- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03723616
Reactions to Warnings on Hookah Ads
Exploring Reactions to Health Warnings on Waterpipe Tobacco Ads
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Young adults who are susceptible to or who are current tobacco smokers (which is defined as at least once in the past month, and using hookah tobacco on at least a monthly basis).
- Must have Internet access for Phase 1 and Phase 2 and have a Turkprime account.
- English speaker
Exclusion Criteria:
- Anyone who is not susceptible to waterpipe tobacco smoking or is not a current waterpipe tobacco smoker
- Anyone who does not have Internet access or a Turkprime account
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Social Allure Ads
Described below is Phase 3. Phase 1 and Phase 2 were small pilots used to inform and select study stimuli. Phase 3 was the larger randomized controlled online trial testing effects of warnings on social allure ads.. Participants were randomized to one of three health warning label (HWL) arms in a 1:2:2 ratio: 1) ads only, 2) ads with text HWLs only, and 3) ads with text + graphic HWLs. Within the latter two groups, participants were then randomized with equal probability to view HWLs in one of four domains: long- and short-term health events, toxicants, and addiction; participants viewed two HWLs within each domain - there were two HWLs per domain. The text or text + graphic HWLs were placed randomly on two social allure ad themes without replacement. Thus, participants viewed two HWLs within the same domain, with each warning being placed on a different social allure ad. Participants in the ads only arm, only viewed two ads without replacement. |
Participants will view 2 ads without replacement.
Participants will view HWLs in one of four domains: long- and short-term health events, toxicants, and addiction; participants viewed two HWLs within each domain - there were two HWLs per domain.
The text HWLs were placed randomly on two ads out of the possible four ad themes without replacement.
Thus, participants viewed two HWLs within the same domain, with each warning being placed on a different ad.
Participants will view HWLs in one of four domains: long- and short-term health events, toxicants, and addiction; participants viewed two HWLs within each domain - there were two HWLs per domain.
The text + graphic HWLs were placed randomly on two ads out of the possible four ad themes without replacement.
Thus, participants viewed two HWLs within the same domain, with each warning being placed on a different ad.
|
|
Active Comparator: Product Ads
Described below is Phase 3. Phase 1 and Phase 2 were small pilots used to inform and select study stimuli. Phase 3 was the larger randomized controlled online trial testing effects of warnings of product ads. Participants were first randomized to one of three health warning label (HWL) arms in a 1:2:2 ratio: 1) ads only, 2) ads with text HWLs only, and 3) ads with text + graphic HWLs. Within the latter two groups, participants were then randomized with equal probability to view HWLs in one of four domains: long- and short-term health events, toxicants, and addiction; participants viewed two HWLs within each domain - there were two HWLs per domain. The text or text + graphic HWLs were placed randomly on two ads that represented a flavored tobacco product or a waterpipe apparatus. Thus, participants viewed two HWLs within the same domain, with each warning being placed on a product ad Participants in the ads only arm, only viewed two product ads without replacement. |
Participants will view 2 ads without replacement.
Participants will view HWLs in one of four domains: long- and short-term health events, toxicants, and addiction; participants viewed two HWLs within each domain - there were two HWLs per domain.
The text HWLs were placed randomly on two ads out of the possible four ad themes without replacement.
Thus, participants viewed two HWLs within the same domain, with each warning being placed on a different ad.
Participants will view HWLs in one of four domains: long- and short-term health events, toxicants, and addiction; participants viewed two HWLs within each domain - there were two HWLs per domain.
The text + graphic HWLs were placed randomly on two ads out of the possible four ad themes without replacement.
Thus, participants viewed two HWLs within the same domain, with each warning being placed on a different ad.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional Reactions to Ads
Time Frame: up to 45 minutes
|
Participants rated on 7-point bipolar scales the extent each ad made them feel not at all anxious/very anxious, not at all worried/very worried, not at all fearful/very fearful and good /bad.
Reported as a composite score created by averaging the items.
Mean scores range from 1 to 7 where higher mean values represent more negative emotional reactions to viewing the ad.
|
up to 45 minutes
|
|
Attitudes Toward Waterpipe Tobacco Smoking (WTS) as Measured by Questionnaire
Time Frame: up to 45 minutes
|
Participant rated on 9-point bipolar scale an ad's portrayal of WTS.
The five attributes that tapped cognitions were: safe/unsafe, healthy/unhealthy, useful/useless, harmful/beneficial, and wise/foolish.
The five attributes that captured affect were: pleasant/unpleasant, nice/nasty, enjoyable/not enjoyable, satisfying/unsatisfying, gratifying/revolting. Reported as a composite score created by averaging the items.
The mean scores could range from 1 to 7 where a higher mean score reflects a more negative attitude towards WTS.
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up to 45 minutes
|
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Reactance to Ads
Time Frame: up to 45 minutes
|
Two items from the University of North Carolina (UNC) short reactance scale were asked from 1=strongly disagree to 7=strongly agree: "This ad is trying to manipulate me", and "This ad annoys me."
Reported as a composite score created by averaging the items.
Mean scores can range from 1 to 7. A higher mean score reflect higher reactance, meaning that participants felt more reactance (e.g., felt their freedoms were being taken away).
|
up to 45 minutes
|
|
Perceived Effectiveness of Health Warnings
Time Frame: up to 45 minutes
|
Participants used a three-item measure as a gestalt assessment of how well an ad dissuaded WTS.
The three items, rated from 1=strongly disagree to 7=strongly agree were: "This ad discourages me from wanting to smoke waterpipe tobacco", "This ad makes me concerned about the health effects of smoking waterpipe tobacco", and "This ad makes smoking waterpipe tobacco seem unpleasant to me".
Reported as a composite score created by averaging the items.
The mean score could ranged from 1 to 7. A higher mean score reflects that the ad was more effective at dissuading WTS.
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up to 45 minutes
|
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Ad Effect on Desire to Smoke
Time Frame: up to 45 minutes
|
Participants were asked, "To what extent did this ad affect your desire to smoke waterpipe tobacco?" from 1=Reduced my desire a lot to 7=Increased my desire a lot.
Mean scores could range from 1 to 7. A higher mean score reflects that the ad increased a participant's desire to smoke waterpipe tobacco.
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up to 45 minutes
|
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Ad Effect on Event Participation
Time Frame: up to 45 minutes
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Participants who completed the social allure study were asked, "If the activities in the ad were to take place in a location near you, how likely are you to participate in those activities?".
Response options were: 1=No chance, 2=Very unlikely, 3=Unlikely, 4=Moderately likely, 5=Likely, 6=Very Likely, and 7=Certain to happen.
Mean scores could range from 1 to 7. A higher mean score reflects a higher probability that the participant would participate in the event depicted in the ad.
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up to 45 minutes
|
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Ad Effect on Product Purchase
Time Frame: up to 45 minutes
|
Participants who completed the social allure study were asked, "How likely are you to buy the product in the ad?".
Response options were: 1=No chance, 2=Very unlikely, 3=Unlikely, 4=Moderately likely, 5=Likely, 6=Very Likely, and 7=Certain to happen.
Means scores could range from 1 to 7. A higher mean score reflects that the study participant would have a higher probability of purchasing the product depicted in the ad.
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up to 45 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Risk as Measured by Questionnaire
Time Frame: up to 45 minutes
|
Participants responded to three questions tapping perceived personal risk, "What do you think is your chance of getting a serious smoking-related disease in your lifetime, such as cancer, lung disease or heart disease, if you do not quit waterpipe tobacco smoking?" (1=No chance to 7=Certain to happen), "How worried are you about getting a serious smoking-related disease in your lifetime, such as cancer, lung disease, or heart disease, if you do not quit waterpipe tobacco smoking?" (1=Not at all worried to 7=Extremely worried, and "Your 'gut feeling' tells you that you are hurting your health when you smoke waterpipe tobacco?" (1=Strongly disagree to 7=Strongly agree).
Reported as a composite score created by averaging the items.
Mean scores could range from 1 to 7. A higher mean score reflects a higher overall belief that one is at higher risk for the negative health effects of smoking waterpipe tobacco.
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up to 45 minutes
|
|
Global Attitude on Waterpipe Tobacco Smoking (WTS)
Time Frame: up to 45 minutes
|
Four 7-point bipolar scales tapped views on WTS: negative/positive, dislike/like, bad/good, undesirable/desirable.
Reported as a composite score created by averaging the items.
The mean scores range from 1 to 7. A higher mean score reflect a more positive overall attitudes towards smoking waterpipe tobacco.
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up to 45 minutes
|
|
Urge to Smoke
Time Frame: up to 45 minutes
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Assessed from 1=Not at all strong to 7=Extremely strong by, "How strong is your urge to smoke waterpipe tobacco right now?" Mean scores range from 1 to 7. A higher mean score reflects the participant had a stronger urge to smoke waterpipe tobacco.
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up to 45 minutes
|
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Avoidance / Acceptance of Health Warnings as Measured by Eye Tracking
Time Frame: up to one hour
|
Participants were going to be positioned to view several ads, and with an apparatus, track their visual movements.
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up to one hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isaac Lipkus, PhD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00092330
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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