Waterpipe Marketing Aim 3

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the impact of marketing claims commonly found on waterpipe, also known as hookah, tobacco packages and in digital marketing on young adults' willingness to try hookah tobacco. Participants will complete two tasks, in random order. Participants will view six sample waterpipe tobacco packages, randomized at the package level to contain a prohibited or potentially-prohibited claim or not (Packaging Task). In the other task, they will view 10 digital marketing advertisements (i.e. Instagram posts or website pages) either with or without prohibited or potentially-prohibited claim, randomized at the advertisements level (Digital Marketing Task).

Detailed Description
-----------------
Background/Objectives The Food and Drug Administration (FDA) has begun to prohibit certain claims on Waterpipe Tobacco (WT) packaging and advertising. Under Section 911 of the Family Smoking Prevention and Tobacco Control Act, manufacturers and retailers are prohibited from making unauthorized modified risk tobacco product (MRTP) claims, including statements that the product or its smoke: (1) results in reduced harm; (2) contains a reduced level of a substance or presents a reduced exposure to a substance; (3) does not contain or is free of a substance; and (4) statements that use modified risk descriptors such as light, mild, low, or similar descriptors. Some prohibited claims are easily identifiable, but others are more difficult to identify due to lack of specificity in the law and the implicit nature of some claims. Evidence is needed specific to WT packaging and marketing to determine which claims may be associated with consumer harm misperceptions to inform future regulatory actions. The study will address this gap by assessing how such claims influence consumer perceptions and behavioral intentions.

Official Title
-----------------
Evaluating the Impact of Waterpipe Tobacco Marketing Claims on Young Adults

Conditions
-----------------
Waterpipe Tobacco Smoking

Intervention / Treatment
-----------------
* Behavioral: Package/Advertisement With Claim
* Behavioral: Package/Advertisement Without Claim


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: United States (U.S.) Resident Has used waterpipe tobacco within the past year (self-report) Has not used waterpipe tobacco within the past year but it susceptible to use (self- report) Exclusion Criteria: Younger than 18 or older than 29 Non U.S. Resident Has not used waterpipe tobacco within in the past year and is not susceptible to use (self-report)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be randomized to see 6 packages and 10 advertisements, with or without the claim of interest on each.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With Claim 0% Tar<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim 0% Tar<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim No Chemicals<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim No Chemicals<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim Apple Image<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim Apple Image<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim 100% Food Grade Glycerin<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim 100% Food Grade Glycerin<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim Ultra Light<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim Ultra Light<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim Fresh Hookah Tobacco<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim Fresh Hookah Tobacco<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim Lower Nicotine Tobacco<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim Lower Nicotine Tobacco<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim Premium Shisha Tobacco<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim Premium Shisha Tobacco<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim High Quality Shisha Tobacco<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim High Quality Shisha Tobacco<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim Don't blow smoke - blow clouds<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim Don't blow smoke - blow clouds<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim Contains natural, unwashed tobacco leaf<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim Contains natural, unwashed tobacco leaf<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim We only use ingredients which are FDA approved<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim We only use ingredients which are FDA approved<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim Passing flavored tobacco smoke through water cools and purifies it<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim Passing flavored tobacco smoke through water cools and purifies it<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim Natural flavor<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim Natural flavor<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim Shisha or hookah tobacco is unique and completely unlike that found in cigarettes<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim Shisha or hookah tobacco is unique and completely unlike that found in cigarettes<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|
| Experimental: With Claim water in the shisha effectively cools and filters the smoke, making smooth and light<br>Package or digital marketing advertisement containing claim of interest | Behavioral: Package/Advertisement With Claim<br>* Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design<br>|
| Experimental: Without Claim water in the shisha effectively cools and filters the smoke, making smooth and light<br>Package or digital marketing advertisement without claim of interest | Behavioral: Package/Advertisement Without Claim<br>* Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Willingness to Try Hookah Tobacco (Packaging Task ) | One item to assess the extent to which young adults are willing to try the waterpipe tobacco product: How likely would you be to try this specific product? Response scale: (1) Not at all likely to (4) Very likely | minute 5 | 
| Willingness to Smoke Hookah Tobacco (Digital Marketing Task ) | One item to assess the extent to which young adults want to try smoking hookah: How much does this advertisement make you want to smoke hookah? Response scale: (1) Not at all to (4) A lot | minute 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Waterpipe tobacco smoking, hookah tobacco warning, hookah tobacco