Waterpipe Tobacco Smoking
Conditions
Keywords
Waterpipe Tobacco Smoking
Brief summary
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.
Interventions
BEHAVIORALPictorial Warnings
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.
BEHAVIORALText Warnings
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.
BEHAVIORALNo 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.
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will be blinded as to the comparators for their arm.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Intentions | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perceived Message Effectiveness | Minute 2 | This outcome will be measured using the 3-item Perceived Measured Effectiveness scale created by Noar and colleagues that includes items on attitudes, risk beliefs, and intentions. Mean scores will be calculated. 1. How much does this warning make smoking hookah seem unpleasant to you? 2. How much does this warning make you concerned about the health effects of smoking hookah? 3. How much does this warning discourage you from wanting to smoke hookah? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal |
| Attention | Minute 1 | One item to measure self-reported attention to the warning. 1\. How much does this warning grab your attention? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal |
| Emotional Reactions | Minute 2 | Three items to measure negative emotional reactions to the warning that the participant saw. Mean scores will be calculated. 1. How much does this warning make you feel anxious? 2. How much does this warning make you feel disgusted? 3. How much does this warning make you feel scared? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal |
| Cognitive Elaboration | Minute 1 | One item to measure the extent to which a participant reports the warning making them think about the risks of hookah smoking. 1\. How much does this warning make you think about the health effects of smoking hookah? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal |
| Self-reported Learning | Minute 1 | One item to measure the extent to which respondents learned something new from the warning. 1\. To what extent did you learn something new from this warning that you did not already know? Response Scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal |
| Product Appeal | Minute 2 | Three items will be used to measure how appealing each waterpipe tobacco package is to respondents, how likely they would be to try the product, and how much the packaging makes the respondent think that the product is harmful. 1. How appealing is this product to you? 2. How likely would you be to try this product? 3. How much does this packaging make you think this product is harmful? Response scale: (1) Not at all / (2) A little / (3) Somewhat / (4) A lot |
| Knowledge | Minute 3 | Six items to measure knowledge of the potential health harms described by the warnings. 1. Hookah smoking causes heart damage. 2. Hookah smoking causes lung damage. 3. Hookah smoking causes mouth cancer. 4. Hookah smoking causes carbon monoxide poisoning. 5. Hookah smoking during pregnancy stunts fetal growth. 6. Hookah smoking causes nicotine addiction. Response scale: (1) True / (2) False / (3) I don't know |
| Beliefs | Minute 3 | Five items to measure the respondent's belief of their own risk of experiencing each of the warning health harms. One item measures risk to pregnant people, rather than the self, since this item will be administered to all participants. 1. If I smoke hookah, I will damage my heart. 2. If I smoke hookah, I will damage my lungs. 3. If I smoke hookah, I will get mouth cancer. 4. If I smoke hookah, I will get carbon monoxide poisoning. 5. If a person smokes hookah during pregnancy, it will stunt fetal growth. 6. If I smoke hookah, I will become addicted. Response scale: (1) Strongly disagree / (2) Somewhat disagree / (3) Neither disagree nor agree / (4) Somewhat agree / (5) Strongly agree |
| Worry | Minute 3 | Five/six items measuring a respondent's concern about their risk of warning health effects. Damage to fetuses will only be asked of respondents who report female sex at birth. 1. If you smoke hookah, how much would you worry about getting mouth cancer? 2. If you smoke hookah, how much would you worry about damaging your heart? 3. If you smoke hookah, how much would you worry about damaging your lungs? 4. If you smoke hookah, how much would you worry about getting carbon monoxide poisoning? 5. If you smoke hookah, how much would you worry about stunting fetal growth, if you were pregnant? 6. If you smoke hookah, how much would you worry about becoming addicted? Response scale: (1) Not at all / (2) A little / (3) Somewhat / (4) A lot |
| Quit Motivation | Minute 1 | Participants who report past-year use will report, on a scale of 1-10, how motivated they are to quit smoking hookah. |
| Social Interactions | Minute 1 | One item to measure self-reported likelihood of discussing the warning shown with one's social contacts within the week following the survey. 1\. How likely are you to talk about this warning with others in the next week? Response Scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Text Warnings Waterpipe tobacco packages shown with text-only warning about health harms of waterpipe smoking
Text Warnings: 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. | 396 |
| Pictorial Warnings Waterpipe tobacco packages shown with pictorial warnings about health harms of waterpipe smoking
Pictorial Warnings: 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. | 402 |
| No Warnings (Control) Waterpipe tobacco package shown without a warning
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. | 417 |
| Total | 1,215 |
Baseline characteristics
| Characteristic | Text Warnings | Total | No Warnings (Control) | Pictorial Warnings |
|---|---|---|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 3.2 | 25 years STANDARD_DEVIATION 3.3 | 25 years STANDARD_DEVIATION 3.3 | 24.9 years STANDARD_DEVIATION 3.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 101 Participants | 264 Participants | 77 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 295 Participants | 951 Participants | 340 Participants | 316 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 11 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 84 Participants | 26 Participants | 33 Participants |
| Race (NIH/OMB) Black or African American | 82 Participants | 271 Participants | 97 Participants | 92 Participants |
| Race (NIH/OMB) More than one race | 34 Participants | 82 Participants | 30 Participants | 18 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 32 Participants | 76 Participants | 23 Participants | 21 Participants |
| Race (NIH/OMB) White | 219 Participants | 689 Participants | 234 Participants | 236 Participants |
| Region of Enrollment United States | 396 participants | 1215 participants | 417 participants | 402 participants |
| Sex/Gender, Customized Female | 253 Participants | 789 Participants | 266 Participants | 270 Participants |
| Sex/Gender, Customized Male | 143 Participants | 425 Participants | 151 Participants | 131 Participants |
| Sex/Gender, Customized Unknown/Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 396 | 0 / 402 | 0 / 417 |
| other Total, other adverse events | 0 / 396 | 0 / 402 | 0 / 417 |
| serious Total, serious adverse events | 0 / 396 | 0 / 402 | 0 / 417 |
Outcome results
Primary
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. 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
Time frame: Minute 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Text Warnings | Behavioral Intentions | 1.83 score on a scale | Standard Error 0.07 |
| Pictorial Warnings | Behavioral Intentions | 1.72 score on a scale | Standard Error 0.05 |
| No Warnings (Control) | Behavioral Intentions | 2.21 score on a scale | Standard Error 0.07 |
Other Pre-specified
Attention
One item to measure self-reported attention to the warning. 1\. How much does this warning grab your attention? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal
Time frame: Minute 1
Other Pre-specified
Beliefs
Five items to measure the respondent's belief of their own risk of experiencing each of the warning health harms. One item measures risk to pregnant people, rather than the self, since this item will be administered to all participants. 1. If I smoke hookah, I will damage my heart. 2. If I smoke hookah, I will damage my lungs. 3. If I smoke hookah, I will get mouth cancer. 4. If I smoke hookah, I will get carbon monoxide poisoning. 5. If a person smokes hookah during pregnancy, it will stunt fetal growth. 6. If I smoke hookah, I will become addicted. Response scale: (1) Strongly disagree / (2) Somewhat disagree / (3) Neither disagree nor agree / (4) Somewhat agree / (5) Strongly agree
Time frame: Minute 3
Other Pre-specified
Cognitive Elaboration
One item to measure the extent to which a participant reports the warning making them think about the risks of hookah smoking. 1\. How much does this warning make you think about the health effects of smoking hookah? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal
Time frame: Minute 1
Other Pre-specified
Emotional Reactions
Three items to measure negative emotional reactions to the warning that the participant saw. Mean scores will be calculated. 1. How much does this warning make you feel anxious? 2. How much does this warning make you feel disgusted? 3. How much does this warning make you feel scared? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal
Time frame: Minute 2
Other Pre-specified
Knowledge
Six items to measure knowledge of the potential health harms described by the warnings. 1. Hookah smoking causes heart damage. 2. Hookah smoking causes lung damage. 3. Hookah smoking causes mouth cancer. 4. Hookah smoking causes carbon monoxide poisoning. 5. Hookah smoking during pregnancy stunts fetal growth. 6. Hookah smoking causes nicotine addiction. Response scale: (1) True / (2) False / (3) I don't know
Time frame: Minute 3
Other Pre-specified
Perceived Message Effectiveness
This outcome will be measured using the 3-item Perceived Measured Effectiveness scale created by Noar and colleagues that includes items on attitudes, risk beliefs, and intentions. Mean scores will be calculated. 1. How much does this warning make smoking hookah seem unpleasant to you? 2. How much does this warning make you concerned about the health effects of smoking hookah? 3. How much does this warning discourage you from wanting to smoke hookah? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal
Time frame: Minute 2
Other Pre-specified
Product Appeal
Three items will be used to measure how appealing each waterpipe tobacco package is to respondents, how likely they would be to try the product, and how much the packaging makes the respondent think that the product is harmful. 1. How appealing is this product to you? 2. How likely would you be to try this product? 3. How much does this packaging make you think this product is harmful? Response scale: (1) Not at all / (2) A little / (3) Somewhat / (4) A lot
Time frame: Minute 2
Other Pre-specified
Quit Motivation
Participants who report past-year use will report, on a scale of 1-10, how motivated they are to quit smoking hookah.
Time frame: Minute 1
Other Pre-specified
Self-reported Learning
One item to measure the extent to which respondents learned something new from the warning. 1\. To what extent did you learn something new from this warning that you did not already know? Response Scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal
Time frame: Minute 1
Other Pre-specified
Social Interactions
One item to measure self-reported likelihood of discussing the warning shown with one's social contacts within the week following the survey. 1\. How likely are you to talk about this warning with others in the next week? Response Scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal
Time frame: Minute 1
Other Pre-specified
Worry
Five/six items measuring a respondent's concern about their risk of warning health effects. Damage to fetuses will only be asked of respondents who report female sex at birth. 1. If you smoke hookah, how much would you worry about getting mouth cancer? 2. If you smoke hookah, how much would you worry about damaging your heart? 3. If you smoke hookah, how much would you worry about damaging your lungs? 4. If you smoke hookah, how much would you worry about getting carbon monoxide poisoning? 5. If you smoke hookah, how much would you worry about stunting fetal growth, if you were pregnant? 6. If you smoke hookah, how much would you worry about becoming addicted? Response scale: (1) Not at all / (2) A little / (3) Somewhat / (4) A lot
Time frame: Minute 3