Reactions to WarningsNCT03723616
Reactions to Warnings on Hookah Ads
A study testing Ads Only, Ads with text-only health warning labels (HWLs) and Ads with text + graphic health warning labels (HWLs) in people with Reactions to Warnings and Hookah Smoking, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to help us better understand what kinds of waterpipe tobacco advertisements appeal to young adults as well as to help evaluate and create health warnings that can be placed on waterpipe tobacco advertisements to inform young adults of the risks associated with smoking hookah tobacco. Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Reactions to Warnings, Hookah Smoking
- What is being tested?
- Ads Only, Ads with text-only health warning labels (HWLs) and Ads with text + graphic health warning labels (HWLs)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,588 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2018to 26 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Reactions to Health Warnings on Waterpipe Tobacco Ads
The purpose of this study is to help us better understand what kinds of waterpipe tobacco advertisements appeal to young adults as well as to help evaluate and create health warnings that can be placed on waterpipe tobacco advertisements to inform young adults of the risks associated with smoking hookah tobacco.
- Conditions
- Reactions to Warnings, Hookah Smoking
- Being tested
- Ads Only, Ads with text-only health warning labels (HWLs), Ads with text + graphic health warning labels (HWLs)
- Keywords
- Hookah, Shisha, Tobacco, Narghile
- Medical subject headings
- Water Pipe Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ads OnlyBehavioural
Participants will view 2 ads without replacement.
Ads with text-only health warning labels (HWLs)Behavioural
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.
Ads with text + graphic health warning labels (HWLs)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Social Allure Ads | Active comparator | 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. Receives: Behavioral: Ads Only; Behavioral: Ads with text-only health warning labels (HWLs); Behavioral: Ads with text + graphic health warning labels (HWLs) |
| Product Ads | Active comparator | 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. Receives: Behavioral: Ads Only; Behavioral: Ads with text-only health warning labels (HWLs); Behavioral: Ads with text + graphic health warning labels (HWLs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Reactions to Ads
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.
Measured: up to 45 minutes
Attitudes Toward Waterpipe Tobacco Smoking (WTS) as Measured by Questionnaire
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.
Measured: up to 45 minutes
Reactance to Ads
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).
Measured: up to 45 minutes
Perceived Effectiveness of Health Warnings
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.
Measured: up to 45 minutes
Ad Effect on Desire to Smoke
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.
Measured: up to 45 minutes
Ad Effect on Event Participation
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.
Measured: up to 45 minutes
Ad Effect on Product Purchase
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.
Measured: up to 45 minutes
Secondary outcomes (4)
Perceived Risk as Measured by Questionnaire
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.
Measured: up to 45 minutes
Global Attitude on Waterpipe Tobacco Smoking (WTS)
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.
Measured: up to 45 minutes
Urge to Smoke
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.
Measured: up to 45 minutes
Avoidance / Acceptance of Health Warnings as Measured by Eye Tracking
Participants were going to be positioned to view several ads, and with an apparatus, track their visual movements.
Measured: up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start5 Oct 2018
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Reactions to WarningsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Lipkus, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723616
- Sponsor's protocol ID
- Pro00092330
- Status last verified
- Dec 2025
- First submitted
- 26 Oct 2018
- Last updated
- 18 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Reactions to Health Warnings on Waterpipe Tobacco Ads
- ClinicalTrials.gov ID
- NCT03723616
- Acronym / sponsor ID
- Pro00092330
- Conditions
- Reactions to Warnings, Hookah Smoking
- Keywords
- Hookah, Shisha, Tobacco, Narghile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,588 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Posted 18 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to help us better understand what kinds of waterpipe tobacco advertisements appeal to young adults as well as to help evaluate and create health warnings that can be placed on waterpipe tobacco advertisements to inform young adults of the risks associated with smoking hookah tobacco.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Allure Ads | Active comparator | Behavioral: Ads Only, Behavioral: Ads with text-only health warning labels (HWLs), Behavioral: Ads with text + graphic health warning labels (HWLs)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. |
| Product Ads | Active comparator | Behavioral: Ads Only, Behavioral: Ads with text-only health warning labels (HWLs), Behavioral: Ads with text + graphic health warning labels (HWLs)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. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ads OnlyParticipants will view 2 ads without replacement. | Behavioural | Product Ads, Social Allure Ads |
| Ads with text-only health warning labels (HWLs)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. | Behavioural | Product Ads, Social Allure Ads |
| Ads with text + graphic health warning labels (HWLs)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. | Behavioural | Product Ads, Social Allure Ads |
Primary outcome
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.
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.
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).
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.
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.
Ad Effect on Event Participation
Time frame: up to 45 minutes
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.
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.
4 secondary outcomes
Perceived Risk as Measured by Questionnaire
Time frame: up to 45 minutes
Global Attitude on Waterpipe Tobacco Smoking (WTS)
Time frame: up to 45 minutes
Urge to Smoke
Time frame: up to 45 minutes
Avoidance / Acceptance of Health Warnings as Measured by Eye Tracking
Time frame: up to one hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac Lipkus, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ads Only, Ads with text-only health warning labels (HWLs) and Ads with text + graphic health warning labels (HWLs) in people with Reactions to Warnings and Hookah Smoking, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Reactions to Ads (time frame: up to 45 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.