Reactions to Warnings on Hookah Ads

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03723616
• Collaborator: (none)
• Enrollment: 4,721
• Location: 1
• Arms: 2
• Actual Duration (Months): 29.7
• Patients Per Site Per Month: 159.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Reactions to Warnings; Hookah Smoking	Behavioral: Control; Behavioral: Text Only; Behavioral: Text + Graphic	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 4721 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Exploring Reactions to Health Warnings on Waterpipe Tobacco Ads
• Actual Study Start Date: Oct 5, 2018
• Actual Primary Completion Date: Mar 26, 2021
• Actual Study Completion Date: Mar 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hookah Tobacco Smokers Young adults, ages 18-34, who smoke hookah tobacco	Behavioral: Control; Participants will view 24 ads with and without health warnings. Additionally, 16 control non-tobacco ads matched for graphical content, presence of text, people, and other factors will be randomly distributed among these ads.; Behavioral: Text Only; Participants will view at random 24 ads twice, each ad will have a different health warning chosen at random with the caveat that each health warning will be seen 3 times. The 16 control ads will have text disclaimers to control for physical features of the ads.; Behavioral: Text + Graphic; This arm is identical to the text only intervention except a graphic will be added to the health warning. Thus, each ad will be seen twice; the text + graphic warnings will be seen three times. The 16 control ads will have text disclaimers and logos or other images to control for physical features of ads.
Active Comparator: Open to Smoking Hookah Tobacco Young adults, ages 18-34, who do not smoke hookah tobacco but are open to trying	Behavioral: Control; Participants will view 24 ads with and without health warnings. Additionally, 16 control non-tobacco ads matched for graphical content, presence of text, people, and other factors will be randomly distributed among these ads.; Behavioral: Text Only; Participants will view at random 24 ads twice, each ad will have a different health warning chosen at random with the caveat that each health warning will be seen 3 times. The 16 control ads will have text disclaimers to control for physical features of the ads.; Behavioral: Text + Graphic; This arm is identical to the text only intervention except a graphic will be added to the health warning. Thus, each ad will be seen twice; the text + graphic warnings will be seen three times. The 16 control ads will have text disclaimers and logos or other images to control for physical features of ads.

Outcome Measures

Primary Outcome Measures

1. Perceived Risk as Measured by Questionnaire [up to 45 minutes]

2. Worry about Harms as Measured by Questionnaire [up to 45 minutes]

3. Attitudes toward Waterpipe Tobacco Smoking as Measured by Questionnaire [up to 45 minutes]

4. Intention to Try (for Susceptible Nonsmokers of Waterpipe Tobacco Smokers) or Quit (for Smokers of Waterpipe Tobacco) as Measured by Questionnaire [up to 45 minutes]

Secondary Outcome Measures

1. Effectiveness of Health Warnings on a 1 to 7 scale [up to 45 minutes]

   1 = Not at all effective to 7 = A great deal effective

2. Avoidance / Acceptance of Health Warnings as Measured by Eye Tracking [up to one hour]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 34 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Isaac Lipkus, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03723616
• Other Study ID Numbers: Pro00092330
• First Posted: Oct 29, 2018
• Last Update Posted: May 11, 2021
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duke University: Hookah; Shisha; Tobacco; Narghile

Study Results

No Results Posted as of May 11, 2021