NCT03800966

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,069

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2019

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

January 9, 2019

Last Update Submit

May 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Intention to smoke cigarettes in children

    1 month

  • Intention to use e-cigarettes in children

    1 month

  • Tobacco control policy support in children

    1 month

  • Attitude towards smoking in children

    1 month

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention leaflets will contain information on the TI's tactics to get young people to smoke.

Other: Leaflet

Control

PLACEBO COMPARATOR

The control leaflets will contain information on the tobacco control in Hong Kong.

Other: Leaflet

Interventions

LeafletOTHER

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.

ControlIntervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents and children should all understand Chinese

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local primary schools

Hong Kong, Hong Kong

Location

Study Officials

  • Sai Yin Ho, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator and associate professor

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 11, 2019

Study Start

January 3, 2019

Primary Completion

March 25, 2019

Study Completion

March 25, 2019

Last Updated

May 23, 2019

Record last verified: 2019-05

Locations