An interventional study of Pictorial Warnings and Text Warnings in Waterpipe Tobacco Smoking, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Prevention
The purpose of this study is to whether exposure to waterpipe tobacco warnings reduce young adults' intentions to smoke waterpipe in the future.
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.
Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Waterpipe tobacco packages shown with pictorial warnings about health harms of waterpipe smoking
Behavioral: Pictorial Warnings
Waterpipe tobacco packages shown with text-only warning about health harms of waterpipe smoking
Behavioral: Text Warnings
Waterpipe tobacco package shown without a warning
Behavioral: No Warnings (Control)
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.
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.
Participants will be shown a single package without a warning. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study.
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Text Warnings | Pictorial Warnings | No Warnings (Control) |
|---|---|---|---|
| Started | 396 | 402 | 417 |
| Completed | 396 | 402 | 417 |
| Not completed | 0 | 0 | 0 |
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
| score on a scale | Text Warnings | Pictorial Warnings | No Warnings (Control) |
|---|---|---|---|
| Behavioral Intentions | 1.83 ± 0.07 | 1.72 ± 0.05 | 2.21 ± 0.07 |
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
Participants who report past-year use will report, on a scale of 1-10, how motivated they are to quit smoking hookah.
Results for this outcome have not been posted.
Collected over From the time of consent up to four weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Text Warnings | 0/396 (0%) | 0/396 (0%) | 0/396 (0%) |
| Pictorial Warnings | 0/402 (0%) | 0/402 (0%) | 0/402 (0%) |
| No Warnings (Control) | 0/417 (0%) | 0/417 (0%) | 0/417 (0%) |
| Age, Continuous(years) | Text Warnings | Pictorial Warnings | No Warnings (Control) | Total |
|---|---|---|---|---|
| Mean | 25 ± 3.2 | 24.9 ± 3.4 | 25 ± 3.3 | 25 ± 3.3 |
| Sex/Gender, Customized(Participants) | Text Warnings | Pictorial Warnings | No Warnings (Control) | Total |
|---|---|---|---|---|
| Female | 253 | 270 | 266 | 789 |
| Male | 143 | 131 | 151 | 425 |
| Unknown/Not Reported | 0 | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Text Warnings | Pictorial Warnings | No Warnings (Control) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 101 | 86 | 77 | 264 |
| Not Hispanic or Latino | 295 | 316 | 340 | 951 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Text Warnings | Pictorial Warnings | No Warnings (Control) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 4 | 1 | 6 | 11 |
| Asian | 25 | 33 | 26 | 84 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 | 2 |
| Black or African American | 82 | 92 | 97 | 271 |
| White | 219 | 236 | 234 | 689 |
| More than one race | 34 | 18 | 30 | 82 |
| Unknown or Not Reported | 32 | 21 | 23 | 76 |
| Region of Enrollment(participants) | Text Warnings | Pictorial Warnings | No Warnings (Control) | Total |
|---|---|---|---|---|
| United States | 396 | 402 | 417 | 1215 |
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Wake Forest University Health Sciences