Waterpipe Tobacco Smoking
Conditions
Keywords
Waterpipe Tobacco Smoking, Tobacco Smoking, waterpipe smoking behavior
Brief 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 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.
Interventions
BEHAVIORALHealth Warnings
Text-only warnings about one health harm will be displayed in the hookah cafés where data collection is being conducted.
BEHAVIORALNo Warnings
No warnings posted in the hookah café
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Expired Carbon Monoxide (eCO Boost) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORErin Sutfin, PhD
Wake Forest University Health Sciences
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| No Warning Control No warnings posted in the hookah café
No Warnings: No warnings posted in the hookah café | 507 |
| 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. | 470 |
| Total | 977 |
Baseline characteristics
| Characteristic | No Warning Control | Total | Health Warning Intervention |
|---|---|---|---|
| Age, Continuous | 30.9 Years STANDARD_DEVIATION 6.9 | 31.2 Years STANDARD_DEVIATION 7.1 | 31.5 Years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants | 61 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 458 Participants | 885 Participants | 427 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 31 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 38 Participants | 66 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 389 Participants | 769 Participants | 380 Participants |
| Race (NIH/OMB) More than one race | 23 Participants | 42 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 37 Participants | 60 Participants | 23 Participants |
| Race (NIH/OMB) White | 12 Participants | 26 Participants | 14 Participants |
| Region of Enrollment United States | 507 participants | 977 participants | 470 participants |
| Sex/Gender, Customized Female | 295 Participants | 584 Participants | 289 Participants |
| Sex/Gender, Customized Male | 203 Participants | 380 Participants | 177 Participants |
| Sex/Gender, Customized Unknown | 9 Participants | 13 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 507 | 0 / 470 |
| other Total, other adverse events | 0 / 507 | 0 / 470 |
| serious Total, serious adverse events | 0 / 507 | 0 / 470 |
Outcome results
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.
Time frame: Baseline and after exiting the café up to 10 hours
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Warning Control | Change in Expired Carbon Monoxide (eCO Boost) | 25.7 parts per million | Standard Error 2.93 |
| Health Warning Intervention | Change in Expired Carbon Monoxide (eCO Boost) | 23.5 parts per million | Standard Error 2.91 |
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. 1. How interested are you in smoking tobacco in a hookah in the next month? 2. How likely are you to smoke tobacco in a hookah in the next month? 3. How much do you plan to smoke tobacco in a hookah in the next month? Response options: (1) Not at all, (2) Very little, (3) Somewhat, (4) Quite a bit, (5) Very much
Time frame: at exit; up to 10 hours
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
Time frame: at exit; up to 10 hours
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. 1. Did you smoke hookah in this café/lounge/bar today? (1) Yes, (2) No 2. (If no) Why didn't you smoke hookah in this café/lounge/bar today? Free text response 3. (If yes) Compared to a typical night, how much did you smoke? (1) Less hookah than usual, (2) About the same amount of hookah as usual, (3) More hookah than usual, (4) This was my first time smoking hookah 4. (If less) Why did you smoke less than usual? Free text response 5. (If more) Why did you smoke more than usual? Free text response
Time frame: at exit; up to 10 hours
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
Time frame: at exit; up to 10 hours
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.
Time frame: at exit; up to 10 hours
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
Time frame: at exit; up to 10 hours
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.
Time frame: at exit; up to 10 hours
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. 1. Was it satisfying? 2. Did it taste good? 3. Did you enjoy the sensations in your mouth? 4. Did you enjoy it? 5. Did it make you dizzy? 6. Did it make you nauseous? 7. Was it too much nicotine? 8. Were there bothersome side effects? Response options: (1) Not at all - (7) Extremely
Time frame: at exit; up to 10 hours
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).
Time frame: at exit; up to 10 hours
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.
Time frame: at exit; up to 10 hours
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)
Time frame: at exit; up to 10 hours