- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07803354
Metaphor-Based Smoking Cessation Intervention
Metaphor-Based Smoking Cessation Intervention: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
This randomized controlled trial evaluates a WeChat-delivered, metaphor-based smoking cessation intervention. Participants in the intervention group will receive staged cessation messages that use metaphors to explain smoking urges, nicotine dependence, behavior change, coping strategies, and relapse prevention. The intervention will also include self-monitoring, personalized feedback, and a personalized journey map to help participants recognize their progress during the cessation process.
Participants in the control group will receive brief smoking cessation advice. The study will compare the two groups in terms of smoking cessation outcomes. It will also assess participants' perceptions of the intervention, including the usefulness and comprehensibility of the metaphors, willingness to engage with the intervention, immersion in the cessation process, perceived support, and overall satisfaction.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xue Weng
- Phone Number: 3621259
- Email: xueweng@bnu.edu.cn
Study Locations
-
-
Guangdong
-
Zhuhai, Guangdong, China, 519087
- Beijing Normal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 18 and above, reside in Zhuhai for the next 6 months;
- smoke at least 1 cigarette or use e-cigarettes daily;
- Having a smartphone and a WeChat account, being able to use WeChat skillfully.
Exclusion Criteria:
- Smokers who have communication barrier (either physically or cognitively);
- Smokers who are currently participating in other SC programmes or services
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
5A's/5R's advice + health warning leaflet
|
The health warning leaflet provides essential information on the dangers of secondhand and thirdhand smoke.
It outlines how exposure to these forms of smoke can harm both smokers and non-smokers, particularly children, by increasing the risk of respiratory illnesses and other health issues.
The 5A's approach (Ask, Advise, Assess, Assist, and Arrange) will be used for participants who are ready to quit, and the 5R's approach (Relevance, Risks, Rewards, Roadblocks, and Repetition) will be used for participants who are not ready to quit.
|
|
Experimental: Metaphor-based intervention group
Metaphor-based smoking cessation intervention + 5A's/5R's advice + health warning leaflet
|
The health warning leaflet provides essential information on the dangers of secondhand and thirdhand smoke.
It outlines how exposure to these forms of smoke can harm both smokers and non-smokers, particularly children, by increasing the risk of respiratory illnesses and other health issues.
Participants will receive a 100-day, WeChat-delivered smoking cessation intervention using metaphors such as "fog" and "restart" to describe smoking urges, nicotine dependence, and the process of behavior change.
The intervention will provide staged messages on smoking-trigger identification, self-monitoring, action planning, coping strategies, environmental modification, social support, and relapse prevention, together with personalized feedback and a personalized journey map to help participants review their cessation experiences and progress.
The 5A's approach (Ask, Advise, Assess, Assist, and Arrange) will be used for participants who are ready to quit, and the 5R's approach (Relevance, Risks, Rewards, Roadblocks, and Repetition) will be used for participants who are not ready to quit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biochemical validated quit rate at 6 months follow-up
Time Frame: 6 months follow-up
|
The primary outcomes are biochemically validated quit rate (exhaled carbon monoxide < 4 ppm or salivary cotinine < 30 ng/ml)
|
6 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported 7-day point prevalence quit rate
Time Frame: 3 and 6 months follow-up
|
Self-reported 7-day point prevalence quit rate in the two groups
|
3 and 6 months follow-up
|
|
Smoking reduction rate
Time Frame: 3 and 6 months follow-up
|
Rate of smoking reduction by at least half of baseline amount in the two groups
|
3 and 6 months follow-up
|
|
Eligibility rate
Time Frame: baseline
|
the percentage of eligible smokers out of the total number of smokers screened
|
baseline
|
|
Consent rate
Time Frame: baseline
|
the percentage of eligible smokers who agree to participate out of the total number of eligible smokers
|
baseline
|
|
Biochemical validated quit rate at 3 months follow-up
Time Frame: 3 months follow-up
|
biochemically validated quit rate (exhaled carbon monoxide < 4 ppm or salivary cotinine < 30 ng/ml)
|
3 months follow-up
|
|
Intervention Engagement
Time Frame: 3 months follow-up
|
Participants' engagement with the intervention, including self-reported reading of WeChat cessation messages, interaction with the health assistant, and viewing of the personalized journey map.
|
3 months follow-up
|
|
Perceived Usefulness of Metaphors
Time Frame: 3 months follow-up
|
Participants' perceived usefulness of the metaphors used in the intervention.
Responses will be assessed using a 7-point Likert scale.
|
3 months follow-up
|
|
Narrative Engagement in the Smoking Cessation Journey
Time Frame: 3 months follow-up
|
Participants' engagement with the journey-based intervention, including whether the staged challenge design increased their motivation to persist, whether they were interested in subsequent stages, and whether they felt immersed in the smoking cessation journey.
Responses will be assessed using a 7-point Likert scale.
|
3 months follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xue Weng, Beijing Normal University
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Metaphor Cessation Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.