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Effectiveness of Ecological Momentary Assessment Based Smoking Cessation Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05212220
Recruitment Status : Active, not recruiting
First Posted : January 28, 2022
Last Update Posted : May 12, 2023
Sponsor:
Collaborator:
Health and Medical Research Fund
Information provided by (Responsible Party):
The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: EMA-based intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-intensity Ecological Momentary Assessment (EMA) for Smoking Cessation Intervention and Tobacco Control Policy Evaluation: a Randomized Controlled Trial Nested Within an EMA-based Observational Study
Actual Study Start Date : March 21, 2022
Actual Primary Completion Date : April 3, 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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
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.

Behavioral: EMA-based intervention
Participants will receive 10-week tailored quitting reminder instant messages via WhatsApp and voluntarily discuss their quit plan with the research staff.

No Intervention: Control
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.



Primary Outcome Measures :
  1. Incremental Behavior Change Towards Smoking Cessation (IBC-S) at 3-month follow-up [ Time Frame: 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.

  2. Prevalence of biochemical validated abstinence at 3-month follow-up [ Time Frame: 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.


Secondary Outcome Measures :
  1. Prevalence of biochemical validated abstinence at 6-month follow-up [ Time Frame: 6-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.

  2. Prevalence of self-reported 7-day abstinence at 3-month follow-up [ Time Frame: 3-month follow-up ]
    Self-reported 7-day abstinence at 3-month follow-up

  3. Prevalence of self-reported 7-day abstinence at 6-month follow-up [ Time Frame: 6-month follow-up ]
    Self-reported 7-day abstinence at 6-month follow-up

  4. Self-reported use of smoking cessation service or medication from baseline at 3-month follow-up [ Time Frame: 3-month follow-up ]
    Use of smoking cessation service or medication from baseline at 3-month follow-up


Other Outcome Measures:
  1. Self-report quit attempts at 3-month follow-up [ Time Frame: 3-month follow-up ]
    Number of quit attempts from baseline at 3-month follow-up

  2. Self-efficacy to quit smoking at 3-month follow-up [ Time Frame: 3-month follow-up ]
    Self-efficacy will be evaluated according to the importance of quitting on a scale of 0 to 10 (0, least important; 10, most important), the difficulty of quitting on a scale of 0 to 10 (0, least difficult; 10, most difficult), and confidence in quitting on a scale of 0 to 10 (0, least confident; 10, most confident). For the scale of measuring quitting importance and confidence, higher scores mean a better outcome and for the scale of measuring difficulty, higher scores mean a worse outcome.

  3. Self-report satisfaction toward instant messages at 3-month follow-up [ Time Frame: 3-month follow-up ]
    Defined by rating the satisfaction of instant messages on a scale of 0 to 4 (0, very dissatisfied; 4 very satisfied)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05212220


Locations
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Hong Kong
Hong Kong University
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Health and Medical Research Fund
Publications of Results:

Other Publications:
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT05212220    
Other Study ID Numbers: 05190077
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Research data and documentation will be available upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 3 years after the completion of the relevant publications.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Hong Kong:
Ecological Momentary Assessment
Intervention
Smoking Cessation
Acceptance and commitment therapy
Unassisted quitting
Tobacco control policy