Developing and Testing Waterpipe-specific Health Warning Labels

NCT05317663 | Completed

• 1 other identifier: 20B16
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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 health advocates on the potential of WP-HWLs policies and provide a model for other states to respond to the WP epidemic.

Conditions

Waterpipe Smoking; Health Warning Label; Harm Perception; Puffing Behaviour; Quitting Smoking; Health Risk Behaviors

Keywords

waterpipe; Health warning label; Young people

Outcome Measures

Primary Outcomes (1)

• Intention and motivation to quit

  Intention and motivation to quit will be measured by using 3 items; "Does the participant intend to reduce WP smoking?"; "Does the participant intend to quit WP smoking?", and "How motivated is the participant to quit WP smoking in the next month?" The scale will be scored on a 5-point scale ranging from 1 (not at all), to 5 (very much).

  pre-/post-smoking and at 3-month assessment. Each session is approximately 45 minutes ad lib use period.

Secondary Outcomes (13)

• Harm perception

  pre-/post-smoking and at 3-month assessment. Each session is approximately 45 minutes ad lib use period.

• Exhaled Breath Condensate (EBC)

  It will be collected pre-post smoking session. Each session is approximately 45 minutes ad lib use period.

• Social interaction

  at 3-month assessment

• Change in WP smoking

  at 3-month assessment

• Toxicant exposure: expired carbon monoxide

  initially at the beginning of the smoking session (abstinence verification), and within 10 minutes after the WP smoking session

Study Arms (2)

Waterpipe with Health Warning Label (HWL)

EXPERIMENTAL

All participants will complete a lab visit where they will smoke waterpipe with HWL for up to 45 minutes.

Behavioral: Test Health Warning Label (HWL)

Absence of Waterpipe without Health Warning Label (HWL)

EXPERIMENTAL

All participants will complete a lab visit where they will smoke waterpipe without HWL for up to 45 minutes.

Behavioral: Test without Health Warning Label (no-HWL)

Interventions

Test Health Warning Label (HWL) BEHAVIORAL

Effect of Health Warning Label (HWL)

Waterpipe with Health Warning Label (HWL)

Test without Health Warning Label (no-HWL) BEHAVIORAL

Effect of no Health Warning Label (no-HWL)

Absence of Waterpipe without Health Warning Label (HWL)

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age of 21-35 years.
• Beginners WP smokers (defined as started WP smoking in the past 6 months, but smoke WP less than weekly); or established WP smokers (defined as smoked at least once a week in the past 6 months).
• Generally healthy individuals (determined by physical examination).
• Is willing to provide informed consent.
• Is willing to attend the lab as required by the study protocol.
• Have abstained from WP for 12 hours prior to each lab session.

You may not qualify if:

• Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).
• Individuals with self-reported history of chronic disease or psychiatric conditions.
• Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control).
• Report tobacco product use regularly (\> 5 times/month in the past year).

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Water Pipe Smoking; Smoking Cessation; Health Risk Behaviors

Condition Hierarchy (Ancestors)

Pipe Smoking; Smoking; Behavior; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will conduct a 2x2x2x4 within-subject (2: HWL vs no-HWL x 2: pre- vs post- smoking) and between-subject (2: beginner vs established smokers x 4: HWLs) experimental study. Participant in each group (beginner, established smoker) will be randomly assigned to one of the 4 HWLs conditions, and undergo 2 WP smoking sessions that differ by HWL on the WP device (HWL vs. no-HWL), with pre-/post-smoking assessment of harm perception, intention to quit, puffing behavior, satisfaction, urge to smoke, and toxicant exposure. The investigators will use Latin Square crossover design balanced for carry-over effect (random order of 4 HWL condition), and to ensure equal distribution of study participants across gender.

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: April 8, 2022
• Study Start: October 3, 2022
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)