Consumer Perceptions of Waterpipe Tobacco Packaging and Digital Marketing Claims

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Waterpipe Tobacco Smoking

Treatments

Behavioral: Package/Advertisement Without Claim
Behavioral: Package/Advertisement With Claim

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05439421
IRB00060111
R01CA239192 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment

1,507 patients

Sex

All

Ages

18 to 29 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

1,507 participants in 32 patient groups

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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