Designing a Smoking Intervention for Youth Smokers Using Q-Methodology: A Pilot Randomized Controlled Trial

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Smoking (Tobacco) Addiction; RCT; Young Adult

Treatments: Behavioral: typology-based intervention; Behavioral: Routine Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07178899

08230208

Details and patient eligibility

About

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.

Full 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 [1], 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 [2]. 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 [3]. Additionally, smoking causes cancers, stroke, cardiovascular diseases and respiratory diseases [4], with around 7000 deaths reported each year [5]. 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 [6]. Published studies consistently highlight the concerning prevalence of youth smoking within our community. Data from the recent school survey [7] 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 [2], 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 [8]. 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 [9] including the effects of nicotine on brain development [10]. The prevalence of tobacco use among youths not only jeopardizes their immediate health but negatively impacts their future well-being [11]. Moreover, observations from our communities [12] 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 [13] 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 our local community through targeted youth SC initiatives, we can significantly mitigate the adverse health effects of tobacco use among our 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Phase 1):

• Hong Kong citizens
• Have ever habitually used conventional cigarettes in the past year
• Not using cigarettes for the past 7 days
• Aged 18-25
• 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 to 30 days without using any cessation services
• Aged 18-25
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention group

Experimental group

Description:

In the intervention group, in addition to routine counselling (15-30 minutes), they will classify their identity with our screening tool (developed in Phase 2) and then apply the counselling protocol for the participants (5-10 minutes). After the counselling session, the personalized e-messages will be sent to the participants by the counsellor for 4 weeks.

Treatment:

Behavioral: typology-based intervention

Control Group

Active Comparator group

Description:

In the control group, the routine smoking cessation counselling, including generic advice on preventing smoking relapse, will be retained, and they will receive brief e-messages that only consist of general quit advice for 4 weeks.

Treatment:

Behavioral: Routine Treatment