- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03264144
Address Tobacco Use Among Adolescents in Hong Kong
May 1, 2018 updated by: Dr. Daniel Sai-Yin Ho, The University of Hong Kong
Changing Social Norms Around Smoking: A Cluster Randomized Controlled Trial to Address Tobacco Use Among Adolescents in Hong Kong
This study will examine the effectiveness of a social norms campaign in correcting smoking misperceptions, reducing smoking susceptibility and changing smoking-related behaviours in Hong Kong adolescents.
Study Overview
Detailed Description
The study involves a behavioural intervention with social norms approaches to correct smoking misperceptions, reduce smoking susceptibility and change smoking-related behaviours in Hong Kong adolescents.
A 2-arm stratified clustered randomised controlled trial (RCT) will be conducted to evaluate the effectiveness of the intervention.
A total of 18 secondary schools will be randomly selected from the 5 regions in Hong Kong and invited to the RCT.
The schools will then be randomly allocated to intervention or control group in the ratio of 1:1.
Secondary 1 to 5 (US Grade 7 to 11) students will be invited.
Students in both intervention and control group will complete a baseline survey, and the intervention group will receive the intervention after the baseline.
Intervention materials includes posters and table tents at school, flyers to students, and online banner on school website.
The intervention adopts social norms approaches, and will highlight the prevalence of adolescents who do not smoke and have no intention to smoke.
It will last for 2 months.
Both intervention and control groups will complete follow-up surveys at 3 and 9 months.
The control group will receive the intervention materials after the RCT.
Study Type
Interventional
Enrollment (Anticipated)
12868
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 Locations
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Hong Kong, Hong Kong
- Local secondary schools
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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
11 years to 20 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Local secondary schools that cover grades 1-6
Exclusion Criteria:
- International secondary schools
- Special schools for adolescents with visual, hearing or other physical impairments or disabilities
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Intervention
Students in the schools assigned to the intervention group will receive the intervention after the baseline survey.
The intervention will be a social norms campaign involving posters, table tents, flyers and an online banner.
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Intervention messages will mainly highlight the prevalence of Hong Kong adolescents who do not smoke cigarettes and have no intention to smoke cigarettes.
The messages will be conveyed to students through posters, table tents, flyers and an online banner.
Posters will be posted at prominent places in schools, table tents will be placed in school canteens, flyers will be distributed to students, and the online banner will be placed at the school website.
The intervention will last for 2 months.
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NO_INTERVENTION: Control
Students in the schools assigned to the control group will not receive anything during the randomised controlled trial.
They will receive the intervention materials after the trial.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perceived adolescent smoking prevalence
Time Frame: At the time of survey
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Perceived prevalence of current smoking secondary school students in Hong Kong
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At the time of survey
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Smoking susceptibility
Time Frame: At the time of survey
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Intention to smoke in the next 12 months, if good friends are smoking in front, and if a good friend offered a cigarette
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At the time of survey
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Smoking intensity
Time Frame: Past 30 days
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Number of smoking days in the past 30 days, average daily cigarette consumption
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Past 30 days
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Intention to quit
Time Frame: At the time of survey
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Intention to quit
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At the time of survey
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Quit attempts
Time Frame: Past 3 months
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Number of quit attempts
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Past 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sai Yin Ho, Dr, The University of Hong Kong
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)
October 13, 2017
Primary Completion (ANTICIPATED)
July 1, 2018
Study Completion (ANTICIPATED)
July 1, 2018
Study Registration Dates
First Submitted
August 24, 2017
First Submitted That Met QC Criteria
August 24, 2017
First Posted (ACTUAL)
August 28, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 3, 2018
Last Update Submitted That Met QC Criteria
May 1, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 17629016
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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