Comparison of Text and Pictorial Waterpipe Tobacco Warnings Among Young Adults

NCT ID: NCT05783843

Last Updated: 2024-05-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2023-04-07

Brief Summary

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The purpose of this study is to whether exposure to waterpipe tobacco warnings reduce young adults' intentions to smoke waterpipe in the future.

Detailed Description

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Young adults, defined as those 18-29 years old, have the highest rates of waterpipe tobacco smoking, which increases their risk of a variety of pulmonary, neurological, and oncological health conditions, among many others. This trial will randomly assign young adult waterpipe users or those susceptible to use to view waterpipe tobacco packages with text warning, pictorial warnings, or no warnings in a one-time online study. Participants will answer a series of questions regarding each package.

Conditions

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Waterpipe Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants randomized to the text-only condition will see six packages with different text warnings. Participants randomized to the pictorial condition will see six packages with different pictorial warnings. Participants in the control condition will see a single package without a warning.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Participants will be blinded as to the comparators for their arm.

Study Groups

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Pictorial Warnings

Waterpipe tobacco packages shown with pictorial warnings about health harms of waterpipe smoking

Group Type EXPERIMENTAL

Pictorial Warnings

Intervention Type BEHAVIORAL

Participants will be shown 6 waterpipe tobacco packages with 6 different pictorial warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm.

Text Warnings

Waterpipe tobacco packages shown with text-only warning about health harms of waterpipe smoking

Group Type EXPERIMENTAL

Text Warnings

Intervention Type BEHAVIORAL

Participants will be shown 6 waterpipe tobacco packages with 6 different text-only warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm.

No Warnings (Control)

Waterpipe tobacco package shown without a warning

Group Type EXPERIMENTAL

No Warnings (Control)

Intervention Type BEHAVIORAL

Participants will be shown a single package without a warning. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study.

Interventions

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Pictorial Warnings

Participants will be shown 6 waterpipe tobacco packages with 6 different pictorial warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm.

Intervention Type BEHAVIORAL

Text Warnings

Participants will be shown 6 waterpipe tobacco packages with 6 different text-only warnings about the health harms of waterpipe smoking. The order of the 6 packages within this trial arm will be randomized. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study and designed the warnings for this arm.

Intervention Type BEHAVIORAL

No Warnings (Control)

Participants will be shown a single package without a warning. Study investigators developed a fictitious waterpipe tobacco brand to be used in this study.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* United States (US) Resident
* Has used waterpipe tobacco within the past year (self-report) OR
* Has not used waterpipe tobacco within the past year but is susceptible to use (self-report)

Exclusion Criteria

* Younger than 18 or older than 29
* Not a US Resident
* Has not used waterpipe tobacco within 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

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01CA241420

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00091946

Identifier Type: -

Identifier Source: org_study_id

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