NCT06451081

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,017

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

June 4, 2024

Last Update Submit

July 17, 2024

Conditions

Tobacco Smoking

Keywords

cessationtobaccobehavioural economicsnudgeopt-out

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Biochemically validated tobacco abstinence

    3 months after randomisation

  • Self-reported 7-day point-prevalence tobacco abstinence

    3 months after randomisation

  • Self-reported 7-day point-prevalence tobacco abstinence

    6 months after randomisation

  • Self-reported 24-hour quit attempt

    3 months after randomisation

  • Self-reported 24-hour quit attempt

    6 months after randomisation

  • +2 more secondary outcomes

Other Outcomes (2)

  • Self-reported reduction of tobacco consumption

    3 months after randomisation

  • Self-reported reduction of tobacco consumption

    6 months after randomisation

Study Arms (3)

Opt-out+ group

EXPERIMENTAL

Brief cessation advice + Opt-out active referral + behavioural economics mobile messaging

Behavioral: Brief cessation adviceBehavioral: Opt-out active referralBehavioral: Behavioral economic mobile messaging

Opt-out group

EXPERIMENTAL

Brief cessation advice + Opt-out active referral

Behavioral: Brief cessation adviceBehavioral: Opt-out active referral

Opt-in group

ACTIVE COMPARATOR

Brief cessation advice + Opt-in active referral

Behavioral: Brief cessation adviceBehavioral: Opt-in active referral

Interventions

Brief cessation adviceBEHAVIORAL

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-in groupOpt-out groupOpt-out+ group
Opt-out active referralBEHAVIORAL

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

Opt-out groupOpt-out+ group
Behavioral economic mobile messagingBEHAVIORAL

Participants will receive behavioural economics-informed messages via mobile instant messaging for 3 months

Opt-out+ group
Opt-in active referralBEHAVIORAL

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

Opt-in group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community sites

Hong Kong, Hong Kong

RECRUITING

Related 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.

    PMID: 29059277BACKGROUND

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco Use

Study Officials

  • Tzu Tsun Luk, PhD, RN

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzu Tsun Luk, PhD, RN

CONTACT

39177574luktt@connect.hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 10, 2024

Study Start

June 15, 2024

Primary Completion

April 30, 2025

Study Completion

May 31, 2025

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)