NCT03595280

Optimizing Risk Messages for Waterpipe Tobacco Cessation in Young Adults

Completed NA Results posted Last updated 20 October 2021

What this trial tests

NA trial testing Hookah tobacco risk messages in Hookah Smoking in 349 participants. Completed in 1 July 2021.

Timeline

28 August 2018

Primary endpoint
1 August 2020

1 July 2021

Quick facts

Lead sponsor	Georgetown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	349
Start date	28 August 2018
Primary completion	1 August 2020
Estimated completion	1 July 2021
Sites	2 locations across United States

Drugs / interventions tested

• Hookah tobacco risk messages

Conditions studied

• Hookah Smoking — all drugs for Hookah Smoking →

Sponsor

Georgetown University

Who can join

Adults 18 to 30, any sex, with Hookah 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.

Perceived Harm Primary · 6-months

Perceived harm of hookah tobacco is measured using valid self-report item assessing perceptions of how likely harms are to occur from hookah tobacco use (response range 1 no chance to 7 certain to happen). Greater perceived likelihood of harm is considered a better outcome. The assessment is administered immediately post intervention, 3-month follow-up, and 6-month follow-up, 6 month follow-up data reported.

Group	Value	95% CI
Control	4.1	3.9 – 4.4
Untailored Messages	4.2	4.0 – 4.5
Tailored Messages	4.5	4.2 – 4.8

Perceived Addictiveness Primary · 6-months

Perceived addictiveness of hookah tobacco is measured using valid self-report item assessing perceptions of how likely one is to become addicted to hookah tobacco (1 = no chance, 7 = certain to happen). Greater perceived likelihood of addictiveness is considered a better outcome. The assessment is administered immediately post-intervention, 3-month follow-up, and 6 month follow-up, 6-month follow-up data reported.

Group	Value	95% CI
Control	3.9	3.5 – 4.2
Untailored Messages	3.9	3.6 – 4.3
Tailored Messages	4.0	3.7 – 4.3

Worry About Harm Primary · 6-months

Worry about the harms of hookah tobacco is measured using a valid self-report item assessing 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 assessment is administered immediately post-intervention, 3-month follow-up, and 6 month follow-up, 6-month follow-up reported.

Group	Value	95% CI
Control	4.6	4.3 – 5.0
Untailored Messages	4.1	3.8 – 4.5
Tailored Messages	4.6	4.3 – 5.0

Worry About Addictiveness Primary · 6 months

Worry about the addictiveness of hookah tobacco is measured using a valid self-report item assessing how much participants worry about becoming addicted to hookah tobacco (1 = Not at all, 7 = very much). Greater perceived addictiveness is considered a better outcome. The assessment is administered immediately post-intervention, 3 month follow-up, and 6 month-follow-up, 6 month follow-up reported.

Group	Value	95% CI
Control	3.6	3.2 – 3.9
Untailored Messages	3.7	3.3 – 4.1
Tailored Messages	3.9	3.5 – 4.3

Motivation to Quit Primary · 6-months

Motivation to quit is measured using a valid self-report item assessing how much participants want to quit smoking hookah tobacco right now (1 = Not at all, 7 = Very). Greater motivation to quit is considered a better outcome. The assessment is administered immediately post-intervention, 3 month follow-up, and 6 month follow-up, 6-month follow-up reported.

Group	Value	95% CI
Control	4.0	3.5 – 4.4
Untailored Messages	4.0	3.5 – 4.4
Tailored Messages	3.5	3.0 – 4.1

Hookah Tobacco Use Frequency Primary · 6 months

Hookah tobacco use frequency is measured using a valid self-report item assessing how often participants have smoked hookah tobacco in the past 30 days. The item measures the number of days in the past month participants have smoked hookah tobacco. Less frequent hookah tobacco use is considered a better outcome. The assessment is administered immediately post-intervention, 3 month follow-up, and 6 month follow-up, 6-month follow-up reported.

Group	Value	95% CI
Control	4.3	3.0 – 5.6
Untailored Messages	4.0	2.6 – 5.2
Tailored Messages	3.5	2.0 – 5.0

Percent of Participants Who Quit Smoking Hookah Tobacco Primary · 6 months

Hookah tobacco cessation is measured using a single valid self-report item assessing if participants 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., responses of "yes") is considered a better outcome. The assessment is administered immediately post intervention, 3 month follow-up, and 6 month follow-up, 6-month follow-up data reported.

Group	Value	95% CI
Control	29.20
Untailored Messages	37.96
Tailored Messages	48.98

Sponsor's own description

The objective of this study is to examine whether messages conveying the harms and addictiveness of waterpipe (i.e., hookah) tobacco delivered by mobile phone multimedia messaging (MMS) are effective for promoting hookah tobacco cessation among young adults ages 18 to 30 years.

Publications & conference data

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

1. Results of a Single Arm Pilot Study of a Mobile Messaging Intervention for Hookah Tobacco Cessation in Young Adults.
   Mays D, Phan L, Johnson AC, Tercyak KP, et al · · 2020 · cited 6× · PMID 32440243 · DOI 10.1177/1179173x20915200
2. Correlates of motivation to quit waterpipe tobacco smoking among US young adults: implications for cessation interventions.
   Alalwan MA, Keller-Hamilton B, Long L, Lipkus I, et al · · 2023 · cited 4× · PMID 36880171 · DOI 10.1093/her/cyad010