NCT04252014

Optimizing Hookah Tobacco Public Education Messages to Reduce Young Adult Use

Completed NA Results posted Last updated 13 February 2023

What this trial tests

NA trial testing Hookah tobacco messages in Hookah Tobacco Smoking in 830 participants. Completed in 30 April 2022.

Timeline

4 February 2020

Primary endpoint
30 April 2022

30 April 2022

Quick facts

Lead sponsor	Georgetown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	830
Start date	4 February 2020
Primary completion	30 April 2022
Estimated completion	30 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Hookah tobacco messages

Conditions studied

• Hookah Tobacco Smoking — all drugs for Hookah Tobacco Smoking →

Sponsor

Georgetown University

Who can join

Adults 18 to 30, any sex, with Hookah Tobacco Smoking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hookah Tobacco Initiation Primary · 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. The outcome measure data reports those who responded "Yes" and are considered to have initiated hookah tobacco at the 6 month follow-up.

Group	Value	95% CI
Non-Tobacco Messages	11
Hookah Tobacco Messages	5

Hookah Tobacco Use Frequency Primary · 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. 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.

Group	Value	95% CI
Non-Tobacco Messages	2.52	± 4.52
Hookah Tobacco Messages	2.39	± 4.51

Hookah Tobacco Cessation Primary · 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. The outcome measure data reports those who responded "Yes" and are considered to have stopped smoking hookah tobacco completely at th

Group	Value	95% CI
Non-Tobacco Messages	66
Hookah Tobacco Messages	55

Hookah Tobacco Curiosity Secondary · 6 months

Curiosity to use hookah tobacco will be measured with a single valid item with a 7-point response ranging from 1 (not at all curious) to 7 (very curious) among those who are baseline susceptible non-users. This item will be administered at all time points. Outcomes from the 6-month follow-up are reported. A lower value on the response is considered a better outcome (i.e., less curious in using hookah tobacco).

Group	Value	95% CI
Non-Tobacco Messages	2.01	± 1.49
Hookah Tobacco Messages	1.90	± 1.27

Motivation to Quit Smoking Hookah Tobacco Secondary · 6 months

Motivation to quit smoking hookah tobacco will be measured with a single valid item with a 7-point response ranging from 1 (not at all motivated) to 7 (very motivated) 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). Outcomes at the 6-month follow-up are reported.

Group	Value	95% CI
Non-Tobacco Messages	3.82	± 2.16
Hookah Tobacco Messages	4.02	± 2.30

Perceived Harm Secondary · 6 months

Perceived harm of hookah tobacco is measured using 4 self-report items. One item assesses perceptions of how harmful hookah tobacco use is (range 1 much less harmful than cigarettes to 5 much more harmful than cigarettes). Another item assesses how likely harms are to occur (range 1 no chance to 7 certain to happen). Another item assesses perceived harms of social hookah tobacco smoking in settings such as bars, cafes, and lounges (range 1 strongly disagree to 5 strongly agree). Another item assesses perceived harms of flavored hookah tobacco compared with unflavored hookah tobacco (range 1 st

Group	Value	95% CI
Non-Tobacco Messages	11.79	± 2.42
Hookah Tobacco Messages	11.85	± 2.61

Perceived Addictiveness Secondary · 6 months

Perceived addictiveness of hookah tobacco is measured using 2 valid self-report items (Mays, Tercyak, \& Lipkus 2016). The items assess perceptions of how addictive hookah tobacco smoking is on a 5 point response (1= much less addictive than cigarettes, 5 = much more addictive than cigarettes) and how likely one is to become addicted to hookah tobacco on a 7 point response(1 = no chance, 7 = certain to happen). Greater perceived addictiveness and perceived likelihood of addictiveness (higher values) are considered better outcomes. The items are administered at 2-month, 4-month, and 6-month fol

Group	Value	95% CI
Non-Tobacco Messages	6.81	± 2.13
Hookah Tobacco Messages	6.98	± 2.30

Worry About Harm Secondary · 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.

Group	Value	95% CI
Non-Tobacco Messages	4.29	± 1.92
Hookah Tobacco Messages	4.25	± 2.04

Worry About Addictiveness Secondary · 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). Higher values indicate greater worry about addictiveness and are considered a better outcome. The items are administered at 2-month, 4-month, and 6-month follow-up.

Group	Value	95% CI
Non-Tobacco Messages	3.83	± 2.00
Hookah Tobacco Messages	3.87	± 2.08

Sponsor's own 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 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integrating Self-Report and Psychophysiological Measures in Waterpipe Tobacco Message Testing: A Novel Application of Multi-Attribute Decision Modeling.
   Stevens EM, Villanti AC, Leshner G, Wagener TL, et al · · 2021 · cited 5× · PMID 34831571 · DOI 10.3390/ijerph182211814
2. Messaging to prevent and reduce young adults' waterpipe tobacco smoking: A randomized trial.
   Keller-Hamilton B, Stevens EM, Villanti AC, Leshner G, et al · · 2023 · cited 3× · PMID 36455379 · DOI 10.1016/j.addbeh.2022.107546
3. Correlates of susceptibility to waterpipe tobacco smoking in young adults.
   Alalwan MA, Long L, Stevens EM, Keller-Hamilton B, et al · · 2024 · PMID 39012868 · DOI 10.1371/journal.pone.0307058