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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03723616
Other study ID # Pro00092330
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2018
Est. completion date March 26, 2021

Study information

Verified date September 2020
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 4721
Est. completion date March 26, 2021
Est. primary completion date March 26, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 34 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
United States Duke University Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Risk as Measured by Questionnaire up to 45 minutes
Primary Worry about Harms as Measured by Questionnaire up to 45 minutes
Primary Attitudes toward Waterpipe Tobacco Smoking as Measured by Questionnaire up to 45 minutes
Primary 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 Effectiveness of Health Warnings on a 1 to 7 scale 1 = Not at all effective to 7 = A great deal effective up to 45 minutes
Secondary Avoidance / Acceptance of Health Warnings as Measured by Eye Tracking up to one hour
See also
  Status Clinical Trial Phase
Completed NCT02147665 - Effects of Hookah Smoking on Blood Flow to the Heart, Muscle and Skin N/A
Recruiting NCT04661683 - Secondhand Effects of Hookah (i.e., Waterpipe) Smoke and Aerosol N/A
Terminated NCT03616002 - Effects of Hookah (Waterpipe) Smoking on Blood Vessel Function N/A
Completed NCT03096860 - Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure N/A
Completed NCT03595280 - Optimizing Risk Messages for Waterpipe Tobacco Cessation in Young Adults N/A