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Smoking CessationNCT04909320

Mobile-based Positive Psychological Support for Smoking Cessation Via "Quit to Win" Contest 2021 (QTW 2021)

A study testing AWARD advice, Brief leaflet on health warning and smoking cessation and Referral card in people with Smoking Cessation, run by The University of Hong Kong at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to explore the effectiveness of a combined intervention using brief cessation advice and personalized chat-based positive psychological support compared with the control group on current smokers who join the Quit to Win Contest. 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?
AWARD advice, Brief leaflet on health warning and smoking cessation and Referral card
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,094 participants
Where
1 siteChina
Study dates
12 Jun 2021to 30 Jun 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 residents aged 18 or above
  • Smoke at least 1 tobacco stick (includes HTP) per day or use e-cigarette daily in the past 3-month
  • Able to communicate in Chinese
  • Saliva cotinine 30 ng/ml or above
  • Intent to quit/reduce smoking
  • Able to use the instant messaging tool (e.g., WhatsApp, WeChat) for communication

Who cannot join

  • Smokers who have communication barrier (either physically or cognitively)
  • Smokers who are currently participating in other SC programmes or services

Trial locations and contacts

1 site in 1 country.

Man Ping Wang, PhD contact

+852 3917 6636

mpwang@hku.hk

Ziqiu Guo, MMed contact

+852 3917 6605

zqguo@hku.hk

China1 site, 1 recruiting
  • Hong Kong Council on Smoking and Health (COSH)

    Hong Kong, Hong Kong, 852

    Fung Wong, +852 2180 5186

    Man Ping Kelvin Wang, PhD

    Recruiting

Other trials in China

About this study

Official title: Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2021: Mobile-based Positive Psychological Support on Smoking Cessation

This study aims to explore the effectiveness of a combined intervention using brief cessation advice and personalized chat-based positive psychological support compared with the control group on current smokers who join the Quit to Win Contest.

Read the detailed description

Smoking is a leading cause of many diseases and deaths globally. Although Hong Kong has a relatively low overall smoking rate of 10.2% (in 2019), health and economic burdens due to smoking are still substantial. The practice of smoking might predispose smokers to COVID-19 infection and poor prognosis. Growing evidence has also suggested that smokers are at higher risk of developing serious respiratory and cardiovascular symptoms in the COVID-19 pandemic than non-smokers. Smoking cessation in the post-COVID-19 era is the key priority to meet the HKSAR Government's target of reducing smoking prevalence to 7.8% by 2025.

Mental health problems are commonly comorbid with smoking and related problems. Our population-based survey amidst the COVID-19 pandemic found current smokers were at higher risk of suffering from anxious symptoms (adjusted OR 1.84 95% CI 1.27, 2.67), depressive symptoms (adjusted OR 2.04 95% CI 1.40, 2.96), and stress symptoms (adjusted β 0.54 95% CI 0.26, 0.82) compared with non-smokers. We also observed mental health burden increased during the COVID-19 pandemic with approximately doubling of the prevalence of anxious symptoms (15.8 vs. 9.3) and depressive symptoms (14.8 vs. 6.3) compared with the pre-COVID-19 pandemic (2017). Mental health can be both precursors and consequences of smoking. Previous studies have suggested that depressive symptoms and low positive affect during and after SC attempts are associated with poor cessation outcomes. This implies that a combined intervention of behavioral and psychological SC intervention is needed, particularly under the circumstance of worsening mental health problems.

Therefore, our study aims to test the effectiveness of a combined intervention using brief cessation advice and personalized chat-based positive psychological support compared with the control group on current smokers who join the Quit to Win Contest.

Being tested
AWARD advice, Brief leaflet on health warning and smoking cessation, Referral card, Self-help smoking cessation booklet, Positive psychological support through 3-people group chat using instant messaging apps
Keywords
smoking cessation, positive psychological support, mobile health, peer supporter
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AWARD adviceBehavioural

    Ask about smoking history; Warn about the high risk; Advise to quit; Refer smokers to smoking cessation services (with a referral card); Do it again

  • Brief leaflet on health warning and smoking cessationOther

    The contents of the leaflet include (1) highlights of the absolute risk of death due to smoking; (2) the whole list of diseases caused by active and second-hand smoking; (3) ten horrible pictorial warnings of health consequences of smoking and second-hand smoking in one page to maximize the impacts; (4) benefits of SC and (5) simple messages to encourage participants to quit smoking and remind them to call the Department of Health SC hotline 183 3183.

  • Referral cardOther

    The contents consist of brief information and highlights of existing SC services, contact methods, motivation information, and strong supporting messages or slogans.

  • Self-help smoking cessation bookletOther

    The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.

  • Positive psychological support through 3-people group chat using instant messaging appsBehavioural

    Each IM chat group will consist of a trained SC counselor (HKU staff), a peer supporter (former smoker), and a participant (smoker). The 3-month group chat-based intervention will consist of regular messages and real-time support through group chat. Regular messages will generally include goal setting, health warnings, abstinence support, positive psychological exercises, and encouragement and will be delivered in a tapering style. During the real-time chatting, SC counsellors and peer supporters will provide real-time chat-based support, and peer supporters will share their quitting experience as appropriate.

  • E-messages via SMSBehavioural

    Regular e-messages via SMS at twice per month within 3 months (total 6).

Study groups in NCT04909320
Study groupRoleWhat they receive
Intervention groupExperimentalNot described
Receives: Behavioral: AWARD advice; Other: Brief leaflet on health warning and smoking cessation; Other: Referral card; Other: Self-help smoking cessation booklet; Behavioral: Positive psychological support through 3-people group chat using instant messaging apps
Control groupActive comparatorNot described
Receives: Behavioral: AWARD advice; Other: Brief leaflet on health warning and smoking cessation; Other: Referral card; Other: Self-help smoking cessation booklet; Behavioral: E-messages via SMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemically validated abstinence

    Defined as exhaled CO level <4ppm and saliva cotinine level ≤30 ng/ml

    Note

    1. If participants refuse to have a face-to-face exhaled carbon monoxide test due to the COVID-19 pandemic in Hong Kong. In that case, the outcome will only be validated by a saliva cotinine test device.
    2. If participants use NRT, the outcome will be validated by exhaled carbon monoxide only.

    Measured: 6-month follow-up

Secondary outcomes (31)
  1. Biochemically validated abstinence

    Defined as exhaled CO level <4ppm and saliva cotinine level ≤30 ng/ml

    Note

    1. If participants refuse to have a face-to-face exhaled carbon monoxide test due to the COVID-19 pandemic in Hong Kong. In that case, the outcome will only be validated by a saliva cotinine test device.
    2. If participants use NRT, the outcome will be validated by exhaled carbon monoxide only.

    Measured: 3-month follow-up

  2. Self-reported 7-day point prevalence quit rate

    Smokers who did not smoke even a puff in the 7 days preceding the follow-up

    Measured: 3-month follow-up

  3. Self-reported 7-day point prevalence quit rate

    Smokers who did not smoke even a puff in the 7 days preceding the follow-up

    Measured: 6-month follow-up

  4. Self-reported reduction

    Defined by at least 50% reduction in baseline daily number of cigarettes

    Measured: 3-month follow-up

  5. Self-reported reduction

    Defined by at least 50% reduction in baseline daily number of cigarettes

    Measured: 6-month follow-up

  6. Self-reported depressive symptoms

    Measured by Patient Health Questionnaire-2 (PHQ-2). PHQ-2 ranges from 0-6, a higher score indicates a severer depressive symptom.

    Measured: 3-month follow-up

  7. Self-reported depressive symptoms

    Measured by Patient Health Questionnaire-2 (PHQ-2). PHQ-2 ranges from 0-6, a higher score indicates a severer depressive symptom.

    Measured: 6-month follow-up

  8. Self-reported anxious symptoms

    Measured by Generalized Anxiety Disorder-2 (GAD-2). GAD-2 ranges from 0-6, a higher score indicates a severer anxious symptom.

    Measured: 6-month follow-up

  9. Self-reported anxious symptoms

    Measured by Generalized Anxiety Disorder-2 (GAD-2). GAD-2 ranges from 0-6, a higher score indicates a severer anxious symptom.

    Measured: 3-month follow-up

  10. Self-reported use of smoking cessation service

    Use of smoking cessation service at 3- and 6- month follow-up

    Measured: 3-month follow-up

  11. Self-reported use of smoking cessation service

    Use of smoking cessation service at 3- and 6- month follow-up

    Measured: 6-month follow-up

  12. Self-rated health

    Self-rated health will be measured as a single item with the response items "excellent", "very good", "good", "fair", or "poor".

    Measured: 3-month follow-up

  13. Self-rated health

    Self-rated health will be measured as a single item with the response items "excellent", "very good", "good", "fair", or "poor".

    Measured: 6-month follow-up

  14. Self-reported happiness

    A single item will measure self-reported happiness with an answer on an 11-point scale (0-10). A higher score indicates a higher level of happiness.

    Measured: 3-month follow-up

  15. Self-reported happiness

    A single item will measure self-reported happiness with an answer on an 11-point scale (0-10). A higher score indicates a higher level of happiness.

    Measured: 6-month follow-up

  16. Self-reported quit attempts

    Number of quit attempts from baseline at 3-month follow-up

    Measured: 3-month follow-up

  17. Self-reported quit attempts

    Number of quit attempts from baseline at 6-month follow-up

    Measured: 6-month follow-up

  18. Self-reported resilience

    A single item will measure self-reported resilience with an answer on an 11-point scale (0-10). A higher score indicates a higher level of resilience.

    Measured: 3-month follow-up

  19. Self-reported resilience

    A single item will measure self-reported resilience with an answer on an 11-point scale (0-10). A higher score indicates a higher level of resilience.

    Measured: 6-month follow-up

  20. Self-reported optimistic

    A single item will measure self-reported optimistic with an answer on an 11-point scale (0-10). A higher score indicates a higher level of optimistic.

    Measured: 3-month follow-up

  21. Self-reported optimistic

    A single item will measure self-reported optimistic with an answer on an 11-point scale (0-10). A higher score indicates a higher level of optimistic.

    Measured: 6-month follow-up

  22. Self-reported loneliness

    A single item will measure self-reported loneliness with an answer on an 11-point scale (0-10). A higher score indicates a higher level of loneliness.

    Measured: 3-month follow-up

  23. Self-reported loneliness

    A single item will measure self-reported loneliness with an answer on an 11-point scale (0-10). A higher score indicates a higher level of loneliness.

    Measured: 6-month follow-up

  24. Self-reported stress

    A single item will measure self-reported stress with an answer on an 11-point scale (0-10). A higher score indicates a higher level of stress.

    Measured: 6-month follow-up

  25. Self-reported stress

    A single item will measure self-reported stress with an answer on an 11-point scale (0-10). A higher score indicates a higher level of stress.

    Measured: 3-month follow-up

  26. Self-reported social support

    A single item will measure self-reported social support with an answer on an 11-point scale (0-10). A higher score indicates a higher level of social support.

    Measured: 3-month follow-up

  27. Self-reported social support

    A single item will measure self-reported social support with an answer on an 11-point scale (0-10). A higher score indicates a higher level of social support.

    Measured: 6-month follow-up

  28. Self-reported positive affect

    The subscale of the Chinese version International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) will measure self-reported positive affect. The I-PANAS-SF uses a 5-point scale, a higher score indicates a higher level of self-reported positive affect.

    Measured: 3-month follow-up

  29. Self-reported positive affect

    The subscale of the Chinese version International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) will measure self-reported positive affect. The I-PANAS-SF uses a 5-point scale, a higher score indicates a higher level of self-reported positive affect.

    Measured: 6-month follow-up

  30. Self-reported negative affect

    The subscale of the Chinese version International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) will measure self-reported negative affect. The I-PANAS-SF uses a 5-point scale, a higher score indicates a higher level of self-reported negative affect.

    Measured: 6-month follow-up

  31. Self-reported negative affect

    The subscale of the Chinese version International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) will measure self-reported negative affect. The I-PANAS-SF uses a 5-point scale, a higher score indicates a higher level of self-reported negative affect.

    Measured: 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2021
  2. Study start12 Jun 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2023 (estimated)

Resources

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
1,094 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04909320
Sponsor's protocol ID
QTW 2021
Status last verified
Aug 2022
First submitted
26 May 2021
Last updated
17 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zeng Y, Wu YS, Luk TT, Zhao SZ, Guo Z, Li Y, Tong HSC, Lai VWY, Cheung YTD, Lam TH, Wang MP. Quitting trajectories of Hong Kong Chinese smokers receiving behavioral smoking cessation interventions: A post hoc analysis of eight randomized controlled trials. Addiction. 2026 Jun;121(6):1568-1579. doi: 10.1111/add.70328. Epub 2026 Jan 17.

    PubMed 41546550
  • Guo Z, Luk TT, Weng X, Wu Y, Zhao S, Lai YK, Cheung DYT, Tong HSC, Lai VWY, Lam TH, Wang MP. Behavioral Support by Ex-Smoking Peers Using Instant Messaging for Smoking Cessation: A Randomized Controlled Trial. Chest. 2026 Jan;169(1):300-311. doi: 10.1016/j.chest.2025.07.4110. Epub 2025 Sep 10.

    PubMed 40939935

Questions about this trial

What is this clinical trial studying?

A study testing AWARD advice, Brief leaflet on health warning and smoking cessation and Referral card in people with Smoking Cessation, run by The University of Hong Kong 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 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 17 Aug 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Man Ping Wang, PhD (+852 3917 6636, mpwang@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically validated abstinence (time frame: 6-month follow-up). 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 NCT04909320, which also lists 2 linked publications.

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 17 Aug 2022.

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