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Food ChoicesMENUNCT07910617

Environmental Harm Menu Labels and Overall Dietary Quality

A study testing Traffic-Light Style Environmental Harm Menu Labels in people with Food Choices, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The primary objective of this study is to evaluate whether repeated exposure to environmental harm menu labels on fast-food restaurant menus changes overall dietary quality. Participants will be randomized to view either a control (QR code) label or traffic-light style environmental harm labels on two alternating… Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Food Choices
What is being tested?
Traffic-Light Style Environmental Harm Menu Labels
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
1 siteUnited States
Study dates
Nov 2026to 1 Apr 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nina Carr, MPH, MBA contact

240-405-2823

ncarr6@jhu.edu

Julia Wolfson, PhD, MPP contact

213-359-2915

jwolfso7@jhu.edu

United States1 site
  • Johns Hopkins Bloomberg School of Public Health

    Baltimore, Maryland, 21205

    Nina Carr, MPH, MBA, 240-405-2823, ncarr6@jhu.edu

    Julia Wolfson, PhD, MPP

Other trials in United States

About this study

Official title: Longitudinal Trial Evaluating the Influence of Environmental Harm Menu Labels on Overall Dietary Quality

The primary objective of this study is to evaluate whether repeated exposure to environmental harm menu labels on fast-food restaurant menus changes overall dietary quality. 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. The outcome is the change in overall dietary quality from baseline to endline, assessed with 24-hour dietary recalls before and after the seven-week ordering period.

Read the detailed description

Fast-food restaurants, where over 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 assesses the change in overall dietary intake after seven weeks of repeated exposure to environmental harm labels on fast-food menus, in a real-world setting in which participants receive the foods chosen foods.

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 their 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.

To assess changes in overall dietary quality, participants will complete two 24-hour dietary recalls at baseline, prior to the seven-week ordering period, and two at follow-up, administered by the Johns Hopkins Institute for Clinical and Translational Research (ICTR) Nutrition Core. Participants will also 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 change in overall dietary quality from baseline to endline, measured with the Healthy Eating Index-2020. Secondary outcomes include changes to the 13 Health Eating Index Score sub-components, and changes in beef consumption, total energy intake, fiber intake, ultra-processed food intake, and dietary quality at different eating occasions and locations. All study activities are conducted remotely; there are no in-person study visits.

Conditions
Food Choices
Being tested
Control (QR Code) Menu Labels, Traffic-Light Style Environmental Harm Menu Labels
Keywords
Food labeling, Menu labeling, Sustainability, Environmental impact, Fast food, Diet quality, Healthy eating index

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control (QR Code) Menu LabelsBehavioural

    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.

  • Traffic-Light Style Environmental Harm Menu LabelsBehavioural

    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.

Study groups in NCT07910617
Study groupRoleWhat they receive
Control LabelPlacebo comparatorParticipants 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 their first restaurant in Weeks 1, 3, 5 and 7 and the other restaurant in Weeks 2, 4 and 6.
Receives: Behavioral: Control (QR Code) Menu Labels
Environmental Harm LabelsExperimentalParticipants 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 their first restaurant in Weeks 1, 3, 5 and 7 and the other restaurant in Weeks 2, 4 and 6.
Receives: Behavioral: Traffic-Light Style Environmental Harm Menu Labels

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in overall dietary quality (Healthy Eating Index-2020)

    Dietary quality is measured with the Healthy Eating Index-2020 (HEI-2020), calculated from mean intake across two 24-hour dietary recalls administered at each timepoint by trained staff of the Johns Hopkins ICTR Nutrition Core. HEI-2020 is a composite measure of dietary quality scored from 0 to 100, based on 13 components: nine adequacy components (e.g., whole grains, total vegetables, seafood and plant proteins) and four moderation components (e.g., refined grains, sodium, added sugars). A higher score indicates better diet quality and closer alignment with the 2020-2025 Dietary Guidelines for Americans.

    Measured: Baseline (Week 0, prior to the ordering period) and endline (Week 8, after the seven-week ordering period)

Secondary outcomes (17)
  1. Change in HEI-2020 sub-component scores (Adequacy and Moderation)

    Adequacy scores range from 0-5 (total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood and plant proteins). Moderation scores range from 0-10 (whole grains, dairy, fatty acids, refined grains, sodium, added sugars, saturated fats). Higher scores indicate healthier intake (higher intake for adequacy components and lower intake for moderation components).

    Measured: Baseline (Week 0) and endline (Week 8)

  2. Change in intake of total fruits (HEI sub-component)

    Total fruit (including 100% fruit juice) intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  3. Change in intake of whole fruits (HEI sub-component)

    Total whole fruit (excluding 100% fruit juice) intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  4. Change in intake of total vegetables (HEI sub-component)

    Total vegetable intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  5. Change in intake of greens and beans (HEI sub-component)

    Total intake of greens and beans in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  6. Change in intake of whole grains (HEI sub-component)

    Total whole grain intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  7. Change in intake of dairy (HEI sub-component)

    Total dairy intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  8. Change in intake of total protein foods (HEI sub-component)

    Total protein food (including legumes) intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  9. Change in intake of seafood and plant proteins (HEI sub-component)

    Total seafood and plant protein (including nuts, seeds, soy products, legumes) intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each time point.

    Measured: Baseline (Week 0) and endline (Week 8)

  10. Change in intake of fatty acids (HEI sub-component)

    Ratio of fatty acids (PUFA + MUFA)/ SFA, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  11. Change in intake of refined grains (HEI sub-component)

    Total refined grain intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  12. Change in intake of sodium (HEI sub-component)

    Total sodium intake in milligrams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  13. Change in intake of added sugar (HEI sub-component)

    Total added sugar intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  14. Change in intake of saturated fat (HEI sub-component)

    Total saturated fat intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  15. Change in beef consumption

    Beef consumption in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. A decrease indicates reduced beef consumption.

    Measured: Baseline (Week 0) and endline (Week 8)

  16. Change in total energy intake

    Total energy intake in kilocalories per day, derived from mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

  17. Change in fiber intake

    Fiber intake in grams per day, derived from mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline.

    Measured: Baseline (Week 0) and endline (Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study startNov 2026 (estimated)
  3. Primary completion1 Apr 2029 (estimated)
  4. Study completion1 Apr 2029 (estimated)

Resources

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 trial has two arms, defined by the label condition applied to the menus during the ordering period: a control (QR code) label and traffic-light style environmental harm labels. Participants are randomized 1:1 to one of two label conditions, so that approximately 225 participants are assigned to each arm. Menu sequence is a counterbalancing factor randomized within each arm so that restaurant and week are not confounded. All participants order from an unlabeled menu in Week 1, establishing a within-person baseline. In Weeks 2-7, the randomized label condition is applied to all main items on the restaurant menus, and the two restaurants alternate weekly. Randomization occurs after enrollment, the baseline survey, both baseline dietary recalls, and the ordering training are complete, and assignment remains fixed for the remainder of the study.
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07910617
Sponsor's protocol ID
IRB00036491-2
Other IDs
R01DK139327
Acronym
MENU
Status last verified
Oct 2026
First submitted
27 Oct 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators will share individual-level data without identifiers with co-investigators and members of the study team who will participate in data analysis. After the investigators have published the findings, per the Data Management and Sharing Plan, the 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.

Questions about this trial

What is this clinical trial studying?

A study testing Traffic-Light Style Environmental Harm Menu Labels in people with Food Choices, run by Johns Hopkins Bloomberg School of Public Health 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 11 inclusion and 14 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: opening soon, as of the sponsor's last update on 2 Nov 2026. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nina Carr, MPH, MBA (240-405-2823, ncarr6@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in overall dietary quality (Healthy Eating Index-2020) (time frame: Baseline (Week 0, prior to the ordering period) and endline (Week 8, after the seven-week ordering period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Nov 2026.

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