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Optimizing Hookah Tobacco Public Education Messages to Reduce Young Adult Use

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ClinicalTrials.gov Identifier: NCT04252014
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Georgetown University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hookah Tobacco Smoking Behavioral: Hookah tobacco messages Not Applicable

Detailed Description:
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 current hookah tobacco users. Primary outcomes of hookah use behavior will be measured at the 6-month follow-up assessment. Secondary outcomes include curiosity to use hookah tobacco among susceptible non-users and motivation to quit using hookah tobacco among current users. All outcomes are also assessed at 2- and 4-month follow-up time points. All trial participants will be recruited from a US national consumer research panel. Eligible participants will be 1) young adults ages 18 to 30 (inclusive); 2) who have never used hookah tobacco but are deemed susceptible or report hookah tobacco use at least once within the past month; and 3) are enrolled members of the partnering consumer research panel. Panel members will be contacted via email with a brief description of the study and a link to an eligibility screener and online informed consent form. Eligible participants will complete a secure online baseline assessment of demographic characteristics, tobacco use history, and measures of hookah tobacco use behavior, beliefs, attitudes, and perceptions. After completing a baseline, participants will be randomly assigned in approximately equal numbers to one of two arms: 1) hookah tobacco messaging arm; 2) control arm. Through 4 brief study communications delivered approximately weekly, participants will receive study messages to which they are randomized and will complete brief self-report measures online on their responses to the messages. For the hookah tobacco messaging arm, communications will consist of study messages conveying risks of hookah tobacco use with random assignment of the order of messages with each exposure. In response to each message, participants will complete measures of message response and hookah-related beliefs, attitudes, and perceptions. Participants in the control condition will receive study communications with brief messages about health behaviors unrelated to tobacco (e.g., sun protection) and will complete the same measures. Hookah tobacco use behaviors, intentions and curiosity to use hookah tobacco (non-users), motivation to quit (current users), and hypothesized mediators will be assessed 2-, 4-, and 6-months after the message exposure period with the primary outcomes captured at 6-month follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention consists of brief 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimizing Hookah Tobacco Public Education Messages to Reduce Young Adult Use
Actual Study Start Date : February 4, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
No Intervention: Non-Tobacco Messages
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.
Experimental: Hookah Tobacco Messages
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.
Behavioral: Hookah tobacco messages
Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.




Primary Outcome Measures :
  1. Hookah Tobacco Initiation [ Time Frame: 6 months ]
    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.

  2. Hookah tobacco use frequency [ Time Frame: 6 months ]
    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. The question asks participants to indicate on how many days in the past 30 days (0 to 30) they have smoked hookah tobacco. Less frequent hookah use is considered a better outcome.

  3. Hookah tobacco cessation [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Hookah tobacco curiosity [ Time Frame: 6 months ]
    Curiosity to use hookah tobacco will be measured with a single valid item with a 7 point response among those who are non-users. This item will be administered at all time points. A lower value on the response is considered a better outcome (i.e., less curious in using hookah tobacco).

  2. Motivation to quit smoking hookah tobacco [ Time Frame: 6 months ]
    Motivation to quit smoking hookah tobacco will be measured with a single valid item with a 7 point response among those who are current hookah users. This item will be administered at all time points. A higher value on the response is considered a better outcome (i.e., more motivated to quit smoking hookah tobacco).


Other Outcome Measures:
  1. Perceived Harm [ Time Frame: 6 months ]
    Perceived harm of hookah tobacco is measured using 4 self-report questionnaire items. One item assesses perceptions of how harmful hookah tobacco use is (score range 1 much less harmful than cigarettes to 5 much more harmful than cigarettes). Another item assesses how likely harms are to occur (response range 1 no chance to 7 certain to happen). Another item assess perceived harms of social hookah tobacco smoking in settings such as bars, cafes, and lounges (score range 1 strongly disagree to 5 strongly agree). Another item assesses perceived harms of flavored hookah tobacco compared with unflavored hookah tobacco (score range 1 strongly disagree to 5 strongly agree). For all 4 items, higher scores are considered better outcomes. The items are administered at 2-month, 4-month, and 6-month follow-up.

  2. Perceived Addictiveness [ Time Frame: 6 months ]
    Perceived addictiveness of hookah tobacco is measured using 2 valid self-report questionnaire items (Mays, Tercyak, & Lipkus 2016). The items assess perceptions of how addictive hookah tobacco smoking is (1 = much less addictive than cigarettes, 5 = much more addictive than cigarettes) and how likely one is to become addicted to hookah tobacco (1 = no chance, 7 = certain to happen). Greater perceived addictiveness and perceived likelihood of addictiveness are considered better outcomes. The items are administered at 2-month, 4-month, and 6-month follow-up.

  3. Worry about Harm [ Time Frame: 6 months ]
    Worry about the harms of hookah tobacco is measured using a single valid self-report questionnaire item (Mays, Tercyak, & Lipkus 2016). The item assesses how much participants worry about the risks of hookah tobacco (1 = Not at all, 7 = Very much). Greater worry about harm is considered a better outcome. The items are administered at 2-month, 4-month, and 6-month follow-up.

  4. Worry about Addictiveness [ Time Frame: 6 months ]
    Worry about the addictiveness of hookah tobacco is measured using a single valid self-report questionnaire item (Mays, Tercyak, & Lipkus 2016). The item assesses how much participants worry about becoming addicted to hookah tobacco (1 = Not at all, 7 = very much). Greater worry about addictiveness is considered a better outcome. The items are administered at 2-month, 4-month, and 6-month follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 to 30
  • Smoked hookah tobacco within the past 30 days, OR never smoked hookah tobacco and deemed susceptible to using hookah tobacco based on answers to screening questions
  • Member of partnering consumer research panel conducting the study

Exclusion Criteria:

  • Age less than 18 or greater than 30
  • Has not smoked hookah tobacco in the past 30 days OR has never smoked hookah tobacco and is not susceptible
  • Not a member of partnering consumer research panel conducting the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252014


Contacts
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Contact: Darren Mays, PhD, MPH 202-687-8937 dmm239@georgetown.edu

Locations
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United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Darren Mays, PhD, MPH    202-687-8937    dmm239@georgetown.edu   
Principal Investigator: Darren Mays, PhD, MPH         
Sponsors and Collaborators
Georgetown University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Darren Mays, PhD, MPH Georgetown University
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT04252014    
Other Study ID Numbers: STUDY00000277
R01CA229082 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: After completion of the study and publication of the primary findings, for a period of up to 2 years.
Access Criteria: Investigators whose proposed use of the data have been approved by an independent review committee (i.e., IRB) for this purpose.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No