NCT05317663

Developing and Testing Waterpipe-specific Health Warning Labels

Completed NA Last updated 10 December 2024

What this trial tests

NA trial testing Test Health Warning Label (HWL) in Waterpipe Smoking in 44 participants. Completed in 9 December 2024.

Timeline

3 October 2022

Primary endpoint
9 December 2024

9 December 2024

Quick facts

Lead sponsor	Florida International University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	44
Start date	3 October 2022
Primary completion	9 December 2024
Estimated completion	9 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Test Health Warning Label (HWL)
• Test without Health Warning Label (no-HWL)

Conditions studied

• Waterpipe Smoking — all drugs for Waterpipe Smoking →
• Health Warning Label — all drugs for Health Warning Label →
• Harm Perception — all drugs for Harm Perception →
• Puffing Behaviour — all drugs for Puffing Behaviour →

Sponsor

Florida International University

Who can join

Adults 21 to 35, any sex, with Waterpipe Smoking or Health Warning Label. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Waterpipe (WP) smoking has become one of the leading tobacco use methods among youth in Florida. The impact of this dramatic rise is amplified by the mounting evidence of WP addictive and harmful nature, as well as the lag of policy response to it. Evidence suggests WP use leads to nicotine addiction, and increases the risk of lung cancer, heart and respiratory disease and exposure to secondhand smoke. The spread of WP use among youth has been fueled by a misperception of reduced-harm compared to cigarettes. Health Warning Labels (HWLs) represent one of the most successful tobacco control strategies to communicate smoking- related risks, and studies have consistently shown that HWLs are associated with a decrease in smoking rates and smoking-related morbidity and mortality. Therefore, communicating WP risks to young people through HWLs has been identified as a priority by major health bodies in the US including the FDA.

Using the Delphi method among international tobacco control experts, our team has developed a set of 12 WP HWLs corresponding to 4 health themes; health risks/addiction, harm to others, WP-specific harm, WP harm compared to cigarettes. Building on this work, and using a mixed- method approach incorporating qualitative and quantitative research, the investigators propose to:

Aim 1: Adapt the 12 HWLs to young WP smokers in Florida using exploratory focus groups.

Aim 2: Test in a clinical lab experiment the performance of the top 4 HWLs on the WP device compared to no-HWL/control on harm perception, intention to quit, and toxicant exposure (Carbon monoxide (CO), nicotine, oxidative stress).

Aim 3: Use the knowledge obtained to advocate for the adoption of WP-HWLs policies and disseminate information about WP harmful effects to young people in Florida and nationally.

Communicating WP risks through HWLs promises to reduce WP use and WP-related morbidly and mortality among young adults in Florida. This pioneering work will inform the FDA and public health advocates on the potential of WP-HWLs policies and provide a model for other states to respond to the WP epidemic.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.