Waterpipe Tobacco SmokingNCT05439421
Consumer Perceptions of Waterpipe Tobacco Packaging and Digital Marketing Claims
A study testing Package/Advertisement With Claim and Package/Advertisement Without Claim in people with Waterpipe Tobacco Smoking, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the impact of marketing claims commonly found on waterpipe, also known as hookah, tobacco packages and in digital marketing on young adults' willingness to try hookah tobacco. Participants will complete two tasks, in random order. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Waterpipe Tobacco Smoking
- What is being tested?
- Package/Advertisement With Claim and Package/Advertisement Without Claim
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,507 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to 23 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- United States (U.S.) Resident
- Has used waterpipe tobacco within the past year (self-report)
- Has not used waterpipe tobacco within the past year but it susceptible to use (self- report)
Who cannot join
- Younger than 18 or older than 29
- Non U.S. Resident
- Has not used waterpipe tobacco within in the past year and is not susceptible to use (self-report)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The purpose of the study is to evaluate the impact of marketing claims commonly found on waterpipe, also known as hookah, tobacco packages and in digital marketing on young adults' willingness to try hookah tobacco. Participants will complete two tasks, in random order. Participants will view six sample waterpipe tobacco packages, randomized at the package level to contain a prohibited or potentially-prohibited claim or not (Packaging Task). In the other task, they will view 10 digital marketing advertisements (i.e. Instagram posts or website pages) either with or without prohibited or potentially-prohibited claim, randomized at the advertisements level (Digital Marketing Task).
Read the detailed description
Background/Objectives The Food and Drug Administration (FDA) has begun to prohibit certain claims on Waterpipe Tobacco (WT) packaging and advertising. Under Section 911 of the Family Smoking Prevention and Tobacco Control Act, manufacturers and retailers are prohibited from making unauthorized modified risk tobacco product (MRTP) claims, including statements that the product or its smoke: (1) results in reduced harm; (2) contains a reduced level of a substance or presents a reduced exposure to a substance; (3) does not contain or is free of a substance; and (4) statements that use modified risk descriptors such as light, mild, low, or similar descriptors. Some prohibited claims are easily identifiable, but others are more difficult to identify due to lack of specificity in the law and the implicit nature of some claims. Evidence is needed specific to WT packaging and marketing to determine which claims may be associated with consumer harm misperceptions to inform future regulatory actions. The study will address this gap by assessing how such claims influence consumer perceptions and behavioral intentions.
- Conditions
- Waterpipe Tobacco Smoking
- Being tested
- Package/Advertisement With Claim, Package/Advertisement Without Claim
- Keywords
- Waterpipe tobacco smoking, hookah tobacco warning, hookah tobacco
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Package/Advertisement With ClaimBehavioural
Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design
Package/Advertisement Without ClaimBehavioural
Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design
| Study group | Role | What they receive |
|---|---|---|
| With Claim 0% Tar | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim 0% Tar | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim No Chemicals | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim No Chemicals | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim Apple Image | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim Apple Image | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim 100% Food Grade Glycerin | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim 100% Food Grade Glycerin | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim Ultra Light | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim Ultra Light | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim Fresh Hookah Tobacco | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim Fresh Hookah Tobacco | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim Lower Nicotine Tobacco | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim Lower Nicotine Tobacco | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim Premium Shisha Tobacco | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim Premium Shisha Tobacco | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim High Quality Shisha Tobacco | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim High Quality Shisha Tobacco | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim Don't blow smoke - blow clouds | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim Don't blow smoke - blow clouds | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim Contains natural, unwashed tobacco leaf | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim Contains natural, unwashed tobacco leaf | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim We only use ingredients which are FDA approved | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim We only use ingredients which are FDA approved | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim Passing flavored tobacco smoke through water cools and purifies it | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim Passing flavored tobacco smoke through water cools and purifies it | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim Natural flavor | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim Natural flavor | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim Shisha or hookah tobacco is unique and completely unlike that found in cigarettes | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim Shisha or hookah tobacco is unique and completely unlike that found in cigarettes | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
| With Claim water in the shisha effectively cools and filters the smoke, making smooth and light | Experimental | Package or digital marketing advertisement containing claim of interest Receives: Behavioral: Package/Advertisement With Claim |
| Without Claim water in the shisha effectively cools and filters the smoke, making smooth and light | Experimental | Package or digital marketing advertisement without claim of interest Receives: Behavioral: Package/Advertisement Without Claim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to Try Hookah Tobacco (Packaging Task )
One item to assess the extent to which young adults are willing to try the waterpipe tobacco product: How likely would you be to try this specific product?
Response scale: (1) Not at all likely to (4) Very likely
Measured: minute 5
Willingness to Smoke Hookah Tobacco (Digital Marketing Task )
One item to assess the extent to which young adults want to try smoking hookah: How much does this advertisement make you want to smoke hookah?
Response scale: (1) Not at all to (4) A lot
Measured: minute 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start25 Oct 2022
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Waterpipe Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to see 6 packages and 10 advertisements, with or without the claim of interest on each.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Erin Sutfin, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439421
- Sponsor's protocol ID
- IRB00060111
- Other IDs
- R01CA239192
- Status last verified
- Aug 2023
- First submitted
- 22 Jun 2022
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumer Perceptions of Waterpipe Tobacco Packaging and Digital Marketing Claims
- ClinicalTrials.gov ID
- NCT05439421
- Acronym / sponsor ID
- IRB00060111
- Conditions
- Waterpipe Tobacco Smoking
- Keywords
- Waterpipe tobacco smoking, hookah tobacco warning, hookah tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,507 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Posted 15 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the impact of marketing claims commonly found on waterpipe, also known as hookah, tobacco packages and in digital marketing on young adults' willingness to try hookah tobacco. Participants will complete two tasks, in random order. Participants will view six sample waterpipe tobacco packages, randomized at the package level to contain a prohibited or potentially-prohibited claim or not (Packaging Task). In the other task, they will view 10 digital marketing advertisements (i.e. Instagram posts or website pages) either with or without prohibited or potentially-prohibited claim, randomized at the advertisements level (Digital Marketing Task).
Detailed description
Background/Objectives The Food and Drug Administration (FDA) has begun to prohibit certain claims on Waterpipe Tobacco (WT) packaging and advertising. Under Section 911 of the Family Smoking Prevention and Tobacco Control Act, manufacturers and retailers are prohibited from making unauthorized modified risk tobacco product (MRTP) claims, including statements that the product or its smoke: (1) results in reduced harm; (2) contains a reduced level of a substance or presents a reduced exposure to a substance; (3) does not contain or is free of a substance; and (4) statements that use modified risk descriptors such as light, mild, low, or similar descriptors. Some prohibited claims are easily identifiable, but others are more difficult to identify due to lack of specificity in the law and the implicit nature of some claims. Evidence is needed specific to WT packaging and marketing to determine which claims may be associated with consumer harm misperceptions to inform future regulatory actions. The study will address this gap by assessing how such claims influence consumer perceptions and behavioral intentions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 32
- Model description
- Participants will be randomized to see 6 packages and 10 advertisements, with or without the claim of interest on each.
| Arm | Type | Receives |
|---|---|---|
| With Claim 0% Tar | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim 0% Tar | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim No Chemicals | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim No Chemicals | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim Apple Image | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim Apple Image | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim 100% Food Grade Glycerin | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim 100% Food Grade Glycerin | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim Ultra Light | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim Ultra Light | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim Fresh Hookah Tobacco | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim Fresh Hookah Tobacco | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim Lower Nicotine Tobacco | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim Lower Nicotine Tobacco | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim Premium Shisha Tobacco | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim Premium Shisha Tobacco | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim High Quality Shisha Tobacco | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim High Quality Shisha Tobacco | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim Don't blow smoke - blow clouds | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim Don't blow smoke - blow clouds | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim Contains natural, unwashed tobacco leaf | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim Contains natural, unwashed tobacco leaf | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim We only use ingredients which are FDA approved | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim We only use ingredients which are FDA approved | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim Passing flavored tobacco smoke through water cools and purifies it | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim Passing flavored tobacco smoke through water cools and purifies it | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim Natural flavor | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim Natural flavor | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim Shisha or hookah tobacco is unique and completely unlike that found in cigarettes | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim Shisha or hookah tobacco is unique and completely unlike that found in cigarettes | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
| With Claim water in the shisha effectively cools and filters the smoke, making smooth and light | Experimental | Behavioral: Package/Advertisement With ClaimPackage or digital marketing advertisement containing claim of interest |
| Without Claim water in the shisha effectively cools and filters the smoke, making smooth and light | Experimental | Behavioral: Package/Advertisement Without ClaimPackage or digital marketing advertisement without claim of interest |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- United States (U.S.) Resident
- Has used waterpipe tobacco within the past year (self-report)
- Has not used waterpipe tobacco within the past year but it susceptible to use (self- report)
Key exclusion criteria (3 listed)
- Younger than 18 or older than 29
- Non U.S. Resident
- Has not used waterpipe tobacco within in the past year and is not susceptible to use (self-report)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Package/Advertisement With ClaimWaterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design | Behavioural | With Claim 0% Tar, With Claim 100% Food Grade Glycerin, With Claim Apple Image, With Claim Contains natural, unwashed tobacco leaf, With Claim Don't blow smoke - blow clouds, With Claim Fresh Hookah Tobacco, With Claim High Quality Shisha Tobacco, With Claim Lower Nicotine Tobacco, With Claim Natural flavor, With Claim No Chemicals, With Claim Passing flavored tobacco smoke through water cools and purifies it, With Claim Premium Shisha Tobacco, With Claim Shisha or hookah tobacco is unique and completely unlike that found in cigarettes, With Claim Ultra Light, With Claim We only use ingredients which are FDA approved, With Claim water in the shisha effectively cools and filters the smoke, making smooth and light |
| Package/Advertisement Without ClaimWaterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design | Behavioural | Without Claim 0% Tar, Without Claim 100% Food Grade Glycerin, Without Claim Apple Image, Without Claim Contains natural, unwashed tobacco leaf, Without Claim Don't blow smoke - blow clouds, Without Claim Fresh Hookah Tobacco, Without Claim High Quality Shisha Tobacco, Without Claim Lower Nicotine Tobacco, Without Claim Natural flavor, Without Claim No Chemicals, Without Claim Passing flavored tobacco smoke through water cools and purifies it, Without Claim Premium Shisha Tobacco, Without Claim Shisha or hookah tobacco is unique and completely unlike that found in cigarettes, Without Claim Ultra Light, Without Claim We only use ingredients which are FDA approved, Without Claim water in the shisha effectively cools and filters the smoke, making smooth and light |
Primary outcome
Willingness to Try Hookah Tobacco (Packaging Task )
Time frame: minute 5
One item to assess the extent to which young adults are willing to try the waterpipe tobacco product: How likely would you be to try this specific product? Response scale: (1) Not at all likely to (4) Very likely
Willingness to Smoke Hookah Tobacco (Digital Marketing Task )
Time frame: minute 5
One item to assess the extent to which young adults want to try smoking hookah: How much does this advertisement make you want to smoke hookah? Response scale: (1) Not at all to (4) A lot
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Sutfin, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Package/Advertisement With Claim and Package/Advertisement Without Claim in people with Waterpipe Tobacco Smoking, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to Try Hookah Tobacco (Packaging Task ) (time frame: minute 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.