A Brief Intervention Programme on ASP

March 6, 2020 updated by: Dr. Daniel Sai-Yin Ho, The University of Hong Kong

A Brief Intervention Programme on Alternative Smoking Products

The brief intervention comprises a 4-page worksheet used in the classroom (main intervention) and subsequent weekly e-messages through WhatsApp (booster intervention). The worksheets for both groups will be printed in colour, and mainly contain pictures and simple texts. Students will be asked to provide smartphone numbers of themselves and their parents for receiving the booster interventions. After sending 4-6 e-messages in 4 weeks, students will complete a 1-month follow-up assessment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

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, 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parents and children should understand Chinese.
  • Parents' consent to their children's participation.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Alternative smoking products (ASP)
Other: Worksheets for ASP
The ASP intervention will cover the harms and misleading marketing strategies of ASPs and other related information.
Other: E-messages for ASP
In the subsequent month after the main intervention, students in the ASP group will receive 4-6 e-messages on ASPs, after which students will be invited to complete a 1-month follow-up assessment.
ACTIVE_COMPARATOR: Sugar-sweetened beverages (SSB)
Other: Worksheets for SSB
The SSB intervention will cover the general information on SSBs, such as the sugar content of SSBs, nutrition labels and the harms of SSBs.
Other: E-messages for SSB
In the subsequent month after the main intervention, students in the SSB group will receive 4-6 e-messages on SSBs, after which students will be invited to complete a 1-month follow-up assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge on the harms and misleading marketing strategies of ASPs
Time Frame: Immediately after intervention

Students will report their opinions towards 5 statements:

  1. Children who use e-cigarettes are more likely to smoke cigarettes in the future;
  2. Hazards of secondhand smoke of e-cigarettes and heated tobacco products are slight;
  3. Nicotine content in heated tobacco products is lower than in the cigarettes, which is more difficult to get addicted;
  4. There are a variety of carcinogens in the heated tobacco products;
  5. Tobacco industries do everything they can to get young people to use tobacco products.

All the statements have 5 options from definitely no to definitely yes. The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating knowing more about the harms and misleading marketing strategies of ASPs.
Immediately after intervention
Attitudes towards ASPs
Time Frame: Immediately after intervention

Students will report their opinions towards 2 questions:

  1. Do you think the usage of e-cigarettes and heated tobacco products will harm your health?

    There will be 11 options from definitely no harm to definitely harm.

  2. Do you accept the primary students use e-cigarettes and heated tobacco products?

There will be 11 options from definitely unacceptable to definitely acceptable.
Immediately after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intention to use ASPs
Time Frame: Immediately after intervention

If one of your good friends offers you an e-cigarette or heated tobacco product, ask you to have a few puffs, and no one will know about this as no more smoking in the future. Will you use them?

There will be 11 options from definitely no to definitely yes.
Immediately after intervention
Knowledge on the harms and misleading marketing strategies of ASPs
Time Frame: 1-month follow-up

Students will report their opinions towards 5 statements:

  1. Hazards of e-cigarettes are slight, can only cause minor health problems;
  2. Reliable evidence shows that e-cigarettes can help quit smoking cigarettes;
  3. Heated tobacco products contain tar, can cause a variety of cancers;
  4. Heated tobacco products are harm reduction products, which is less harmful than cigarettes;
  5. Tobacco industries conceal the harms of tobacco products for commercial gain.

All the statements have 5 options from definitely no to definitely yes. The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating knowing more about the harms and misleading marketing strategies of ASPs.
1-month follow-up
Attitudes towards ASPs
Time Frame: 1-month follow-up

Students will report their opinions towards 2 questions:

  1. Do you think the usage of e-cigarettes and heated tobacco products will harm your health?

    There will be 11 options from definitely no harm to definitely harm.

  2. Do you accept the primary students use e-cigarettes and heated tobacco products?

There will be 11 options from definitely unacceptable to definitely acceptable.
1-month follow-up
Intention to use ASPs
Time Frame: 1-month follow-up

If one of your good friends offers you an e-cigarette or heated tobacco product, ask you to have a few puffs, and no one will know about this as no more smoking in the future. Will you use them?

There will be 11 options from definitely no to definitely yes.
1-month follow-up

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

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 (ANTICIPATED)

May 18, 2020

Primary Completion (ANTICIPATED)

July 31, 2020

Study Completion (ANTICIPATED)

July 31, 2020

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (ACTUAL)

March 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • coshdrama2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Subscribe