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

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06127589
• Other study ID #: QFK
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: Sophia SC Chan, PhD
• Phone: 85239176610
• Email: nssophia[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Those who have communication barriers (either physically or cognitively)

• Those who are currently participating in other smoking cessation programmes or services

Related Conditions & MeSH terms

• Second Hand Tobacco Smoke
• Smoking Cessation

Intervention

Behavioral:
• Brief cessation advice (AWARD)
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).

Drug:
• Nicotine Replacement Therapy (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.

Behavioral:
• Instant messaging Support (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)
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 booklet
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 intervention
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.

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically validated abstinence	Defined as exhaled carbon monoxide level <4ppm and saliva cotinine level =30ng/ml	6-month after recruitment
Secondary	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	3- and 6-month after recruitment
Secondary	Self-reported reduction rate (for smokers)	Defined by at least 50% reduction in baseline daily number of cigarettes.	3- and 6-month after recruitment
Secondary	Self-reported intention to quit (for smokers)	Defined by readiness to quit in 30 days.	3- and 6-month after recruitment
Secondary	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.	3- and 6-month after recruitment
Secondary	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?")	3- and 6-month after recruitment
Secondary	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.	3- and 6-month after recruitment
Secondary	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?"	3- and 6-month after recruitment
Secondary	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?"	3- and 6-month after recruitment
Secondary	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)	3- and 6-month after recruitment
Secondary	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.	3- and 6-month after recruitment
Secondary	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.	3- and 6-month after recruitment
Secondary	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.	3- and 6-month after recruitment
Secondary	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).	3- and 6-month after recruitment