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NCT05317663 · ClinicalTrials.gov registry record · NA
Developing and Testing Waterpipe-specific Health Warning Labels
A NA study, sponsored by Florida International University.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT05317663 is a NA study that has completed, run by Florida International University. The registered enrollment target is 44 participants.
The verdict
NCT05317663, a NA study, has completed, sponsored by Florida International University.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
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 he
Interventions
- BEHAVIORAL Test Health Warning Label (HWL)
- BEHAVIORAL Test without Health Warning Label (no-HWL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2024-12-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05317663
The ClinicalTrials.gov registry entry for NCT05317663 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida International University, which has 89 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Test Health Warning Label (HWL) is the first listed.
NCT05317663 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05317663 about?
NCT05317663 is a clinical study titled "Developing and Testing Waterpipe-specific Health Warning Labels". 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 addictio...
What is the current status of trial NCT05317663?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2022-10-03. Estimated completion is 2024-12-09.
What interventions are being tested in trial NCT05317663?
The interventions under investigation include: Test Health Warning Label (HWL) (BEHAVIORAL), Test without Health Warning Label (no-HWL) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05317663?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
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