Quit Smoking: Optimizing Health Promotion Strategy

NCT06077058 | Unknown

• 1 other identifier: Factorial_Trial
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this factorial trail is to to optimize an intervention package to enhance quit attempt preparations, quit attempts, and tobacco abstinence among smokers without a plan to quit. 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?

Conditions

Smoking Cessation

Keywords

Smoking Behaviors; Smoking

Outcome Measures

Primary Outcomes (1)

• Incremental Behaviour Change toward Smoking cessation (IBC-S)

  This 15-item scale measures a spectrum of behaviours and cognitions antecedent to prepare smoking cessation. The minimum value is 3 and the maximum value is 27. Higher scores mean a better outcome.

  3-month

Secondary Outcomes (38)

• The proportion of smokers who self report quit attempts

  3-month

• Self-reported tobacco abstinence in the past 30 days

  3-month

• Biochemically validated abstinence

  3-month

• Time spend for offering simple exercise education (SEE)

  Baseline

• Time spent on Nicotine Replacement Therapy (NRT) medication advice

  Baseline

Other Outcomes (7)

• Covariate 1

  Baseline

• Covariate 2

  Baseline

• Covariate 3

  Baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: Nicotine Replace Therapy (NRT) sampling; Behavioral: Simple exercise education (SEE); Other: Chat-based instant messaging; Other: Chatbot for smoking cessation

Control group

NO INTERVENTION

The control group will only provide simple smoking cessation advice with no intervention after recruitment

Interventions

Nicotine Replace Therapy (NRT) sampling OTHER

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.

Intervention group

Simple exercise education (SEE) BEHAVIORAL

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.

Intervention group

Chat-based instant messaging OTHER

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.

Intervention group

Chatbot for smoking cessation OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a Hong Kong resident aged ≥18 years;
• 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.

You may not qualify if:

• Cannot communicate in Cantonese or read Chinese;
• Currently using smoking cessation services and medication;
• Self-reported psychosis, bipolar disorder, or on psychiatric medication; and
• Pregnant smokers.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Health and Medical Research Fund: collaborator

Study Sites (1)

Faculty of Medicine

Hong Kong, Hong Kong

RECRUITING

Related Publications (19)

• Census & Statistics Department (Hong Kong SAR government. In: Thematic Household Survey, Report No 70: Pattern of Smoking. Hong Kong: Census & Statistics Department; 2020.

  RESULT

• 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.

  PMID: 26612457 RESULT

• 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.

  PMID: 25323093 RESULT

• 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.

  PMID: 27613910 RESULT

• 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.

  PMID: 29903568 RESULT

• 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.

  PMID: 26711164 RESULT

• 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.

  PMID: 22123796 RESULT

• 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.

  PMID: 32335288 RESULT

• 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.

  PMID: 26116584 RESULT

• 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.

  PMID: 32269028 RESULT

• 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

  RESULT

• 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.

  PMID: 31404466 RESULT

• 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: 33323188 RESULT

• 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.

  PMID: 32149425 RESULT

• 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.

  PMID: 31522134 RESULT

• 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.

  RESULT

• 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.

  PMID: 28655173 RESULT

• 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.

  PMID: 21215528 RESULT

• 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: 30702431 RESULT

MeSH Terms

Conditions

Smoking Cessation; Smoking

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Derek Yee Tak Cheung, PhD

CONTACT

39176652; derekcheung@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 11, 2023
• Study Start: June 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 years after the completion of the relevant publications

Locations

HK (1)