NCT04252014|CompletedResults
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Sponsor study identifier
Secondary identifiers
NIH
interventional
830
1 country
1
Study Start
February 4, 2020
Actual (reported)Primary Completion
April 30, 2022
Actual (reported)Study Completion
April 30, 2022
Actual (reported)This is a 2-arm randomized controlled trial to test the effects of hookah tobacco public education messages among young adults who are susceptible non-users of hookah tobacco and those who are current hookah tobacco users. The primary outcomes are hookah tobacco use behavior (initiation among baseline susceptible non-users, frequency of use and cessation among baseline current users) at 6-month follow-up. Secondary outcomes are curiosity to use hookah tobacco (susceptible non-users) and motivation to quit using hookah tobacco (current hookah users) measured at 6-month follow-up. These outcomes will also be measured at 2- and 4-month follow-up time points.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2020
Actual (reported)February 4, 2020
Actual (reported)February 5, 2020
Actual (reported)April 30, 2022
Actual (reported)April 30, 2022
Actual (reported)February 13, 2023
Actual (reported)Hookah Tobacco Initiation
Hookah tobacco initiation among those who are susceptible non-users at baseline will be measured using a single valid survey question asking if participants have ever used hookah tobacco, even one or two puffs, at follow-up. The question asks if participants have ever smoked hookah tobacco based on a yes/no response. No hookah tobacco initiation is considered a better outcome. The outcome measure data reports those who responded "Yes" and are considered to have initiated hookah tobacco at the 6 month follow-up.
6 months
Hookah Tobacco Use Frequency
Hookah tobacco use frequency will be measured in baseline current hookah users with a single valid question asking on how many days they smoked hookah tobacco in the past 30 days. Baseline current hookah users who reported they quit were coded as smoking 0 of the past 30 days. Less frequent hookah use is considered a better outcome.
6 months
Hookah Tobacco Cessation
Hookah tobacco cessation is measured using a single valid question adapted from the national Population Assessment of Tobacco and Health (PATH) survey asking participants who report they have not smoked hookah tobacco if they have stopped smoking hookah tobacco completely. The item asks if participants have completely stopped smoking hookah tobacco based on a yes/no response. Quitting hookah tobacco use (i.e., a response of "yes") is considered a better outcome. The outcome measure data reports those who responded "Yes" and are considered to have stopped smoking hookah tobacco completely at the 6 month follow-up.
6 months
Hookah Tobacco Curiosity
6 months
Motivation to Quit Smoking Hookah Tobacco
6 months
Perceived Harm
6 months
Perceived Addictiveness
6 months
Worry About Harm
6 months
Participants in the control group will receive messages about health topics unrelated to tobacco use (e.g., sun safety). Messages will be delivered online through 4 brief study communications.
Participants in the hookah tobacco messaging group will receive hookah tobacco public education messages delivered online through 4 brief study communications. Messages will communicate about the risks of hookah tobacco use in the following theme areas: 1) Health Harms; 2) Addictiveness; 3) Social Use; 4) Flavorings. The order of message themes delivered in each study communication will be randomized.
Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Georgetown University
Washington D.C., District of Columbia, 20007, United States
Darren Mays, PhD, MPH
Georgetown University
830 participants (actual enrollment reported by the registry).
First Submitted
January 30, 2020
First Posted
February 5, 2020
Contact the study team to confirm eligibility.
Study Start
February 4, 2020
Actual (reported)Primary Completion
April 30, 2022
Actual (reported)Study Completion
April 30, 2022
Actual (reported)Last Updated
February 13, 2023
Results First Posted
February 13, 2023
Record last verified: 2022-07
Individual participant data that underlie study results will be made available upon request by researchers after completion of the study and publication of primary findings.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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