Smoking CessationNCT06234475
Smoking Cessation Program for the Older Smokers
A study testing Mobile health support, Financial incentive and Combine intervention in people with Smoking Cessation and Aged, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to assess the effect of mobile health (mHealth) support or financial incentives and their interactive intervention effect on smoking cessation (SC) in old smokers in Hong Kong (HK). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Aged, Telemedicine
- What is being tested?
- Mobile health support, Financial incentive and Combine intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Feb 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smokers aged 60 years or above;
- Currently smoking cigarettes or alternative tobacco products daily in the past 3 months with an exhaled carbon monoxide (CO) level ≥4ppm or salivary cotinine >30 ng/ml;
- Have a mobile phone that can receive short message/messaging Service (SMS) or instant messages (IM);
- Having a household monthly income lower than the median income of domestic household in Hong Kong
- 6. Hong Kong residents able to communicate in Chinese.
Who cannot join
- Smokers not physically nor mentally fit for communication;
- Smokers currently using SC services;
- Hospitalized smokers;
- Not having a mobile phone or perceived difficulty in using mobile phone or communication Apps
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized 2 by 2 Factorial Trial on mHealth Support and Financial Incentives to Promote Smoking Cessation in Deprived Older Smokers
This study aims to assess the effect of mobile health (mHealth) support or financial incentives and their interactive intervention effect on smoking cessation (SC) in old smokers in Hong Kong (HK).
Read the detailed description
Low-income older smokers are disproportionally harmed by tobacco use and the evidence of effectiveness of smoking cessation (SC) intervention for this deprived group is scarce. Leveraging evidence of effectiveness of mHealth support and financial incentives in other adults, the investigators propose a scalable mHealth and/or financial incentives model using age-friendly components for the deprived older smokers.
The 2x2 factorial design consists of 2 interventions, including (1) smartphone mHealth support by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months, and (2) an escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively.
The study aims to assess the effectiveness of two interventions and their interactive intervention effect.
- Conditions
- Smoking Cessation, Aged, Telemedicine, Motivation
- Being tested
- Mobile health support, Financial incentive, Combine intervention, Control group
- Keywords
- Smoking Cessation, Low-income older smokers, Mobile health, Incentive, Real-time personalized support, Factorial study
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health supportBehavioural
- Brief smoking cessation advice
- Health warning leaflet
- Smoking cessation information booklet
- Referral card
- E-messages on SC-related information and details on community SC services for 3 months
- Acceptance and Commitment Therapy based real-time Chat-based support for 3 months
Financial incentiveBehavioural
- Brief smoking cessation advice
- Health warning leaflet
- Smoking cessation information booklet
- Referral card
- An escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively.
Combine interventionBehavioural
- Brief smoking cessation advice
- Health warning leaflet
- Smoking cessation information booklet
- Referral card
- E-messages on SC-related information and details on community SC services for 3 months
- Acceptance and Commitment Therapy based real-time Chat-based support for 3 months
- An escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively.
Control groupBehavioural
- Brief smoking cessation advice
- Health warning leaflet
- Smoking cessation information booklet
- Referral card
- E-messages on SC-related information and details on community SC services for 3 months for those without abstinence at 12-month follow-up after follow-ups ending
- Acceptance and Commitment Therapy based rear-time Chat-based support for 3 months for those without abstinence at 12-month follow-up after follow-ups ending
| Study group | Role | What they receive |
|---|---|---|
| Mobile health group | Experimental | Smartphone mHealth support for smoking cessation by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months. Receives: Behavioral: Mobile health support |
| Financial incentive group | Experimental | An escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively. Receives: Behavioral: Financial incentive |
| Combined intervention group | Experimental | Smartphone mHealth support for smoking cessation by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months and an escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively. Receives: Behavioral: Combine intervention |
| Control group | Active comparator | Brief advice Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The biochemically validated smoking abstinence
Smoking abstinence is defined by exhaled CO < 4 ppm and salivary cotinine <30 ng/ml
Measured: the 6-month follow-ups
Secondary outcomes (8)
The biochemically validated smoking abstinence
Smoking abstinence is defined by exhaled CO < 4 ppm and salivary cotinine <30 ng/ml
Measured: the 3- and 12-month follow-ups
Self-reported 7-day point-prevalence abstinence
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
Measured: 3-, 6-, and 12-month follow-ups
Self-reported smoking change
Self-reported change in number of cigarettes smoked daily of at least less 50% of the baseline number
Measured: 3-, 6-, and 12-month follow-ups
Self-reported self-efficacy of quitting
Self-reported self-efficacy of quitting includes the perception of quitting importance, difficulty and confidence, assessing by an item scaled with 0-10, respectively. The score of zero refers to very unimportant, very easy, or very unconfident. The score of 10 refers to very important, very difficult or very confident, respectively. Higher score refers to higher perception of quitting importance, difficulty and confidence.
Measured: 3-, 6-, and 12-month follow-ups
Self-reported quit attempts
Self-reported quit attempt
Measured: 3-, 6-, and 12-month follow-ups
Nicotine dependence level
Fagerstrom Test for Nicotine Dependence (FTND)
Measured: 3-, 6-, and 12-month follow-ups
Smoking cessation services use
Using the smoking cessation service from hospitals or government in Hong Kong
Measured: 3-, 6-, and 12-month follow-ups
Self-reported intention to quit
self-reported intention to quit in next days
Measured: 3-, 6-, and 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 posted31 Jan 2024
- Study start20 Feb 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- University Grants Committee, Hong Kong
- Responsible party
- Principal investigator, Prof. Wang Man-Ping, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234475
- Sponsor's protocol ID
- SCFO
- Status last verified
- Dec 2025
- First submitted
- 22 Jan 2024
- Last updated
- 15 Dec 2025
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized 2 by 2 Factorial Trial on mHealth Support and Financial Incentives to Promote Smoking Cessation in Deprived Older Smokers
- ClinicalTrials.gov ID
- NCT06234475
- Acronym / sponsor ID
- SCFO
- Conditions
- Smoking Cessation, Aged, Telemedicine, Motivation
- Keywords
- Smoking Cessation, Low-income older smokers, Mobile health, Incentive, Real-time personalized support, Factorial study
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- University Grants Committee, Hong Kong
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 31 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.
This study aims to assess the effect of mobile health (mHealth) support or financial incentives and their interactive intervention effect on smoking cessation (SC) in old smokers in Hong Kong (HK).
Detailed description
Low-income older smokers are disproportionally harmed by tobacco use and the evidence of effectiveness of smoking cessation (SC) intervention for this deprived group is scarce. Leveraging evidence of effectiveness of mHealth support and financial incentives in other adults, the investigators propose a scalable mHealth and/or financial incentives model using age-friendly components for the deprived older smokers.
The 2x2 factorial design consists of 2 interventions, including (1) smartphone mHealth support by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months, and (2) an escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively.
The study aims to assess the effectiveness of two interventions and their interactive intervention effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mobile health group | Experimental | Behavioral: Mobile health supportSmartphone mHealth support for smoking cessation by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months. |
| Financial incentive group | Experimental | Behavioral: Financial incentiveAn escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively. |
| Combined intervention group | Experimental | Behavioral: Combine interventionSmartphone mHealth support for smoking cessation by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months and an escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively. |
| Control group | Active comparator | Behavioral: Control groupBrief advice |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Smokers aged 60 years or above;
- Currently smoking cigarettes or alternative tobacco products daily in the past 3 months with an exhaled carbon monoxide (CO) level ≥4ppm or salivary cotinine >30 ng/ml;
- Have a mobile phone that can receive short message/messaging Service (SMS) or instant messages (IM);
- Having a household monthly income lower than the median income of domestic household in Hong Kong
- 6. Hong Kong residents able to communicate in Chinese.
Key exclusion criteria (4 listed)
- Smokers not physically nor mentally fit for communication;
- Smokers currently using SC services;
- Hospitalized smokers;
- Not having a mobile phone or perceived difficulty in using mobile phone or communication Apps
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 |
|---|---|---|
| Mobile health support1. Brief smoking cessation advice 2. Health warning leaflet 3. Smoking cessation information booklet 4. Referral card 5. E-messages on SC-related information and details on community SC services for 3 months 6. Acceptance and Commitment Therapy based real-time Chat-based support for 3 months | Behavioural | Mobile health group |
| Financial incentive1. Brief smoking cessation advice 2. Health warning leaflet 3. Smoking cessation information booklet 4. Referral card 5. An escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively. | Behavioural | Financial incentive group |
| Combine intervention1. Brief smoking cessation advice 2. Health warning leaflet 3. Smoking cessation information booklet 4. Referral card 5. E-messages on SC-related information and details on community SC services for 3 months 6. Acceptance and Commitment Therapy based real-time Chat-based support for 3 months 7. An escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively. | Behavioural | Combined intervention group |
| Control group1. Brief smoking cessation advice 2. Health warning leaflet 3. Smoking cessation information booklet 4. Referral card 5. E-messages on SC-related information and details on community SC services for 3 months for those without abstinence at 12-month follow-up after follow-ups ending 6. Acceptance and Commitment Therapy based rear-time Chat-based support for 3 months for those without abstinence at 12-month follow-up after follow-ups ending | Behavioural | Control group |
Primary outcome
The biochemically validated smoking abstinence
Time frame: the 6-month follow-ups
Smoking abstinence is defined by exhaled CO < 4 ppm and salivary cotinine <30 ng/ml
8 secondary outcomes
The biochemically validated smoking abstinence
Time frame: the 3- and 12-month follow-ups
Self-reported 7-day point-prevalence abstinence
Time frame: 3-, 6-, and 12-month follow-ups
Self-reported smoking change
Time frame: 3-, 6-, and 12-month follow-ups
Self-reported self-efficacy of quitting
Time frame: 3-, 6-, and 12-month follow-ups
Self-reported quit attempts
Time frame: 3-, 6-, and 12-month follow-ups
Nicotine dependence level
Time frame: 3-, 6-, and 12-month follow-ups
Smoking cessation services use
Time frame: 3-, 6-, and 12-month follow-ups
Self-reported intention to quit
Time frame: 3-, 6-, and 12-month follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- 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 Mobile health support, Financial incentive and Combine intervention in people with Smoking Cessation and Aged, 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
The biochemically validated smoking abstinence (time frame: the 6-month follow-ups). 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 15 Dec 2025.