- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536126
Testing Non-Nutrition Menu Labels on Food Selections
Testing Non-Nutrition Menu Labels on Food Selections: A Nationally Representative Online Survey Experiment in Two Fast-Food Restaurants
Study Overview
Status
Conditions
Detailed Description
This online randomized trial will test the relative effects of environmental harm menu label designs on the healthfulness of consumers' fast-food meal choices and perceptions of menu items. The survey research firm Verasight will recruit a nationally representative sample of 7,000 adults aged 18 years and older who speak English and reside in the United States from their survey panel.
Participants will complete a between-subjects online experiment in which the participants will be randomized to view two fast-food online ordering menus (in randomized order) with one of five labeling schemes applied: (1) a QR code on all items (control); (2) a low environmental harm label on all low harm items (3) a high environmental harm label on high harm items; (4) traffic light labels on all items by level of environmental harm; and (5) environmental grade labels on all items by level of environmental harm. Each restaurant menu will be presented across 2 pages; page 1 will display all main items, and page 2 will display categories for side, dessert, and drink items. Labels will only appear alongside main menu items and will be assigned using thresholds for environmental harm set a priori which factor in estimated cropland, pastureland, and water usage associated with each food item. Each hypothetical order must include between 1 and 4 items. Participants will be required to select 1 main item and, optionally, up to 3 additional items (drinks, sides, desserts). After completing the meal ordering task, participants will be prompted to answer questions about whether they noticed the correct label for their condition, whether they used the label when making their meal selections, perceptions of the labeled menu items and the labeling condition which the participants were randomized to view. Additionally, participants will be asked about their level of food security, participation in the Supplemental Nutrition Assistance Program (SNAP), support of governmental policies and practices regarding food and nutrition, use of GLP-1 agonists, personal values, dietary patterns, and other demographic information.
The primary outcome will be the healthfulness of meal orders selected from the online menu, indicated by a modified Nutrient Profile Index meal score for all food items ordered. Secondary outcomes will include total calories ordered, whether a sugar-sweetened beverage was ordered, and perceived message effectiveness of the environmental harm labels.
Analyses will be conducted overall (summing the meal selections across both restaurants) and stratified by restaurant.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nina M Carr, MPH, MBA
- Phone Number: 2404052823
- Email: ncarr6@jhu.edu
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Recruiting
- Johns Hopkins Bloomberg School of Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- Member of the Verasight Panel
- Residing in the United States
Exclusion Criteria:
- <18 years of age
- Not residing in the United States
- Completed the survey in less than one-third of the median completion duration of all participants
- Respondents with high refusal rates (skipped or refused more than 50% of questions)
- Respondents who 'straight-line' all question grids with 6 or more items, where responses are not internally consistent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Control (QR) Labels
A black label featuring a QR code and white text that reads "SCAN HERE" will be placed beneath all main menu items on two restaurant menus.
Explanatory text describing the label's meaning will be displayed at the top of the menu.
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Participants will view two fast-food restaurant menus presented in a random order.
Each menu will include main, side, dessert, and drink items, and each menu item will be displayed with an image of the item, name, price, and total calories.
For main items only, Control (QR) labels will be displayed beneath each item.
Participants will be instructed to select at least 1 and up to 4 menu items for a hypothetical meal order.
Participants will be required to select a main item and, optionally, up to 3 additional items (drinks, sides, desserts).
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Experimental: Low Environmental Harm Labels
A green icon-plus-text label that reads "LOW ENVIRONMENTAL HARM" in white text against a green background will be placed on two restaurant menus beneath main menu items that are less harmful to the environment compared to unlabeled main menu items, based on use of cropland, pastureland, and water.
Labels will include a white globe icon directly preceding the label text.
Explanatory text describing the label's meaning will be displayed at the top of the menu.
|
Participants will view two fast-food restaurant menus presented in a random order.
Each menu will include main, side, dessert, and drink items, and each menu item will be displayed with an image of the item, name, price, and total calories.
For main items only, Low Environmental Harm labels will be displayed beneath a subset of items.
Participants will be instructed to select at least 1 and up to 4 menu items for a hypothetical meal order.
Participants will be required to select a main item and, optionally, up to 3 additional items (drinks, sides, desserts).
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Experimental: High Environmental Harm Labels
A red icon-plus-text label that reads "HIGH ENVIRONMENTAL HARM" in white text against a red background will be placed on two restaurant menus beneath main menu items that are more harmful to the environment compared to unlabeled main menu items, based on use of cropland, pastureland, and water.
Labels will include a white globe icon directly preceding the label text.
Explanatory text describing the label's meaning will be displayed at the top of the menu.
|
Participants will view two fast-food restaurant menus presented in a random order.
Each menu will include main, side, dessert, and drink items, and each menu item will be displayed with an image of the item, name, price, and total calories.
For main items only, Environmental Harm labels will be displayed beneath select items.
Participants will be instructed to select at least 1 and up to 4 menu items for a hypothetical meal order.
Participants will be required to select a main item and, optionally, up to 3 additional items (drinks, sides, desserts).
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Experimental: Environmental Harm Traffic Light Labels
Traffic Light labels will be placed on two restaurant menus beneath all main menu items.
Using estimated cropland, pastureland, and water use, each item will be assigned one of three icon-plus-text labels within this scheme: low-, medium-, or high-impact label.
Each will read, "HIGH ENVIRONMENTAL HARM" within a red label, "MED.
ENVIRONMENTAL HARM" in a yellow label, and "LOW ENVIRONMENTAL HARM" in a green label.
Text for all labels will be written in white, and a white globe icon will precede the text.
Explanatory text describing the meaning of the labels will be displayed at the top of the menu.
|
Participants will view two fast-food restaurant menus presented in a random order.
Each menu will include main, side, dessert, and drink items, and each menu item will be displayed with an image of the item, name, price, and total calories.
For main items only, Environmental Harm Traffic Light labels will be displayed beneath each item.
Participants will be instructed to select at least 1 and up to 4 menu items for a hypothetical meal order.
Participants will be required to select a main item and, optionally, up to 3 additional items (drinks, sides, desserts).
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|
Experimental: Environmental Grade Labels
Environmental Grade labels will be placed on two restaurant menus beneath all main menu items, using estimated cropland, pastureland, and water use to assign one of five icon-plus-text labels which indicate a specific environmental grade (A, B, C, D, and F).
All labels are solid black with a white globe icon followed by white text which reads "ENVIRONMENTAL GRADE".
On the left side of each label, a grade is displayed, capitalized and in a white font within a solid-colored box.
The color of the box corresponds with each letter grade: A = dark green, B = light green, C = yellow, D = orange, F = red.
Beneath the letter grade, a gradient of all possible grades is displayed horizontally in smaller font, each grade atop a small solid box in the respective grade color.
Explanatory text describing the meaning of the labels will be displayed at the top of the menu.
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Participants will view two fast-food restaurant menus presented in a random order.
Each menu will include main, side, dessert, and drink items, and each menu item will be displayed with an image of the item, name, price, and total calories.
For main items only, Environmental Grade labels will be displayed beneath each item.
Participants will be instructed to select at least 1 and up to 4 menu items for a hypothetical meal order.
Participants will be required to select a main item and, optionally, up to 3 additional items (drinks, sides, desserts).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Nutrient Profile Index score
Time Frame: Immediately upon viewing the menus
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The primary outcome measure will be the healthfulness of the fast-food meal selections, measured with a modified Nutrient Profile Index (NPI) score.
NPI scores are based on the United Kingdom (UK) Ofcom Nutrient Profiling Model, which is used to score individual foods in the UK to determine which ones can be marketed to children.
The NPI is a 0 to 100-point score for foods; a score of >=64 is considered healthy.
Higher score is better.
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Immediately upon viewing the menus
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perception that label grabbed attention
Time Frame: Immediately after viewing the menu excerpt and label image
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After viewing the label, participants will be asked how much the participant agrees or disagrees with the following statement: "This label grabs my attention".
Response options are a unipolar 5-point Likert scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal.
A higher ranking is better.
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Immediately after viewing the menu excerpt and label image
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Nutrient Profile Index score
Time Frame: Immediately upon viewing the menus
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The healthfulness of the fast-food main item selections, measured with a Nutrient Profile Index (NPI) score.
NPI scores are based on the United Kingdom (UK) Ofcom Nutrient Profiling Model, which is used to score individual foods in the UK to determine which ones can be marketed to children.
The NPI is a 0 to 100-point score for foods; a score of >=64 is considered healthy.
Higher score is better
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Immediately upon viewing the menus
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Number of Participants who Notice labels (Attention to label)
Time Frame: Immediately after viewing the menus
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Measured by whether participants noticed labels on the menus, in addition to calorie labels.
The exact question is, "On the menus you saw, did you notice any labels (other than calories) next to or below the menu items?"
Response options are "Yes", "No", and "Don't Know".
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Immediately after viewing the menus
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Number of Participants who Recall Label Purpose
Time Frame: Immediately after viewing the menus
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Measured by whether participants who noticed labels in addition to calorie labels correctly, identify the purpose of the labels.
Response options are "Sugar", "Sodium", "QR code", "Environmental Harm", "Organic", "Healthy", "Unhealthy", "None of these", and "I don't know/ I can't remember".
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Immediately after viewing the menus
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Number of Participants Who Use of label
Time Frame: Immediately after viewing the menus
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Measured by whether participants who noticed labels in addition to calorie labels, used the labels in selecting a hypothetical meal order.
The exact question is, "Did you use these labels you saw when deciding what to order?".
Response options are "Yes" and "No".
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Immediately after viewing the menus
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Participant's Perceived label believability
Time Frame: Immediately after viewing the menu excerpt and label image
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After viewing images of a labeled menu excerpt and a zoomed in label, participants will be asked how much the participant agrees or disagrees with the following statement: "This label is believable to me".
Response options are a unipolar 5-point Likert scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=A great deal.
A higher ranking is better.
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Immediately after viewing the menu excerpt and label image
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Perceived message effectiveness (PME) as assessed by the University of North Carolina (UNC) PME scale
Time Frame: Immediately after viewing the menu excerpt and label image
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This modified 4-item UNC-PME scale measures how much the label placed beneath high environmental impact menu items discouraged consumption, or evoked concern or unpleasantness about consumption, of high environmental impact foods.
Responses measured on a 5-point Likert scale from 1=Not at all to 5= A great deal, with higher scores interpreted as better.
Preceding the questions, participants will view a menu excerpt with the assigned label applied and a prompt, and likert scale.
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Immediately after viewing the menu excerpt and label image
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Total price of meal order
Time Frame: Immediately upon viewing the menus
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Measured by the cumulative total price (USD) of participants' hypothetical meal orders per restaurant, based on the prices displayed on the survey menus.
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Immediately upon viewing the menus
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Beef item selected
Time Frame: Immediately upon viewing the menus
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Measured as a dichotomous variable (yes/no) indicating whether participants' hypothetical meal orders include an item containing beef.
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Immediately upon viewing the menus
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Total energy selected
Time Frame: Immediately upon viewing the menus
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The total number of calories in participants' hypothetical meal orders, calculated as the sum of calories across all menu items selected.
Higher values indicate more calories selected.
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Immediately upon viewing the menus
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Total saturated fat selected
Time Frame: Immediately upon viewing the menus
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The total amount of saturated fat in participants' hypothetical meal orders, calculated as the sum of saturated fat (grams) across all menu items selected.
Higher values indicate more saturated fat selected.
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Immediately upon viewing the menus
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Total sugar selected
Time Frame: Immediately upon viewing the menus
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The total amount of sugar in participants' hypothetical meal orders, calculated as the sum of sugar (grams) across all menu items selected.
Higher values indicate more sugar selected.
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Immediately upon viewing the menus
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Total protein selected
Time Frame: Immediately upon viewing the menus
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The total amount of protein in participants' hypothetical meal orders, calculated as the sum of protein (grams) across all menu items selected.
Higher values indicate more protein selected.
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Immediately upon viewing the menus
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Total fiber selected
Time Frame: Immediately upon viewing the menus
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The total amount of fiber in participants' hypothetical meal orders, calculated as the sum of fiber (grams) across all menu items selected.
Higher values indicate more fiber selected.
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Immediately upon viewing the menus
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Total sodium selected
Time Frame: Immediately upon viewing the menus
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The total amount of sodium in participants' hypothetical meal orders, calculated as the sum of sodium (milligrams) across all menu items selected.
Higher values indicate more sodium selected.
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Immediately upon viewing the menus
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Sugar-sweetened beverage selected
Time Frame: Immediately upon viewing the menus
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Measured as a dichotomous variable (yes/no) indicating whether participants' hypothetical meal orders include a sugar-sweetened beverage.
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Immediately upon viewing the menus
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Collaborators and Investigators
Investigators
- Principal Investigator: Julia Wolfson, PhD MPP, Johns Hopkins Bloomberg School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00035394-1
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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