Comparison of Text and Pictorial Waterpipe Tobacco Warnings Among Young Adults

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

Study Overview

• Status: Completed
• Conditions: Waterpipe Tobacco Smoking
• Intervention / Treatment: Behavioral: Pictorial Warnings; Behavioral: Text Warnings; Behavioral: No Warnings (Control)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1215
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pictorial Warnings; Waterpipe tobacco packages shown with pictorial warnings about health harms of waterpipe smoking	Behavioral: 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.
Experimental: Text Warnings; Waterpipe tobacco packages shown with text-only warning about health harms of waterpipe smoking	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.
Experimental: No Warnings (Control); Waterpipe tobacco package shown without a warning	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Intentions	The primary outcome is intention to smoke tobacco in a waterpipe within the next year, measured by averaging three items to create a composite score (adapted from research on cigarette smoking). The primary outcome will be measured after the exposure to waterpipe packages. Score ranges from 1-5 with higher score indicating greater intention to smoke hookah.; How interested are you in smoking hookah in the next year?; How likely are you to smoke hookah in the next year?; How much do you plan to smoke hookah in the next year? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) Very interested/likely/much	Minute 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product Appeal	Three items will be used to measure how appealing each waterpipe tobacco package is to respondents, how likely they would be to try the product, and how much the packaging makes the respondent think that the product is harmful.; How appealing is this product to you?; How likely would you be to try this product?; How much does this packaging make you think this product is harmful? Response scale: (1) Not at all / (2) A little / (3) Somewhat / (4) A lot	Minute 2
Perceived Message Effectiveness	This outcome will be measured using the 3-item Perceived Measured Effectiveness scale created by Noar and colleagues that includes items on attitudes, risk beliefs, and intentions. Mean scores will be calculated.; How much does this warning make smoking hookah seem unpleasant to you?; How much does this warning make you concerned about the health effects of smoking hookah?; How much does this warning discourage you from wanting to smoke hookah? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal	Minute 2
Attention	One item to measure self-reported attention to the warning. 1. How much does this warning grab your attention? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal	Minute 1
Emotional Reactions	Three items to measure negative emotional reactions to the warning that the participant saw. Mean scores will be calculated.; How much does this warning make you feel anxious?; How much does this warning make you feel disgusted?; How much does this warning make you feel scared? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal	Minute 2
Cognitive Elaboration	One item to measure the extent to which a participant reports the warning making them think about the risks of hookah smoking. 1. How much does this warning make you think about the health effects of smoking hookah? Response scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal	Minute 1
Self-reported Learning	One item to measure the extent to which respondents learned something new from the warning. 1. To what extent did you learn something new from this warning that you did not already know? Response Scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal	Minute 1
Social Interactions	One item to measure self-reported likelihood of discussing the warning shown with one's social contacts within the week following the survey. 1. How likely are you to talk about this warning with others in the next week? Response Scale: (1) Not at all / (2) Very little / (3) Somewhat / (4) Quite a bit / (5) A great deal	Minute 1
Knowledge	Six items to measure knowledge of the potential health harms described by the warnings.; Hookah smoking causes heart damage.; Hookah smoking causes lung damage.; Hookah smoking causes mouth cancer.; Hookah smoking causes carbon monoxide poisoning.; Hookah smoking during pregnancy stunts fetal growth.; Hookah smoking causes nicotine addiction. Response scale: (1) True / (2) False / (3) I don't know	Minute 3
Beliefs	Five items to measure the respondent's belief of their own risk of experiencing each of the warning health harms. One item measures risk to pregnant people, rather than the self, since this item will be administered to all participants.; If I smoke hookah, I will damage my heart.; If I smoke hookah, I will damage my lungs.; If I smoke hookah, I will get mouth cancer.; If I smoke hookah, I will get carbon monoxide poisoning.; If a person smokes hookah during pregnancy, it will stunt fetal growth.; If I smoke hookah, I will become addicted. Response scale: (1) Strongly disagree / (2) Somewhat disagree / (3) Neither disagree nor agree / (4) Somewhat agree / (5) Strongly agree	Minute 3
Worry	Five/six items measuring a respondent's concern about their risk of warning health effects. Damage to fetuses will only be asked of respondents who report female sex at birth.; If you smoke hookah, how much would you worry about getting mouth cancer?; If you smoke hookah, how much would you worry about damaging your heart?; If you smoke hookah, how much would you worry about damaging your lungs?; If you smoke hookah, how much would you worry about getting carbon monoxide poisoning?; If you smoke hookah, how much would you worry about stunting fetal growth, if you were pregnant?; If you smoke hookah, how much would you worry about becoming addicted? Response scale: (1) Not at all / (2) A little / (3) Somewhat / (4) A lot	Minute 3
Quit Motivation	Participants who report past-year use will report, on a scale of 1-10, how motivated they are to quit smoking hookah.	Minute 1

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Erin Sutfin, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): April 7, 2023
• Study Completion (Actual): April 7, 2023

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Waterpipe Tobacco Smoking
• Other Study ID Numbers: IRB00091946; R01CA241420 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No