Waterpipe Marketing Aim 3

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05439421
Collaborator
(none)
1,500
1
2
4
374.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Package/Advertisement With Claim
  • Behavioral: Package/Advertisement Without Claim
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized to see 6 packages and 10 advertisements, with or without the claim of interest on each.Participants will be randomized to see 6 packages and 10 advertisements, with or without the claim of interest on each.
Masking:
Single (Participant)
Masking Description:
Participants will be blinded to which stimuli have the claims of interest and which do not.
Primary Purpose:
Prevention
Official Title:
Evaluating the Impact of Waterpipe Tobacco Marketing Claims on Young Adults
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: With Claim

Package or digital marketing advertisement containing claim of interest

Behavioral: Package/Advertisement With Claim
Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design

Experimental: Without Claim

Package or digital marketing advertisement without claim of interest

Behavioral: Package/Advertisement Without Claim
Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design

Outcome Measures

Primary Outcome Measures

  1. Willingness to try hookah tobacco (Packaging Task ) [minute 5]

    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

  2. Willingness to smoke hookah tobacco (Digital Marketing Task ) [minute 5]

    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

Other Outcome Measures

  1. Absolute harm perception (Packaging Task ) [minute 5]

    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

  2. Absolute harm perception (Digital Marketing Task ) [minute 5]

    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

  3. Product appeal (Packaging Task ) [minute 5]

    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

  4. Product appeal (Digital Marketing Task ) [minute 5]

    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

  5. Absolute safety perception (Packaging Task) [minute 5]

    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

  6. Absolute safety perception (Digital Marketing Task) [minute 5]

    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

  7. Relative safety perception (Packaging Task [minute 5]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 29 Years
Sexes Eligible for Study:
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:
  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Erin Sutfin, PhD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT05439421
Other Study ID Numbers:
  • IRB00060111
First Posted:
Jun 30, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences

Study Results

No Results Posted as of Aug 24, 2022