Trial Outcomes & Findings for Comparison of Text and Pictorial Waterpipe Tobacco Warnings Among Young Adults (NCT NCT05783843)
NCT ID: NCT05783843
Last Updated: 2024-05-21
Results Overview
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
COMPLETED
NA
1215 participants
Minute 2
2024-05-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
396
|
402
|
417
|
|
Overall Study
COMPLETED
|
396
|
402
|
417
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Text and Pictorial Waterpipe Tobacco Warnings Among Young Adults
Baseline characteristics by cohort
| Measure |
Text Warnings
n=396 Participants
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.
|
Pictorial Warnings
n=402 Participants
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.
|
No Warnings (Control)
n=417 Participants
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.
|
Total
n=1215 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
24.9 years
STANDARD_DEVIATION 3.4 • n=7 Participants
|
25 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
25 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
253 Participants
n=5 Participants
|
270 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
789 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
143 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
425 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Unknown/Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
101 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
295 Participants
n=5 Participants
|
316 Participants
n=7 Participants
|
340 Participants
n=5 Participants
|
951 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
82 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
271 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
219 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
689 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
34 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
396 participants
n=5 Participants
|
402 participants
n=7 Participants
|
417 participants
n=5 Participants
|
1215 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Minute 2The 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
Outcome measures
| Measure |
Text Warnings
n=396 Participants
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.
|
Pictorial Warnings
n=402 Participants
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.
|
No Warnings (Control)
n=417 Participants
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.
|
|---|---|---|---|
|
Behavioral Intentions
|
1.83 score on a scale
Standard Error 0.07
|
1.72 score on a scale
Standard Error 0.05
|
2.21 score on a scale
Standard Error 0.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Minute 2Three 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minute 2This 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minute 1One 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minute 2Three 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minute 1One 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minute 1One 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minute 1One 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minute 3Six 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minute 3Five 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minute 3Five/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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minute 1Participants who report past-year use will report, on a scale of 1-10, how motivated they are to quit smoking hookah.
Outcome measures
Outcome data not reported
Adverse Events
Text Warnings
Pictorial Warnings
No Warnings (Control)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Erin L. Sutfin, PhD
Wake Forest University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place