Environmental Harm Menu Labels and the Healthfulness of Real-World Fast-Food Orders (MENU)

November 2, 2026 updated by: Johns Hopkins Bloomberg School of Public Health

Longitudinal Trial Evaluating the Effect of Environmental Harm Menu Labels on the Healthfulness of Real-World Fast-Food Meal Orders

The primary objective of this study is to evaluate whether repeated exposure to environmental harm menu labels on fast-food restaurant menus improves the healthfulness of real-world fast-food meal orders. Participants will be randomized to view either a control (QR code) label or traffic-light style environmental harm labels on two alternating fast-food restaurant menus, and will order one lunch per week for seven weeks through a study ordering website, with each meal delivered to the participant the following day.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Fast-food restaurants, where more than one-third of Americans eat on a typical day, are an important setting for dietary interventions aimed at reducing nutrition-related chronic diseases. Prior research on eco-labels, including this team's preliminary studies, has tested labels in online randomized experiments in which food choices are hypothetical. This trial tests the degree to which repeated exposure to environmental harm labels on fast-food menus promotes healthier food choices over time in a real-world setting in which participants receive and consume the foods the participant chooses.

A total of 450 adults aged 18 to 64 years who consume fast food at least twice per month will be recruited from the greater Baltimore/Washington, D.C. metropolitan area. Participants will be randomized 1:1 into two groups (approximately 225 per group) using a computer-generated simple randomization sequence, to view one of two labels: control QR code label vs. traffic-light style environmental harm labels with the sequence in which the two restaurant menus are presented during the ordering period also randomized 1:1. The environmental harm labels were identified through preliminary studies within the parent project, which tested ecolabel text, designs, and schemes for effectiveness in increasing the healthfulness of hypothetical fast-food meal orders.

Over seven weeks, participants will order one lunch per week from a website designed to imitate the experience of ordering fast food using a commercial online platform. Menus alternate each week between a burger restaurant and a sandwich restaurant, with the starting menu randomized. In Week 1, all participants order from an unlabeled menu, establishing a within-person baseline; in Weeks 2-7, participants view menus with the participants randomized label condition applied to the main item menus. Each meal selected is delivered to the participant the following day via a third-party food delivery service coordinated by study staff. Participants must order at least one main item and must spend a minimum amount of a predetermined meal budget on each order, with unspent funds returned at the end of the study, to reflect real-world cost trade-offs in food choice.

Participants will complete brief online surveys at baseline and endline. The baseline survey collects demographics, food security status, food-related behaviors, and personal health; the endline survey collects participants' experience with the ordering task, perceptions of the menus and food ordered, experience with the label condition to which the participants were randomized, fast-food consumption outside of study-provided lunches, knowledge of the environmental impact of foods, and current food security status.

The primary outcome is the healthfulness of food selections during the weekly meal orders, measured with a modified Nutrient Profile Index score. Secondary outcomes include selection of a beef item, the total energy of the order, and other nutrients of the order. All study activities are conducted remotely; there are no in-person study visits.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nina Carr, MPH, MBA
  • Phone Number: 240-405-2823
  • Email: ncarr6@jhu.edu

Study Contact Backup

  • Name: Julia Wolfson, PhD, MPP
  • Phone Number: 213-359-2915
  • Email: jwolfso7@jhu.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins Bloomberg School of Public Health
        • Contact:
          • Nina Carr, MPH, MBA
          • Phone Number: 240-405-2823
          • Email: ncarr6@jhu.edu
        • Principal Investigator:
          • Julia Wolfson, PhD, MPP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 to 64 years
  • Consumes fast food two or more times per month
  • Willing to eat meat
  • Lives or works within the greater Washington, D.C./Baltimore metropolitan area, defined as the counties and county equivalents within the Baltimore-Columbia-Towson, MD and Washington-Arlington-Alexandria, DC-VA-MD-WV Core Based Statistical Areas (excluding Jefferson County, West Virginia)
  • Has access to the internet during the daytime
  • Has access to an internet-capable device (smartphone, tablet, or computer)
  • Able to send and receive phone calls and text messages at a unique primary phone number (number if not affiliated with a separate prospective or enrolled participant record)
  • Available to receive a weekly lunch delivery one day per week (Tuesday-Friday, 11:00 am - 3:00 pm) for seven weeks at a consistent address within the sample frame (this includes screening for potentially disruptive travel plans during ordering period)
  • Within the delivery zone for both restaurants in the study
  • Willing to complete training on lunch ordering procedures
  • Willing and able to complete dietary recalls and surveys

Exclusion Criteria:

  • Under 18 years of age
  • Over 64 years of age
  • Consumes fast food fewer than two times per month
  • Pescatarian, vegetarian, or vegan (due to menu content)
  • Lives and works outside of the greater Washington, D.C./Baltimore metropolitan area
  • Lacks access to the internet during the daytime
  • Lacks access to an internet-capable device
  • Unable to send and receive phone calls and text messages at a unique primary phone number (phone number is affiliated with a separate prospective or enrolled participant record)
  • Lives or works outside the delivery zone for either or both study restaurants
  • Unavailable to receive seven weeks of consecutive lunch deliveries on a selected day Tuesday through Friday between 11:00 am and 3:00 pm at a consistent address within the sample frame
  • Unwilling to complete training on lunch ordering procedures
  • Unwilling or unable to complete dietary recalls and surveys
  • Fails verification via Cloudfare Turnstile check when accessing REDCap Interest Survey
  • Answers the hidden bot-detection question embedded in the Interest Survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Placebo Comparator: Control Label

Participants order one lunch per week for seven weeks from two alternating fast-food restaurant menus. The Week 1 menu is unlabeled. In Weeks 2-7, a control label consisting of a QR code is applied to all main items on the restaurant menus. Participants in this arm are randomized in equal numbers to begin with the burger restaurant menu or the sandwich restaurant menu in Week 1; the two restaurants then alternate weekly, so that each participant sees the first restaurant in Weeks 1, 3, 5 and 7 and the other restaurant in Weeks 2, 4 and 6.
Behavioral: Control (QR Code) Menu Labels

A control label consisting of a QR code is applied to the main items on both restaurant menus in Weeks 2-7. The label carries no environmental information.
Experimental: Environmental Harm Labels

Participants order one lunch per week for seven weeks from two alternating fast-food restaurant menus. The Week 1 menu is unlabeled. In Weeks 2-7, traffic-light style environmental harm labels are applied to all main items on the restaurant menus. Participants in this arm are randomized in equal numbers to begin with the burger restaurant menu or the sandwich restaurant menu in Week 1; the two restaurants then alternate weekly, so that each participant sees the first restaurant in Weeks 1, 3, 5 and 7 and the other restaurant in Weeks 2, 4 and 6.
Behavioral: Traffic-Light Style Environmental Harm Menu Labels

Traffic-light style environmental harm labels are applied to the main items on both restaurant menus in Weeks 2-7. Each label conveys the environmental harm of the item, defined for participants as how much water and land are required to produce it. Harm levels are assigned from ingredient-level land use and water use factors applied to the ingredients of each menu item.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Nutrient Profile Index score of weekly fast-food meal orders
Time Frame: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)

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 better. NPI awards points from nutrients to encourage (e.g., fiber, protein) and nutrients of concern (e.g., sodium, sugar) per 100 grams. The investigators will generate a modified NPI score to evaluate the healthfulness of full meals comprised of multiple food items. This measure will be determined by calculating the weighted mean NPI score of all food items selected per meal, with each item's NPI score weighted by its proportionate contribution of mass in grams to the total mass of the meal. Beverages are excluded from the meal score and assessed separately.
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrient Profile Index score of the weekly fast-food main item
Time Frame: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)

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 better.
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
Total energy of the weekly meal order
Time Frame: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)

Total calories of each weekly meal order, summed across all items ordered, derived from the nutrient composition of the items selected.
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
Protein content of the weekly meal order
Time Frame: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)

Protein content of each weekly meal order, in grams, summed across all items ordered and derived from the nutrient composition of the items selected.
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
Fiber content of the weekly meal order
Time Frame: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)

Fiber content of each weekly meal order, in grams, summed across all items ordered and derived from the nutrient composition of the items selected.
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
Saturated fat content of the weekly meal order
Time Frame: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)

Saturated fat content of each weekly meal order, in grams, summed across all items ordered and derived from the nutrient composition of the items selected.
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
Sugar content of the weekly meal order
Time Frame: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)

Sugar content of each weekly meal order, in grams, summed across all items ordered and derived from the nutrient composition of the items selected.
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
Sodium content of the weekly meal order
Time Frame: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)

Sodium content of each weekly meal order, in milligrams, summed across all items ordered and derived from the nutrient composition of the items selected.
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pennsylvania
University of California, Davis
Harvard School of Public Health (HSPH)

Investigators

  • Principal Investigator: Julia Wolfson, PhD, MPP, Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

October 27, 2026

First Submitted That Met QC Criteria

October 27, 2026

First Posted (Actual)

November 2, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00036491-1
  • R01DK139327 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Investigators will share individual-level data without identifiers with co-investigators and members of the study team who will participate in data analysis. After findings are published, per the Data Management and Sharing Plan, investigators will upload de-identified datasets to the Open Science Framework (OSF) repository, a free open platform to share research. Stored data on OSF will have a unique, persistent URL for citing and sharing.

IPD Sharing Time Frame

After the study team has published results, investigators will make data and other documents available. There is no end date for availability.

IPD Sharing Access Criteria

Data and supporting documentation will be publicly available on the Open Science Framework website.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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