- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05777005
Promoting Smoking Cessation in Campus
December 6, 2023 updated by: Beijing Normal University
Promoting Smoking Cessation in Campus Via Smoking Cessation Contest: a Chatbot-based Smoking Cessation Intervention
This study aims to explore the feasibility, preliminary effectiveness, and implementation outcomes of chatbot-led smoking cessation support in community smokers.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xue Weng
- Phone Number: 3621259
- Email: xueweng@bnu.edu.cn
Study Locations
-
-
Guangdong
-
Zhuhai, Guangdong, China, 519087
- Recruiting
- Beijing Normal University
-
Contact:
- Xue Weng
- Email: xueweng@bnu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
5A's/5R's advice+ Chatbot-led group support+ Counselor-led individual support+ health warning leaflet+ Self-help booklet
|
5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.
The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.
The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.
Participants will receive three months of counselor-led individual support via WeChat.
The regular messages and instant messaging on psychosocial support aim to provide cessation advice, increase self-efficacy and confidence, and social support and behavioral capacity of quitting.
Participants will receive three months of chatbot-led group support via WeChat.
|
Active Comparator: Control group
5A's/5R's advice+ Chatbot-led group support+ health warning leaflet+ Self-help booklet
|
5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.
The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.
The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.
Participants will receive three months of chatbot-led group support via WeChat.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participation rate of eligible smokers
Time Frame: Baseline
|
The percentage of eligible smokers who agree to participate in the intervention
|
Baseline
|
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
|
Biochemical validated quit rate
Time Frame: 3 and 6 months follow-up
|
The primary outcomes are biochemically validated quit rate (exhaled CO < 4 ppm or salivary cotinine < 30 ng/ml) at 3-month in the two groups
|
3 and 6 months follow-up
|
Engagement in chatbot-led group support and/or counselor-led individual support
Time Frame: 3 and 6 months follow-up
|
Self-reported engagement in chatbot-led/counselor-led support in the two groups
|
3 and 6 months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
March 8, 2023
First Submitted That Met QC Criteria
March 8, 2023
First Posted (Actual)
March 20, 2023
Study Record Updates
Last Update Posted (Estimated)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 6, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Smoking Cessation in Campus
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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