An RCT of a Smartphone-based TID Programme

September 10, 2018 updated by: Dr. Daniel Sai-Yin Ho, The University of Hong Kong

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

163

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

      • Hong Kong, Hong Kong
        • Local primary schools

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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: 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

This is where you will find people and organizations involved with this study.

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 22, 2018

Primary Completion (Actual)

June 29, 2018

Study Completion (Actual)

June 29, 2018

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 9, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

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)?

UNDECIDED

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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