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Smoking CessationNCT06127589

The "Quit-for-Kids" Project: to Increase Abstinence and Protect Children From Tobacco Smoke Exposure

A study testing Brief cessation advice (AWARD), Nicotine Replacement Therapy (NRT) and Instant messaging Support (IM) in people with Smoking Cessation and Second Hand Tobacco Smoke, run by The University of Hong Kong at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This project aims to test the effectiveness of an integrated intervention of brief cessation advice (AWARD), Nicotine Replacement Therapy, and Instant Messaging support compared with waitlist control participants among adult daily smokers who lived with their children and non-smoking partners. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation, Second Hand Tobacco Smoke
What is being tested?
Brief cessation advice (AWARD), Nicotine Replacement Therapy (NRT) and Instant messaging Support (IM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteChina
Study dates
5 Feb 2024to 30 Sep 2027
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • 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 preceding 3-month and verified by exhaled carbon monoxide level of 4ppm (parts per million) or above, assessed by a validated Carbon monoxide Smokerlyzer®
  • Living with at least one child of primary 6 or below (aged 12 or below)
  • Living with at least one non-smoking family member
  • Living in deprived households (monthly household income of less than the median of household monthly income in Hong Kong, HK$ 28,000, or living in subdivided flats or social housing)
  • Able to communicate in Chinese (including reading Chinese in IM)
  • Able to use the instant messaging tool (e.g., WhatsApp, WeChat) for communication

Who cannot join

  • Those who have communication barriers (either physically or cognitively)
  • Those who are currently participating in other smoking cessation programmes or services

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sophia SC Chan, PhD contact

85239176610

nssophia@hku.hk

China1 site, 1 recruiting
  • The University of Hong Kong

    Hong Kong

    Sophia SC Chan, PHD, 85239176610, nssophia@hku.hk

    Sophia SC Chan, PhD

    Recruiting

Other trials in China

About this study

Official title: An Integrated Smoking Cessation Intervention Model of Brief Advice, Nicotine Replacement Therapy and Mobile Health Support for Smoking Parents to Increase Abstinence and Protect Children From Tobacco Smoke Exposure: A Randomized Controlled Trial

This project aims to test the effectiveness of an integrated intervention of brief cessation advice (AWARD), Nicotine Replacement Therapy, and Instant Messaging support compared with waitlist control participants among adult daily smokers who lived with their children and non-smoking partners.

Read the detailed description

Background: Around 40% of children worldwide were exposed to secondhand smoke (SHS). Despite reaching a single-digit smoking prevalence of 9.5% in 2022, about one in three children in Hong Kong (36.2%) are still exposed to SHS, mostly at home. Especially children from deprived households, suffer from a higher risk of more pervasive SHS exposure. Aim: The project aims to apply evidence-based interventions to increase smoking cessation and reduce SHS exposure in children of disadvantaged families. The specific objectives of the study are (1) to evaluate the effectiveness of a novel, family-based intervention model in increasing smoking cessation and reducing SHS exposure in children of disadvantaged families, (2) to alert parents in recognizing their child's exposure level and take actions in protecting their child from exposure, (3) to advocate for the adoption of this resource-efficient intervention model in Non-Governmental Organizations(NGOs), District Health Centre Express(DHC/Es), and other smoking cessation service providers in Hong Kong.

Methods: A family-based smoking cessation that collect comprehensive biochemical and environmental data of SHS exposure, and apply evidence-based interventions to prevent the SHS exposure and support quitting in deprived households. Two domains of outcome will be assessed: (1) Effectiveness and overall impact of smoking cessation intervention. (2) Cost-effectiveness analysis and qualitative interviews to estimate the scalability and mechanisms of interventions.

Procedure: Participants will be actively recruited through different channels including direct referral from Non-Governmental Organizations (NGOs) with social housing schemes, referral and recruitment from District Health Centre (DHC), community-based recruitment activities in smoking hotspots, and online advertisement on search engines and social media sites. The eligibility of smokers and non-smokers will be assessed by counselors and invited to join the randomized controlled trial and allocated to one of the groups of the smoking cessation intervention. 6 follow ups at 1 week, 1,2,3,6,12 months will be conducted to both smokers and non-smokers to reveal their SHS exposure level and smoker's quitting progress.

Hypothesis: We hypothesize that the assessment-guided intervention will lead to significant increases in rates of smoking cessation in the intervention group than the control group. Another hypothesis to be investigated is that designated intervention messages are effective to reduce the level of SHS participants and their family members exposed to.

Being tested
Brief cessation advice (AWARD), Nicotine Replacement Therapy (NRT), Instant messaging Support (IM), Financial Incentive (FI), Self-help smoking cessation booklet
Keywords
Smoking Cessation, Second Hand Smoke Exposure, Children Health, Mobile Health Intervention, Nicotine Replacement Therapy, Family-based 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 cessation advice (AWARD)Behavioural

    Also called Brief Advice (BA)

    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 refuse to set a quit date).

  • Nicotine Replacement Therapy (NRT)Drug

    Also called NRT

    1-week sampling of Nicotine Replacement Therapy (NRT) will be provided to support quit attempt. Full pharmacological treatment (12-week) will be available if needed.

  • Instant messaging Support (IM)Behavioural

    Also called IM

    Chat-based mHealth personalized psychosocial and behavioural counselling (smoking cessation and SHS exposure reduction messages will be derived from previously tested interventional studies) using baseline children health and biofeedback data to support quitting throughout the intervention period of 3 months.

  • Financial Incentive (FI)Behavioural

    Also called FI

    A financial incentive (vouchers) of HK$ 500 will be provided for biochemically validated smoking abstinence at 3- and 6-month follow-up. Considering a possibly low engagement rate of the smokers in mHealth-based support (17% in our previous trial, non-engagement mostly due to busy work), additional HK$ 200 will be provided for participants who actively engaged in the mHealth counselling (defined by have discussed quitting process for >2 times) at 3-month follow-up.

  • Self-help smoking cessation bookletBehavioural

    Also called Self-help material

    A well-designed self-help booklet will be provided to guide and provide detailed information on smoking cessation. The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.

  • Environmental assessment derived interventionBehavioural

    In a selected subgroup of 50 families with an additional signed consents, four home visits will be done to: 1. Setup an indoor air quality (IAQ) monitor to collect 24hr air quality data (2 weeks), 2. Collect the monitor for data retrieval, 3. Setup the monitor at 6 months follow-up (2 weeks), 4. Collect the monitor for data retrieval.

    Environmental assessment derived intervention, including results interpretation and health advice, will be provided via phone calls for the 50 families within 1 week after the data collection.

Study groups in NCT06127589
Study groupRoleWhat they receive
Brief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial IncentivesExperimentalParticipants will receive a special designed evidence-based intervention using health advice, behavioral and pharmacological support, mobile health technologies, and awareness building (highlight harms) based on the biofeedback results of SHS exposure in the child. A selected sample of 50 families will receive environmental assessment-derived intervention, including results interpretation and health advice, which will be provided via phone calls for the 50 families within 1 week after the data collection.
Receives: Behavioral: Brief cessation advice (AWARD); Drug: Nicotine Replacement Therapy (NRT); Behavioral: Instant messaging Support (IM); Behavioral: Financial Incentive (FI); Behavioral: Self-help smoking cessation booklet; Behavioral: Environmental assessment derived intervention
Brief cessation advice (AWARD) + Waitlist for same interventionActive comparatorParticipants in the control group will receive the same AWARD brief advice model, self-help booklet at baseline, and financial incentives for validated abstinence at 3- and 6-month follow-up. After the 6-month follow-up, participants who continued to smoke will receive the remaining intervention components: 1-week sampling of NRT and 3 months instant messaging chat-based personalized psychosocial and behavioural counselling for quitting. Participants who validated abstinence at the 12 months or actively engaged in mobile Health counselling will also receive the financial incentives of HK$ 500 and HK$ 200, respectively (waitlist control). Similar to the Intervention group, environmental assessment derived intervention, including results interpretation and health advice, will be provided via phone calls for the 50 families within 1 week after the data collection.
Receives: Behavioral: Brief cessation advice (AWARD); Behavioral: Self-help smoking cessation booklet; Behavioral: Environmental assessment derived intervention

What is being measured

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

  1. Biochemically validated abstinence

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

    Measured: 6-month after recruitment

Secondary outcomes (13)
  1. Self-reported 7-day point prevalence quit rate (for smokers)

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

    Measured: 3- and 6-month after recruitment

  2. Self-reported reduction rate (for smokers)

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

    Measured: 3- and 6-month after recruitment

  3. Self-reported intention to quit (for smokers)

    Defined by readiness to quit in 30 days.

    Measured: 3- and 6-month after recruitment

  4. Smoking cessation service use (for smokers)

    The number of calling a hotline of the smoking cessation services, booking an appointment, smoking cessation clinic attendance, and counseling session attendance.

    Measured: 3- and 6-month after recruitment

  5. Self-rated health (for smokers)

    Self-reported health status will be measured using a single-item scale (in general, would you say that your health is excellent, very good, good, fair, or poor?")

    Measured: 3- and 6-month after recruitment

  6. Children's secondhand smoke exposure (for children)

    The children's SHS exposure will be assessed by the nicotine or cotinine level in urine, saliva, or hair using isotope dilution liquid chromatography and tandem mass spectrometry with a limit of detection of < 50 parts per trillion.

    Measured: 3- and 6-month after recruitment

  7. Academic performance (for children)

    Participant's academic performance will be assessed by "In general, would you say your academic performance is Excellent/Very good/Good/Fair/Poor?"

    Measured: 3- and 6-month after recruitment

  8. Cognitive function (for children)

    Participant's cognitive function will be assessed by "In general, would you say your cognitive function is Excellent/Very good/Good/Fair/Poor?"

    Measured: 3- and 6-month after recruitment

  9. Self-reported secondhand smoke exposure (for children and family member)

    Self-reported secondhand smoke exposure will be measured using a single-item scale (In the past week, have you inhaled secondhand smoke in your home? No or Yes, for___days)

    Measured: 3- and 6-month after recruitment

  10. Quality of life (for smokers and family member)

    Quality of life will be measured by Health-related Quality of life-short form (SF12), which contains eight dimensions (General Health, Physical Function, Role Physical, Bodily Pain, Vitality, Social Functioning, Role Emotional, and Mental Health). The scale ranges from 0 to 100, with the higher the score, the better and healthier they feel subjectively.

    Measured: 3- and 6-month after recruitment

  11. Depression and anxiety (for smokers, family member and children)

    The Patient Health Questionnaire-4 (PHQ-4) will be used to measure depression and anxiety. The 4-item questionnaire consists of a 2-item depression sub-scale and 2-item anxiety sub-scale. The questions are answered on a four-point Likert Scale. The sum of the scores is categorized into normal (0-2), mild (3-5), moderate (6-8) and severe (9-12). The total score of 3 or greater on each sub-scale suggest depression or anxiety, respectively.

    Measured: 3- and 6-month after recruitment

  12. Family well-being (for smokers, family member and children)

    Family well-being will be measured by family health, harmony, and happiness (3Hs): three separate questions asked, "How healthy/harmonious/happy do you think your family is?" and will be answered using an 11-point scale ranging from 0 to 10, with higher scores indicating higher level of family well-being.

    Measured: 3- and 6-month after recruitment

  13. Respiratory symptoms (for smokers, family member and children)

    Respiratory symptoms will be measured by a single-item scale (In the past week, if you have had any of the following symptoms, with the response of having trouble with your eyes, sore throat, cough, shortness of breath, runny nose, loss of appetite, and rapid heartbeat).

    Measured: 3- and 6-month after recruitment

Timeline

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

  1. First posted13 Nov 2023
  2. Study start5 Feb 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion30 Sep 2027 (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
NCT06127589
Sponsor's protocol ID
QFK
Status last verified
Apr 2026
First submitted
10 Oct 2023
Last updated
4 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Brief cessation advice (AWARD), Nicotine Replacement Therapy (NRT) and Instant messaging Support (IM) in people with Smoking Cessation and Second Hand Tobacco Smoke, 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 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: looking for participants now, as of the sponsor's last update on 4 May 2026. 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?

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?

Contact Sophia SC Chan, PhD (85239176610, nssophia@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 after recruitment). 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 4 May 2026.

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