- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03723616
Reactions to Warnings on Hookah Ads
May 7, 2021 updated by: Duke University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4721
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 34 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Hookah Tobacco Smokers
Young adults, ages 18-34, who smoke hookah tobacco
|
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.
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.
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
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perceived Risk as Measured by Questionnaire
Time Frame: up to 45 minutes
|
up to 45 minutes
|
Worry about Harms as Measured by Questionnaire
Time Frame: up to 45 minutes
|
up to 45 minutes
|
Attitudes toward Waterpipe Tobacco Smoking as Measured by Questionnaire
Time Frame: up to 45 minutes
|
up to 45 minutes
|
Intention to Try (for Susceptible Nonsmokers of Waterpipe Tobacco Smokers) or Quit (for Smokers of Waterpipe Tobacco) as Measured by Questionnaire
Time Frame: up to 45 minutes
|
up to 45 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of Health Warnings on a 1 to 7 scale
Time Frame: up to 45 minutes
|
1 = Not at all effective to 7 = A great deal effective
|
up to 45 minutes
|
Avoidance / Acceptance of Health Warnings as Measured by Eye Tracking
Time Frame: up to one hour
|
up to one hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Isaac Lipkus, PhD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2018
Primary Completion (Actual)
March 26, 2021
Study Completion (Actual)
March 26, 2021
Study Registration Dates
First Submitted
October 26, 2018
First Submitted That Met QC Criteria
October 26, 2018
First Posted (Actual)
October 29, 2018
Study Record Updates
Last Update Posted (Actual)
May 11, 2021
Last Update Submitted That Met QC Criteria
May 7, 2021
Last Verified
September 1, 2020
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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