Nutrition KnowledgeNCT06666725
Effect of Added-sugar Menu Labels
A study testing Menu label in people with Nutrition Knowledge and Dietary Behaviour, run by University of California, Davis at 1 site in United States.
Trial summary
To compare two added-sugar menu label--(1) red, icon-only, 150% of the menu text height and (2) black, icon-plus-text, 100% of the menu text height--to a no-label control on grams of added sugar ordered using two different added-sugar labeling thresholds: (1) ≥50% of Daily Value for added sugar (equivalent to ≥25g)… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Knowledge, Dietary Behaviour
- What is being tested?
- Menu label
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,275 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2024to 13 Feb 2025
- 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
- Equal or greater than 18 years of age
- English-speaking
- U.S. residents
- Have eaten restaurant food at least once in the last month
- Participants will reflect the U.S. Census Bureau's American Community Survey 5-year estimates for sex, race/ethnicity, educational attainment, and age
Who cannot join
- Failing the attention check question
- Completing the survey in less than 33% of the median completion time
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616
About this study
Official title: Restaurant Menu Labeling: Added-sugar Labels and Labeling Thresholds
To compare two added-sugar menu label--(1) red, icon-only, 150% of the menu text height and (2) black, icon-plus-text, 100% of the menu text height--to a no-label control on grams of added sugar ordered using two different added-sugar labeling thresholds: (1) ≥50% of Daily Value for added sugar (equivalent to ≥25g) and (2) ≥100% of Daily Value for added sugar (equivalent to ≥50g)
Read the detailed description
The main goal of this study is to compare two added-sugar menu labels--(1) red, icon-only, 150% of the menu text height and (2) black, icon-plus-text, 100% of the menu text height--to a no-label control on grams of added sugar ordered using two different added-sugar labeling thresholds: (1) ≥50% of Daily Value for added sugar (equivalent to ≥25g) and (2) ≥100% of Daily Value for added sugar (equivalent to ≥50g). This results in 5 conditions: (1) icon-only at 50% threshold, (2) icon-plus-text at 50% threshold, (3) icon-only at 100% threshold, (4) icon-plus-text at 100% threshold, and (5) no-label control.
The two primary outcomes are (1) grams of added sugar ordered averaged across a fast-food and full-service restaurant menus and (2) grams of added sugar ordered from a café menu. The secondary outcomes are (1) noticing a high added sugar nutrition label and (2) knowledge of items' added sugar content.
For continuous outcomes (e.g., grams of added sugar, knowledge), linear regression models regressing the outcome on an indicator for experimental condition will be used. If the outcomes are not normally distributed, alternative modeling approaches or data transformations will be explored. For dichotomous outcomes (e.g., noticing the added-sugar label), the probability ratio will be modeled using Poisson regression with a robust error variance, regressing the outcome on an indicator for experimental condition.
Exploration of effect modification of the labels on primary outcomes by type 2 diabetes status and sociodemographic variables important for health equity will be conducted using interaction terms and stratified models.
Exploratory process outcomes include (1) selection of at least one item that contains ≥50% of the Daily Value of added sugar and (2) selection of at least one item that contains ≥100% of Daily Value of added sugar. Other exploratory outcomes include the perception that the labels grabbed attention and support for an added sugars warning label policy. Additionally, differences in the primary outcomes between each of the 5 unique conditions will be examined. If there is evidence of interactions, the modeling approach will be modified.
- Conditions
- Nutrition Knowledge, Dietary Behaviour
- Being tested
- Menu label
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menu labelOther
Participants will select food items from three restaurant menus, displayed with labels as specified by their assigned group
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participant will order food and beverages from three menus. The menus will not contain any added sugar labels. |
| Large, red, icon-only label, 50% daily value | Experimental | Participant will order food and beverages from three menus containing labels next to items that contain equal to or higher than half the daily value of added sugar (greater than or equal to 25 grams). The label will be on the right of the item, colored red, icon only design, and height that is 150% of size of the menu text height. Receives: Other: Menu label |
| Large, red, icon-only label, 100% daily value | Experimental | Participant will order food and beverages from three menus containing labels next to items that contain equal to or higher than the total daily value of added sugar (greater than or equal to 50 grams). The label will be on the right of the item, colored red, icon only design, and height that is 150% of size of the menu text height. Receives: Other: Menu label |
| Small, black, icon-plus-text label, 50% daily value | Experimental | Participant will order food and beverages from three menus containing labels next to items that contain equal to or higher than half the daily value of added sugar (greater than or equal to 25 grams). The label will be on the right of the item, colored black, icon plus text design, and height that is 100% of size of the menu text height. Receives: Other: Menu label |
| Small, black, icon-plus-text label, 100% daily value | Experimental | Participant will order food and beverages from three menus containing labels next to items that contain equal to or higher than the total daily value of added sugar (greater than or equal to 50 grams). The label will be on the right of the item, colored black, icon plus text design, and height that is 100% of size of the menu text height. Receives: Other: Menu label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grams of added sugar ordered averaged across fast-food and full-service menus
Continuous variable. Average grams of added sugar in foods and beverages selected, averaged across fast-food and full-service menus, analyzed using linear regression to examine differences between factor levels
Measured: Within approximately 2 minutes of intervention exposure
Grams of added sugar ordered from a cafe menu
Continuous variable. Total grams of added sugar in menu items selected from a cafe menu, analyzed using linear regression to examine differences between factor levels
Measured: Within approximately 2 minutes of intervention exposure
Secondary outcomes (2)
Noticing and recall of added-sugar nutrient label - dichotomous variable "Correct" (Answered "Yes" to noticing, answered "Added sugars" to recall, and answered "high" for high low recall question) or "Incorrect" (otherwise)
Noticing a nutrition label - Measured with "Think back to the beginning of this survey when you imagined you were ordering dinner from restaurant menus. Did you notice any nutrition labels (other than the calories) next to any of the menu items?" Response options are "Yes", "No", and "Don't know".
Recalling the label's meaning - [If answered "Yes"] Measured with "What did the nutrition label tell you about?" Response options are (displayed in survey in a random order) "Sodium", "Added sugars", "Trans fats", "Fiber", "Calcium", "Healthy items", "Unhealthy items", "Vegetarian", "Organic", "Gluten-free", "Sustainable", "None of these", "Not sure".
High/low - [If answered "Added sugars"] "What did the label tell you about added sugars?" Response options are "High in added sugars", "Low in added sugars", "Something else", "I don't know".
There is no formal name for this measure/scale.
Measured: Within approximately 10 minutes of intervention exposure
Knowledge of menu items high in added sugar
Measured with "(While viewing menu excerpt) Click on the menu items that you think have equal to or more than half [or "equal to or more than the total", if assigned 100% threshold] the daily limit for added sugars." Continuous variable using the percent of 8 items correctly classified. Higher percentages of items correctly classified represent more knowledge.
Measured: Within approximately 10 minutes of intervention exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start23 Dec 2024
- Primary completion13 Feb 2025
- Study completion13 Feb 2025
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 Nutrition KnowledgeStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 11,275 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Falbe, University of California, Davis
- Investigators
- Jennifer Falbe, ScD, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666725
- Sponsor's protocol ID
- 1641776-8
- Status last verified
- May 2025
- First submitted
- 17 Oct 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All variables used in the results of this study (experimental condition and individual level data on reactions to, perceptions of, and hypothetical behaviors in response to added-sugar menu label designs).
Publications
Huang Y, Lemmon B, Musicus AA, Roberto CA, Hall MG, Falbe J. Effects of added-sugar warning labels on restaurant menus in the USA: an online randomised controlled trial. Lancet Public Health. 2026 Jun;11(6):e375-e385. doi: 10.1016/S2468-2667(26)00074-5.
PubMed 42202820
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restaurant Menu Labeling: Added-sugar Labels and Labeling Thresholds
- ClinicalTrials.gov ID
- NCT06666725
- Acronym / sponsor ID
- 1641776-8
- Conditions
- Nutrition Knowledge, Dietary Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,275 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 31 Oct 2024 (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.
To compare two added-sugar menu label--(1) red, icon-only, 150% of the menu text height and (2) black, icon-plus-text, 100% of the menu text height--to a no-label control on grams of added sugar ordered using two different added-sugar labeling thresholds: (1) ≥50% of Daily Value for added sugar (equivalent to ≥25g) and (2) ≥100% of Daily Value for added sugar (equivalent to ≥50g)
Detailed description
The main goal of this study is to compare two added-sugar menu labels--(1) red, icon-only, 150% of the menu text height and (2) black, icon-plus-text, 100% of the menu text height--to a no-label control on grams of added sugar ordered using two different added-sugar labeling thresholds: (1) ≥50% of Daily Value for added sugar (equivalent to ≥25g) and (2) ≥100% of Daily Value for added sugar (equivalent to ≥50g). This results in 5 conditions: (1) icon-only at 50% threshold, (2) icon-plus-text at 50% threshold, (3) icon-only at 100% threshold, (4) icon-plus-text at 100% threshold, and (5) no-label control.
The two primary outcomes are (1) grams of added sugar ordered averaged across a fast-food and full-service restaurant menus and (2) grams of added sugar ordered from a café menu. The secondary outcomes are (1) noticing a high added sugar nutrition label and (2) knowledge of items' added sugar content.
For continuous outcomes (e.g., grams of added sugar, knowledge), linear regression models regressing the outcome on an indicator for experimental condition will be used. If the outcomes are not normally distributed, alternative modeling approaches or data transformations will be explored. For dichotomous outcomes (e.g., noticing the added-sugar label), the probability ratio will be modeled using Poisson regression with a robust error variance, regressing the outcome on an indicator for experimental condition.
Exploration of effect modification of the labels on primary outcomes by type 2 diabetes status and sociodemographic variables important for health equity will be conducted using interaction terms and stratified models.
Exploratory process outcomes include (1) selection of at least one item that contains ≥50% of the Daily Value of added sugar and (2) selection of at least one item that contains ≥100% of Daily Value of added sugar. Other exploratory outcomes include the perception that the labels grabbed attention and support for an added sugars warning label policy. Additionally, differences in the primary outcomes between each of the 5 unique conditions will be examined. If there is evidence of interactions, the modeling approach will be modified.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participant will order food and beverages from three menus. The menus will not contain any added sugar labels. |
| Large, red, icon-only label, 50% daily value | Experimental | Other: Menu labelParticipant will order food and beverages from three menus containing labels next to items that contain equal to or higher than half the daily value of added sugar (greater than or equal to 25 grams). The label will be on the right of the item, colored red, icon only design, and height that is 150% of size of the menu text height. |
| Large, red, icon-only label, 100% daily value | Experimental | Other: Menu labelParticipant will order food and beverages from three menus containing labels next to items that contain equal to or higher than the total daily value of added sugar (greater than or equal to 50 grams). The label will be on the right of the item, colored red, icon only design, and height that is 150% of size of the menu text height. |
| Small, black, icon-plus-text label, 50% daily value | Experimental | Other: Menu labelParticipant will order food and beverages from three menus containing labels next to items that contain equal to or higher than half the daily value of added sugar (greater than or equal to 25 grams). The label will be on the right of the item, colored black, icon plus text design, and height that is 100% of size of the menu text height. |
| Small, black, icon-plus-text label, 100% daily value | Experimental | Other: Menu labelParticipant will order food and beverages from three menus containing labels next to items that contain equal to or higher than the total daily value of added sugar (greater than or equal to 50 grams). The label will be on the right of the item, colored black, icon plus text design, and height that is 100% of size of the menu text height. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Equal or greater than 18 years of age
- English-speaking
- U.S. residents
- Have eaten restaurant food at least once in the last month
- Participants will reflect the U.S. Census Bureau's American Community Survey 5-year estimates for sex, race/ethnicity, educational attainment, and age
Key exclusion criteria (2 listed)
- Failing the attention check question
- Completing the survey in less than 33% of the median completion time
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 select food items from three restaurant menus, displayed with labels as specified by their assigned group | Other | Large, red, icon-only label, 100% daily value, Large, red, icon-only label, 50% daily value, Small, black, icon-plus-text label, 100% daily value, Small, black, icon-plus-text label, 50% daily value |
Primary outcome
Grams of added sugar ordered averaged across fast-food and full-service menus
Time frame: Within approximately 2 minutes of intervention exposure
Continuous variable. Average grams of added sugar in foods and beverages selected, averaged across fast-food and full-service menus, analyzed using linear regression to examine differences between factor levels
Grams of added sugar ordered from a cafe menu
Time frame: Within approximately 2 minutes of intervention exposure
Continuous variable. Total grams of added sugar in menu items selected from a cafe menu, analyzed using linear regression to examine differences between factor levels
2 secondary outcomes
Noticing and recall of added-sugar nutrient label - dichotomous variable "Correct" (Answered "Yes" to noticing, answered "Added sugars" to recall, and answered "high" for high low recall question) or "Incorrect" (otherwise)
Time frame: Within approximately 10 minutes of intervention exposure
Knowledge of menu items high in added sugar
Time frame: Within approximately 10 minutes of intervention exposure
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 11 May 2025.
- Derived from this study: PubMed 42202820Huang Y, Lemmon B, Musicus AA, Roberto CA, Hall MG, Falbe J. Effects of added-sugar warning labels on restaurant menus in the USA: an online randomised controlled trial. Lancet Public Health. 2026 Jun;11(6):e375-e385. doi: 10.1016/S2468-2667(26)00074-5.
- Individual participant dataSharing planned: Yes. All variables used in the results of this study (experimental condition and individual level data on reactions to, perceptions of, and hypothetical behaviors in response to added-sugar menu label designs).
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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 Nutrition Knowledge and Dietary Behaviour, 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 5 inclusion and 2 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 11 May 2025. 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?
Grams of added sugar ordered averaged across fast-food and full-service menus (time frame: Within approximately 2 minutes of intervention exposure). The study lists 2 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 NCT06666725, 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 11 May 2025.