Clinical trial NCT05439421: Consumer Perceptions of Waterpipe Tobacco Packaging and Digital Marketing Claims
Official title: Consumer Perceptions of Waterpipe Tobacco Packaging and Digital Marketing Claims
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Waterpipe Tobacco Smoking
Keywords: Waterpipe tobacco smoking
hookah tobacco warning
hookah tobacco
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-06-30
Enrollment: 1507
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized to see 6 packages and 10 advertisements, with or without the claim of interest on each.
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Willingness to Try Hookah Tobacco (Packaging Task )
timeFrame: minute 5
measure: Willingness to Smoke Hookah Tobacco (Digital Marketing Task )
timeFrame: minute 5
Secondary outcomes:
Other outcomes:
measure: Absolute Harm Perception (Packaging Task )
timeFrame: minute 5
measure: Absolute Harm Perception (Digital Marketing Task )
timeFrame: minute 5
measure: Product Appeal (Packaging Task )
timeFrame: minute 5
measure: Product Appeal (Digital Marketing Task )
timeFrame: minute 5
measure: Absolute Safety Perception (Packaging Task)
timeFrame: minute 5
measure: Absolute Safety Perception (Digital Marketing Task)
timeFrame: minute 5
measure: Relative Safety Perception (Packaging Task
timeFrame: minute 5
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Erin Sutfin, PhD
role: PRINCIPAL_INVESTIGATOR
References: