Effectiveness of Ecological Momentary Assessment Based Smoking Cessation Intervention

NCT05212220 | Completed

• 1 other identifier: 05190077
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 1

Brief Summary

The EMA-based intervention in this proposal is aimed to motivate the majority of smokers who do not prefer to use traditional cessation aids for quitting and help them quit smoking. The smartphone application (app) and the EMA-based phone reminders at low cost and short intervention time make this approach attractive for the majority of smokers. Identification of accurate and specific pro-smoking cues in the real-word and real-time environmental cues via the app will provide valuable information to guide new tobacco control policies.

Conditions

Smoking Cessation

Keywords

Ecological Momentary Assessment; Intervention; Smoking Cessation; Acceptance and commitment therapy; Unassisted quitting; Tobacco control policy

Outcome Measures

Primary Outcomes (2)

• Incremental Behavior Change Towards Smoking Cessation (IBC-S) at 3-month follow-up

  Behavioral progression towards smoking cessation will be detected by 15-item Incremental Behavior Change towards Smoking Cessation. 15-item Incremental Behavior Change towards Smoking Cessation contains two parts: behavioral and cognitive changes. Item 1 to Item 12 are binary questions on a scale of 0 to 1 (0, no; 1, yes) to evaluate the behavioral changes. Cognitive changes are measured by item 13 to 15 on a scale of 0 to 4 (0, not at all; 4 always). Higher score means a better outcome.

  3-month follow-up

• Prevalence of biochemical validated abstinence at 3-month follow-up

  Tobacco abstinence in the past 7 days, which is validated using an exhaled carbon monoxide level of\< 4 ppm, and a saliva cotinine level of \< 30 ng/ml. Noted: 1. Suppose participants refuse to have a face-to-face exhaled carbon monoxide test due to the pandemic of COVID-19 in Hong Kong. In that case, the outcome will be validated by a cotinine saliva test device only. 2. If participants use NRT, the outcome will be validated by exhaled carbon monoxide only.

  3-month follow-up

Secondary Outcomes (4)

• Prevalence of biochemical validated abstinence at 6-month follow-up

  6-month follow-up

• Prevalence of self-reported 7-day abstinence at 3-month follow-up

  3-month follow-up

• Prevalence of self-reported 7-day abstinence at 6-month follow-up

  6-month follow-up

• Self-reported use of smoking cessation service or medication from baseline at 3-month follow-up

  3-month follow-up

Other Outcomes (3)

• Self-report quit attempts at 3-month follow-up

  3-month follow-up

• Self-efficacy to quit smoking at 3-month follow-up

  3-month follow-up

• Self-report satisfaction toward instant messages at 3-month follow-up

  3-month follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will first receive 5 times EMA per day for one week. The EMA will document participants smoking behaviors, smoking cues, smoking cravings, etc. The intervention group will receive 15-30 minutes of a nurse-led phone call, and 10-week instant messaging after completing the one-week EMA documentation.

Behavioral: EMA-based intervention

Control

NO INTERVENTION

The control group will first receive 5 times EMA per day for one week. The EMA will document participants smoking behaviors, smoking cues, smoking cravings, etc. No intervention will be provided to the control group after completing the one-week EMA documentation.

Interventions

EMA-based intervention BEHAVIORAL

A personal quit plan includes (1) self-help techniques on handling craving; (2) suggestions to avoid the reported pro-smoking cues; (3) whether to quit progressively or abruptly; (4) referral for existing smoking cessation service; and (5) instruction of using over-the-counter (OTC) nicotine replacement therapy (NRT), if OTC-NRT is preferred by the participant will be designed and give to the participants via a nurse-led phone call.

Intervention

Eligibility Criteria

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

You may qualify if:

• Daily consumption of tobacco products (including traditional cigarettes, electronic cigarettes, and heated tobacco products) in the past week;
• Age ≥18 years;
• Owning a mobile smartphone with internet access;
• Staying in Hong Kong during the 1-week EMA study period;
• Able to read and write Chinese
• Exhaled carbon monoxide will be measured and required to be 4ppm or above, or saliva cotinine to be 30ng/ml or above

You may not qualify if:

• Plan to use smoking cessation services or medication in the coming month
• Using smoking cessation services, or using nicotine replacement therapy in the past 7 days
• Having mental illnesses
• Female smokers who are pregnant

Sponsors & Collaborators

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

Study Sites (1)

Hong Kong University

Hong Kong, Hong Kong

Location

Related Publications (18)

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  PMID: 16300724 BACKGROUND

• 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

• 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 YT, Wang MP, Li HC, Kwong A, Lai V, Chan SS, Lam TH. Effectiveness of a small cash incentive on abstinence and use of cessation aids for adult smokers: A randomized controlled trial. Addict Behav. 2017 Mar;66:17-25. doi: 10.1016/j.addbeh.2016.11.006. Epub 2016 Nov 10.

  PMID: 27863323 RESULT

• Hartmann-Boyce J, Livingstone-Banks J, Ordonez-Mena JM, Fanshawe TR, Lindson N, Freeman SC, Sutton AJ, Theodoulou A, Aveyard P. Behavioural interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD013229. doi: 10.1002/14651858.CD013229.pub2.

  PMID: 33411338 RESULT

• Hernandez-Lopez M, Luciano MC, Bricker JB, Roales-Nieto JG, Montesinos F. Acceptance and commitment therapy for smoking cessation: a preliminary study of its effectiveness in comparison with cognitive behavioral therapy. Psychol Addict Behav. 2009 Dec;23(4):723-30. doi: 10.1037/a0017632.

  PMID: 20025380 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

• Hoeppner BB, Hoeppner SS, Abroms LC. How do text-messaging smoking cessation interventions confer benefit? A multiple mediation analysis of Text2Quit. Addiction. 2017 Apr;112(4):673-682. doi: 10.1111/add.13685. Epub 2016 Dec 12.

  PMID: 27943511 RESULT

• Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.

  PMID: 19996233 RESULT

• Yu DS. Insomnia Severity Index: psychometric properties with Chinese community-dwelling older people. J Adv Nurs. 2010 Oct;66(10):2350-9. doi: 10.1111/j.1365-2648.2010.05394.x. Epub 2010 Aug 16.

  PMID: 20722803 RESULT

• Cropsey KL, Trent LR, Clark CB, Stevens EN, Lahti AC, Hendricks PS. How low should you go? Determining the optimal cutoff for exhaled carbon monoxide to confirm smoking abstinence when using cotinine as reference. Nicotine Tob Res. 2014 Oct;16(10):1348-55. doi: 10.1093/ntr/ntu085. Epub 2014 Jun 2.

  PMID: 24891552 RESULT

• Cooke F, Bullen C, Whittaker R, McRobbie H, Chen MH, Walker N. Diagnostic accuracy of NicAlert cotinine test strips in saliva for verifying smoking status. Nicotine Tob Res. 2008 Apr;10(4):607-12. doi: 10.1080/14622200801978680.

  PMID: 18418783 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

• Gilbert H, Sutton S, Morris R, Petersen I, Galton S, Wu Q, Parrott S, Nazareth I. Effectiveness of personalised risk information and taster sessions to increase the uptake of smoking cessation services (Start2quit): a randomised controlled trial. Lancet. 2017 Feb 25;389(10071):823-833. doi: 10.1016/S0140-6736(16)32379-0. Epub 2017 Jan 25.

  PMID: 28129989 RESULT

• Casagrande JT, Pike MC. An improved approximate formula for calculating sample sizes for comparing two binomial distributions. Biometrics. 1978 Sep;34(3):483-6. No abstract available.

  PMID: 719125 RESULT

• Shiffman S. Conceptualizing analyses of ecological momentary assessment data. Nicotine Tob Res. 2014 May;16 Suppl 2(Suppl 2):S76-87. doi: 10.1093/ntr/ntt195. Epub 2013 Dec 9.

  PMID: 24323571 RESULT

• Cheung YTD, Zhang MJ, Luk TT, Ho SY, Lam TH, Wang MP. Telephone Counseling and Messaging Guided by Mobile Profiling of Tobacco Users for Smoking Cessation: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250764. doi: 10.1001/jamanetworkopen.2025.0764.

  PMID: 40085082 DERIVED

• Zhang MJ, He WJA, Luk TT, Wang MP, Chan SSC, Cheung YTD. Effectiveness of personalized smoking cessation intervention based on ecological momentary assessment for smokers who prefer unaided quitting: protocol for a randomized controlled trial. Front Public Health. 2023 Jul 31;11:1147096. doi: 10.3389/fpubh.2023.1147096. eCollection 2023.

  PMID: 37583881 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

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: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 28, 2022
• Study Start: March 21, 2022
• Primary Completion: April 3, 2023
• Study Completion: July 4, 2023
• Last Updated: January 3, 2025

Record last verified: 2023-05

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)