourable behaviour as a preliminary to further change. The rationale is that a small successful step increases readiness to take a further, larger step, in this case, smoking cessation.
Given that the exponential growth in the number of users of mobile instant messaging tools, they represent a resource for efforts to promote health and enhance treatment compliance. These were among the considerations that informed the development in this study of an intervention using brief MI delivered by mobile instant messaging tools to facilitate smoking cessation among unmotivated smokers with chronic diseases.
- Conditions
- Smoking Cessation
- Being tested
- Brief MI intervention, Placebo intervention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief MI interventionBehavioural
Brief MI intervention
Placebo interventionBehavioural
Generic health advice consultations and self-help smoking cessation booklets
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The participants in the intervention group will be asked to identify an unfavourable behaviour that they wish to change when filling out the baseline questionnaire. The research nurse will conduct the individual face-to-face brief MI interviews for this purpose, which will last for approximately five to ten minutes. After the face-to-face brief MI interviews, the participants in the intervention group will receive brief MI messages individually by means of mobile instant messaging for six months from the baseline. After six months, the brief MI messages will cease to be delivered to the participants in the intervention group, with whom the research team will then maintain only minimal contact until the 12-month follow-up. Receives: Behavioral: Brief MI intervention |
| Control group | Placebo comparator | Participants in the control group will be asked to identify an unfavourable behaviour that they want to change at the baseline but, rather than brief MI interviews delivered face-to-face, received generic health advice consultations on the selected unfavourable behaviour that lasted approximately five to ten minutes. Each participant will receive a self-help smoking cessation booklet titled Be Smart, Quit Smoking! published by the Hong Kong Council on Smoking and Health with information about the negative health consequences of smoking, reasons to quit, strategies for quitting, and smoking cessation services available in Hong Kong along with a public quitline number (specifically, 1833183). Those who express the intention to quit at follow-ups will receive usual smoking cessation support. Receives: Behavioral: Placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated smoking abstinence at 12 months
The participants who self-reported not smoking within the past seven days will be invited to submit to a biochemical verification test of smoking abstinence, including an exhaled CO test and a salivary cotinine test. Smoking abstinence is defined as an exhaled CO level of less than 4 ppm and a saliva cotinine level lower than 15 ng/ml.
Measured: 12-month follow-up
Secondary outcomes (6)
Biochemically validated smoking abstinence at 6 months
The participants who self-reported not smoking within the past seven days will be invited to submit to a biochemical verification test of smoking abstinence, including an exhaled CO test and a salivary cotinine test. Smoking abstinence is defined as an exhaled CO level of less than 4 ppm and a saliva cotinine level lower than 15 ng/ml.
Measured: 6-month follow-up
Self-reported smoking abstinence
Self-reported not smoking within the past seven days
Measured: 3-, 6-, or 12-month follow-ups
Intention to quit
Individual's readiness to quit smoking within six months
Measured: 3-, 6-, or 12-month follow-ups
Self-reported smoking reduction of at least 50%
Reduction in cigarette consumption from the baseline by at least 50%
Measured: 3-, 6-, or 12-month follow-ups
Quit attempts
A period of intentional abstinence of more than 24 hours
Measured: 3-, 6-, or 12-month follow-ups
Self-reported behavioural change
Individual's perceived modification of the selected unfavourable behaviour
Measured: 3-, 6-, or 12-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Jun 2021
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 728 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho Cheung William Li, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890223
- Sponsor's protocol ID
- NTWCREC19001_R1
- Status last verified
- Aug 2023
- First submitted
- 12 May 2021
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Brief Motivational Interviewing Delivered Via Mobile Instant Messaging Tools to Promote Smoking Cessation Among Unmotivated Smokers With Chronic Diseases
- ClinicalTrials.gov ID
- NCT04890223
- Acronym / sponsor ID
- NTWCREC19001_R1
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 18 May 2021 (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 study aims to examine the efficacy of brief MI delivered by mobile instant messaging tools in promoting smoking cessation among unmotivated smokers with chronic diseases. Participants in the intervention group will receive a brief MI intervention while the control group will receive a placebo intervention.
Detailed description
Smoking plays a causal role in the development of chronic diseases and may increase the risk of disease progression or recurrence, elevate the risk of mortality, and reduce the efficacy of treatment for disease sufferers. However, a majority of smokers with chronic diseases are unmotivated, having no intention to quit. These characteristics underscore the critical need for appropriate and effective smoking cessation interventions targeting this population. Nevertheless, most existing smoking cessation services are generic, and none seems to target smokers suffering from chronic diseases. A systematic review indicated that no study had yet examined the efficacy of a smoking cessation intervention designed specifically for unmotivated smokers with chronic diseases. Though MI was effective in promoting smoking cessation among the general population, was not effective for smokers with chronic diseases, who as has been seen tend to be unmotivated smokers. Brief MI, accordingly, is better suited to reaching these smokers in clinical settings, but the application of this approach to smoking cessation contexts has not been well studied.
The proposed intervention will be designed to promote smoking cessation among unmotivated smokers with chronic diseases. To reduce the influence of the participants' baseline characteristics on the efficacy of the intervention, this study will be designed to motivate them to change a selected unfavourable behaviour as a means to reduce their resistance to the intervention. The foot-in-the-door technique served both to facilitate the recruitment for the study and to enhance the participants' compliance with the intervention, in the latter case by promoting change in their selected unfavourable behaviour as a preliminary to further change. The rationale is that a small successful step increases readiness to take a further, larger step, in this case, smoking cessation.
Given that the exponential growth in the number of users of mobile instant messaging tools, they represent a resource for efforts to promote health and enhance treatment compliance. These were among the considerations that informed the development in this study of an intervention using brief MI delivered by mobile instant messaging tools to facilitate smoking cessation among unmotivated smokers with chronic diseases.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Brief MI interventionThe participants in the intervention group will be asked to identify an unfavourable behaviour that they wish to change when filling out the baseline questionnaire. The research nurse will conduct the individual face-to-face brief MI interviews for this purpose, which will last for approximately five to ten minutes. After the face-to-face brief MI interviews, the participants in the intervention group will receive brief MI messages individually by means of mobile instant messaging for six months from the baseline. After six months, the brief MI messages will cease to be delivered to the participants in the intervention group, with whom the research team will then maintain only minimal contact until the 12-month follow-up. |
| Control group | Placebo comparator | Behavioral: Placebo interventionParticipants in the control group will be asked to identify an unfavourable behaviour that they want to change at the baseline but, rather than brief MI interviews delivered face-to-face, received generic health advice consultations on the selected unfavourable behaviour that lasted approximately five to ten minutes. Each participant will receive a self-help smoking cessation booklet titled Be Smart, Quit Smoking! published by the Hong Kong Council on Smoking and Health with information about the negative health consequences of smoking, reasons to quit, strategies for quitting, and smoking cessation services available in Hong Kong along with a public quitline number (specifically, 1833183). Those who express the intention to quit at follow-ups will receive usual smoking cessation support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hong Kong Chinese over the age of 17
- Had smoked at least one cigarette per day over the previous three months
- Had been diagnosed with at least one chronic disease
- Able to speak Cantonese and read Chinese
- Willing to take action to improve their health but had no intention to quit smoking
Key exclusion criteria (2 listed)
- Participating in other smoking cessation programs or services
- With mental or cognitive impairment or communication problems
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 |
|---|---|---|
| Brief MI interventionBrief MI intervention | Behavioural | Intervention group |
| Placebo interventionGeneric health advice consultations and self-help smoking cessation booklets | Behavioural | Control group |
Primary outcome
Biochemically validated smoking abstinence at 12 months
Time frame: 12-month follow-up
The participants who self-reported not smoking within the past seven days will be invited to submit to a biochemical verification test of smoking abstinence, including an exhaled CO test and a salivary cotinine test. Smoking abstinence is defined as an exhaled CO level of less than 4 ppm and a saliva cotinine level lower than 15 ng/ml.
6 secondary outcomes
Biochemically validated smoking abstinence at 6 months
Time frame: 6-month follow-up
Self-reported smoking abstinence
Time frame: 3-, 6-, or 12-month follow-ups
Intention to quit
Time frame: 3-, 6-, or 12-month follow-ups
Self-reported smoking reduction of at least 50%
Time frame: 3-, 6-, or 12-month follow-ups
Quit attempts
Time frame: 3-, 6-, or 12-month follow-ups
Self-reported behavioural change
Time frame: 3-, 6-, or 12-month follow-ups
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 7 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.
Ho Cheung William Li, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief MI intervention in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
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 7 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: finished, as of the sponsor's last update on 7 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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 smoking abstinence at 12 months (time frame: 12-month follow-up). 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 7 Aug 2023.