RCT, Smoking (Tobacco) Addiction, Young Adult
Conditions
Keywords
Smoking Cessation, Young Adult, RCT
Brief summary
This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counsellors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC counsellors who deliver the new intervention? (2) What is the preliminary evidence on the efficacy of the typology-based smoking relapse prevention to increase tobacco abstinence in ex-smokers who have recently quit? If the intervention shows at least a small effect size (i.e. risk ratio\>1.3), or the intervention is feasible while modifications can potentially increase the efficacy, a future definitive RCT is warranted.
Detailed description
Phase 1 Q-method outcomes The outcomes of Phase 1 of this study will be Q-sorts completed by participants which will be inter-correlated producing a matrix for factor rotation and automatic flagging, and the z-score and the factor of the Q-sorts will be calculated. The tobacco epidemic remains a pressing global health challenge, with tobacco-related illness contributing significantly to a high death rate worldwide. Smoking is the predominant mode of tobacco consumption worldwide and serves as the driving force behind this epidemic. According to the World Health Organization, there are an estimated 1.3 billion tobacco users worldwide currently. In Hong Kong, the smoking rate is estimated to be around 9.5%, with approximately 580 000 daily smokers in 2021. Despite the rate has decreased significantly from 23.3% in 1982, the Hong Kong government aims to further reduce the prevalence from 9.5% to 7.8% in 2025. The high prevalence of smoking imposes a significant public health burden worldwide, with tobacco use killing up to 50% of its users. Additionally, smoking causes cancers, stroke, cardiovascular diseases and respiratory diseases, with around 7000 deaths reported each year. One approach to reduce the smoking prevalence is to promote smoking cessation (SC) treatment among current smokers. Young smokers constitute a large cohort of new smokers every year. It is estimated that up to 90% of daily smokers first tried smoking before 18 years old. Published studies consistently highlight the concerning prevalence of youth smoking within Hong Kong's community. Data from the recent school survey highlighted that despite only 1.2% of secondary school engages in smoking, a significant portion (7.4%, equivalent to around 24 000 students) of the youth population have previously engaged in smoking behaviour. The rate of youth ever smokers remain high at 7.4% in Hong Kong, equivalent to approximately 24 000 secondary school students, suggesting that youths are eagerly experimenting. This is also evident in the high prevalence of youths trying other tobacco products such as e-cigarettes or heated tobacco products, from 57.4% (178/310) in 2017 to 2018 to 85.9% (243/283) in 2019 to 2020. The shift from occasional smoking to dependency in youth is a crucial stage, making the adolescent years a key period for understanding and addressing smoking behaviours. It represents a key window for targeted interventions to prevent the progression towards regular smoking habits. Smoking imposes severe health risks and long-term consequences. Effects of tobacco are well demonstrated including the effects of nicotine on brain development. The prevalence of tobacco use among youths not only jeopardizes their immediate health but negatively impacts their future well-being. Moreover, observations from Hong Kong further emphasize the pressing need for effective SC initiatives tailored to the unique needs of youths. The multifaceted challenges such as peer pressure and social influences are faced by struggling youths. In response to these identified needs, it is imperative to develop comprehensive youth-orientated SC programs that encompass various aspects of prevention, intervention and support. Evidence-based strategies such as counselling services have shown promising outcomes in promoting smoke-free lifestyles among youths. Additionally, collaborations among healthcare institutions, government agencies and community organizations are crucial for maximizing the reach and effectiveness of cessation efforts. By addressing the health needs of local community through targeted youth SC initiatives, the investigators can significantly mitigate the adverse health effects of tobacco use among Hong Kong's young population. Phase 3 Randomized control trial outcomes The primary outcomes of Phase 3 of this study will be smokers' (1) self-reported abstinence in the past 30 days at 2-month follow-up; (2) iScreen OFD Cotinine Saliva Test Kit (\<30ng/ml) biochemical validated tobacco abstinence; (3) the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group.
Interventions
BEHAVIORALtypology-based intervention
The typology-based intervention includes: (1) a typology-based counselling, (2) instant response from a specially designed AI Chatbot for 30 days (3) Chatbot initiated AI message for 4 weeks (one message per week). All interventions and materials are delivered by smoking counselling.
BEHAVIORALRoutine Treatment
The routine smoking cessation intervention includes: (1) Routine counselling generic advice on preventing smoking relapse
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
two arms: typology-based intervention (intervention group) & routine treatment (control group)
Eligibility
Sex/Gender
ALL
Age
No minimum to 25 Years
Healthy volunteers
Yes
Inclusion criteria
(Phase 1): * Hong Kong citizens * Have ever habitually used conventional cigarettes in the past year * Not using cigarettes for the past 7-30 days * Aged 25 or below (parental consent is required for participants under 18 years old) * No barriers in communicating in Cantonese and reading and writing Chinese * Quit smoking without using cessation services Inclusion Criteria (Phase 3): * Hong Kong citizens * Have ever habitually used conventional cigarettes in the past year * Received at least 4 weeks of smoking cessation service before enrolling into the study * abstained from tobacco use for 7 days without concurrent use of any cessation services * Aged 25 or below (parental consent is required for participants under 18 years old) * No barriers in communicating in Cantonese and reading and writing Chinese
Exclusion criteria
(Phase 1 \& 3): * Have unstable physical or psychological conditions as advised by doctors or counsellors * Are users of illicit drugs (e.g., heroin, marijuana, ketamine, etc.) * Have become pregnant in the past two months * unable to communicate in Cantonese and read Chinese Inclusion Criteria (Phase 2) (for SC counsellors) : * SC counsellors from local SC clinics under HKU Youth Quit Line, Tung Wah Group of Hospitals Integrated Center on Smoking Cessation and United Christian Nethersole Community Health Service
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| self-reported abstinence in the past 30 days at 2-month follow-up | 2 mouths | — |
| iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence | 2 months | Participants who report tobacco abstinence will be invited for a biochemical validation to test if his/her saliva cotinine is less than 30ng/ml measured by the iScreen OFD Cotinine Saliva Test Kit. |
| the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group. | 2 months | The investigators will have 4 feasibility questions and 4 appropriateness questions for counsellor to answer from 1 (Completely disagree) to 5 (Completely agree). Also, the investigators will have 4 acceptability questions for ex-smokers to answer. The investigators would like to observe if there is a difference between the intervention group and the control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time required for the counselling | End of all follow-up (approximately 6 month) | The average time required for the typological counselling in minutes |
| Compliance rate of the SC counsellors in following the intervention protocol | End of all follow-up (approximately 6 month) | There were 26 questions in the counselling protocol. SC counsellors have to record the number of questions asked during the typological counselling. The rate is calculated by "number of questions asked"/26 |
| Proportion of screened clients who participate in the RCT | End of all follow-up (approximately 6 month) | The proportion is calculated by "Number of enrolled participants" / "Total number of participant screened" |
| Dropout rate of the participants who consent to the RCT | End of all follow-up (approximately 6 month) | The dropout rate is calculated by "Number of participants dropout from study" / "Total number of enrolled participant" |
| Satisfaction on the SC counsellors | 2 months | Satisfaction on the SC counsellors is measured by a 5 point Likert scale reported by the enrolled participants, from 1: Very Dissatisfied to 5: Very Satisfied. |
| Satisfaction on the AI chatbot and the chatbot initiated e-messages | 2 months | Satisfaction on AI chatbot and the chatbot initiated is measured by a 10 point Likert scale reported by the enrolled participants, from 1: Very Dissatisfied to 10: Very Satisfied. |
| Frequency of reading the chatbot initiated e-messages | 2 months | The Frequency of reading the e-messages is measured by 5 point Likert scale, that indicate the number of e-messages that the participant had read, from 1 (indicate the participant had read none of the e-messages), to 5 (indicate the participant had read all of the e-messages). |
| Perceived effectiveness on the intervention | 2 months | The perceived effectiveness on the intervention is measured by a 10 point likert scale. Participant will rate the usefulness of the intervention received in helping them to maintain smoking abstinence (10: Very useful \| 0: Useless). |
| Satisfaction on the enrolment procedures | 2 months | Satisfaction on the enrolment procedures is measured by a 10 point Likert scale reported by the participants (0: The enrollment procedure is slow and complicated \| 10: the enrollment procedure is fast and simple). |
| Intention to recommend the intervention to other smokers | 2 months | Intention to recommend the intervention to other smokers is measured by a 10 point Likert scale, 10: strongly recommended to other smokers \| 0: not recommended to other smoker |
| Satisfaction about the intervention from SC counsellor | End of all follow-up (approximately 6 month) | Satisfaction about the intervention from SC counsellor is measured by a 5 point Likert scale. SC counsellor will rate the effectiveness of the typological counselling in helping their client to quit smoking, from 1: very ineffective to 5: very effective. |
| Perceived appropriateness of the intervention length from SC counsellor | End of all follow-up (approximately 6 month) | The perceived appropriateness of the intervention length from SC counsellor is measured by a 5 point Likert scale. SC counsellor will be asked if they agreed that the length of the typological counselling is suitable for their client, from 1 strongly disagree to 5 strongly agree. |
| Satisfaction on the enrolment and counselling procedures from SC counsellors | End of all follow-up (approximately 6 month) | The satisfaction on the enrolment procedures from SC counsellors is measured by a 5 point Likert scale. Counsellors will be asked if they agreed that enrolment and counselling procedures is simple and could be easily done in the SC clinics, from 1: strongly disagree to 5: strongly agree. |
| Perceived effectiveness of the counselling protocol from SC counsellor | End of all follow-up (approximately 6 month) | The perceived effectiveness of the counselling protocol from SC counsellor is measured by a 5 point Likert scale. SC counsellor will be asked if they agreed that the typological intervention can help them screen out smokers who are prone to relapse, from 1: strongly disagree to 5: strongly agree. |
| Perceived clients' acceptance of the intervention from SC counsellor | 2 months | The Perceived clients' acceptance of the intervention from SC counsellor is measured by a 5 point Likert scale. Participants are asked if they agreed that counselling content provided the SC counselling gain their trust and acceptance, from 1: strongly disagree to 5: strongly agree. |
| Intention to apply this intervention in other clients from SC counsellors | End of all follow-up (approximately 6 month) | Intention to apply this intervention in other clients from SC counsellors is measured by a 5 point Likert scale. SC counsellors are asked if they want to apply the typological intervention to other clients in future, from 1: SC counsellors will not apply it to their client in the future, to 5: SC counsellors want to apply it their client in the future. |
Countries
Hong Kong
Contacts
CONTACTCara Hor Yine Cheung, Dr.
Outcome results
None listed