CClinicalTrials.gg
CompletedNCT05439421Updated Mar 19, 2024Results posted

Consumer Perceptions of Waterpipe Tobacco Packaging and Digital Marketing Claims

An interventional study of Package/Advertisement With Claim and Package/Advertisement Without Claim in Waterpipe Tobacco Smoking, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,507
Allocation
Randomized
Ages
18 Years to 29 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Waterpipe Tobacco Smoking

Keywords

  • Waterpipe tobacco smoking
  • hookah tobacco warning
  • hookah tobacco
03

In context

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
1,507 participants (actual)

Study arms

  • Experimental
    With Claim 0% Tar

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim 0% Tar

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    With Claim No Chemicals

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim No Chemicals

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    With Claim Apple Image

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim Apple Image

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    With Claim 100% Food Grade Glycerin

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim 100% Food Grade Glycerin

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    With Claim Ultra Light

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim Ultra Light

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    With Claim Fresh Hookah Tobacco

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim Fresh Hookah Tobacco

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    With Claim Lower Nicotine Tobacco

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim Lower Nicotine Tobacco

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    With Claim Premium Shisha Tobacco

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim Premium Shisha Tobacco

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    With Claim High Quality Shisha Tobacco

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim High Quality Shisha Tobacco

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    With Claim Don't blow smoke - blow clouds

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim Don't blow smoke - blow clouds

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    With Claim Contains natural, unwashed tobacco leaf

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim Contains natural, unwashed tobacco leaf

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    With Claim We only use ingredients which are FDA approved

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim We only use ingredients which are FDA approved

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

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

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

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

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    With Claim Natural flavor

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

  • Experimental
    Without Claim Natural flavor

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

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

    Package or digital marketing advertisement containing claim of interest

    Behavioral: Package/Advertisement With Claim

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

    Package or digital marketing advertisement without claim of interest

    Behavioral: Package/Advertisement Without Claim

  • Experimental
    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

    Behavioral: Package/Advertisement With Claim

  • Experimental
    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

    Behavioral: Package/Advertisement Without Claim

Interventions

  • BehavioralPackage/Advertisement With Claim

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

  • BehavioralPackage/Advertisement Without Claim

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: minute 5

  2. 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

    Time frame: minute 5

Other outcomes

  1. Absolute Harm Perception (Packaging Task )

    One item to assess young adults' perceptions of how the packaging influences their opinions on the harmfulness of the hookah tobacco: How much does this packaging make you think this product is harmful? Response scale: (1) Not at all to (4) A lot

    Time frame: minute 5

  2. Absolute Harm Perception (Digital Marketing Task )

    One item to assess young adults' perception of how the advertisement influences their opinions on the harmfulness of smoking hookah: How much does this advertisement make you think smoking hookah is harmful? Response scale: (1) Not at all to (4) A lot

    Time frame: minute 5

  3. Product Appeal (Packaging Task )

    One item to assess the pictured product's appeal: How appealing is this specific product to you? Response scale: (1) Not at all appealing to (4) Very appealing

    Time frame: minute 5

  4. Product Appeal (Digital Marketing Task )

    One item to assess the appeal of smoking hookah in the context of the advertisement: How appealing does this advertisement make smoking hookah seem to you? Response scale: (1) Not at all appealing to (4) Very appealing

    Time frame: minute 5

  5. Absolute Safety Perception (Packaging Task)

    One item to assess young adults' perceptions of how the packaging influences their opinions of how safe the product is: How much does this packaging make you think this product is safe? Response scale: (1) Not at all to (4) A lot

    Time frame: minute 5

  6. Absolute Safety Perception (Digital Marketing Task)

    One item to assess young adults' perception of how the advertisement influences their opinions on the safety of smoking hookah: How much does this advertisement make you think smoking hookah is safe? Response scale: (1) Not at all to (4) A lot

    Time frame: minute 5

  7. Relative Safety Perception (Packaging Task

    One item to assess young adults' perceptions of how safe the product is as compared to other hookah tobacco that might be available to them: Compared to other hookah tobacco on the market, how safe do you think this specific product is? Response scale: (1) Much less safe to (5) Much more safe

    Time frame: minute 5

07

Results

Posted Nov 15, 2023

Participant flow

Participants were randomized to see 6 packages and 10 advertisements with/without the claim of interest on each (32 arms). The randomization was repeated prior to each claim of interest. 1507 unique were enrolled in total.

Zero Percent Tar
Participant flow — Zero Percent Tar
MilestoneWith ClaimWithout Claim
Started742765
Completed742765
Not completed00
No Chemicals
Participant flow — No Chemicals
MilestoneWith ClaimWithout Claim
Started764743
Completed764743
Not completed00
Apple Image
Participant flow — Apple Image
MilestoneWith ClaimWithout Claim
Started743764
Completed743764
Not completed00
Hundred Percent Food Grade Glycerin
Participant flow — Hundred Percent Food Grade Glycerin
MilestoneWith ClaimWithout Claim
Started746761
Completed746761
Not completed00
Ultra Light
Participant flow — Ultra Light
MilestoneWith ClaimWithout Claim
Started731776
Completed731776
Not completed00
Fresh Hookah Tobacco
Participant flow — Fresh Hookah Tobacco
MilestoneWith ClaimWithout Claim
Started706801
Completed706801
Not completed00
Lower Nicotine Tobacco
Participant flow — Lower Nicotine Tobacco
MilestoneWith ClaimWithout Claim
Started742765
Completed742765
Not completed00
Premium Shisha Tobacco
Participant flow — Premium Shisha Tobacco
MilestoneWith ClaimWithout Claim
Started764743
Completed764743
Not completed00
High Quality Shisha Tobacco
Participant flow — High Quality Shisha Tobacco
MilestoneWith ClaimWithout Claim
Started743764
Completed743764
Not completed00
Don't Blow Smoke - Blow Clouds
Participant flow — Don't Blow Smoke - Blow Clouds
MilestoneWith ClaimWithout Claim
Started746761
Completed746761
Not completed00
Contains Natural, Unwashed Tobacco Leaf
Participant flow — Contains Natural, Unwashed Tobacco Leaf
MilestoneWith ClaimWithout Claim
Started731776
Completed731776
Not completed00
We Only Use FDA Approved Ingredients
Participant flow — We Only Use FDA Approved Ingredients
MilestoneWith ClaimWithout Claim
Started706801
Completed706801
Not completed00
H2O Cools Puirfies Tobacco Smoke
Participant flow — H2O Cools Puirfies Tobacco Smoke
MilestoneWith ClaimWithout Claim
Started753754
Completed753754
Not completed00
Natural Flavor
Participant flow — Natural Flavor
MilestoneWith ClaimWithout Claim
Started783724
Completed783724
Not completed00
Shisha/Hookah Tobacco is Unique
Participant flow — Shisha/Hookah Tobacco is Unique
MilestoneWith ClaimWithout Claim
Started749758
Completed749758
Not completed00
Shisha H2O Cools and Filters Smoke
Participant flow — Shisha H2O Cools and Filters Smoke
MilestoneWith ClaimWithout Claim
Started722785
Completed722785
Not completed00

Outcome measures

PrimaryWillingness 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

Time frame:
minute 5
Reported as:
Mean · score on a scale
Willingness to Try Hookah Tobacco (Packaging Task )
score on a scaleWith Claim 0% TarWithout Claim 0% TarWith Claim No ChemicalsWithout Claim No ChemicalsWith Claim Apple ImageWithout Claim Apple ImageWith Claim 100% Food Grade GlycerinWithout Claim 100% Food Grade GlycerinWith Claim Ultra LightWithout Claim Ultra LightWith Claim Fresh Hookah TobaccoWithout Claim Fresh Hookah TobaccoWith Claim Lower Nicotine TobaccoWithout Claim Lower Nicotine TobaccoWith Claim Premium Shisha TobaccoWithout Claim Premium Shisha TobaccoWith Claim High Quality Shisha TobaccoWithout Claim High Quality Shisha TobaccoWith Claim Don't Blow Smoke - Blow CloudsWithout Claim Don't Blow Smoke - Blow CloudsWith Claim Contains Natural, Unwashed Tobacco LeafWithout Claim Contains Natural, Unwashed Tobacco LeafWith Claim We Only Use Ingredients Which Are FDA ApprovedWithout Claim We Only Use Ingredients Which Are FDA ApprovedWith Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWithout Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWith Claim Natural FlavorWithout Claim Natural FlavorWith Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWithout Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWith Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and LightWithout Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and Light
Willingness to Try Hookah Tobacco (Packaging Task )1.9 ± 0.051.87 ± 0.051.9 ± 0.061.63 ± 0.051.95 ± 0.061.78 ± 0.051.81 ± 0.051.79 ± 0.051.84 ± 0.061.81 ± 0.051.86 ± 0.061.80 ± 0.05————————————————————
PrimaryWillingness 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

Time frame:
minute 5
Reported as:
Mean · score on a scale
Willingness to Smoke Hookah Tobacco (Digital Marketing Task )
score on a scaleWith Claim 0% TarWithout Claim 0% TarWith Claim No ChemicalsWithout Claim No ChemicalsWith Claim Apple ImageWithout Claim Apple ImageWith Claim 100% Food Grade GlycerinWithout Claim 100% Food Grade GlycerinWith Claim Ultra LightWithout Claim Ultra LightWith Claim Fresh Hookah TobaccoWithout Claim Fresh Hookah TobaccoWith Claim Lower Nicotine TobaccoWithout Claim Lower Nicotine TobaccoWith Claim Premium Shisha TobaccoWithout Claim Premium Shisha TobaccoWith Claim High Quality Shisha TobaccoWithout Claim High Quality Shisha TobaccoWith Claim Don't Blow Smoke - Blow CloudsWithout Claim Don't Blow Smoke - Blow CloudsWith Claim Contains Natural, Unwashed Tobacco LeafWithout Claim Contains Natural, Unwashed Tobacco LeafWith Claim We Only Use Ingredients Which Are FDA ApprovedWithout Claim We Only Use Ingredients Which Are FDA ApprovedWith Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWithout Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWith Claim Natural FlavorWithout Claim Natural FlavorWith Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWithout Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWith Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and LightWithout Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and Light
Willingness to Smoke Hookah Tobacco (Digital Marketing Task )————————————1.74 ± .051.78 ± .051.46 ± .051.42 ± .041.67 ± .051.75 ± .041.81 ± .051.88 ± .051.74 ± .051.62 ± .051.76 ± .051.69 ± .051.66 ± .051.63 ± .052.00 ± .051.91 ± .051.93 ± .051.78 ± .051.83 ± .051.73 ± .05
Other pre-specifiedAbsolute Harm Perception (Packaging Task )

One item to assess young adults' perceptions of how the packaging influences their opinions on the harmfulness of the hookah tobacco: How much does this packaging make you think this product is harmful? Response scale: (1) Not at all to (4) A lot

Time frame:
minute 5
Reported as:
Mean · score on a scale
Absolute Harm Perception (Packaging Task )
score on a scaleWith Claim 0% TarWithout Claim 0% TarWith Claim No ChemicalsWithout Claim No ChemicalsWith Claim Apple ImageWithout Claim Apple ImageWith Claim 100% Food Grade GlycerinWithout Claim 100% Food Grade GlycerinWith Claim Ultra LightWithout Claim Ultra LightWith Claim Fresh Hookah TobaccoWithout Claim Fresh Hookah TobaccoWith Claim Lower Nicotine TobaccoWithout Claim Lower Nicotine TobaccoWith Claim Premium Shisha TobaccoWithout Claim Premium Shisha TobaccoWith Claim High Quality Shisha TobaccoWithout Claim High Quality Shisha TobaccoWith Claim Don't Blow Smoke - Blow CloudsWithout Claim Don't Blow Smoke - Blow CloudsWith Claim Contains Natural, Unwashed Tobacco LeafWithout Claim Contains Natural, Unwashed Tobacco LeafWith Claim We Only Use Ingredients Which Are FDA ApprovedWithout Claim We Only Use Ingredients Which Are FDA ApprovedWith Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWithout Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWith Claim Natural FlavorWithout Claim Natural FlavorWith Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWithout Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWith Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and LightWithout Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and Light
Absolute Harm Perception (Packaging Task )1.74 ± 0.041.74 ± 0.051.78 ± 0.051.67 ± 0.051.79 ± 0.051.77 ± 0.051.82 ± 0.061.79 ± 0.051.76 ± 0.051.72 ± 0.051.83 ± 0.051.80 ± 0.05————————————————————
Other pre-specifiedAbsolute Harm Perception (Digital Marketing Task )

One item to assess young adults' perception of how the advertisement influences their opinions on the harmfulness of smoking hookah: How much does this advertisement make you think smoking hookah is harmful? Response scale: (1) Not at all to (4) A lot

Time frame:
minute 5
Reported as:
Mean · score on a scale
Absolute Harm Perception (Digital Marketing Task )
score on a scaleWith Claim 0% TarWithout Claim 0% TarWith Claim No ChemicalsWithout Claim No ChemicalsWith Claim Apple ImageWithout Claim Apple ImageWith Claim 100% Food Grade GlycerinWithout Claim 100% Food Grade GlycerinWith Claim Ultra LightWithout Claim Ultra LightWith Claim Fresh Hookah TobaccoWithout Claim Fresh Hookah TobaccoWith Claim Lower Nicotine TobaccoWithout Claim Lower Nicotine TobaccoWith Claim Premium Shisha TobaccoWithout Claim Premium Shisha TobaccoWith Claim High Quality Shisha TobaccoWithout Claim High Quality Shisha TobaccoWith Claim Don't Blow Smoke - Blow CloudsWithout Claim Don't Blow Smoke - Blow CloudsWith Claim Contains Natural, Unwashed Tobacco LeafWithout Claim Contains Natural, Unwashed Tobacco LeafWith Claim We Only Use Ingredients Which Are FDA ApprovedWithout Claim We Only Use Ingredients Which Are FDA ApprovedWith Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWithout Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWith Claim Natural FlavorWithout Claim Natural FlavorWith Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWithout Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWith Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and LightWithout Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and Light
Absolute Harm Perception (Digital Marketing Task )————————————1.90 ± .051.79 ± .051.63 ± .051.67 ± .051.73 ± .061.58 ± .041.86 ± .051.81 ± .051.70 ± .051.61 ± .051.79 ± .051.73 ± .051.80 ± .061.70 ± .051.77 ± .051.59 ± .051.72 ± .051.58 ± .041.71 ± .041.74 ± .05
Other pre-specifiedProduct Appeal (Packaging Task )

One item to assess the pictured product's appeal: How appealing is this specific product to you? Response scale: (1) Not at all appealing to (4) Very appealing

Time frame:
minute 5
Reported as:
Mean · score on a scale
Product Appeal (Packaging Task )
score on a scaleWith Claim 0% TarWithout Claim 0% TarWith Claim No ChemicalsWithout Claim No ChemicalsWith Claim Apple ImageWithout Claim Apple ImageWith Claim 100% Food Grade GlycerinWithout Claim 100% Food Grade GlycerinWith Claim Ultra LightWithout Claim Ultra LightWith Claim Fresh Hookah TobaccoWithout Claim Fresh Hookah TobaccoWith Claim Lower Nicotine TobaccoWithout Claim Lower Nicotine TobaccoWith Claim Premium Shisha TobaccoWithout Claim Premium Shisha TobaccoWith Claim High Quality Shisha TobaccoWithout Claim High Quality Shisha TobaccoWith Claim Don't Blow Smoke - Blow CloudsWithout Claim Don't Blow Smoke - Blow CloudsWith Claim Contains Natural, Unwashed Tobacco LeafWithout Claim Contains Natural, Unwashed Tobacco LeafWith Claim We Only Use Ingredients Which Are FDA ApprovedWithout Claim We Only Use Ingredients Which Are FDA ApprovedWith Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWithout Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWith Claim Natural FlavorWithout Claim Natural FlavorWith Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWithout Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWith Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and LightWithout Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and Light
Product Appeal (Packaging Task )1.99 ± 0.052.01 ± 0.061.91 ± 0.051.70 ± 0.052.01 ± 0.061.81 ± 0.051.89 ± 0.051.84 ± 0.051.91 ± 0.061.95 ± 0.052.02 ± 0.061.89 ± 0.05————————————————————
Other pre-specifiedProduct Appeal (Digital Marketing Task )

One item to assess the appeal of smoking hookah in the context of the advertisement: How appealing does this advertisement make smoking hookah seem to you? Response scale: (1) Not at all appealing to (4) Very appealing

Time frame:
minute 5
Reported as:
Mean · score on a scale
Product Appeal (Digital Marketing Task )
score on a scaleWith Claim 0% TarWithout Claim 0% TarWith Claim No ChemicalsWithout Claim No ChemicalsWith Claim Apple ImageWithout Claim Apple ImageWith Claim 100% Food Grade GlycerinWithout Claim 100% Food Grade GlycerinWith Claim Ultra LightWithout Claim Ultra LightWith Claim Fresh Hookah TobaccoWithout Claim Fresh Hookah TobaccoWith Claim Lower Nicotine TobaccoWithout Claim Lower Nicotine TobaccoWith Claim Premium Shisha TobaccoWithout Claim Premium Shisha TobaccoWith Claim High Quality Shisha TobaccoWithout Claim High Quality Shisha TobaccoWith Claim Don't Blow Smoke - Blow CloudsWithout Claim Don't Blow Smoke - Blow CloudsWith Claim Contains Natural, Unwashed Tobacco LeafWithout Claim Contains Natural, Unwashed Tobacco LeafWith Claim We Only Use Ingredients Which Are FDA ApprovedWithout Claim We Only Use Ingredients Which Are FDA ApprovedWith Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWithout Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWith Claim Natural FlavorWithout Claim Natural FlavorWith Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWithout Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWith Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and LightWithout Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and Light
Product Appeal (Digital Marketing Task )————————————1.88 ± .051.88 ± .051.53 ± .041.51 ± .051.81 ± .051.89 ± .051.9 ± .052.00 ± .061.86 ± .051.77 ± .051.83 ± .051.78 ± .051.71 ± .051.78 ± .052.09 ± .052.08 ± .062.03 ± .051.93 ± .061.97 ± .051.80 ± .05
Other pre-specifiedAbsolute Safety Perception (Packaging Task)

One item to assess young adults' perceptions of how the packaging influences their opinions of how safe the product is: How much does this packaging make you think this product is safe? Response scale: (1) Not at all to (4) A lot

Time frame:
minute 5
Reported as:
Mean · score on a scale
Absolute Safety Perception (Packaging Task)
score on a scaleWith Claim 0% TarWithout Claim 0% TarWith Claim No ChemicalsWithout Claim No ChemicalsWith Claim Apple ImageWithout Claim Apple ImageWith Claim 100% Food Grade GlycerinWithout Claim 100% Food Grade GlycerinWith Claim Ultra LightWithout Claim Ultra LightWith Claim Fresh Hookah TobaccoWithout Claim Fresh Hookah TobaccoWith Claim Lower Nicotine TobaccoWithout Claim Lower Nicotine TobaccoWith Claim Premium Shisha TobaccoWithout Claim Premium Shisha TobaccoWith Claim High Quality Shisha TobaccoWithout Claim High Quality Shisha TobaccoWith Claim Don't Blow Smoke - Blow CloudsWithout Claim Don't Blow Smoke - Blow CloudsWith Claim Contains Natural, Unwashed Tobacco LeafWithout Claim Contains Natural, Unwashed Tobacco LeafWith Claim We Only Use Ingredients Which Are FDA ApprovedWithout Claim We Only Use Ingredients Which Are FDA ApprovedWith Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWithout Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWith Claim Natural FlavorWithout Claim Natural FlavorWith Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWithout Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWith Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and LightWithout Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and Light
Absolute Safety Perception (Packaging Task)1.95 ± 0.051.86 ± 0.051.89 ± 0.051.81 ± 0.051.89 ± 0.051.80 ± 0.051.82 ± 0.051.86 ± 0.051.89 ± 0.051.77 ± 0.051.8 ± 0.051.8 ± 0.05————————————————————
Other pre-specifiedAbsolute Safety Perception (Digital Marketing Task)

One item to assess young adults' perception of how the advertisement influences their opinions on the safety of smoking hookah: How much does this advertisement make you think smoking hookah is safe? Response scale: (1) Not at all to (4) A lot

Time frame:
minute 5
Reported as:
Mean · score on a scale
Absolute Safety Perception (Digital Marketing Task)
score on a scaleWith Claim 0% TarWithout Claim 0% TarWith Claim No ChemicalsWithout Claim No ChemicalsWith Claim Apple ImageWithout Claim Apple ImageWith Claim 100% Food Grade GlycerinWithout Claim 100% Food Grade GlycerinWith Claim Ultra LightWithout Claim Ultra LightWith Claim Fresh Hookah TobaccoWithout Claim Fresh Hookah TobaccoWith Claim Lower Nicotine TobaccoWithout Claim Lower Nicotine TobaccoWith Claim Premium Shisha TobaccoWithout Claim Premium Shisha TobaccoWith Claim High Quality Shisha TobaccoWithout Claim High Quality Shisha TobaccoWith Claim Don't Blow Smoke - Blow CloudsWithout Claim Don't Blow Smoke - Blow CloudsWith Claim Contains Natural, Unwashed Tobacco LeafWithout Claim Contains Natural, Unwashed Tobacco LeafWith Claim We Only Use Ingredients Which Are FDA ApprovedWithout Claim We Only Use Ingredients Which Are FDA ApprovedWith Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWithout Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWith Claim Natural FlavorWithout Claim Natural FlavorWith Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWithout Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWith Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and LightWithout Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and Light
Absolute Safety Perception (Digital Marketing Task)————————————1.99 ± .051.69 ± .051.57 ± .051.60 ± .041.73 ± .051.80 ± .051.70 ± .051.67 ± .051.85 ± .051.78 ± .052.10 ± .051.64 ± .051.90 ± .051.72 ± .051.94 ± .051.87 ± .062.15 ± .051.88 ± .051.97 ± .061.88 ± .05
Other pre-specifiedRelative Safety Perception (Packaging Task

One item to assess young adults' perceptions of how safe the product is as compared to other hookah tobacco that might be available to them: Compared to other hookah tobacco on the market, how safe do you think this specific product is? Response scale: (1) Much less safe to (5) Much more safe

Time frame:
minute 5
Reported as:
Mean · score on a scale
Relative Safety Perception (Packaging Task
score on a scaleWith Claim 0% TarWithout Claim 0% TarWith Claim No ChemicalsWithout Claim No ChemicalsWith Claim Apple ImageWithout Claim Apple ImageWith Claim 100% Food Grade GlycerinWithout Claim 100% Food Grade GlycerinWith Claim Ultra LightWithout Claim Ultra LightWith Claim Fresh Hookah TobaccoWithout Claim Fresh Hookah TobaccoWith Claim Lower Nicotine TobaccoWithout Claim Lower Nicotine TobaccoWith Claim Premium Shisha TobaccoWithout Claim Premium Shisha TobaccoWith Claim High Quality Shisha TobaccoWithout Claim High Quality Shisha TobaccoWith Claim Don't Blow Smoke - Blow CloudsWithout Claim Don't Blow Smoke - Blow CloudsWith Claim Contains Natural, Unwashed Tobacco LeafWithout Claim Contains Natural, Unwashed Tobacco LeafWith Claim We Only Use Ingredients Which Are FDA ApprovedWithout Claim We Only Use Ingredients Which Are FDA ApprovedWith Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWithout Claim Passing Flavored Tobacco Smoke Through Water Cools and Purifies itWith Claim Natural FlavorWithout Claim Natural FlavorWith Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWithout Claim Shisha or Hookah Tobacco is Unique and Completely Unlike That Found in CigarettesWith Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and LightWithout Claim Water in the Shisha Effectively Cools and Filters the Smoke, Making Smooth and Light
Relative Safety Perception (Packaging Task2.88 ± 0.052.73 ± 0.052.78 ± 0.052.70 ± 0.052.65 ± 0.052.68 ± 0.052.68 ± 0.052.68 ± 0.052.68 ± 0.062.74 ± 0.042.73 ± 0.052.74 ± 0.04————————————————————

Adverse events

Collected over From the time of consent up to about 4 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Male0/538 (0%)0/538 (0%)0/538 (0%)
Female0/969 (0%)0/969 (0%)0/969 (0%)

Baseline characteristics

Participants were randomized to see 6 packages and 10 advertisements with/without the claim of interest on each (32 arms). The randomization was repeated prior to each claim of interest. 1507 unique were enrolled in total.

Age, Continuous
Age, Continuous(years)With ClaimWithout ClaimTotal
Mean25.1 ± 3.224.7 ± 3.224.9 ± 3.2
Sex: Female, Male
Sex: Female, Male(Participants)With ClaimWithout ClaimTotal
Female481488969
Male261277538
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)With ClaimWithout ClaimTotal
Hispanic or Latino167163330
Not Hispanic or Latino5756021177
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)With ClaimWithout ClaimTotal
American Indian or Alaska Native6915
Asian5660116
Native Hawaiian or Other Pacific Islander426
Black or African American163182345
White432429861
More than one race313263
Unknown or Not Reported5051101
08

Study locations

1 site
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 16, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05439421
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 30, 2022
Start date
Oct 25, 2022
Primary completion
Nov 23, 2022
Completion
Nov 23, 2022
Results posted
Nov 15, 2023
Last update
Mar 19, 2024

Study contacts

Erin Sutfin, PhD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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