Waterpipe Tobacco SmokingNCT05916170
A Study of Hookah Café Customers in the Atlanta Area
A study testing Health Warnings and No 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 the study is to assess the effectiveness of health warnings on waterpipe smoking behavior in a real-world setting. The primary hypothesis is that hookah café customers who are in the intervention (warning) arm will smoke less than customers who are in the control (no warning) arm, determined by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Waterpipe Tobacco Smoking
- What is being tested?
- Health Warnings and No Warnings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 977 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 21 Nov 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Planning to enter the hookah café where study is being conducted
- Age 18 or older
- English speaking
- Planning to smoke hookah inside
- Not planning to smoke cigarettes, cigars, cigarillos or marijuana while at the hookah café
- Had not previously entered the café earlier in the day on the same day/night as data collection
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- Has not been approached to participate in the study at another café or another day/night at the current café
- Are not employees of the business
- Have capacity to participate as determined by the staff member conducting eligibility screening
Who cannot join
- Not planning to enter the hookah café where the study is being conducted
- Age 17 and under
- Non-English speaking
- Not planning to smoke hookah in the café
- Planning to smoke cigarettes, cigars, or marijuana while at the hookah café
- Are employees of the business
Show all 9Show fewer
- Had previously entered the café on the same day/night as data collection
- Has not been approached to participate in the study previously
- Does not have capacity to participate as determined by the staff member conducting eligibility screening
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
Official title: Communicating Waterpipe Tobacco Harms to Reduce Use Among Young Adults: A Study of Hookah Café Customers in the Atlanta Area
The purpose of the study is to assess the effectiveness of health warnings on waterpipe smoking behavior in a real-world setting. The primary hypothesis is that hookah café customers who are in the intervention (warning) arm will smoke less than customers who are in the control (no warning) arm, determined by differences in the boost in expired carbon monoxide from café entry to after café exit.
Read the detailed description
Expired carbon monoxide is an objective biological marker of combustible tobacco smoking and is strongly correlated with the amount of smoke inhaled. In the intervention arm, warning messages will be displayed at various agreed-upon locations in the café, such as on hookah pipes, tables, countertops, walls, and menus. The goal is to maximize the potential for customers to be exposed to warnings. Participants will be patrons of the café and will be recruited before entering the café. Participants will complete a brief survey and provide a breath sample to measure expired carbon monoxide. When leaving the café, they will complete another survey and provide a second breath sample.
- Conditions
- Waterpipe Tobacco Smoking
- Being tested
- Health Warnings, No Warnings
- Keywords
- Waterpipe Tobacco Smoking, Tobacco Smoking, waterpipe smoking behavior
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health WarningsBehavioural
Text-only warnings about one health harm will be displayed in the hookah cafés where data collection is being conducted.
No WarningsBehavioural
No warnings posted in the hookah café
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Health Warnings | Experimental | Cafes will display text-only warning signs Receives: Behavioral: Health Warnings |
| Control - No Warnings | Experimental | No warnings posted in the hookah café Receives: Behavioral: No Warnings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Expired Carbon Monoxide (eCO Boost)
Change in eCO from baseline (before entry into the hookah café) to follow-up (upon exit from the hookah café) - eCO will be measured with the Bedfont Micro+ Smokerlyzer. Higher scores represent higher concentrations of Carbon Monoxide (CO), which is correlated with greater waterpipe use.
Measured: Baseline and after exiting the café up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Jun 2023
- Primary completion21 Nov 2024
- Study completion21 Nov 2024
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
- The design of the study is a cluster randomized crossover trial, where the hookah café is the cluster and randomization is at the cluster level. Each hookah café will serve as its own control and will be used for data collection for both arms of the study. Cafes will start in the no-warning control arm and then will cross over to the intervention arm, where they will display one of four text-only warning signs. Participants will only participate in one of the arms.
- Masking
- None (open label)
- Enrolment
- 977 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
- NCT05916170
- Sponsor's protocol ID
- IRB00095123
- Other IDs
- R01CA241420
- Status last verified
- Mar 2024
- First submitted
- 10 May 2023
- Last updated
- 2 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating Waterpipe Tobacco Harms to Reduce Use Among Young Adults: A Study of Hookah Café Customers in the Atlanta Area
- ClinicalTrials.gov ID
- NCT05916170
- Acronym / sponsor ID
- IRB00095123
- Conditions
- Waterpipe Tobacco Smoking
- Keywords
- Waterpipe Tobacco Smoking, Tobacco Smoking, waterpipe smoking behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 977 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Posted 23 Dec 2025
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 assess the effectiveness of health warnings on waterpipe smoking behavior in a real-world setting. The primary hypothesis is that hookah café customers who are in the intervention (warning) arm will smoke less than customers who are in the control (no warning) arm, determined by differences in the boost in expired carbon monoxide from café entry to after café exit.
Detailed description
Expired carbon monoxide is an objective biological marker of combustible tobacco smoking and is strongly correlated with the amount of smoke inhaled. In the intervention arm, warning messages will be displayed at various agreed-upon locations in the café, such as on hookah pipes, tables, countertops, walls, and menus. The goal is to maximize the potential for customers to be exposed to warnings. Participants will be patrons of the café and will be recruited before entering the café. Participants will complete a brief survey and provide a breath sample to measure expired carbon monoxide. When leaving the café, they will complete another survey and provide a second breath sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The design of the study is a cluster randomized crossover trial, where the hookah café is the cluster and randomization is at the cluster level. Each hookah café will serve as its own control and will be used for data collection for both arms of the study. Cafes will start in the no-warning control arm and then will cross over to the intervention arm, where they will display one of four text-only warning signs. Participants will only participate in one of the arms.
| Arm | Type | Receives |
|---|---|---|
| Intervention - Health Warnings | Experimental | Behavioral: Health WarningsCafes will display text-only warning signs |
| Control - No Warnings | Experimental | Behavioral: No WarningsNo warnings posted in the hookah café |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Planning to enter the hookah café where study is being conducted
- Age 18 or older
- English speaking
- Planning to smoke hookah inside
- Not planning to smoke cigarettes, cigars, cigarillos or marijuana while at the hookah café
Key exclusion criteria (9 listed)
- Not planning to enter the hookah café where the study is being conducted
- Age 17 and under
- Non-English speaking
- Not planning to smoke hookah in the café
- Planning to smoke cigarettes, cigars, or marijuana while at the hookah café
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 |
|---|---|---|
| Health WarningsText-only warnings about one health harm will be displayed in the hookah cafés where data collection is being conducted. | Behavioural | Intervention - Health Warnings |
| No WarningsNo warnings posted in the hookah café | Behavioural | Control - No Warnings |
Primary outcome
Change in Expired Carbon Monoxide (eCO Boost)
Time frame: Baseline and after exiting the café up to 10 hours
Change in eCO from baseline (before entry into the hookah café) to follow-up (upon exit from the hookah café) - eCO will be measured with the Bedfont Micro+ Smokerlyzer. Higher scores represent higher concentrations of Carbon Monoxide (CO), which is correlated with greater waterpipe use.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- 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 Health Warnings and No 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 9 inclusion and 9 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 2 Feb 2026. 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 23 Dec 2025). 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?
Change in Expired Carbon Monoxide (eCO Boost) (time frame: Baseline and after exiting the café up to 10 hours). 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 2 Feb 2026.