- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04382599
Designing Impactful Warnings for Sugary Drinks
The goal of this online RCT study is to examine how sugar-sweetened beverage (SSB) health warnings influence US adults' perceptions and reactions. The investigators have the following predictions:
- SSB warnings will be perceived as more effective than the control (message topic)
- Icon and graphic warnings will be perceived as more effective than text-only warnings (message type)
The investigators will also examine the interaction of warning topic and warning type, but have no specific hypothesis about this interaction.
Finally, the investigators will test the following predictions about the secondary outcomes:
SSB warnings (vs. control), as well as icon and graphic warnings (vs text.warnings), will lead to lower perceived product healthfulness, lower purchase intentions, and higher cognitive elaboration.
Study Overview
Status
Conditions
Detailed Description
Childhood obesity is a major public health problem in the US among racial and ethnic minorities, including among the US's growing Latino population. One promising but understudied policy for addressing childhood obesity is requiring warnings on the front of sugar-sweetened beverage containers. However, the topic and design of warnings that are most effective in communicating the harms of sugar-sweetened beverages remains unknown. This study assess which warning topics and which warning designs lead to the greatest perceived message effectiveness among US Latino and non-Latino parents of children ages 2-12. The investigators focus on parents as they are the primary decision-makers and purchasers of food products for children and exert strong influence over their children's dietary intake and food attitudes.
Setting: The trial will take place online on a survey developed using Qualtrics.
Recruitment: Participants will be recruited online by CloudResearch PrimePanels, a survey research platform with access to over 20 million participants. As such, participants will have to be PrimePanels members in order to participate.
Informed Consent: After determining eligibility, eligible participants will be directed to a page on Qualtrics with the consent form. Participants acknowledge their consent in the study by clicking the "next page" arrow and proceeding to the study.
Randomization: After consenting, the participant is randomly assigned to to view one of the 5 warning topics. "WARNING: High in added sugar" (added sugar), "WARNING: Excess consumption of drinks with added sugar contributes to weight gain" (weight gain), "WARNING: Excess consumption of drinks with added sugar contributes to type 2 diabetes" (Type 2 diabetes), "WARNING: Excess consumption of drinks with added sugar contributes to heart damage" (heart damage), and "Please refrain from littering" (control). Within each of the four experimental arms, participants see the message displayed on four different types of warning designs: a text warning on a square background, a text warning on a octagon background, and icon warning, and a graphic warning. Within the control arm, participants see the message displayed on three different types of warning designs: a text warning on a square background, an icon warning, and a graphic warning. Participants randomly see the different warning designs in a random order.
Survey: The participants complete a survey answering behavioral perceptions and intentions questions about the different warning labels.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina Chapel Hill
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- at least 18 years old
- Prime Panels member
- have at least one child ages 2-12
- Currently reside in the US
Exclusion Criteria:
- less than 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Added sugar warning message
Message displayed on warning labels is: "WARNING: High in added sugar."
|
The warning message is in white text on a black square background
The warning message is in white text on a black octagon background
The warning message in in white text on a black background, below an icon that conveys the topic the warning is about
The warning message in in white text on a black background, below a graphic that conveys the topic the warning is about
|
Experimental: Weight gain warning message
Message displayed on warning labels is: "WARNING: Excess consumption of drinks with added sugar contributes to weight gain."
|
The warning message is in white text on a black square background
The warning message is in white text on a black octagon background
The warning message in in white text on a black background, below an icon that conveys the topic the warning is about
The warning message in in white text on a black background, below a graphic that conveys the topic the warning is about
|
Experimental: Type 2 diabetes warning message
Message displayed on warning labels is: "WARNING: Excess consumption of drinks with added sugar contributes to type 2 diabetes."
|
The warning message is in white text on a black square background
The warning message is in white text on a black octagon background
The warning message in in white text on a black background, below an icon that conveys the topic the warning is about
The warning message in in white text on a black background, below a graphic that conveys the topic the warning is about
|
Experimental: Heart damage warning message
Message displayed on warning labels is: "WARNING: Excess consumption of drinks with added sugar contributes to heart damage."
|
The warning message is in white text on a black square background
The warning message is in white text on a black octagon background
The warning message in in white text on a black background, below an icon that conveys the topic the warning is about
The warning message in in white text on a black background, below a graphic that conveys the topic the warning is about
|
Active Comparator: Neutral message
Message displayed on control label is: "Please refrain from littering."
|
The warning message is in white text on a black square background
The warning message in in white text on a black background, below an icon that conveys the topic the warning is about
The warning message in in white text on a black background, below a graphic that conveys the topic the warning is about
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived message effectiveness
Time Frame: During survey, which lasts approximately 12-15 minutes.
|
Perceived message effectiveness as measured by average response to three statements: This message makes me concerned about the health effects of drinking beverages with added sugar. Response options are on a scale (1=Strongly disagree...5=Strongly agree). This message makes drinking beverages with added sugar seem unpleasant to me. Response options are on a scale (1=Strongly disagree...5=Strongly agree). This message discourages me from wanting to drink beverages with added sugar. Response options are on a scale (1=Strongly disagree...5=Strongly agree). |
During survey, which lasts approximately 12-15 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived product healthfulness of beverages with added sugar
Time Frame: During survey, which lasts approximately 12-15 minutes.
|
Measured with the question, "How healthy or unhealthy would it be for your child to drink beverages with added sugar every day?" Response options are on a scale (1= Very unhealthy...5=Very healthy).
|
During survey, which lasts approximately 12-15 minutes.
|
Intentions to purchase beverages with added sugar
Time Frame: During survey, which lasts approximately 12-15 minutes.
|
Measured with the question, "How likely are you to buy beverages with added sugar for your child in the next four weeks?"
Response options are on a scale (1 = Not at all likely...5 = Extremely likely).
|
During survey, which lasts approximately 12-15 minutes.
|
Thinking about the health problems from beverages with added sugar
Time Frame: During survey, which lasts approximately 12-15 minutes.
|
Measured with the question, "How much does this message make you think about the health problems caused by drinking beverages with added sugar?" Response options are on a scale (1=Not at all...5=Very much).
|
During survey, which lasts approximately 12-15 minutes.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marissa G Hall, PhD, University of North Carolina
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19-0277a
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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