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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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