Consumer Perceptions of Waterpipe Tobacco Packaging and Digital Marketing Claims

NCT ID: NCT05439421

Last Updated: 2024-03-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2022-11-23

Brief Summary

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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

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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.

Conditions

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Waterpipe Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be randomized to see 6 packages and 10 advertisements, with or without the claim of interest on each.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Participants will be blinded to which stimuli have the claims of interest and which do not.

Study Groups

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With Claim 0% Tar

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim 0% Tar

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim No Chemicals

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim No Chemicals

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim Apple Image

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim Apple Image

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim 100% Food Grade Glycerin

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim 100% Food Grade Glycerin

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim Ultra Light

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim Ultra Light

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim Fresh Hookah Tobacco

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim Fresh Hookah Tobacco

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim Lower Nicotine Tobacco

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim Lower Nicotine Tobacco

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim Premium Shisha Tobacco

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim Premium Shisha Tobacco

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim High Quality Shisha Tobacco

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim High Quality Shisha Tobacco

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim Don't blow smoke - blow clouds

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim Don't blow smoke - blow clouds

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim Contains natural, unwashed tobacco leaf

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim Contains natural, unwashed tobacco leaf

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim We only use ingredients which are FDA approved

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim We only use ingredients which are FDA approved

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim Passing flavored tobacco smoke through water cools and purifies it

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim Passing flavored tobacco smoke through water cools and purifies it

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim Natural flavor

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim Natural flavor

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim Shisha or hookah tobacco is unique and completely unlike that found in cigarettes

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim Shisha or hookah tobacco is unique and completely unlike that found in cigarettes

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

With Claim water in the shisha effectively cools and filters the smoke, making smooth and light

Package or digital marketing advertisement containing claim of interest

Group Type EXPERIMENTAL

Package/Advertisement With Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Without Claim water in the shisha effectively cools and filters the smoke, making smooth and light

Package or digital marketing advertisement without claim of interest

Group Type EXPERIMENTAL

Package/Advertisement Without Claim

Intervention Type BEHAVIORAL

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

Interventions

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Package/Advertisement With Claim

Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Intervention Type BEHAVIORAL

Package/Advertisement Without Claim

Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Sutfin, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01CA239192

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00060111

Identifier Type: -

Identifier Source: org_study_id

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