- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05148520
Provision of Service of a YQL Programme For Youth Smokers
November 25, 2021 updated by: Dr Eva Ho, The Hong Kong Polytechnic University
Provision of Service of a Youth Quitline Programme For Youth Smokers
This project is funded by Department of Health.
We will run a quitline which provides telephone smoking cessation counseling to youth smokers aged 25 or below.
After baseline counseling based on trans-theoretical model, follow-up counseling will be provided by trained counselors (i.e.
nursing students or students from other healthrelated disciplines) at 1 week, 1, 3, 6, 9 and 12 months.
It is expected that the quitline can assist youth smokers to quit smoking, thus saving the healthcare cost attributed to smoking in long-term.
Study Overview
Detailed Description
This project will last for 15 months (from 1st Dec 2020 to 28th Feb 2022).
Prior to commencement, a month will be spent on preparation, including setting up the quitline and website, designing and printing publicity materials, connecting with secondary and post-secondary schools and training peer counsellors.
We will operate the quitline for 15 months and provide telephone counselling for eligible youth smokers.
Self-reported quitters at 6-month follow-up will be invited for biochemical validation.
Study Type
Interventional
Enrollment (Anticipated)
400
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: Ka Wai Lam, PhD
- Phone Number: 27666420
- Email: kwkatlam@polyu.edu.hk
Study Locations
-
-
Hong Kong,China
-
Hong Kong, Hong Kong,China, Hong Kong, 0000
- Recruiting
- Ka Yan Ho
-
-
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
No older than 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 25 or below
- Self-reported to smoke any types of tobacco products within the past 1 month
- Speak Cantonese and
- Provide verbal consent to counselling service.
Exclusion Criteria:
- have psychiatric disease
- and/or currently receive any smoking cessation intervention from other service providers
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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 5A's model
The practice guideline emphasizes on the use of '5A's' model that contains five major steps in providing smoking cessation counselling.
Specifically, our counsellors will take the following steps to provide telephone counselling for youth smokers who are ready to quit smoking
|
(1) Ask - ask youth smokers about their smoking habit, (2) Advise - advise youth smokers to quit smoking, (3) Assess - assess youth smokers about their willingness to quit smoking, (4) Assist - assist youth smokers who are willing to make a quit attempt, and (5) Arrange - arrange for follow-up. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported 7-point prevalence
Time Frame: at the 6-month follow-up
|
The self-reported abstinence will be validated if the level of carbon monoxide in expired air was less than 4 parts per million and saliva cotinine level was less than100 ng/mL in parallel tests.
|
at the 6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ka Yan Ho, phd, The Hong Kong Polytechnic University
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)
November 1, 2020
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
November 25, 2021
First Submitted That Met QC Criteria
November 25, 2021
First Posted (Actual)
December 8, 2021
Study Record Updates
Last Update Posted (Actual)
December 8, 2021
Last Update Submitted That Met QC Criteria
November 25, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- YQL
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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