Health BehaviorNCT04382599
Designing Impactful Warnings for Sugary Drinks
A study testing Text warning with square background, Text warning with octagon background and Icon warning in people with Health Behavior, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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: 1. SSB warnings will be perceived as more effective than the control (message topic) 2. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Text warning with square background, Text warning with octagon background and Icon warning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,078 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2019to 4 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years old
- Prime Panels member
- have at least one child ages 2-12
- Currently reside in the US
Who cannot join
- less than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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)
Read more
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.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- Text warning with square background, Text warning with octagon background, Icon warning, Graphic warning
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text warning with square backgroundBehavioural
The warning message is in white text on a black square background
Text warning with octagon backgroundBehavioural
The warning message is in white text on a black octagon background
Icon warningBehavioural
The warning message in in white text on a black background, below an icon that conveys the topic the warning is about
Graphic warningBehavioural
The warning message in in white text on a black background, below a graphic that conveys the topic the warning is about
| Study group | Role | What they receive |
|---|---|---|
| Added sugar warning message | Experimental | Message displayed on warning labels is: "WARNING: High in added sugar." Receives: Behavioral: Text warning with square background; Behavioral: Text warning with octagon background; Behavioral: Icon warning; Behavioral: Graphic warning |
| Weight gain warning message | Experimental | Message displayed on warning labels is: "WARNING: Excess consumption of drinks with added sugar contributes to weight gain." Receives: Behavioral: Text warning with square background; Behavioral: Text warning with octagon background; Behavioral: Icon warning; Behavioral: Graphic warning |
| Type 2 diabetes warning message | Experimental | Message displayed on warning labels is: "WARNING: Excess consumption of drinks with added sugar contributes to type 2 diabetes." Receives: Behavioral: Text warning with square background; Behavioral: Text warning with octagon background; Behavioral: Icon warning; Behavioral: Graphic warning |
| Heart damage warning message | Experimental | Message displayed on warning labels is: "WARNING: Excess consumption of drinks with added sugar contributes to heart damage." Receives: Behavioral: Text warning with square background; Behavioral: Text warning with octagon background; Behavioral: Icon warning; Behavioral: Graphic warning |
| Neutral message | Active comparator | Message displayed on control label is: "Please refrain from littering." Receives: Behavioral: Text warning with square background; Behavioral: Icon warning; Behavioral: Graphic warning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived message effectiveness
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).
Measured: During survey, which lasts approximately 12-15 minutes.
Secondary outcomes (3)
Perceived product healthfulness of beverages with added sugar
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).
Measured: During survey, which lasts approximately 12-15 minutes.
Intentions to purchase beverages with added sugar
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).
Measured: During survey, which lasts approximately 12-15 minutes.
Thinking about the health problems from beverages with added sugar
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).
Measured: During survey, which lasts approximately 12-15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start7 Oct 2019
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,078 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Marissa G Hall, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382599
- Sponsor's protocol ID
- 19-0277a
- Status last verified
- Jan 2021
- First submitted
- 6 May 2020
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hall MG, Lazard AJ, Grummon AH, Higgins ICA, Bercholz M, Richter APC, Taillie LS. Designing warnings for sugary drinks: A randomized experiment with Latino parents and non-Latino parents. Prev Med. 2021 Jul;148:106562. doi: 10.1016/j.ypmed.2021.106562. Epub 2021 Apr 18.
PubMed 33878350
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing Impactful Warnings for Sugary Drinks
- ClinicalTrials.gov ID
- NCT04382599
- Acronym / sponsor ID
- 19-0277a
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,078 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Added sugar warning message | Experimental | Behavioral: Text warning with square background, Behavioral: Text warning with octagon background, Behavioral: Icon warning, Behavioral: Graphic warningMessage displayed on warning labels is: "WARNING: High in added sugar." |
| Weight gain warning message | Experimental | Behavioral: Text warning with square background, Behavioral: Text warning with octagon background, Behavioral: Icon warning, Behavioral: Graphic warningMessage displayed on warning labels is: "WARNING: Excess consumption of drinks with added sugar contributes to weight gain." |
| Type 2 diabetes warning message | Experimental | Behavioral: Text warning with square background, Behavioral: Text warning with octagon background, Behavioral: Icon warning, Behavioral: Graphic warningMessage displayed on warning labels is: "WARNING: Excess consumption of drinks with added sugar contributes to type 2 diabetes." |
| Heart damage warning message | Experimental | Behavioral: Text warning with square background, Behavioral: Text warning with octagon background, Behavioral: Icon warning, Behavioral: Graphic warningMessage displayed on warning labels is: "WARNING: Excess consumption of drinks with added sugar contributes to heart damage." |
| Neutral message | Active comparator | Behavioral: Text warning with square background, Behavioral: Icon warning, Behavioral: Graphic warningMessage displayed on control label is: "Please refrain from littering." |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years old
- Prime Panels member
- have at least one child ages 2-12
- Currently reside in the US
Key exclusion criteria (1 listed)
- less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text warning with square backgroundThe warning message is in white text on a black square background | Behavioural | Added sugar warning message, Heart damage warning message, Neutral message, Type 2 diabetes warning message, Weight gain warning message |
| Text warning with octagon backgroundThe warning message is in white text on a black octagon background | Behavioural | Added sugar warning message, Heart damage warning message, Type 2 diabetes warning message, Weight gain warning message |
| Icon warningThe warning message in in white text on a black background, below an icon that conveys the topic the warning is about | Behavioural | Added sugar warning message, Heart damage warning message, Neutral message, Type 2 diabetes warning message, Weight gain warning message |
| Graphic warningThe warning message in in white text on a black background, below a graphic that conveys the topic the warning is about | Behavioural | Added sugar warning message, Heart damage warning message, Neutral message, Type 2 diabetes warning message, Weight gain warning message |
Primary outcome
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).
3 secondary outcomes
Perceived product healthfulness of beverages with added sugar
Time frame: 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.
Thinking about the health problems from beverages with added sugar
Time frame: During survey, which lasts approximately 12-15 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Derived from this study: PubMed 33878350Hall MG, Lazard AJ, Grummon AH, Higgins ICA, Bercholz M, Richter APC, Taillie LS. Designing warnings for sugary drinks: A randomized experiment with Latino parents and non-Latino parents. Prev Med. 2021 Jul;148:106562. doi: 10.1016/j.ypmed.2021.106562. Epub 2021 Apr 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marissa G Hall, PhD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text warning with square background, Text warning with octagon background and Icon warning in people with Health Behavior, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived message effectiveness (time frame: During survey, which lasts approximately 12-15 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04382599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.