Tobacco Industry Denormalisation BeliefsNCT03342768
An RCT of a Smartphone-based TID Programme
A study testing Smartphone-based messages in people with Tobacco Industry Denormalisation Beliefs and Tobacco-related Communications, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The study aims to test the effect a smartphone-based intervention on primary school students and their parents' attitudes towards tobacco industry and their tobacco-related communications. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tobacco Industry Denormalisation Beliefs, Tobacco-related Communications
- What is being tested?
- Smartphone-based messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Mar 2018to 29 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents and children should all understand Chinese.
- Parents should have a smartphone and use WhatsApp (a smartphone-based app)
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Smartphone Messaging Programme for Tobacco Industry Denormalisation - a Randomised Controlled Trial
The study aims to test the effect a smartphone-based intervention on primary school students and their parents' attitudes towards tobacco industry and their tobacco-related communications.
- Being tested
- Smartphone-based messages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based messagesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TID | Experimental | Messages will be sent 1-2 times per week containing information that aims to denormalise the tobacco industry. Receives: Other: Smartphone-based messages |
| Sugar sweetened beverages | Other | Messages will be sent 1-2 times per week containing information on the adverse health effects of sugar sweetened beverages. Receives: Other: Smartphone-based messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
TID beliefs in parents
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.
Measured: 1 month
TID beliefs in children
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.
Measured: 1 month
Secondary outcomes (12)
Tobacco related communication reported by parents
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.
Measured: 1 month
Sugar sweetened beverage (SSB) related communication reported by parents
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.
Measured: 1 month
Tobacco related communication reported by children
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.
Measured: 1 month
SSB related communication reported by children
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.
Measured: 1 month
Intention to smoke in children
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.
Measured: 1 month
Home exposure to secondhand smoke in children reported by children
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.
Measured: 1 month
Home exposure to secondhand smoke in children reported by parents
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.
Measured: 1 month
Parents' support for tobacco control
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.
Measured: 1 month
Negative attitude towards smoking in parents
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.
Measured: 1 month
Negative attitude towards smoking in children
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.
Measured: 1 month
Past 7-day consumption of SSB and water in children reported by children
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.
Measured: 1 month
Past 7-day consumption of SSB and water in children reported by parents
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start22 Mar 2018
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Industry Denormalisation BeliefsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Daniel Sai-Yin Ho, The University of Hong Kong
- Investigators
- Sai Yin Ho, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342768
- Sponsor's protocol ID
- coshdrama
- Status last verified
- Sep 2018
- First submitted
- 8 Nov 2017
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smartphone Messaging Programme for Tobacco Industry Denormalisation - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03342768
- Acronym / sponsor ID
- coshdrama
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to test the effect a smartphone-based intervention on primary school students and their parents' attitudes towards tobacco industry and their tobacco-related communications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TID | Experimental | Other: Smartphone-based messagesMessages will be sent 1-2 times per week containing information that aims to denormalise the tobacco industry. |
| Sugar sweetened beverages | Other | Other: Smartphone-based messagesMessages will be sent 1-2 times per week containing information on the adverse health effects of sugar sweetened beverages. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parents and children should all understand Chinese.
- Parents should have a smartphone and use WhatsApp (a smartphone-based app)
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-based messagesFor 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, TID |
Primary outcome
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.
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.
12 secondary outcomes
Tobacco related communication reported by parents
Time frame: 1 month
Sugar sweetened beverage (SSB) related communication reported by parents
Time frame: 1 month
Tobacco related communication reported by children
Time frame: 1 month
SSB related communication reported by children
Time frame: 1 month
Intention to smoke in children
Time frame: 1 month
Home exposure to secondhand smoke in children reported by children
Time frame: 1 month
Home exposure to secondhand smoke in children reported by parents
Time frame: 1 month
Parents' support for tobacco control
Time frame: 1 month
Negative attitude towards smoking in parents
Time frame: 1 month
Negative attitude towards smoking in children
Time frame: 1 month
Past 7-day consumption of SSB and water in children reported by children
Time frame: 1 month
Past 7-day consumption of SSB and water in children reported by parents
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sai Yin Ho, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based messages in people with Tobacco Industry Denormalisation Beliefs and Tobacco-related Communications, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TID beliefs in parents (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.