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Smoking CessationNCT03992742

Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2019

A study testing Initial phase: personalized instant messaging (PIM), Second phase: optional cocktail interventions (OCI) and Initial phase: regular instant messaging (RIM) in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The present study will examine (1) effectiveness of a combined intervention of AWARD advice, active referral, instant messaging and optional cocktail intervention to increase abstinence using a sequential multiple assignment randomised trial (SMART) and (2) explore the use of CBPR model to build capacity and to engage… 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 instant messaging (PIM), Second phase: optional cocktail interventions (OCI) and Initial phase: regular instant messaging (RIM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteHong Kong
Study dates
21 Jun 2019to 30 Jun 2021
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 cigarette per day in the past 3-month
  • Able to communicate in Cantonese (including reading Chinese)
  • Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO Smokerlyzer.
  • Intent to quit / reduce smoking
  • Able to use instant messaging tool (e.g., WhatsApp, WeChat) for communication.

Who cannot join

  • Smokers who have communication barrier (either physically or cognitively)
  • Have participation in other smoking cessation programmes or services

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • School of Nursing, The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2019: Personalized Cocktail Interventions to Increase Abstinence: a Sequential, Multiple Assignment, Randomized Trial (SMART)

The present study will examine (1) effectiveness of a combined intervention of AWARD advice, active referral, instant messaging and optional cocktail intervention to increase abstinence using a sequential multiple assignment randomised trial (SMART) and (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, a process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.

Read the detailed description

Although smoking prevalence is decreasing in Hong Kong, there are still 615,000 daily cigarette smokers in Hong Kong in 2017 and half will be killed by smoking which accounts for over 7,000 deaths per year. Smoking also accounts for a large amount of medical cost, long-term care and productivity loss of US$688 million (0.6% Hong Kong GDP). Smoking is a highly addictive behavior and it is difficult for smokers with strong nicotine dependence to quit without assistance. On the other hand, reaching and helping the many smokers who have no intention to quit is a challenge, because they are unlikely to seek professional help from smoking cessation services.

The Quit and Win programme provides an opportunity to reach and encourage a large group of smokers to make quit attempt and maintain abstinence. The Quit and Win model posits that smokers participating in the contest will have higher motivation to quit with incentives and better social support. Studies have found that such quitting contests or incentive programs appeared to reach a large number of smokers and demonstrated a significantly higher quit rate for the quit and win group than for the control group.

We propose to use adaptive design for the QTW 2019 specifically a two-phase adaptive design, i.e., a sequential, multiple assignment, randomized trial (SMART) design. Optional cocktail cessation supports will be provided based on smokers' smoking status and preference. The supports, including multimedia messages, active referral plus financial incentive, phone counseling, social support and medications, are empirically evidence-supported and most have been used in our previous QTW interventions.

Therefore, the present study will examine (1) effectiveness of a combined intervention of AWARD advice, active referral, instant messaging and optional cocktail intervention to increase abstinence using a SMART design and (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, a process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.

Being tested
Initial phase: personalized instant messaging (PIM), Second phase: optional cocktail interventions (OCI), Initial phase: regular instant messaging (RIM), Second phase: personalized instant messaging (PIM), AWARD advice
Keywords
Smoking cessation, Quit to Win, Cocktail intervention, 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 instant messaging (PIM)Behavioural

    intervention Group participants will receive three months of personalized interaction through IM Apps (e.g. WhatsApp, WeChat). Our counsellors will trigger the conversation and encourage the participants to set a quit day. A total of pre-set 26 messages will be sent with the schedule of once daily for 1 week (the week across the quit date), 3 times a week for 4 weeks (2 weeks each before and after the week with quit date) and once a week for remaining 7 weeks. These messages covered generic information about the benefits of quitting, methods to avoid/ manage craving or withdrawal symptoms, and encouragement to quit and use SC services.

    At the end of the initial phase (1-month), complete responders (quitters) will continue to receive PIM (subgroup C). Incomplete responders (smokers) will be randomized to continue PIM (subgroup B) or receive OCI (subgroup A).

  • Second phase: optional cocktail interventions (OCI)Behavioural

    For incomplete respondents (subgroup A) randomized to OCI, the available intervention options include multi-media messages, active referral plus financial incentive, phone counseling, family/peer support and medications (NRT). Participants will be guided by cessation counsellors at 1-month follow-up telephone survey to choose any combination of OCI based on their preference. If OCI participants cannot be followed up at 1-month, they will receive multi-media messages by default.

  • Initial phase: regular instant messaging (RIM)Behavioural

    Participants enrolled in the Control Group will receive regular messages via IM services (e.g. WhatsApp, WeChat) since initial contact and until 3-month after baseline with a tapering schedule: 1) Baseline to 4-week (1-month): 2 times/ week (8 in total); 2) 4-week to 12-week (2- \& 3-month): 1 time/week (8 in total).

    SC messages will generally include benefits of SC, encouragement on abstinence and use of SC services, tips on avoiding/ handling craving and reminder of participating in telephone follow-up. A reminder to participate in the telephone follow-up will also be sent at 1-, 2-, 3- and 6-month, making up a total of 20 messages.

    At the end of the initial phase (1-month), complete responders (quitters) will continue to receive RIM (subgroup F). Incomplete responders (smokers) will be second randomized to continue RIM (subgroup E) or receive PIM (subgroup D). Those who are unable to follow up at 1-month will be considered as nonresponsive to the intervention.

  • Second phase: personalized instant messaging (PIM)Behavioural

    For incomplete responders allocated to PIM (subgroup D), participants will receive the same intervention as the Group A delivered at the initial stage. Participants will receive two months of personalized interaction through IM application. Please refer to Intervention Group "Initial phase: personalized instant messaging (PIM)" for details.

  • AWARD adviceBehavioural

    Also called Ask, Warn, Advise, Refer, Do-it-again

    Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).

  • Warning leafletBehavioural

    Also called Brief leaflet on health warning and smoking cessation

    The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation

  • Referral cardBehavioural

    Also called Smoking Cessation Service Card

    The 3-folded "Smoking Cessation Services" card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans

  • COSH bookletBehavioural

    Also called COSH self-help smoking cessation booklet

    A general smoking cessation self-help booklet

Study groups in NCT03992742
Study groupRoleWhat they receive
Intervention Group (subgroup A+B+C)ExperimentalPersonalized instant messaging (PIM) + optional cocktail interventions (OCI) + AWARD advice + referral card + warning leaflet+ COSH booklet
Receives: Behavioral: Initial phase: personalized instant messaging (PIM); Behavioral: Second phase: optional cocktail interventions (OCI); Behavioral: AWARD advice; Behavioral: Warning leaflet; Behavioral: Referral card; Behavioral: COSH booklet
Control Group (subgroup D+E+F)ExperimentalRegular instant messaging (RIM) + personalized instant messaging (PIM) + AWARD advice + referral card + warning leaflet+ COSH booklet
Receives: Behavioral: Initial phase: regular instant messaging (RIM); Behavioral: Second phase: personalized instant messaging (PIM); Behavioral: AWARD advice; Behavioral: Warning leaflet; Behavioral: Referral card; Behavioral: COSH booklet

What is being measured

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

  1. Validated abstinence of PIM + OCI vs. RIM + PIM

    PIM + OCI (subgroup A+B+C) vs. RIM + PIM (subgroup D+E+F) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml)

    Measured: 6-month follow-up

  2. Validated abstinence of OCI vs. RIM in incomplete responders

    OCI (subgroup A) vs. RIM (subgroup E) in incomplete responders (those who are still smoking at 1-month) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml)

    Measured: 6-month follow-up

Secondary outcomes (11)

  1. Validated abstinence of PIM + OCI vs. RIM + PIM adjusted for potential imbalance of baseline characteristic

    PIM + OCI (subgroup A+B+C) vs. RIM + PIM (subgroup D+E+F) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) adjusted for potential imbalance of baseline characteristic.

    Measured: 6-month follow-up

  2. Validated abstinence of OCI vs. RIM in incomplete responders adjusted for potential imbalance of baseline characteristic

    OCI (subgroup A) vs. RIM (subgroup E) in incomplete responders (those who are still smoking at 1-month) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) adjusted for potential imbalance of baseline characteristic

    Measured: 6-month follow-up

  3. Validated and self-reported abstinence of OCI vs. PIM in incomplete responders

    OCI (subgroup A) vs. PIM (subgroup B) in incomplete responders (those who are still smoking with 1-month) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence

    Measured: 3- and 6-month follow-up

  4. Validated and self-reported abstinence of PIM vs. RIM in incomplete responders

    PIM (subgroup D) vs. RIM (subgroup E) in incomplete responders (those who are still smoking with 1-month) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence

    Measured: 3- and 6-month follow-up

  5. Validated and self-reported abstinence of PIM vs. RIM

    PIM (subgroup B+C) vs. RIM (subgroup E+F) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence

    Measured: 3- and 6-month follow-up

  6. PIM intervention engagement on validated and self-reported abstinence

    Difference between engagement of PIM intervention vs. no engagement of PIM intervention vs. RIM intervention on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence.

    PIM intervention include subgroup B+C+D, RIM intervention include subgroup E+F.

    Measured: 3- and 6-month follow-up

  7. OCI intervention engagement on validated and self-reported abstinence

    Difference between engagement of OCI intervention vs. no engagement of OCI intervention vs. engagement of PIM intervention vs. no engagement of PIM intervention vs. RIM intervention on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence.

    OCI intervention include subgroup A, PIM intervention include subgroup B+C+D, RIM intervention include subgroup E+F.

    Measured: 3- and 6-month follow-up

  8. Smoking reduction rate change from baseline at 3- and 6-month follow-up

    Rate of smoking reduction by at least half of baseline amount

    Measured: 3- and 6-month follow-up

  9. Smoking cessation service use

    Use of smoking cessation service

    Measured: 3- and 6-month follow-up

  10. Nicotine independence (HSI) on abstinence and intervention engagement

    Subgroup analyses of high nicotine independence vs. low nicotine independence on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence, and intervention engagement (use of PIM and/or OCI intervention)

    Measured: 3- and 6-month follow-up

  11. Intention to quit analyses on abstinence and intervention engagement

    Subgroup analyses of high intention to quit vs. low intention to quit on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence, and intervention engagement (use of OCI intervention and/or PIM intervention and/or RIM intervention).

    Measured: 3- and 6-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 posted20 Jun 2019
  2. Study start21 Jun 2019
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2021 (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
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03992742
Sponsor's protocol ID
QTW 2019
Status last verified
Aug 2020
First submitted
12 Jun 2019
Last updated
20 Aug 2020
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

  • Zhao SZ, Weng X, Luk TT, Wu Y, Cheung DYT, Li WHC, Tong H, Lai V, Lam TH, Wang MP. Adaptive interventions to optimise the mobile phone-based smoking cessation support: study protocol for a sequential, multiple assignment, randomised trial (SMART). Trials. 2022 Aug 18;23(1):681. doi: 10.1186/s13063-022-06502-7.

    PubMed 35982468

Questions about this trial

What is this clinical trial studying?

A study testing Initial phase: personalized instant messaging (PIM), Second phase: optional cocktail interventions (OCI) and Initial phase: regular instant messaging (RIM) 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 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 20 Aug 2020. 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?

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?

Validated abstinence of PIM + OCI vs. RIM + PIM (time frame: 6-month follow-up). 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?

On the ClinicalTrials.gov record for NCT03992742, 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 20 Aug 2020.

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