A Brief Intervention Programme for TID

A Leaflet-based Programme for Tobacco Industry Denormalisation - a Brief Randomised Controlled Trial

The brief RCT will be conducted in the form of a questionnaire survey, with two kinds of leaflets embedded in the same questionnaire. The RCT will be conducted in classrooms by teachers who will be given two kinds of questionnaires (with leaflet embedded) used for intervention and control groups. The questionnaires will be mixed in a way that two adjacent questionnaires are always different. The intervention leaflets will contain information for tobacco industry denormalisation. The control leaflets will contain information for tobacco control policy in Hong Kong. The study aims to test the effect of a leaflet-based intervention on primary school students' attitudes towards tobacco industry.

Study Overview

• Status: Completed
• Conditions: Attitudes Towards Tobacco Industry
• Intervention / Treatment: Other: Leaflet

• Study Type: Interventional
• Enrollment (Actual): 1069
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Local primary schools

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parents and children should all understand Chinese

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention leaflets will contain information on the TI's tactics to get young people to smoke.	Other: Leaflet; Leaflets for both groups will be printed in colour. Leaflet in each group contains 8 pictures and 8 statement, whose sequences will be scrambled. Primary school students need to do the matching, to ensure they read the statements.
Placebo Comparator: Control; The control leaflets will contain information on the tobacco control in Hong Kong.	Other: Leaflet; Leaflets for both groups will be printed in colour. Leaflet in each group contains 8 pictures and 8 statement, whose sequences will be scrambled. Primary school students need to do the matching, to ensure they read the statements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attitudes towards tobacco industry in children	Children will report their opinions towards 4 statements: 1); Tobacco companies are a trustworthy industry; 2) Tobacco industries use many tactics to resist tobacco control regulations; 3) Tobacco industries do everything they can to get young people to smoke; 4) Tobacco industries cheated the public for commercial gain. 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 as measurement of attitudes towards tobacco industry in primary school students.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intention to smoke cigarettes in children	Two questions will be used to assess this outcome: 1) If one of your good friends offers you a cigarette, will you smoke it? 2) Do you think you will smoke cigarettes in the next 12 months? Response options are definitely not /probably not /not sure /probably yes /definitely yes. Those choosing options "definitely not" for all the two questions will be deemed having no intention to smoke cigarettes; other responses will be deemed having intention to smoke cigarettes.	1 month
Intention to use e-cigarettes in children	Two questions will be used to assess this outcome: 1) If one of your good friends offers you an e-cigarette, will you use it? 2) Do you think you will use e-cigarettes in the next 12 months? Response options are definitely not /probably not /not sure /probably yes /definitely yes. Those choosing options "definitely not" for all the two questions will be deemed having no intention to use e-cigarettes; other responses will be deemed having intention to use e-cigarettes.	1 month
Tobacco control policy support in children	Children will report their opinions towards 2 statements: 1) The Hong Kong government should enact a total ban on e-cigarettes promptly; 2) The Hong Kong government should prohibit the sale of all tobacco products by legislation. All the 2 questions have 5 options from definitely yes to definitely no. The options will be recoded into 4-0, with higher scores indicating stronger support towards the tobacco control policy in Hong Kong. A sum of scores from the 2 questions will be deemed as measurement of support for tobacco control policy in Hong Kong in primary school students.	1 month
Attitude towards smoking in children	Children will report their opinions towards one statement: Smoking is personal choice, there is no right and wrong. The question has 5 options from definitely yes to definitely no. The options will be recoded into 4-0, with higher scores indicating more negative attitudes towards smoking. Score from that question will be deemed as measurement of attitude towards smoking in primary school students.	1 month

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): March 25, 2019
• Study Completion (Actual): March 25, 2019

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: coshdrama201819

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