AR Enhanced Pictorial Warnings on Smoking Cessation

May 19, 2023 updated by: Dr. Wang Man-Ping, The University of Hong Kong

Mobile Phone Based Personalized and Interactive Augmented Reality (AR) Pictures on Enhancing Brief Advice Model for Smoking Cessation: a Pilot Randomized Controlled Trial

This pilot randomized controlled trail aims to test the effects of AR enhanced pictorial effects in harms of smoking and benefit of smoking cessation.

Study Overview

Status

Status

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

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.

Detailed Description

Conventional health warnings on smoking harms mostly include pictures showing smoking consequences such as lung diseases, peripheral vascular diseases, aging, skin lesions, and benefit of quitting such as improved cardiopulmonary functions, skin conditions and risk of diseases, etc. The effects of the information are limited by the generic messages, unattractive images, and lack of interaction. This proposal aims to enhance the "Warn" and "Advice" materials using mobile phone-based augmented reality (AR) technologies to provide personalized, interactive, and attractive images to encourage smokers to quit smoking.

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 (Actual)

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.
80

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 Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • School of Nursing, The University of Hong Kong

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Hong Kong adults aged 18 or above;
  • Smoke at least 1 cigarette daily in the past 30 days;
  • Own a smartphone and familiar with instant messaging apps;
  • Able to read and communicate in Chinese.

Exclusion Criteria:

  • Participate in other smoking cessation services or projects

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: AR group
Brief AWARD advice + active referral + leaflet + 3 months chat-based support with AR pictures
Behavioral: Brief AWARD advice and active referral to somking cessation services
The AWARD advice includes: (1) Ask about smoking history; (2) Warn about the high risk of smoking; (3) Advise to quit or reduce smoking as soon as possible; (4) Refer smokers to smoking cessation services (with a referral card); (5) Do it again: to repeat the intervention.
Behavioral: Chat-based support through Instant Messaging apps
Participants in the intervention group will receive 3 months of chat-based support through Instant Messaging apps (e.g., WhatsApp, WeChat). The support mainly includes (1) regular messages on health warnings, benefits and methods of quitting, coping craving approach, and promotion to use the SC services; (2) real-time, personalized, and interactive behavioral and psychosocial support through Instant Messaging apps.
Other: Leaflet
Leaflet on harms of smoking
Behavioral: AR images
AR images of the harms of smoking and the benefit of abstinence.
Active Comparator: Control group
Brief AWARD advice + active referral + leaflet + 3 months chat-based support
Behavioral: Brief AWARD advice and active referral to somking cessation services
The AWARD advice includes: (1) Ask about smoking history; (2) Warn about the high risk of smoking; (3) Advise to quit or reduce smoking as soon as possible; (4) Refer smokers to smoking cessation services (with a referral card); (5) Do it again: to repeat the intervention.
Behavioral: Chat-based support through Instant Messaging apps
Participants in the intervention group will receive 3 months of chat-based support through Instant Messaging apps (e.g., WhatsApp, WeChat). The support mainly includes (1) regular messages on health warnings, benefits and methods of quitting, coping craving approach, and promotion to use the SC services; (2) real-time, personalized, and interactive behavioral and psychosocial support through Instant Messaging apps.
Other: Leaflet
Leaflet on harms of smoking

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
Self-reported past 7-day point prevalence abstinence
Time Frame: 3 months after baseline
Abstain from smoking in the past 7 days
3 months after baseline

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
Self-reported past 7-day point prevalence abstinence
Time Frame: 1 months after baseline
Abstain from smoking in the past 7 days
1 months after baseline
Self-reported smoking reduction by at least 50%
Time Frame: 3 months after baseline
Defined by at least 50% reduction in baseline daily cigarette consumption
3 months after baseline
Self-reported smoking reduction by at least 50%
Time Frame: 1 months after baseline
Defined by at least 50% reduction in baseline daily cigarette consumption
1 months after baseline
Self-reported quit attempts
Time Frame: 3 months after baseline
Defined by abstinence for at least 24 hours
3 months after baseline
Self-reported quit attempts
Time Frame: 1 months after baseline
Defined by abstinence for at least 24 hours
1 months after baseline
Recall of pictorial warnings
Time Frame: 3 months after baseline
Defined by the recall of the quitline on warning pictures
3 months after baseline
Recall of pictorial warnings
Time Frame: 1 months after baseline
Defined by the recall of the quitline on warning pictures
1 months after baseline
Attention of pictorial warnings
Time Frame: 1 months after baseline
Defined by notice of pictorial warning
1 months after baseline
Attention of pictorial warnings
Time Frame: 3 months after baseline
Defined by notice of pictorial warning
3 months after baseline
Self-reported intention to quit
Time Frame: 1 months after baseline
Defined by readiness to quit in 30 days
1 months after baseline
Self-reported intention to quit
Time Frame: 3 months after baseline
Defined by readiness to quit in 30 days
3 months after baseline
Reactions to the pictorial warnings
Time Frame: 3 months after baseline
Defined by behaviors to avoid seeing pictorial warnings
3 months after baseline
Reactions to the pictorial warnings
Time Frame: 1 months after baseline
Defined by behaviors to avoid seeing pictorial warnings
1 months after baseline
Perceived effectiveness of AR images
Time Frame: 1 months after baseline
Defined by ratings on the effectiveness of AR images to encourage quitting
1 months after baseline
Perceived effectiveness of AR images
Time Frame: 3 months after baseline
Defined by ratings on the effectiveness of AR images to encourage quitting
3 months after baseline

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Man Ping Wang, PhD, 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 (Actual)

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.
April 23, 2021

Primary Completion (Actual)

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.
March 31, 2022

Study Completion (Actual)

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.
June 30, 2022

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 24, 2021

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 31, 2021

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.
April 2, 2021

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.
May 22, 2023

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.
May 19, 2023

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.
May 1, 2023

More Information

Terms related to this study

Keywords

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.
  • Pictorial warning AR

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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