- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03342768
An RCT of a Smartphone-based TID Programme
A Smartphone Messaging Programme for Tobacco Industry Denormalisation - a Randomised Controlled Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Local primary schools
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parents and children should all understand Chinese.
- Parents should have a smartphone and use WhatsApp (a smartphone-based app)
Exclusion Criteria:
- n/a
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TID
Messages will be sent 1-2 times per week containing information that aims to denormalise the tobacco industry.
|
For the TID arm, the messages' contents include the tobacco industry's (TI's) anti-smoking campaigns that made smoking more grown-up and more appealing to youth; the TI's role in smoking in movies; etc. For the sugar sweetened beverage (SSB) arm, the messages' contents include the disease conditions linked to SSBs, and the interference of sugar industry in scientific research. |
|
Other: Sugar sweetened beverages
Messages will be sent 1-2 times per week containing information on the adverse health effects of sugar sweetened beverages.
|
For the TID arm, the messages' contents include the tobacco industry's (TI's) anti-smoking campaigns that made smoking more grown-up and more appealing to youth; the TI's role in smoking in movies; etc. For the sugar sweetened beverage (SSB) arm, the messages' contents include the disease conditions linked to SSBs, and the interference of sugar industry in scientific research. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TID beliefs in parents
Time Frame: 1 month
|
Parents will report their opinions towards 4 sentences: 1) Tobacco companies are a respectable industry; 2) the tobacco industry does everything it can to get young people to smoke; 2) the tobacco industry use many tactics to resist tobacco control regulations; 4) the tobacco industry deceived the public for financial interests.
All the 4 questions have 5 options from definitely yes to definitely no.
The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating more negative attitudes towards the industry.
A sum of scores from the 4 questions will be deemed a measurement of TID beliefs.
|
1 month
|
|
TID beliefs in children
Time Frame: 1 month
|
Students will report their opinions towards 4 sentences: 1) Tobacco companies are a respectable industry; 2) the tobacco industry does everything it can to get young people to smoke; 2) the tobacco industry use many tactics to resist tobacco control regulations; 4) the tobacco industry deceived the public for financial interests.
All the 4 questions have 5 options from definitely yes to definitely no.
The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating more negative attitudes towards the industry.
A sum of scores from the 4 questions will be deemed a measurement of TID beliefs.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tobacco related communication reported by parents
Time Frame: 1 month
|
Parents will report whether they said the following to children in the past 30 days: 1) harm of smoking 2) harm of secondhand smoking 3) criticise smoking behaviour 4) approve tobacco control measures.
Each of the messages will be analyse as a binary outcome.
|
1 month
|
|
Sugar sweetened beverage (SSB) related communication reported by parents
Time Frame: 1 month
|
Parents will report whether they said the following to children in the past 30 days: 1) harm of SSB 2) certain kind of drinks contain sugar 3) don't drink or drink less SSB.
Each of the messages will be analyse as a binary outcome.
|
1 month
|
|
Tobacco related communication reported by children
Time Frame: 1 month
|
Students will report whether they heard the following from parents in the past 30 days: 1) harm of smoking 2) harm of secondhand smoking 3) criticize smoking behaviour 4) approve tobacco control measures.
Each of the messages will be analyse as a binary outcome.
|
1 month
|
|
SSB related communication reported by children
Time Frame: 1 month
|
Students will report whether they heard the following from parents in the past 30 days: 1) harm of SSB 2) certain kind of drinks contain sugar 3) don't drink or drink less SSB.
Each of the messages will be analyse as a binary outcome.
|
1 month
|
|
Intention to smoke in children
Time Frame: 1 month
|
Two questions will be used to assess this outcome: 1) do you think you will smoke in the next 12 months?
2) If one of your good friends offers you a cigarette, will you smoke it?
Response options are definitely not/probably not/probably yes/definitely yes.
Those choosing options other than "definitely not" for either of the questions will be deemed having intention to smoke; the other students will be deemed having no intention to smoke.
|
1 month
|
|
Home exposure to secondhand smoke in children reported by children
Time Frame: 1 month
|
One question will be asked: 1) On how many of the past 7 days did someone smoke near you at home? (Options 0 day/1/2/3/4/5/6/7).
The responses will dichotomised into a binary indicator of secondhand smoke exposure (no/any) and analysed as an outcome.
|
1 month
|
|
Home exposure to secondhand smoke in children reported by parents
Time Frame: 1 month
|
One question will be asked: 1) On how many of the past 7 days did someone smoke near your children at home? (Options 0 day/1/2/3/4/5/6/7).
The responses will dichotomised into a binary indicator of secondhand smoke exposure (no/any) and analysed as an outcome.
|
1 month
|
|
Parents' support for tobacco control
Time Frame: 1 month
|
Parents will report their opinions towards 4 sentences: 1) government should adopt plain packaging; 2) government should impose stronger regulation on tobacco; 3) government should strengthen the prevention of the harm of tobacco.
The options were strongly support/support/neutral/oppose/strongly oppose.
The options will be recoded into 4-0, with higher scores indicating stronger support for tobacco control.
A sum of scores from the 4 questions will be deemed a measurement of parents' support for tobacco control.
|
1 month
|
|
Negative attitude towards smoking in parents
Time Frame: 1 month
|
Parents will be asked "your attitude towards smoking is" with options of very positive/positive/neutral/negative/very negative.
The options will be dichotomised as very negative vs others (negative/neutral/positive/very positive) for analysis.
|
1 month
|
|
Negative attitude towards smoking in children
Time Frame: 1 month
|
Children will be asked "your attitude towards smoking is" with options of very positive/positive/neutral/negative/very negative.
The options will be dichotomised as very negative vs others (negative/neutral/positive/very positive) for analysis.
|
1 month
|
|
Past 7-day consumption of SSB and water in children reported by children
Time Frame: 1 month
|
Children will be asked "On how many of the past 7 days did you drink SSBs?" and "On how many of the past 7 days did you drink water?"
For both questions, the options were 0/1/2/3/4/5/6/7 days.
These two variables will be analysed as both binary (No (0 day) vs any (1/2/3/4/5/6/7 days)) and continuous variables.
|
1 month
|
|
Past 7-day consumption of SSB and water in children reported by parents
Time Frame: 1 month
|
Parents will be asked "On how many of the past 7 days did you drink SSBs?" and "On how many of the past 7 days did you drink water?"
For both questions, the options were 0/1/2/3/4/5/6/7 days.
These two variables will be analysed as both binary (No (0 day) vs any (1/2/3/4/5/6/7 days)) and continuous variables.
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- coshdrama
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.
Clinical Trials on Tobacco Industry Denormalisation Beliefs
-
The University of Hong KongCompleted
-
The University of Hong KongCompleted
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)CompletedTobacco Product Beliefs and UseUnited States
Clinical Trials on Smartphone-based messages
-
Johns Hopkins Bloomberg School of Public HealthMaryland Cigarette RestitutionNot yet recruiting
-
Johns Hopkins Bloomberg School of Public HealthRecruitingTobacco Cigarette SmokingUnited States
-
Johns Hopkins Bloomberg School of Public HealthCompletedTobacco Cigarette SmokingUnited States
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH); University of MichiganRecruiting
-
Ohio State University Comprehensive Cancer CenterRecruitingPancreatic AdenocarcinomaUnited States
-
Hanoi University of Public HealthNational Institutes of Health (NIH); Fogarty International Center of the National... and other collaboratorsRecruitingSmoking | Smoking Cessation | Telemedicine | MindfulnessVietnam
-
The University of Hong KongRecruitingDepressive SymptomsHong Kong
-
Mclean HospitalNot yet recruitingDepression | Anxiety | Psychosis | RuminationUnited States
-
University of MinnesotaCompletedTobacco Use | Text Messaging | Faith-Based | Community-engagedUnited States
-
University of GlasgowCompletedCovid19 | VaccinationUnited Kingdom