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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA241420 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - Health Warnings | Experimental | Cafes will display text-only warning signs |
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| Control - No Warnings | Experimental | No warnings posted in the hookah café |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Warnings | Behavioral | Text-only warnings about one health harm will be displayed in the hookah cafés where data collection is being conducted. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and after exiting the café up to 10 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Behavioral Intention | Participants will be asked at three items assessing their anticipated hookah smoking within the next month. Items will be averaged to create a composite score of intent to continue the behavior within the next month.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Sutfin, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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The Control and Intervention arms are reported as two periods in a single arm for this crossover study. The total enrollment to the study across both periods was 977. 507 participants were enrolled during the Control period of the cafes and 470 were enrolled during the Intervention period. Participants did not participate in more than one period.
This is a cluster randomized crossover trial in which hookah cafes started in the No Warning Control condition and then crossed over to the Health Warnings Intervention, in which they were randomized to display one of four health warning messages (Milestones). Participants were cafe patrons on the days/nights that data collection was being conducted. Participants were only permitted to participate in one instance of data collection at one hookah cafe. Some cafes only had Control period.
| ID | Title | Description |
|---|---|---|
| FG000 | Hookah Cafes in Atlanta, GA | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No Warning Control |
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| Health Warning Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | No Warning Control | No warnings posted in the hookah café No Warnings: No warnings posted in the hookah café |
| BG001 | Health Warning Intervention | Cafes will display text-only warning signs Health Warnings: Text-only warnings about one health harm will be displayed in the hookah cafés where data collection is being conducted. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants were included in analysis if they completed both pre- and post-cafe eCO collection in cafes that completed both the control and intervention arms of this crossover trial. Participants in each arm are unique. | Posted | Mean | Standard Error | parts per million | Baseline and after exiting the café up to 10 hours |
|
Adverse event data were collected during the time that the participant was in the cafe, approximately 3 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control - No Warnings | No warnings posted in the hookah café No Warnings: No warnings posted in the hookah café |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erin Sutfin | Wake Forest University Health Sciences | 336-713-5282 | erin.sutfin@wfusm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2024 | Oct 31, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 8, 2024 | Jan 30, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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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.
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| No Warnings | Behavioral | No warnings posted in the hookah café |
|
| at exit; up to 10 hours |
| Quit Motivation | One item to measure participants' motivation to quit smoking hookah, rated on a 1-10 scale of Not at all motivated to Extremely motivated | at exit; up to 10 hours |
| Hookah Use Behavior | Participants will be asked a variety of items to assess their hookah smoking behaviors within the café. Items will be scored individually.
| at exit; up to 10 hours |
| Subjective Experiences of Smoking Hookah | Eight items from the Product Evaluation Scale (Hatsukami et al. 2013) will be used to assess participants' subjective experiences of smoking hookah. Items scores will be averaged across the subscale.
| at exit; up to 10 hours |
| Knowledge | Four items to assess participants' knowledge of health harms based on warning statements used across the study. We will calculate a sum score for each individual with higher scores indicating more accurate knowledge. Response options: True / False / I don't know | at exit; up to 10 hours |
| Beliefs | Four items to assess the participants' agreement with statements of how each of the four health harms utilized across the study apply to their own health. We will calculate a mean score across all four items for each individual, where higher scores indicate stronger beliefs about personal harm from hookah smoking. Response options: (1) Strongly disagree to (5) Strongly agree | at exit; up to 10 hours |
| Warning Recall | One Y/N item to assess participants' exposure to warnings. If participants report warning exposure, an open-ended item will assess warning recall. | at exit; up to 10 hours |
| Warning Recognition | Participants in the intervention arm will be asked to select the warning(s) that they saw at the café from four possible warnings. For each warning message that they report having seen, they will be asked to select where they saw the warning from a list of possible locations. (Intervention arm only) | at exit; up to 10 hours |
| Social Interaction | For each warning selected in the Warning Recognition section, participants will be asked if they discussed the warning with others. If they answer positively, they will be given a list of topics to choose from to describe what they talked about, including a free-text option. | at exit; up to 10 hours |
| Perceived Influence of Warning on Smoking Behavior Answers | Participants will be asked whether they changed their smoking behavior as a result of the warning(s) they saw (as reported in the Warning Recognition section). They will be asked to report whether they smoked more, less, or the same amount as they usually do. These items will be asked for each warning the participant reports seeing. | at exit; up to 10 hours |
| Time Spent in the café | Duration of time in café will be calculated from the time of completion of eCO measurement at Time 1 to start of survey at Time 2. Additionally, we will utilize a subjective measure of time spent in the café: Compared to what you planned, how long did you stay at the café/lounge/bar? (Longer, shorter, about the same). | at exit; up to 10 hours |
| CO Poison Warning |
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| Fetal Damage Warning |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Each cafe displayed signs communicating one of four health warning messages. The primary outcome is reported as all of the health warnings aggregated versus the no warning control. |
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| Other Pre-specified | Behavioral Intention | Participants will be asked at three items assessing their anticipated hookah smoking within the next month. Items will be averaged to create a composite score of intent to continue the behavior within the next month.
| Not Posted | at exit; up to 10 hours | Participants |
| Other Pre-specified | Quit Motivation | One item to measure participants' motivation to quit smoking hookah, rated on a 1-10 scale of Not at all motivated to Extremely motivated | Not Posted | at exit; up to 10 hours | Participants |
| Other Pre-specified | Hookah Use Behavior | Participants will be asked a variety of items to assess their hookah smoking behaviors within the café. Items will be scored individually.
| Not Posted | at exit; up to 10 hours | Participants |
| Other Pre-specified | Subjective Experiences of Smoking Hookah | Eight items from the Product Evaluation Scale (Hatsukami et al. 2013) will be used to assess participants' subjective experiences of smoking hookah. Items scores will be averaged across the subscale.
| Not Posted | at exit; up to 10 hours | Participants |
| Other Pre-specified | Knowledge | Four items to assess participants' knowledge of health harms based on warning statements used across the study. We will calculate a sum score for each individual with higher scores indicating more accurate knowledge. Response options: True / False / I don't know | Not Posted | at exit; up to 10 hours | Participants |
| Other Pre-specified | Beliefs | Four items to assess the participants' agreement with statements of how each of the four health harms utilized across the study apply to their own health. We will calculate a mean score across all four items for each individual, where higher scores indicate stronger beliefs about personal harm from hookah smoking. Response options: (1) Strongly disagree to (5) Strongly agree | Not Posted | at exit; up to 10 hours | Participants |
| Other Pre-specified | Warning Recall | One Y/N item to assess participants' exposure to warnings. If participants report warning exposure, an open-ended item will assess warning recall. | Not Posted | at exit; up to 10 hours | Participants |
| Other Pre-specified | Warning Recognition | Participants in the intervention arm will be asked to select the warning(s) that they saw at the café from four possible warnings. For each warning message that they report having seen, they will be asked to select where they saw the warning from a list of possible locations. (Intervention arm only) | Not Posted | at exit; up to 10 hours | Participants |
| Other Pre-specified | Social Interaction | For each warning selected in the Warning Recognition section, participants will be asked if they discussed the warning with others. If they answer positively, they will be given a list of topics to choose from to describe what they talked about, including a free-text option. | Not Posted | at exit; up to 10 hours | Participants |
| Other Pre-specified | Perceived Influence of Warning on Smoking Behavior Answers | Participants will be asked whether they changed their smoking behavior as a result of the warning(s) they saw (as reported in the Warning Recognition section). They will be asked to report whether they smoked more, less, or the same amount as they usually do. These items will be asked for each warning the participant reports seeing. | Not Posted | at exit; up to 10 hours | Participants |
| Other Pre-specified | Time Spent in the café | Duration of time in café will be calculated from the time of completion of eCO measurement at Time 1 to start of survey at Time 2. Additionally, we will utilize a subjective measure of time spent in the café: Compared to what you planned, how long did you stay at the café/lounge/bar? (Longer, shorter, about the same). | Not Posted | at exit; up to 10 hours | Participants |
| 0 |
| 507 |
| 0 |
| 507 |
| 0 |
| 507 |
| EG001 | Intervention - Health Warnings | Cafes will display text-only warning signs Health Warnings: Text-only warnings about one health harm will be displayed in the hookah cafés where data collection is being conducted. | 0 | 470 | 0 | 470 | 0 | 470 |
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