The "Quit-for-Kids" Project: to Increase Abstinence and Protect Children From Tobacco Smoke Exposure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Those who have communication barriers (either physically or cognitively)
Those who are currently participating in other smoking cessation programmes or services
Trial design
Design model
Parallel
Treatments tested in this trial
Brief cessation advice (AWARD)
BehavioralAsk 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)
Drug1-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)
BehavioralChat-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)
BehavioralA 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
BehavioralA 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
BehavioralIn 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.
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: Brief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial IncentivesExperimental treatment 6 interventions
Group B: Brief cessation advice (AWARD) + Waitlist for same interventionActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Biochemically validated abstinence
Defined as exhaled carbon monoxide level \<4ppm and saliva cotinine level ≤30ng/ml
Time frame
6-month after recruitmentSecondary outcomes
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
Time frame
3- and 6-month after recruitment2
Self-reported reduction rate (for smokers)
Defined by at least 50% reduction in baseline daily number of cigarettes.
Time frame
3- and 6-month after recruitment3
Self-reported intention to quit (for smokers)
Defined by readiness to quit in 30 days.
Time frame
3- and 6-month after recruitment4
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.
Time frame
3- and 6-month after recruitmentSponsors and contacts
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Source ClinicalTrials.gov