Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
160 participants
INTERVENTIONAL
2023-06-01
2024-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main questions it aims to answer are:
* What are the main effects of the four intervention components for increasing quit attempt preparation?
* Are there synergistic or antagonistic interactions between components?
* Does chat-based instant message or chatbot enhance the effects of nicotine replacement therapy sampling and/or simple exercise education in increasing motivation to quit?
* When participants experienced successful quitting by using the nicotine replacement therapy patch, will other tools, such as simple exercise education, chat-based instant messages, or chatbot, could help in the process and strengthen the effects of the nicotine replacement therapy patch and solve the possible problems they may encounter in using nicotine replacement therapy patch in a timely manner?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Comparison of the Effectiveness of Two Approaches in Achieving Smoking Abstinence
NCT02701686
Interactive Communication Technologies and Nicotine Replacement Therapy Sampling for Smokers
NCT04001972
Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation
NCT03800719
Semi-personalized IM Smoking Cessation Interventions
NCT03574077
Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2017
NCT03182790
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
2. Study design A pilot balanced full factorial design with four components/factors: 1) SEE versus none; 2) NRTS versus none; 3) CBIM versus none; and 4) chatbot for smoking cessation versus none, and to 2 x 2 x 2 x 2=16 trial groups. All participants will be randomly and evenly assigned to these 16 intervention groups. This study protocol complies with Declaration of Helsinki and International Conference on Harmonisation Guideline for Good Clinical Practice (ICH-GCP).
3. Subjects Inclusion criteria will include 1) being a Hong Kong resident aged ≥18 years; 2) using any tobacco products every day; 3) having WhatsApp installed on their cell phone; 4) no injuries in hands and arms; 5) no medical contraindications to NRT (no severe angina, serious cardiac arrhythmias and hypertension); and 6) no plan to quit in the next 30 days. Exclusion criteria will include smokers who 1) cannot communicate in Cantonese or read Chinese; 2) currently using smoking cessation services and medication; 3) self-reported psychosis, bipolar disorder, or on psychiatric medication; and 4) pregnant smokers. As this is a pilot study to test the feasibility of conducting a full factorial design, we will recruit (10 participants x 16 groups) 160 participants to enroll in this study.
4. Recruitment strategy In the outdoor recruitment sessions, the recruitment staff will approach and distribute souvenirs or leaflets to the smokers who are smoking for 3-4 hours in the daytime. If a smoker is willing to accept them and talk to the recruitment staff, the staff will introduce the study, invite them to consent for participation, and complete a simple baseline questionnaire for further contacts and intervention delivery. Participants who complete the enrolment procedures will be offered a HKD50 shopping voucher to compensate their time spent. We will conduct 3 follow-up calls. They will be conducted after 1 week, 1 month and 3 months. In the 1 month and 3 months follow-up calls, if the participants claim s/he has already quitted smoking for equal to or more than 7 days, we will test the carbon monoxide and codinine level. Since smokers normally have higher levels of cotinine and carbon monoxide levels, we could prove if s/he quit smoking or not. We will implement carbon monoxide detector to check the carbon monoxide level, while cotinine will be used to test the cotinine level in the saliva.
5. Intervention Factor 1: Simple exercise education (SEE) All participants will be given a handgrip at study enrolment. The SEE includes a Zoom/WhatsApp meeting or face-to-face session including 1) watching a 5-minute video (www.youtube.com/watch?v=mZex2Wwy3fU) showing a chair professor of public health demonstrating the 10s-E, including the simple exercises with and without handgrip. The video also encourages participants to 1) follow the exercise instructions during the video demonstration; 2) perform the exercises whenever they experience craving or an urge to smoke during the quitting process; and 3) increase their exercise frequency and intensity as much as possible, which may also increase their grip strength. Participants will also receive a leaflet with exercise instructions and motivational messages.
Factor 2: NRT sampling The intervention includes a Zoom/WhatsApp meeting or face-to-face session, where a trained counsellor will introduce the instruction of NRT use and possible side effects to the participant based on an intervention guide we used in the previous RCT of NRTS. The trained counsellor will suggest the NRT patch's dosage based on his/her daily cigarette consumption. If the intervention is delivered online, an intervention pack including a pamphlet and 1-week free NRT sample (patch: 14mg or 21mg) will be mailed to the participants. At 1-week after sending the NRT, the trained counsellor will follow-up with the participant. If the participant has completed all patches and willing to use more, the counsellor will mail 1 additional pack of NRT to him/her and ask him/her to obtain more from the current smoking cessation service or purchase in pharmacy. Users of NRT patch may experience skin reactions, insomnia and/or vivid dreams. If participants experience severe side effects of NRT use, the counsellor will ask them to cease use.
Factor 3: Chat-based instant messaging Participants will receive individualized chat-based encouragement and support messages about motivation and preparation for quit attempts using WhatsApp for 8 weeks. A trained smoking cessation counsellor will have real-time (synchronous), one-to-one interaction with the participants and provide personalized motivational, behavioural support according to the participants' needs. The conversation intensity will be flexible and depend on the participant. The conversation will also be integrated with brief advice using the Behaviour Change Techniques (BCTs) (18) and the AWARD (Ask, Warn, Advise, Refer, Do-it-again) intervention model (11). The intervention protocol will be similar as that in our previous RCT on CBIM (19). For participants who receive the SEE and NRTS, the trained counsellor shall follow-up on their compliance and provide adequate advice in adhering to these interventions.
Factor 4: Chatbot for smoking cessation The information and access to the chatbot will be introduced to participants. Through the chatbot service, participants shall access to practical information on smoking cessation 24 hours at any time, such as details on cessation services and skills for tackling cravings. By using the second-generation chatbot, participants could receive personalized risk information and recommendations for smoking cessation, as well as reach to a counsellor through WhatsApp live chat for urgently needed advice.
6. Randomization, allocation concealment and blinding The random allocation sequence will be computer-generated by an investigator who has no other involvement in the study. Simple individual randomization by sequentially numbered, opaque sealed envelopes (SNOSE) will be used to ensure the recruitment staff and the participants will be concealed in the allocation sequence before the group allocation.
Blinding of participants and the research staff who deliver the intervention will not be possible. Follow-up outcome assessments will be conducted by research assistants who will be blinded for the group allocation.
7. Evaluation plan To examine whether the intervention can be delivered as it is designed (scalability), we will evaluate the intervention fidelity and smokers' adherence to the intervention. Regarding to SEE, counsellors will document the time spent on delivering the SEE and participants' response. Regarding NRTS, counsellors will document the time spent on medication advice, what will be included in the advice, and any side effects or concerns reported by the participants at 1-week follow-up. Regarding CBIM, number of messages sent by counsellors and the participants will be documented. For chatbot, number of messages sent by participants will be recorded.
8. Data analyses All statistical analysis will be conducted in STATA/MP version 16.1. The primary analysis will examine the intervention's main and interaction effects on the primary outcome by intention-to-treat, assuming non-respondents at follow-up are smokers without quit attempts. Between-subject factorial linear mixed model (LMM) will be used to evaluate the main effects, six 2-way interactions (SEE X NRTS, SEE X CBIM, NRTS X CBIM, SEE X chatbot, NRTS X chatbot, CBIM X chatbot), four 3-way interaction (SEE X NRT X CBIM, SEE X NRT X chatbot, SEE X CBIM X chatbot and NRT X CBIM X chatbot) and one 4-way interaction (SEE X NRTS X CBIM x chatbot) using effect coding (levels are coded -1 and +1) on IBC-S. Analyses will be adjusted for demographics and smoking-related covariates, and supplemented with multiple imputation and complete-case analysis. The IBC-S score of sub-groups involved in a significant interaction (5% level of significance) will be plotted on a bar chart to visualize the comparisons.
9. Direct access to source data/documents The raw data will be stored in the CD-ROM and locked in a cupboard with keys kept by the Principal Investigator. Only the Investigators and Research Assistants of the project will be permitted access to raw data and/or study records. The data will be kept for 10 years after the study is completed.
10. Dissemination of study result The initial findings will be submitted for application for the coming round of the Health Medical Research Fund or the General Research Fund. The findings will be disseminated through publication in the journal Addiction or other peer-reviewed journals. Also, the findings will be useful evidence for expert comments or deputations of smoking-related issues in the Legislation Council.
11. Consent Eligible participants will be invited to participate in the study by obtaining written consent.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
Factorial design with four components/factors: 1) SEE versus none; 2) NRTS versus none; 3) CBIM versus none; and 4) chatbot for smoking cessation versus none, and to 2 x 2 x 2 x 2=16 trial groups. All participants will be randomly and evenly assigned to these 16 intervention groups.
Nicotine Replace Therapy (NRT) sampling
The intervention involves a Zoom/WhatsApp meeting or face-to-face session with a trained counselor who introduces NRT use, possible side effects, and patch dosage based on a previous RCT guide. An online intervention pack with a pamphlet and 1-week free NRT sample (14mg or 21mg patch) is mailed to participants. After 1 week, the counselor follows up. If participants need more patches, an additional pack is mailed, and they are advised to obtain further patches from smoking cessation services or pharmacies. NRT patch users may experience skin reactions, insomnia, or vivid dreams; if severe side effects occur, they are asked to stop using NRT.
Simple exercise education (SEE)
All participants will be given a handgrip at study enrolment. The SEE includes a Zoom/WhatsApp meeting or face-to-face session including 1) watching a 5-minute video (www.youtube.com/watch?v=mZex2Wwy3fU) showing a chair professor of public health demonstrating the 10s-E, including the simple exercises with and without handgrip. The video also encourages participants to 1) follow the exercise instructions during the video demonstration; 2) perform the exercises whenever they experience craving or an urge to smoke during the quitting process; and 3) increase their exercise frequency and intensity as much as possible, which may also increase their grip strength. Participants will also receive a leaflet with exercise instructions and motivational messages.
Chat-based instant messaging
Participants will receive individualized chat-based encouragement and support messages about motivation and preparation for quit attempts using WhatsApp for 8 weeks. A trained smoking cessation counsellor will have real-time (synchronous), one-to-one interaction with the participants and provide personalized motivational, behavioural support according to the participants' needs. The conversation intensity will be flexible and depends on the participant. The conversation will also be integrated with brief advice using the Behaviour Change Techniques (BCTs) (18) and the AWARD (Ask, Warn, Advise, Refer, Do-it-again) intervention model (11). The intervention protocol will be similar as that in our previous RCT on CBIM (19). For participants who receive the SEE and NRTS, the trained counsellor shall follow-up on their compliance and provide adequate advice in adhering to these interventions.
Chatbot for smoking cessation
The information and access to the chatbot will be introduced to participants. Through the chatbot service, participants shall access to practical information on smoking cessation 24 hours at any time, such as details on cessation services and skills for tackling cravings. By using the second-generation chatbot, participants could receive personalized risk information and recommendations for smoking cessation, as well as reach to a counsellor through WhatsApp live chat for urgently needed advice.
Control group
The control group will only provide simple smoking cessation advice with no intervention after recruitment
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nicotine Replace Therapy (NRT) sampling
The intervention involves a Zoom/WhatsApp meeting or face-to-face session with a trained counselor who introduces NRT use, possible side effects, and patch dosage based on a previous RCT guide. An online intervention pack with a pamphlet and 1-week free NRT sample (14mg or 21mg patch) is mailed to participants. After 1 week, the counselor follows up. If participants need more patches, an additional pack is mailed, and they are advised to obtain further patches from smoking cessation services or pharmacies. NRT patch users may experience skin reactions, insomnia, or vivid dreams; if severe side effects occur, they are asked to stop using NRT.
Simple exercise education (SEE)
All participants will be given a handgrip at study enrolment. The SEE includes a Zoom/WhatsApp meeting or face-to-face session including 1) watching a 5-minute video (www.youtube.com/watch?v=mZex2Wwy3fU) showing a chair professor of public health demonstrating the 10s-E, including the simple exercises with and without handgrip. The video also encourages participants to 1) follow the exercise instructions during the video demonstration; 2) perform the exercises whenever they experience craving or an urge to smoke during the quitting process; and 3) increase their exercise frequency and intensity as much as possible, which may also increase their grip strength. Participants will also receive a leaflet with exercise instructions and motivational messages.
Chat-based instant messaging
Participants will receive individualized chat-based encouragement and support messages about motivation and preparation for quit attempts using WhatsApp for 8 weeks. A trained smoking cessation counsellor will have real-time (synchronous), one-to-one interaction with the participants and provide personalized motivational, behavioural support according to the participants' needs. The conversation intensity will be flexible and depends on the participant. The conversation will also be integrated with brief advice using the Behaviour Change Techniques (BCTs) (18) and the AWARD (Ask, Warn, Advise, Refer, Do-it-again) intervention model (11). The intervention protocol will be similar as that in our previous RCT on CBIM (19). For participants who receive the SEE and NRTS, the trained counsellor shall follow-up on their compliance and provide adequate advice in adhering to these interventions.
Chatbot for smoking cessation
The information and access to the chatbot will be introduced to participants. Through the chatbot service, participants shall access to practical information on smoking cessation 24 hours at any time, such as details on cessation services and skills for tackling cravings. By using the second-generation chatbot, participants could receive personalized risk information and recommendations for smoking cessation, as well as reach to a counsellor through WhatsApp live chat for urgently needed advice.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Using any tobacco products every day;
* Having WhatsApp installed on their cell phone;
* No injuries in hands and arms;
* No medical contraindications to NRT (no severe angina, serious cardiac arrhythmias and hypertension); and
* No plan to quit in the next 30 days.
Exclusion Criteria
* Currently using smoking cessation services and medication;
* Self-reported psychosis, bipolar disorder, or on psychiatric medication; and
* Pregnant smokers.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Health and Medical Research Fund
OTHER_GOV
The University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Medicine
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yee Tak Derek Cheung, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Census & Statistics Department (Hong Kong SAR government. In: Thematic Household Survey, Report No 70: Pattern of Smoking. Hong Kong: Census & Statistics Department; 2020.
Leung DY, Chan SS, Chan V, Lam TH. Hardcore smoking after comprehensive smoke-free legislation and health warnings on cigarette packets in Hong Kong. Public Health. 2016 Mar;132:50-6. doi: 10.1016/j.puhe.2015.10.007. Epub 2015 Nov 21.
Richter KP, Ellerbeck EF. It's time to change the default for tobacco treatment. Addiction. 2015 Mar;110(3):381-6. doi: 10.1111/add.12734. Epub 2014 Oct 16.
Flocke SA, Step MM, Lawson PJ, Smith S, Zyzanski SJ. Development of a Measure of Incremental Behavior Change Toward Smoking Cessation. Nicotine Tob Res. 2017 Dec 13;20(1):73-80. doi: 10.1093/ntr/ntw217.
Ali A, Kaplan CM, Derefinko KJ, Klesges RC. Smoking Cessation for Smokers Not Ready to Quit: Meta-analysis and Cost-effectiveness Analysis. Am J Prev Med. 2018 Aug;55(2):253-262. doi: 10.1016/j.amepre.2018.04.021. Epub 2018 Jun 12.
Catley D, Goggin K, Harris KJ, Richter KP, Williams K, Patten C, Resnicow K, Ellerbeck EF, Bradley-Ewing A, Lee HS, Moreno JL, Grobe JE. A Randomized Trial of Motivational Interviewing: Cessation Induction Among Smokers With Low Desire to Quit. Am J Prev Med. 2016 May;50(5):573-583. doi: 10.1016/j.amepre.2015.10.013. Epub 2015 Dec 23.
Carpenter MJ, Hughes JR, Gray KM, Wahlquist AE, Saladin ME, Alberg AJ. Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial. Arch Intern Med. 2011 Nov 28;171(21):1901-7. doi: 10.1001/archinternmed.2011.492.
Amante DJ, Blok AC, Nagawa CS, Wijesundara JG, Allison JJ, Person SD, Morley J, Conigliaro J, Mattocks KM, Garber L, Houston TK, Sadasivam RS. The 'Take a Break' game: Randomized trial protocol for a technology-assisted brief abstinence experience designed to engage lower-motivated smokers. Contemp Clin Trials. 2020 Jun;93:106002. doi: 10.1016/j.cct.2020.106002. Epub 2020 Apr 23.
Chan SS, Wong DC, Cheung YT, Leung DY, Lau L, Lai V, Lam TH. A block randomized controlled trial of a brief smoking cessation counselling and advice through short message service on participants who joined the Quit to Win Contest in Hong Kong. Health Educ Res. 2015 Aug;30(4):609-21. doi: 10.1093/her/cyv023. Epub 2015 Jun 25.
Cheung YTD, Chan CHH, Ho KS, Tang C, Lau CWH, Li WHC, Wang MP, Lam TH. Effectiveness of nicotine replacement therapy sample at outdoor smoking hotspots for initiating quit attempts and use of smoking cessation services: a protocol for a cluster randomised controlled trial. BMJ Open. 2020 Apr 7;10(4):e036339. doi: 10.1136/bmjopen-2019-036339.
Collins LM. Optimization of Behavioral, Biobehavioral, and Biomedical Interventions: The Multiphase Optimization Strategy (MOST) [Internet]. Cham: Springer International Publishing; 2018 [cited 2021 Feb 9]. (Statistics for Social and Behavioral Sciences). Available from: http://link.springer.com/10.1007/978-3-319-72206-1
Cheung YTD, Cheung Li WH, Wang MP, Lam TH. Delivery of a Nicotine Replacement Therapy Sample at Outdoor Smoking Hotspots for Promoting Quit Attempts: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2020 Aug 24;22(9):1468-1475. doi: 10.1093/ntr/ntz138.
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.
Weng X, Luk TT, Suen YN, Wu Y, Li HCW, Cheung YTD, Kwong ACS, Lai VWY, Chan SSC, Lam TH, Wang MP. Effects of simple active referrals of different intensities on smoking abstinence and smoking cessation services attendance: a cluster-randomized clinical trial. Addiction. 2020 Oct;115(10):1902-1912. doi: 10.1111/add.15029. Epub 2020 Mar 25.
Cheung YT, Lam TH, Chan CHH, Ho KS, Fok WYP, Wang MP, Li WHC. Brief handgrip and isometric exercise intervention for smoking cessation: A pilot randomized trial. Addict Behav. 2020 Jan;100:106119. doi: 10.1016/j.addbeh.2019.106119. Epub 2019 Sep 4.
Fiore MC, Jaén CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ. Treating tobacco use and dependence: 2008 update-clinical practice guideline. 2008. Rockville, MD: Public Health Service, US Department of Health and Human Services; 2008.
Cheung YTD, Lam TH, Li WHC, Wang MP, Chan SSC. Feasibility, Efficacy, and Cost Analysis of Promoting Smoking Cessation at Outdoor Smoking "Hotspots": A Pre-Post Study. Nicotine Tob Res. 2018 Nov 15;20(12):1519-1524. doi: 10.1093/ntr/ntx147.
Michie S, Hyder N, Walia A, West R. Development of a taxonomy of behaviour change techniques used in individual behavioural support for smoking cessation. Addict Behav. 2011 Apr;36(4):315-9. doi: 10.1016/j.addbeh.2010.11.016. Epub 2010 Dec 15.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Factorial_Trial
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.