Trial Outcomes & Findings for Optimizing Hookah Tobacco Public Education Messages to Reduce Young Adult Use (NCT NCT04252014)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

830 participants

Primary outcome timeframe

6 months

Results posted on

2023-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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. Hookah tobacco messages: Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
Overall Study STARTED	414	416
Overall Study COMPLETED	325	332
Overall Study NOT COMPLETED	89	84

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optimizing Hookah Tobacco Public Education Messages to Reduce Young Adult Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Tobacco Messages n=414 Participants 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.	Hookah Tobacco Messages n=416 Participants 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. Hookah tobacco messages: Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.	Total n=830 Participants Total of all reporting groups
Age, Continuous	25.2 years STANDARD_DEVIATION 3.2 • n=5 Participants	25.5 years STANDARD_DEVIATION 3.1 • n=7 Participants	25.4 years STANDARD_DEVIATION 3.1 • n=5 Participants
Sex: Female, Male Female	259 Participants n=5 Participants	247 Participants n=7 Participants	506 Participants n=5 Participants
Sex: Female, Male Male	155 Participants n=5 Participants	169 Participants n=7 Participants	324 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	103 Participants n=5 Participants	98 Participants n=7 Participants	201 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	311 Participants n=5 Participants	318 Participants n=7 Participants	629 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	38 Participants n=5 Participants	43 Participants n=7 Participants	81 Participants n=5 Participants
Race/Ethnicity, Customized Black	129 Participants n=5 Participants	113 Participants n=7 Participants	242 Participants n=5 Participants
Race/Ethnicity, Customized Multiple Races	46 Participants n=5 Participants	35 Participants n=7 Participants	81 Participants n=5 Participants
Race/Ethnicity, Customized Other Race(s)	36 Participants n=5 Participants	39 Participants n=7 Participants	75 Participants n=5 Participants
Race/Ethnicity, Customized White	165 Participants n=5 Participants	186 Participants n=7 Participants	351 Participants n=5 Participants
Region of Enrollment United States	414 Participants n=5 Participants	416 Participants n=7 Participants	830 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants who were susceptible never waterpipe smokers at baseline that were retained at the six month follow up.

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.

Outcome measures

Outcome measures
Measure	Non-Tobacco Messages n=119 Participants 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.	Hookah Tobacco Messages n=122 Participants 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. Hookah tobacco messages: Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
Hookah Tobacco Initiation	11 Participants	5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants who were current hookah smokers at baseline and retained to the 6 month follow-up. Some participants retained did not answer all outcomes questions.

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.

Outcome measures

Outcome measures
Measure	Non-Tobacco Messages n=174 Participants 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.	Hookah Tobacco Messages n=181 Participants 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. Hookah tobacco messages: Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
Hookah Tobacco Use Frequency	2.52 days Standard Deviation 4.52	2.39 days Standard Deviation 4.51

PRIMARY outcome

Timeframe: 6 months

Population: Participants who were current hookah tobacco smokers at baseline retained to the 6 month follow-up. Some participants retained did not answer all outcomes questions.

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.

Outcome measures

Outcome measures
Measure	Non-Tobacco Messages n=180 Participants 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.	Hookah Tobacco Messages n=182 Participants 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. Hookah tobacco messages: Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
Hookah Tobacco Cessation	66 Participants	55 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants who were susceptible never hookah smokers at baseline retained to the 6 month follow-up. Some participants retained did not answer all outcomes questions.

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).

Outcome measures

Outcome measures
Measure	Non-Tobacco Messages n=108 Participants 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.	Hookah Tobacco Messages n=117 Participants 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. Hookah tobacco messages: Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
Hookah Tobacco Curiosity	2.01 units on a scale Standard Deviation 1.49	1.90 units on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: 6 months

Population: Baseline current hookah smokers who were retained at 6 month follow-up and did not quit. Some participants retained did not answer all outcomes questions.

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.

Outcome measures

Outcome measures
Measure	Non-Tobacco Messages n=113 Participants 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.	Hookah Tobacco Messages n=125 Participants 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. Hookah tobacco messages: Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
Motivation to Quit Smoking Hookah Tobacco	3.82 units on a scale Standard Deviation 2.16	4.02 units on a scale Standard Deviation 2.30

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Participants at baseline who were retained to the 6 month follow up. Some participants retained did not answer all outcomes questions.

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 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. Outcomes reported at 6-month follow-up reflect the sum of responses to the 4 items. The sum ranges from 4 (min) to 22 (max) with higher values considered better outcomes.

Outcome measures

Outcome measures
Measure	Non-Tobacco Messages n=324 Participants 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.	Hookah Tobacco Messages n=329 Participants 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. Hookah tobacco messages: Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
Perceived Harm	11.79 units on a scale Standard Deviation 2.42	11.85 units on a scale Standard Deviation 2.61

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Participants at baseline who were retained to the 6 month follow-up. Some participants retained did not answer all outcomes questions.

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 follow-up. Outcomes reported are for the 6 month follow up timepoint and represent the sum of responses to the two items. The sum ranges from 2 (min) to 12 (max) with higher values considered better outcomes.

Outcome measures

Outcome measures
Measure	Non-Tobacco Messages n=322 Participants 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.	Hookah Tobacco Messages n=327 Participants 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. Hookah tobacco messages: Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
Perceived Addictiveness	6.81 units on a scale Standard Deviation 2.13	6.98 units on a scale Standard Deviation 2.30

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Participants at baseline who were retained to the 6 month follow up. Some participants retained did not answer all outcomes questions.

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.

Outcome measures

Outcome measures
Measure	Non-Tobacco Messages n=324 Participants 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.	Hookah Tobacco Messages n=328 Participants 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. Hookah tobacco messages: Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
Worry About Harm	4.29 units on a scale Standard Deviation 1.92	4.25 units on a scale Standard Deviation 2.04

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Participants at baseline who were retained to the 6 month follow-up. Some participants retained did not answer all outcomes questions.

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.

Outcome measures

Outcome measures
Measure	Non-Tobacco Messages n=324 Participants 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.	Hookah Tobacco Messages n=330 Participants 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. Hookah tobacco messages: Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
Worry About Addictiveness	3.83 units on a scale Standard Deviation 2.00	3.87 units on a scale Standard Deviation 2.08

Adverse Events

Non-Tobacco Messages

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hookah Tobacco Messages

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Darren Mays

Georgetown University

Phone: 2026878937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place