- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06204913
Menu Label Noticeability
Restaurant Menu Study: Label Noticeability
Study Overview
Status
Intervention / Treatment
Detailed Description
The objective of this aim is to assess the relative noticeability of legally-viable added-sugar menu label characteristics. The investigators will use a between-subject experiment with a factorial design. Participants will be randomized to label type (icon-only vs. icon-plus-text label vs. boxed icon), color (black vs. red), size (100% vs. 150% of the height of the menu item text), and placement (left vs. right side of item). This results in 24 arms of the experiment.
The primary outcomes are noticing a nutrition label and recognition of the label. Secondary outcomes are knowledge of items that are high in added sugar and perceived message effectiveness (PME) of labels.
For dichotomous outcomes (e.g., noticing the label, recalling label meaning), the investigators will directly estimate the probability ratio using Poisson regression with a robust error variance, regressing the outcome on an indicator for the level of the factor. For continuous outcomes (e.g., knowledge, PME scale), the investigators will use linear regression models regressing the outcome on an indicator for experimental condition.
A critical alpha 0.05 will be used, and statistical tests will be two-tailed. Exploratory outcomes include selection of ≥1 item high in added sugar and grams of sugar ordered from each menu, analyzed using the methods described above. The investigators will also explore proportions or means for the following process measures about reactions to the warning labels: Perception that the labels grabbed attention and support for an added sugars warning label policy. Additionally, the investigators will explore differences in the primary outcomes between each of the 24 unique conditions. If there is evidence of interactions between label elements, investigators will modify the modeling approach to account for those interactions (e.g., using interaction terms and stratified models).The investigators will use multiple testing corrections for families of outcomes (primary and secondary).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Davis, California, United States, 95616
- University of California, Davis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Equal or greater than 18 years of age-
- Less than 100 years of age
- English-speaking
- U.S. residents
- Participants will reflect the U.S. Census Bureau's 2021 American Community Survey 5-year estimates for gender, race/ethnicity, educational attainment, and age
Exclusion Criteria:
- Failing the attention check question
- Completing the survey in less than 33% of the median completion time
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Left, black, icon only, 100% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the left of the item, colored black, icon only design, and height that is 100% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Left, black, icon plus text, 100% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the left of the item, colored black, icon plus text design, and height that is 100% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Left, black, boxed icon, 100% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the left of the item, colored black, boxed icon design, and height that is 100% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Right, black, icon only, 100% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the right of the item, colored black, icon only design, and height that is 100% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Right, black, icon plus text, 100% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
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.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Right, black, boxed icon, 100% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the right of the item, colored black, boxed icon design, and height that is 100% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Left, red, icon only, 100% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the left of the item, colored red, icon only design, and height that is 100% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Left, red, icon plus text, 100% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the left of the item, colored red, icon plus text design, and height that is 100% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Left, red, boxed icon, 100% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the left of the item, colored red, boxed icon design, and height that is 100% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Right, red, icon only, 100% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the right of the item, colored red, icon only design, and height that is 100% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Right, red, icon plus text, 100% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the right of the item, colored red, icon plus text design, and height that is 100% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Right, red, boxed icon, 100% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the right of the item, colored red, boxed icon design, and height that is 100% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Left, black, icon only, 150% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the left of the item, colored black, icon only design, and height that is 150% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Left, black, icon plus text, 150% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the left of the item, colored black, icon plus text design, and height that is 150% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Right, black, icon only, 150% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the right of the item, colored black, icon only design, and height that is 150% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Right, black, icon plus text, 150% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the right of the item, colored black, icon plus text design, and height that is 150% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Left, red, icon only, 150% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the left of the item, colored red, icon only design, and height that is 150% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Left, red, icon plus text, 150% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the left of the item, colored red, icon plus text design, and height that is 150% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Right, red, icon only, 150% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
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.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Right, red, icon plus text, 150% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the right of the item, colored red, icon plus text design, and height that is 150% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Left, red, boxed icon, 150% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the left of the item, colored red, boxed icon design, and height that is 150% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Left, black, boxed icon, 150% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the left of the item, colored black, boxed icon design, and height that is 150% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Right, red, boxed icon, 150% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the right of the item, colored red, boxed icon design, and height that is 150% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
|
Experimental: Right, black, boxed icon, 150% height
Participant will order meals from two menus containing labels next to items high in added sugars (exceeding half the daily value).
The label will be on the right of the item, colored black, boxed icon design, and height that is 150% of size of the menu text height.
|
Participants will select food items from two restaurant menus, displayed with labels as specified by their assigned group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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: up to approximately 1 minute
|
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. |
up to approximately 1 minute
|
|
Recognition of label - dichotomous variable "Correct" (selected the label they were assigned to" or "Incorrect" (any other option).
Time Frame: up to approximately 1 minute
|
Measured with "Please look at the following labels and select which label (if any) you saw on the menus while selecting your food and beverage items." Response options will include images of 7 labels with the designs based on the participant's assigned color (black vs red) and label type (icon-only vs. boxed-icon vs, boxed icon-plus-text label) and the options, "Not sure" and "None of these". There is no formal name for this measure/scale. It was developed for this study. |
up to approximately 1 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of menu items high in added sugar - continuous variable using the percent of 8 items correctly classified
Time Frame: up to approximately 2 minutes
|
Measured with "(While viewing menu excerpt) Click on the menu items that you think have more than half the daily limit for added sugars."
Higher percents of items correctly classified represent more knowledge.
|
up to approximately 2 minutes
|
|
Perceived Message Effectiveness of label - continuous variable based on a 3-item scale in which each item uses a 1-5 response scale
Time Frame: up to approximately 2 minutes
|
Measured with 3-item University of North Carolina Perceived Message Effectiveness Scale: "How much does this label make you concerned about the health effects of consuming menu items high in added sugars?", "How much does this label makes consuming menu items high in added sugars seem unpleasant?", and "How much does this label discourage you from wanting to consume menu items high in added sugars?".
Response options include a 1-5 scale where higher values represent higher amounts of the construct.
|
up to approximately 2 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Selection of at least one item high in added sugar
Time Frame: up to approximately 2 minutes
|
Exploratory outcome, dichotomous - "Yes" (ordered at least one item high in added sugar) or "No" (did not order any items high in added sugar), analyzed using Poisson regression to examine differences between factor levels
|
up to approximately 2 minutes
|
|
Grams of sugar ordered
Time Frame: up to approximately 2 minutes
|
Exploratory outcome, continuous - total grams of sugar in menu items selected, analyzed using linear regression to examine differences between factor levels
|
up to approximately 2 minutes
|
|
Perception that the labels grabbed attention
Time Frame: up to approximately 1 minute
|
Exploratory outcome, continuous - 1-5 Likert scale, descriptive analysis of proportions and means to examine differences between factor levels
|
up to approximately 1 minute
|
|
Support for an added sugars warning label policy
Time Frame: up to approximately 1 minute
|
Exploratory outcome, continuous - 1-5 Likert scale, descriptive analysis of proportions and means to examine differences between factor levels
|
up to approximately 1 minute
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Falbe, ScD, MPH, University of California, Davis
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
- 1641776-1
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
product manufactured in and exported from the U.S.
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.
Clinical Trials on Noticing Nutrition Information
-
Weill Medical College of Cornell UniversityNew York State Department of HealthCompletedHealth Care Utilization | Health Information Technology | Health Information Exchange | Virtual Health RecordUnited States
-
Elizabeth Glaser Pediatric AIDS FoundationJohnson & JohnsonCompletedInformation DisclosureCameroon
-
Christiana Care Health ServicesThomas Jefferson UniversityCompleted
-
Brigham and Women's HospitalNot yet recruitingHospital Information Systems
-
State University of New York at BuffaloNational Cancer Institute (NCI)Active, not recruiting
-
Washington University School of MedicineAgency for Healthcare Research and Quality (AHRQ)Completed
-
London School of Hygiene and Tropical MedicineCompletedInformation Seeking BehaviorUnited Kingdom
-
Washington University School of MedicineNational Center for Advancing Translational Sciences (NCATS)RecruitingInformation DisseminationUnited States
-
University Hospital, BordeauxUniversity of BordeauxCompletedEvaluation of a National Health Information Technology-based Program to Improve Healthcare Coordination and Access to InformationFrance
-
Agency for Healthcare Research and Quality (AHRQ)University of Illinois at ChicagoCompletedInterprofessional Relations | Information DisseminationUnited States
Clinical Trials on Menu label
-
University of California, DavisCompleted
-
University of California, DavisCenter for Science in the Public Interest (CSPI)Completed
-
University of California, DavisCompleted
-
Texas A&M UniversityRecruiting
-
University of JenaCompleted
-
San Diego State UniversityCompleted
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Henry Ford Health SystemUniversity of Michigan; Geisinger ClinicCompletedImprove Dietary Behaviors in Young Adults 21-30 Years of AgeUnited States
-
University of Texas at AustinBaylor UniversityNot yet recruitingMental Health | Autism
-
University of LiverpoolUniversity of Bristol; Liverpool John Moores UniversityCompletedFood Labelling | Food Choice | PMEUnited Kingdom