NCT05370352

Brief Summary

Most smokers return to smoking (relapse) after making a quit attempt, but evidence of effective intervention to prevent relapse is scarce. Taking advantage of recent advances in mobile technologies, this study aims to evaluate the effectiveness of a mobile chat messaging-based relapse prevention intervention in promoting successful quitting in people who recently quit smoking (recent abstainers) using a randomised controlled trial design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
590

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

May 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

November 20, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

May 6, 2022

Last Update Submit

November 17, 2025

Conditions

Smoking Cessation

Keywords

relapse preventionrecurrencemHealthinstant messagingWhatsAppchatbotconversational agentChinese

Outcome Measures

Primary Outcomes (1)

  • Biochemically validated tobacco abstinence

    Verified by an exhaled carbon monoxide level of lower than 5 parts per million or a negative salivary cotinine test

    6 months after randomisation

Secondary Outcomes (9)

  • Self-reported 6-month prolonged tobacco abstinence

    6 months after randomisation

  • Self-reported 7-day point prevalent tobacco abstinence

    3 months after randomisation

  • Self-reported 7-day point prevalent tobacco abstinence

    6 months after randomisation

  • Self-reported relapse rate

    3 months after randomisation

  • Self-reported relapse rate

    6 months after randomisation

  • +4 more secondary outcomes

Study Arms (2)

Mobile chat messaging

EXPERIMENTAL

Standard smoking cessation treatment + Personalised chat messaging

Behavioral: Standard smoking cessation treatmentBehavioral: Personalised chat messaging

SMS messaging

ACTIVE COMPARATOR

Standard smoking cessation treatment + Regular SMS text messaging generic information about the harms of smoking and the benefits of quitting

Behavioral: Standard smoking cessation treatmentBehavioral: SMS text messaging

Interventions

Standard smoking cessation treatmentBEHAVIORAL

Standard smoking cessation treatment (behavioural and pharmacotherapy) provided by Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation

Mobile chat messagingSMS messaging
Personalised chat messagingBEHAVIORAL

Personalised chat messaging focusing on smoking relapse prevention for 3 months from randomisation. A trained counsellor will interact with a participant individually and provide relapse prevention advice via WhatsApp. The participant can also access a supportive chatbot in WhatsApp, which will provide on-demand smoking relapse prevention support when the counsellor is not available (e.g., during nighttime).

Mobile chat messaging
SMS text messagingBEHAVIORAL

SMS text messaging on generic information about the harms of smoking and the benefits of quitting for 3 months from randomisation.

SMS messaging

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
  • Own a smartphone with WhatsApp installed
  • Enrolled in a smoking cessation program under Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
  • Smoked daily before the present quit attempt
  • Abstained from smoking for 3 to 30 days

You may not qualify if:

  • Diagnosed with a mental disease or on regular psychotropic drugs
  • Participating in other ongoing smoking cessation studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation

Hong Kong, Hong Kong

Location

United Christian Nethersole Community Health Service Smoking Cessation Programme

Hong Kong, Hong Kong

Location

Related Publications (6)

  • Luk TT, Wong SW, Lee JJ, Chan SS, Lam TH, Wang MP. Exploring Community Smokers' Perspectives for Developing a Chat-Based Smoking Cessation Intervention Delivered Through Mobile Instant Messaging: Qualitative Study. JMIR Mhealth Uhealth. 2019 Jan 31;7(1):e11954. doi: 10.2196/11954.

    PMID: 30702431BACKGROUND

  • Luk TT, Li WHC, Cheung DYT, Wong SW, Kwong ACS, Lai VWY, Chan SS, Lam TH, Wang MP. Chat-based instant messaging support combined with brief smoking cessation interventions for Chinese community smokers in Hong Kong: Rationale and study protocol for a pragmatic, cluster-randomized controlled trial. Contemp Clin Trials. 2019 Feb;77:70-75. doi: 10.1016/j.cct.2018.12.013. Epub 2018 Dec 26.

    PMID: 30593882BACKGROUND

  • Wang MP, Luk TT, Wu Y, Li WH, Cheung DY, Kwong AC, Lai V, Chan SS, Lam TH. Chat-based instant messaging support integrated with brief interventions for smoking cessation: a community-based, pragmatic, cluster-randomised controlled trial. Lancet Digit Health. 2019 Aug;1(4):e183-e192. doi: 10.1016/S2589-7500(19)30082-2. Epub 2019 Jul 31.

    PMID: 33323188BACKGROUND

  • Luk TT, Cheung YTD, Chan HC, Fok PW, Ho KS, Sze CD, Lam TH, Wang MP. Mobile Chat Messaging for Preventing Smoking Relapse Amid the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2023 Jan 5;25(2):291-297. doi: 10.1093/ntr/ntac045.

    PMID: 35166327BACKGROUND

  • Luk TT, Su X, Wong V, Chan HC, Wong GN, Lee JKH, Ho SY, Lam TH, Cheung YTD, Wang MP. Mobile Chat Messaging for Smoking Relapse Prevention: A Randomized Clinical Trial. JAMA Intern Med. 2026 Jan 20:e257439. doi: 10.1001/jamainternmed.2025.7439. Online ahead of print.

    PMID: 41557345DERIVED

  • Su X, Wong V, Cheung YTD, Chan HC, Wong GN, Lee JKH, Ho SY, Wang MP, Luk TT. Mobile chat messaging for preventing relapse among people who recently quit smoking: Study protocol for a randomized controlled trial. Digit Health. 2024 Oct 21;10:20552076241291709. doi: 10.1177/20552076241291709. eCollection 2024 Jan-Dec.

    PMID: 39439726DERIVED

MeSH Terms

Conditions

Smoking CessationRecurrence

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tzu Tsun Luk, PhD, RN

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 11, 2022

Study Start

March 14, 2023

Primary Completion

February 16, 2025

Study Completion

August 10, 2025

Last Updated

November 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Request to obtain IPD can be made to the principal invesitgator on reasonable request

Locations

HK(2)