NCT03723616

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,588

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2021

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

December 18, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

October 26, 2018

Results QC Date

March 24, 2022

Last Update Submit

December 3, 2025

Conditions

Keywords

HookahShishaTobaccoNarghile

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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).

    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.

    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.

    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.

    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.

    up to 45 minutes

Secondary Outcomes (4)

  • Perceived Risk as Measured by Questionnaire

    up to 45 minutes

  • Global Attitude on Waterpipe Tobacco Smoking (WTS)

    up to 45 minutes

  • Urge to Smoke

    up to 45 minutes

  • Avoidance / Acceptance of Health Warnings as Measured by Eye Tracking

    up to one hour

Study Arms (2)

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.

Behavioral: Ads OnlyBehavioral: 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.

Behavioral: Ads OnlyBehavioral: Ads with text-only health warning labels (HWLs)Behavioral: Ads with text + graphic health warning labels (HWLs)

Interventions

Ads OnlyBEHAVIORAL

Participants will view 2 ads without replacement.

Product AdsSocial Allure Ads

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.

Product AdsSocial Allure Ads

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.

Product AdsSocial Allure Ads

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Water Pipe Smoking

Condition Hierarchy (Ancestors)

Pipe SmokingSmokingBehavior

Results Point of Contact

Title
Isaac Lipkus Reiner, Ph.D.
Organization
Duke University

Study Officials

  • Isaac Lipkus, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2018

First Posted

October 29, 2018

Study Start

October 5, 2018

Primary Completion

March 26, 2021

Study Completion

March 26, 2021

Last Updated

December 18, 2025

Results First Posted

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations