Brief Behavioural Economic Intervention for Smoking Cessation (QTW2024)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Smoking
• Intervention / Treatment: Behavioral: Brief cessation advice; Behavioral: Opt-out active referral; Behavioral: Behavioral economic mobile messaging; Behavioral: Opt-in active referral

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.

• Study Type: Interventional
• Enrollment (Estimated): 1017
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tzu Tsun Luk, PhD, RN; Phone Number: 39177574; Email: luktt@connect.hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Community Sites
    • Contact: Tzu Tsun Luk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opt-out+ group; Brief cessation advice + Opt-out active referral + behavioural economics mobile messaging	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; Behavioral: 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: Behavioral economic mobile messaging; Participants will receive behavioural economics-informed messages via mobile instant messaging for 3 months
Experimental: Opt-out group; Brief cessation advice + Opt-out active referral	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; Behavioral: 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
Active Comparator: Opt-in group; Brief cessation advice + Opt-in active referral	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; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Self-reported 7-day point-prevalence tobacco abstinence	Tobacco abstinence in the past 7 days	3 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence	Tobacco abstinence in the past 7 days	6 months after randomisation
Self-reported 24-hour quit attempt	Tobacco abstinence for at least 24 hours	3 months after randomisation
Self-reported 24-hour quit attempt	Tobacco abstinence for at least 24 hours	6 months after randomisation
Self-reported use of smoking cessation service	Use of any smoking cessation service during the follow-up period	3 months after randomisation
Self-reported use of smoking cessation service	Use of any smoking cessation service during the follow-up period	6 months after randomisation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported reduction of tobacco consumption	Smoking reduction by at least half of the baseline daily number of cigarettes	3 months after randomisation
Self-reported reduction of tobacco consumption	Smoking reduction by at least half of the baseline daily number of cigarettes	6 months after randomisation

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Hong Kong Council on Smoking and Health
• Investigators: Principal Investigator: Tzu Tsun Luk, PhD, RN, The University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: tobacco; cessation; opt-out; nudge; behavioural economics
• Other Study ID Numbers: QTW2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No