Clinical trial NCT06451081: Brief Behavioural Economic Intervention for Smoking Cessation
Official title: Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2024: a Randomised Controlled Trial of a Brief Behavioural Economic Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Smoking
Keywords: cessation
tobacco
behavioural economics
nudge
opt-out
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Council on Smoking and Health
First posted: 2024-06-10
Enrollment: 1017
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the effectiveness of brief behavioural economic intervention in promoting smoking cessation among smokers in the community.

Detailed description: Smoking cessation services are free and effective but underused in Hong Kong. Active referral to smoking cessation services has consistently been found effective in promoting service use and successful quitting as a stand-alone strategy or when combined with other interventions. Participants who received active referral are introduced about the cessation services in Hong Kong and offered connection to the services of their choices. Contacts of participants who agreed to be referred are transferred to the selected cessation providers, who will subsequently contact the participants for further treatment.

The current active referral intervention uses an opt-in approach, where participants are required to actively choose to be connected to the services. By leveraging behavioural economic principles, a simple yet promising strategy to strengthen the active referral intervention is to utilize an "opt-out" approach, where participants are automatically referred to the service unless they actively decline the referral. By making referral to smoking cessation services as the default choice, the investigators aim to increase the uptake of these services and thus improve smoking cessation outcomes. Additionally, mobile messaging informed by behavioural economics principles can serve as nudges to prompt smokers to initiate quitting and utilise cessation services.

The clinical trial aims to test the effectiveness of opt-out referral, with or without behavioural economic-based mobile messaging, compared to opt-in referral, in promoting smoking cessation. The trial will be nested within the 15th "Quit to Win" Smoke-free Community Campaign organised by the Hong Kong Council on Smoking and Health.

Eligibility criteria: Inclusion Criteria:

1. Hong Kong residents aged 18 years or above
2. Smoke cigarette or heated tobacco product or e-cigarette daily in the past 3 months
3. Exhaled carbon monoxide level ≥4 parts per million or a positive salivary cotinine test
4. Able to communicate in and read Chinese
5. Own a smartphone with a mobile instant messaging app installed

Exclusion Criteria:

* Participating in another smoking cessation programme or using any smoking cessation drug or nicotine replacement therapy

Primary outcomes:
measure: Biochemically validated tobacco abstinence
timeFrame: 6 months after randomisation
Secondary outcomes:
measure: Biochemically validated tobacco abstinence
timeFrame: 3 months after randomisation
measure: Self-reported 7-day point-prevalence tobacco abstinence
timeFrame: 3 months after randomisation
measure: Self-reported 7-day point-prevalence tobacco abstinence
timeFrame: 6 months after randomisation
measure: Self-reported 24-hour quit attempt
timeFrame: 3 months after randomisation
measure: Self-reported 24-hour quit attempt
timeFrame: 6 months after randomisation
measure: Self-reported use of smoking cessation service
timeFrame: 3 months after randomisation
measure: Self-reported use of smoking cessation service
timeFrame: 6 months after randomisation
Other outcomes:
measure: Self-reported reduction of tobacco consumption
timeFrame: 3 months after randomisation
measure: Self-reported reduction of tobacco consumption
timeFrame: 6 months after randomisation
Locations:
city: Hong Kong
country: Hong Kong
facility: Community sites
Study officials:
affiliation: The University of Hong Kong
name: Tzu Tsun Luk, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang MP, Suen YN, Li WH, Lam CO, Wu SY, Kwong AC, Lai VW, Chan SS, Lam TH. Intervention With Brief Cessation Advice Plus Active Referral for Proactively Recruited Community Smokers: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2017 Dec 1;177(12):1790-1797. doi: 10.1001/jamainternmed.2017.5793.