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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06451081
Other study ID # QTW2024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 15, 2024
Est. completion date May 31, 2025

Study information

Verified date June 2024
Source The University of Hong Kong
Contact Tzu Tsun Luk, PhD, RN
Phone 39177574
Email luktt@connect.hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1017
Est. completion date May 31, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief cessation advice
Participants will receive brief cessation advice following the AWARD (ask, warn, advise, refer, do-it-again) model: A: Ask about the tobacco use status; W: Warn about the hazards of tobacco use; A: Advise the smokers to quit; R: Refer the smokers to cessation services; D: Do-it-again
Opt-out active referral
Participants will be automatically referred to a smoking cessation service upon joining the trial, unless they choose to opt out. Contacts of participants will be delivered to a service provider of their choice or based on their living district and preferred treatment modality
Behavioral economic mobile messaging
Participants will receive behavioural economics-informed messages via mobile instant messaging for 3 months
Opt-in active referral
Participants will be offered a referral to a smoking cessation service. Contacts of participants who opt-in will be delivered to a service provider of their choice

Locations

Country Name City State
Hong Kong Community sites Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
The University of Hong Kong Hong Kong Council on Smoking and Health

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Self-reported reduction of tobacco consumption Smoking reduction by at least half of the baseline daily number of cigarettes 3 months after randomisation
Other Self-reported reduction of tobacco consumption Smoking reduction by at least half of the baseline daily number of cigarettes 6 months after randomisation
Primary Biochemically validated tobacco abstinence Verified by an exhaled carbon monoxide level of <4 parts per million and a negative salivary cotinine test 6 months after randomisation
Secondary Biochemically validated tobacco abstinence Verified by an exhaled carbon monoxide level of <4 parts per million and a negative salivary cotinine test 3 months after randomisation
Secondary Self-reported 7-day point-prevalence tobacco abstinence Tobacco abstinence in the past 7 days 3 months after randomisation
Secondary Self-reported 7-day point-prevalence tobacco abstinence Tobacco abstinence in the past 7 days 6 months after randomisation
Secondary Self-reported 24-hour quit attempt Tobacco abstinence for at least 24 hours 3 months after randomisation
Secondary Self-reported 24-hour quit attempt Tobacco abstinence for at least 24 hours 6 months after randomisation
Secondary Self-reported use of smoking cessation service Use of any smoking cessation service during the follow-up period 3 months after randomisation
Secondary Self-reported use of smoking cessation service Use of any smoking cessation service during the follow-up period 6 months after randomisation
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