- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05370352
Mobile Chat Messaging for Smoking Relapse Prevention
Effectiveness of Mobile Chat Messaging for Preventing Relapse in Smokers Who Have Recently Quit Smoking: a Randomised Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Most smokers who made quit attempts and achieved short-term abstinence return to smoking (relapse) over time, even when aided by effective smoking cessation treatment. Since relapse mostly occurred in the first 4 weeks of abstinence, relapse prevention in the early phase of abstinence could potentially boost long-term abstinence. Several behavioural interventions for smoking relapse prevention have been proposed and tested in RCTs. Yet, a 2019 Cochrane review did not find traditional approaches, including self-help materials, telephone counselling and group therapy, effective in increasing long-term abstinence at 6 months or longer.
The widespread use of mobile devices has provided a highly accessible and scalable means for novel behavioural interventions for smoking cessation. A formative qualitative study in current smokers conducted by the investigators showed that mobile chat messaging is a feasible and acceptable platform for delivering smoking cessation support. A subsequent cluster randomised controlled trial on 1148 smokers found that mobile chat messaging combined with brief intervention was effective in increasing biochemically validated abstinence at 6 months. Nonetheless, whether mobile chat messaging could prevent relapse in recent abstainers has remained untested.
The investigators did a pilot trial to confirm the feasibility and acceptability of mobile chat messaging for relapse prevention in recent abstainers. This study aims to evaluate the effectiveness of mobile chat messaging relapse prevention intervention in promoting abstinence in recent abstainers.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tzu Tsun Luk, PhD, RN
- Phone Number: 39177574
- Email: lukkevin@hku.hk
Study Locations
-
-
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Hong Kong, Hong Kong
- Recruiting
- Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
-
Contact:
- Nga Ting Grace Wong
- Phone Number: 2332 8977
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Hong Kong, Hong Kong
- Recruiting
- United Christian Nethersole Community Health Service Smoking Cessation Programme
-
Contact:
- Ka Hong John Lee, MMedSci
- Phone Number: 31569012
- Email: john.lee@ucn.org.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Diagnosed with a mental disease or on regular psychotropic drugs
- Participating in other ongoing smoking cessation studies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobile chat messaging
Standard smoking cessation treatment + Personalised chat messaging
|
Standard smoking cessation treatment (behavioural and pharmacotherapy) provided by Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
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).
|
Active Comparator: SMS messaging
Standard smoking cessation treatment + Regular SMS text messaging generic information about the harms of smoking and the benefits of quitting
|
Standard smoking cessation treatment (behavioural and pharmacotherapy) provided by Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
SMS text messaging on generic information about the harms of smoking and the benefits of quitting for 3 months from randomisation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemically validated tobacco abstinence
Time Frame: 6 months after randomisation
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported 6-month prolonged tobacco abstinence
Time Frame: 6 months after randomisation
|
Not more than five lapses permitted for 6 months after baseline
|
6 months after randomisation
|
Self-reported 7-day point prevalent tobacco abstinence
Time Frame: 3 months after randomisation
|
Being completely smoke-free in the past 7 days
|
3 months after randomisation
|
Self-reported 7-day point prevalent tobacco abstinence
Time Frame: 6 months after randomisation
|
Being completely smoke-free in the past 7 days
|
6 months after randomisation
|
Self-reported relapse rate
Time Frame: 3 months after randomisation
|
Defined as use of tobacco products for 7 consecutive days or longer
|
3 months after randomisation
|
Self-reported relapse rate
Time Frame: 6 months after randomisation
|
Defined as use of tobacco products for 7 consecutive days or longer
|
6 months after randomisation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tzu Tsun Luk, PhD, RN, The University of Hong Kong
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19201341
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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