Health KnowledgeNCT04637412
Perceived Effectiveness of Added Sugar Labels
A study testing Menu label in people with Health Knowledge and Attitude to Health, run by University of California, Davis at 1 site in United States.
Trial summary
This study aims to develop a restaurant menu label to indicate foods and beverage items on restaurant menus that contain high amounts of added sugars and to test its perceived effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitude to Health
- What is being tested?
- Menu label
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,448 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2020to 26 Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Equal or greater than 18 years of age
- Less than 100 years of age
- English-speaking
- U.S. residents
- Had to have purchased food from a restaurant at least once per month prior to the COVID-19 pandemic
- Participants will reflect the U.S. Census Bureau's 2018 American Community Survey 5-year estimates for gender, race/ethnicity, educational attainment, and age
Who cannot join
- Failing the attention check question
- Completing the survey in less than 30% of the median completion time
- Straightlining
- Providing nonsensical responses to open-ended questions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616
About this study
This study aims to develop a restaurant menu label to indicate foods and beverage items on restaurant menus that contain high amounts of added sugars and to test its perceived effectiveness.
Read the detailed description
Objectives and hypotheses:
The goal of this study is to examine how added sugar restaurant menu labels influence U.S. adults' perceptions and reactions. Predictions:
In a between-subjects experiment with 3 arms (control label, icon-only added sugars label, and icon plus text added sugars label):
- Added sugar labels will be perceived as more effective than the control label.
- The text plus icon label will be perceived as more effective than the icon-only label.
- A larger proportion of participants who see the added sugar labels will report learning something new than those who see the control label.
- Added sugar labels will lead participants to more accurately identify restaurant menu items high in added sugars compared to the control label, and the text plus icon label will outperform the icon-only label on this outcome.
Additionally, using a within-subjects design:
The study will examine which label (control, icon, text plus icon) most discourages wanting to consume menu items high in added sugars.
Analyses will compare various icon and text options for the added sugars label to determine which icon and which text variations are perceived as most discouraging for wanting to consume items high in added sugars. The is no hypothesis about which will be perceived as more discouraging.
Planned analyses:
For predictions 1-2: linear regression model (OLS) regressing PME on indicator variables for experimental condition. The margins command in STATA will be used to conduct pairwise comparisons between each condition (i.e., icon-only vs. icon plus text label). Also, PME will be regressed on an indicator variable combining the added sugar label groups.
For predictions 3-4, Poisson regression with robust standard errors will be used to estimate relative probability, regressing each dichotomous outcome on indicator variables for experimental condition. The margins command in STATA will be used to conduct pairwise comparisons between each condition. The outcomes will be regressed on an indicator variable combining the added sugar label groups. If the Poisson regressions do not converge, logistic regression will be used.
For the within-subjects comparisons, mixed effects linear models will be used to assess the relationship between condition and rating of label discouragement for consuming items high in added sugars.
A critical alpha 0.05 will be used, and statistical tests will be two-tailed. Because this is an initial, exploratory study to help identify the best performing label to use in a larger trial, alpha level will not be adjusted to control for multiple comparisons.
If there is evidence of deviations from modeling assumptions required for the parametric tests above, non-parametric sensitivity analyses will be conducted.
- Conditions
- Health Knowledge, Attitude to Health
- Being tested
- Menu label
- Keywords
- Added Sugars, Health messaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menu labelOther
Participants will be shown a sample of items from a restaurant menu, displayed with labels
| Study group | Role | What they receive |
|---|---|---|
| Control label | Experimental | Participant will see a QR code and footnote saying, "Scan the QR code for more menu information." The label will be applied to all menu items displayed. Receives: Other: Menu label |
| Icon plus text added sugars label | Experimental | Participant will see a label containing an icon plus text label with an explanatory footnote. The label will be applied to items high in added sugars (exceeding half the daily value). Participants will randomly view one of 18 variations of icons and text in this arm. Receives: Other: Menu label |
| Icon only added sugars label | Experimental | Participant will see a label containing an icon only with an explanatory footnote. The label will be applied to items high in added sugars (exceeding half the daily value). Participants will randomly view one of 6 variations of icons in this arm. Receives: Other: Menu label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived message effectiveness (PME)
Measured using 3 items adapted from Baig et al. (2018): scale 1-5, "This label makes me concerned about the health effects of consuming menu items high in added sugars", "This label makes consuming menu items high in added sugars seem unpleasant", "This label discourages me from wanting to consume menu items high in added sugars." This outcome is for the between-subjects experiment.
Measured: Up to approximately 5 minutes
Perception of how discouraging the label is for wanting to consume items high in added sugars
Based on a single item adapted from Baig et al. (2018): "This label discourages me from wanting to consume menu items high in added sugar" (scale 1-5). This outcome is the within-subjects objectives.
Measured: Up to approximately 7 minutes
Perception of knowledge gain
Dichotomous response (yes/no) to the question, "Did you learn something new from this label?" This outcome is for the between-subjects experiment.
Measured: Up to approximately 1 minute
Correct identification of items high in added sugars
"Now please look at the menu items below, and select all the ones you think have more than half the daily value for added sugars" with 8 possible responses. A dichotomous outcome variable based on the distribution of correct answers in the sample will be created. This outcome is for the between-subjects experiment.
Measured: Up to approximately 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start13 Nov 2020
- Primary completion26 Dec 2020
- Study completion26 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health KnowledgeStudies of the same condition, open and under way.
- 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
- Model description
- The study uses both a between- and within-subjects design. Between-subjects design: Participants will be randomized to view restaurant menu items with a control label (QR code) or either one of two added sugars labels: an icon based label or the same icon plus text. (Within the icon condition, participants will be randomized to view 1 of 6 label icons. In the icon plus text condition, participants will be randomized to see 1 of 3 text options accompanying 1 of the 6 icons. Within-subjects design: To identify which label is perceived as most discouraging, participants will view the 3 labels one-by-one in random order, for a total of 3 conditions. To identify which design variations in icon and text are perceived as most discouraging, participants will view 6 icon-only labels one-by-one in random order. Then participants will view each of the 3 text variations together with one of the icons one-by-one in random order.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,448 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Science in the Public Interest (CSPI)
- Responsible party
- Sponsor
- Investigators
- Jennifer Falbe, ScD, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637412
- Sponsor's protocol ID
- 1641776
- Status last verified
- Jan 2021
- First submitted
- 16 Nov 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baig SA, Noar SM, Gottfredson NC, Boynton MH, Ribisl KM, Brewer NT. UNC Perceived Message Effectiveness: Validation of a Brief Scale. Ann Behav Med. 2019 Jul 17;53(8):732-742. doi: 10.1093/abm/kay080.
PubMed 30321252Sigala DM, Hall MG, Musicus AA, Roberto CA, Solar SE, Fan S, Sorscher S, Nara D, Falbe J. Perceived effectiveness of added-sugar warning label designs for U.S. restaurant menus: An online randomized controlled trial. Prev Med. 2022 Jul;160:107090. doi: 10.1016/j.ypmed.2022.107090. Epub 2022 May 17.
PubMed 35594928
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Effectiveness of Added Sugar Labels
- ClinicalTrials.gov ID
- NCT04637412
- Acronym / sponsor ID
- 1641776
- Conditions
- Health Knowledge, Attitude to Health
- Keywords
- Added Sugars, Health messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,448 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Center for Science in the Public Interest (CSPI)
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 26 Dec 2020 (actual)
- Study completion
- 26 Dec 2020 (actual)
- First posted
- 19 Nov 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.
This study aims to develop a restaurant menu label to indicate foods and beverage items on restaurant menus that contain high amounts of added sugars and to test its perceived effectiveness.
Detailed description
Objectives and hypotheses:
The goal of this study is to examine how added sugar restaurant menu labels influence U.S. adults' perceptions and reactions. Predictions:
In a between-subjects experiment with 3 arms (control label, icon-only added sugars label, and icon plus text added sugars label):
- Added sugar labels will be perceived as more effective than the control label.
- The text plus icon label will be perceived as more effective than the icon-only label.
- A larger proportion of participants who see the added sugar labels will report learning something new than those who see the control label.
- Added sugar labels will lead participants to more accurately identify restaurant menu items high in added sugars compared to the control label, and the text plus icon label will outperform the icon-only label on this outcome.
Additionally, using a within-subjects design:
The study will examine which label (control, icon, text plus icon) most discourages wanting to consume menu items high in added sugars.
Analyses will compare various icon and text options for the added sugars label to determine which icon and which text variations are perceived as most discouraging for wanting to consume items high in added sugars. The is no hypothesis about which will be perceived as more discouraging.
Planned analyses:
For predictions 1-2: linear regression model (OLS) regressing PME on indicator variables for experimental condition. The margins command in STATA will be used to conduct pairwise comparisons between each condition (i.e., icon-only vs. icon plus text label). Also, PME will be regressed on an indicator variable combining the added sugar label groups.
For predictions 3-4, Poisson regression with robust standard errors will be used to estimate relative probability, regressing each dichotomous outcome on indicator variables for experimental condition. The margins command in STATA will be used to conduct pairwise comparisons between each condition. The outcomes will be regressed on an indicator variable combining the added sugar label groups. If the Poisson regressions do not converge, logistic regression will be used.
For the within-subjects comparisons, mixed effects linear models will be used to assess the relationship between condition and rating of label discouragement for consuming items high in added sugars.
A critical alpha 0.05 will be used, and statistical tests will be two-tailed. Because this is an initial, exploratory study to help identify the best performing label to use in a larger trial, alpha level will not be adjusted to control for multiple comparisons.
If there is evidence of deviations from modeling assumptions required for the parametric tests above, non-parametric sensitivity analyses will be conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The study uses both a between- and within-subjects design. Between-subjects design: Participants will be randomized to view restaurant menu items with a control label (QR code) or either one of two added sugars labels: an icon based label or the same icon plus text. (Within the icon condition, participants will be randomized to view 1 of 6 label icons. In the icon plus text condition, participants will be randomized to see 1 of 3 text options accompanying 1 of the 6 icons. Within-subjects design: To identify which label is perceived as most discouraging, participants will view the 3 labels one-by-one in random order, for a total of 3 conditions. To identify which design variations in icon and text are perceived as most discouraging, participants will view 6 icon-only labels one-by-one in random order. Then participants will view each of the 3 text variations together with one of the icons one-by-one in random order.
| Arm | Type | Receives |
|---|---|---|
| Control label | Experimental | Other: Menu labelParticipant will see a QR code and footnote saying, "Scan the QR code for more menu information." The label will be applied to all menu items displayed. |
| Icon plus text added sugars label | Experimental | Other: Menu labelParticipant will see a label containing an icon plus text label with an explanatory footnote. The label will be applied to items high in added sugars (exceeding half the daily value). Participants will randomly view one of 18 variations of icons and text in this arm. |
| Icon only added sugars label | Experimental | Other: Menu labelParticipant will see a label containing an icon only with an explanatory footnote. The label will be applied to items high in added sugars (exceeding half the daily value). Participants will randomly view one of 6 variations of icons in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Equal or greater than 18 years of age
- Less than 100 years of age
- English-speaking
- U.S. residents
- Had to have purchased food from a restaurant at least once per month prior to the COVID-19 pandemic
Key exclusion criteria (4 listed)
- Failing the attention check question
- Completing the survey in less than 30% of the median completion time
- Straightlining
- Providing nonsensical responses to open-ended questions
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 |
|---|---|---|
| Menu labelParticipants will be shown a sample of items from a restaurant menu, displayed with labels | Other | Control label, Icon only added sugars label, Icon plus text added sugars label |
Primary outcome
Perceived message effectiveness (PME)
Time frame: Up to approximately 5 minutes
Measured using 3 items adapted from Baig et al. (2018): scale 1-5, "This label makes me concerned about the health effects of consuming menu items high in added sugars", "This label makes consuming menu items high in added sugars seem unpleasant", "This label discourages me from wanting to consume menu items high in added sugars." This outcome is for the between-subjects experiment.
Perception of how discouraging the label is for wanting to consume items high in added sugars
Time frame: Up to approximately 7 minutes
Based on a single item adapted from Baig et al. (2018): "This label discourages me from wanting to consume menu items high in added sugar" (scale 1-5). This outcome is the within-subjects objectives.
Perception of knowledge gain
Time frame: Up to approximately 1 minute
Dichotomous response (yes/no) to the question, "Did you learn something new from this label?" This outcome is for the between-subjects experiment.
Correct identification of items high in added sugars
Time frame: Up to approximately 2 minutes
"Now please look at the menu items below, and select all the ones you think have more than half the daily value for added sugars" with 8 possible responses. A dichotomous outcome variable based on the distribution of correct answers in the sample will be created. This outcome is for the between-subjects experiment.
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 8 Jan 2021.
- Background: PubMed 30321252Baig SA, Noar SM, Gottfredson NC, Boynton MH, Ribisl KM, Brewer NT. UNC Perceived Message Effectiveness: Validation of a Brief Scale. Ann Behav Med. 2019 Jul 17;53(8):732-742. doi: 10.1093/abm/kay080.
- Derived from this study: PubMed 35594928Sigala DM, Hall MG, Musicus AA, Roberto CA, Solar SE, Fan S, Sorscher S, Nara D, Falbe J. Perceived effectiveness of added-sugar warning label designs for U.S. restaurant menus: An online randomized controlled trial. Prev Med. 2022 Jul;160:107090. doi: 10.1016/j.ypmed.2022.107090. Epub 2022 May 17.
- 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.
Jennifer Falbe, ScD, MPH principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menu label in people with Health Knowledge and Attitude to Health, run by University of California, Davis 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 6 inclusion and 4 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 8 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 (PME) (time frame: Up to approximately 5 minutes). The study lists 4 primary outcomes in all. 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 NCT04637412, which also lists 2 linked publications.
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 8 Jan 2021.