Waterpipe Tobacco SmokingNCT05783843
Comparison of Text and Pictorial Waterpipe Tobacco Warnings Among Young Adults
A study testing Pictorial Warnings and Text Warnings in people with Waterpipe Tobacco Smoking, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to whether exposure to waterpipe tobacco warnings reduce young adults' intentions to smoke waterpipe in the future. 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?
- Pictorial Warnings and Text Warnings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,215 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2023to 7 Apr 2023
- 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 (US) Resident
- Has used waterpipe tobacco within the past year (self-report) OR
- Has not used waterpipe tobacco within the past year but is susceptible to use (self-report)
Who cannot join
- Younger than 18 or older than 29
- Not a US Resident
- Has not used waterpipe tobacco within 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 this study is to whether exposure to waterpipe tobacco warnings reduce young adults' intentions to smoke waterpipe in the future.
Read the detailed description
Young adults, defined as those 18-29 years old, have the highest rates of waterpipe tobacco smoking, which increases their risk of a variety of pulmonary, neurological, and oncological health conditions, among many others. This trial will randomly assign young adult waterpipe users or those susceptible to use to view waterpipe tobacco packages with text warning, pictorial warnings, or no warnings in a one-time online study. Participants will answer a series of questions regarding each package.
- Conditions
- Waterpipe Tobacco Smoking
- Being tested
- Pictorial Warnings, Text Warnings, No Warnings (Control)
- Keywords
- Waterpipe Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pictorial WarningsBehavioural
Participants will be shown 6 waterpipe tobacco packages with 6 different pictorial warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm.
Text WarningsBehavioural
Participants will be shown 6 waterpipe tobacco packages with 6 different text-only warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm.
No Warnings (Control)Behavioural
Participants will be shown a single package without a warning. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study.
| Study group | Role | What they receive |
|---|---|---|
| Pictorial Warnings | Experimental | Waterpipe tobacco packages shown with pictorial warnings about health harms of waterpipe smoking Receives: Behavioral: Pictorial Warnings |
| Text Warnings | Experimental | Waterpipe tobacco packages shown with text-only warning about health harms of waterpipe smoking Receives: Behavioral: Text Warnings |
| No Warnings (Control) | Experimental | Waterpipe tobacco package shown without a warning Receives: Behavioral: No Warnings (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Intentions
The primary outcome is intention to smoke tobacco in a waterpipe within the next year, measured by averaging three items to create a composite score (adapted from research on cigarette smoking). The primary outcome will be measured after the exposure to waterpipe packages. Score ranges from 1-5 with higher score indicating greater intention to smoke hookah.
- How interested are you in smoking hookah in the next year?
- How likely are you to smoke hookah in the next year?
- How much do you plan to smoke hookah in the next year? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) Very interested/likely/much
Measured: Minute 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start9 Mar 2023
- Primary completion7 Apr 2023
- Study completion7 Apr 2023
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
- Parallel groups
- Model description
- Participants randomized to the text-only condition will see six packages with different text warnings. Participants randomized to the pictorial condition will see six packages with different pictorial warnings. Participants in the control condition will see a single package without a warning.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,215 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
- NCT05783843
- Sponsor's protocol ID
- IRB00091946
- Other IDs
- R01CA241420
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 21 May 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 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Text and Pictorial Waterpipe Tobacco Warnings Among Young Adults
- ClinicalTrials.gov ID
- NCT05783843
- Acronym / sponsor ID
- IRB00091946
- Conditions
- Waterpipe Tobacco Smoking
- Keywords
- Waterpipe Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,215 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Posted 21 May 2024
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 this study is to whether exposure to waterpipe tobacco warnings reduce young adults' intentions to smoke waterpipe in the future.
Detailed description
Young adults, defined as those 18-29 years old, have the highest rates of waterpipe tobacco smoking, which increases their risk of a variety of pulmonary, neurological, and oncological health conditions, among many others. This trial will randomly assign young adult waterpipe users or those susceptible to use to view waterpipe tobacco packages with text warning, pictorial warnings, or no warnings in a one-time online study. Participants will answer a series of questions regarding each package.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants randomized to the text-only condition will see six packages with different text warnings. Participants randomized to the pictorial condition will see six packages with different pictorial warnings. Participants in the control condition will see a single package without a warning.
| Arm | Type | Receives |
|---|---|---|
| Pictorial Warnings | Experimental | Behavioral: Pictorial WarningsWaterpipe tobacco packages shown with pictorial warnings about health harms of waterpipe smoking |
| Text Warnings | Experimental | Behavioral: Text WarningsWaterpipe tobacco packages shown with text-only warning about health harms of waterpipe smoking |
| No Warnings (Control) | Experimental | Behavioral: No Warnings (Control)Waterpipe tobacco package shown without a warning |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- United States (US) Resident
- Has used waterpipe tobacco within the past year (self-report) OR
- Has not used waterpipe tobacco within the past year but is susceptible to use (self-report)
Key exclusion criteria (3 listed)
- Younger than 18 or older than 29
- Not a US Resident
- Has not used waterpipe tobacco within 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 |
|---|---|---|
| Pictorial WarningsParticipants will be shown 6 waterpipe tobacco packages with 6 different pictorial warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm. | Behavioural | Pictorial Warnings |
| Text WarningsParticipants will be shown 6 waterpipe tobacco packages with 6 different text-only warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm. | Behavioural | Text Warnings |
| No Warnings (Control)Participants will be shown a single package without a warning. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study. | Behavioural | No Warnings (Control) |
Primary outcome
Behavioral Intentions
Time frame: Minute 2
The primary outcome is intention to smoke tobacco in a waterpipe within the next year, measured by averaging three items to create a composite score (adapted from research on cigarette smoking). The primary outcome will be measured after the exposure to waterpipe packages. Score ranges from 1-5 with higher score indicating greater intention to smoke hookah. 1. How interested are you in smoking hookah in the next year? 2. How likely are you to smoke hookah in the next year? 3. How much do you plan to smoke hookah in the next year? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) Very interested/likely/much
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 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 Pictorial Warnings and Text Warnings 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 21 May 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 21 May 2024). 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?
Behavioral Intentions (time frame: Minute 2). 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 21 May 2024.