An interventional study of Control (QR Code) Menu Labels and Traffic-Light Style Environmental Harm Menu Labels in Food Choices, sponsored by Johns Hopkins Bloomberg School of Public Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention
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.
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.
Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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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 their 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
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 their 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
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 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.
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.
Time frame: Baseline (Week 0, prior to the ordering period) and endline (Week 8, after the seven-week ordering period)
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).
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
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.
Time frame: Baseline (Week 0) and endline (Week 8)
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: After the study team has published results, the investigators will make data and other documents available. There is no end date for availability.
Access criteria: Data and supporting documentation will be publicly available on the Open Science Framework website.
No publications or documents are linked to this record.
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