NutritionNCT06516627

Front-of-Package Nutrition Labels

A study testing Positive Labels, Spectrum Labels and FDA High In Labels in people with Nutrition and Food Selection, run by Harvard Pilgrim Health Care at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Nutrition, Food Selection, Food Preferences
What is being tested?: Positive Labels, Spectrum Labels and FDA High In Labels
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6,002 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2024to 21 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged 18 years or older
Reside in the US
Can read and speak English
Are their household's primary shopper (do 50% or more of the grocery shopping for their household)

Who cannot join

Under the age of 18
Reside outside of the United States
Unable to complete a survey in English
Are not their household's primary shopper (do <50% of the grocery shopping for their household)

Trial locations and contacts

1 site in 1 country.

United States1 site

Harvard Pilgrim Health Care Institute
Boston, Massachusetts, 02215-3325

Other trials in United States

About this study

Official title: Online Randomized Experiment Evaluating Front-of-Package Nutrition Labeling Systems

The goal of this study is to determine whether certain front-of-package food labeling systems improve the healthfulness of consumers' grocery selections. US adults who are their households' primary shoppers will complete a shopping task in a naturalistic online grocery store. They will be exposed to different front-of-package food labeling systems and asked to shop for groceries. The online store will record participants' selections. Participants will also be asked to complete survey measures.

Read the detailed description

This study aims to determine whether certain front-of-package food labeling systems improve the healthfulness of consumers' grocery selections. The survey research company Cloud Research will recruit a sample of approximately 5,610 US adults ages 18+ who read and speak English and who are their households' primary grocery shopper.

Participants will complete a between-subjects online randomized experiment. They will be randomized to 1 of 6 front-of-package labeling systems: 1) positive labels, 2) spectrum labels, 3) Food and Drug Administration (FDA) high in labels, 4) FDA traffic light labels, 5) FDA high in labels plus positive labels, or 6) FDA traffic light labels plus positive labels. Participants will complete a shopping task in a naturalistic online grocery store. Participants will be instructed to shop as they usually would for items in the following categories: non-alcoholic beverages (e.g., juice, coffee, tea, soda, sports drinks, water), breads and baked goods, breakfast cereals, soups, boxed and frozen meals, and snacks (e.g., chips, crackers, nuts, applesauce, dried fruit). They will be given a budget based on average spending in these categories in a large supermarket chain. The store will record participants' selections. After completing the shopping task, participants will complete an online survey.

Conditions: Nutrition, Food Selection, Food Preferences, Dietary Habits, Healthy Diet
Being tested: Positive Labels, Spectrum Labels, FDA High In Labels, FDA Traffic Light Labels
Medical subject headings: Food Preferences, Feeding Behavior

What participants receive

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

Positive LabelsBehavioural
Products that meet Guiding Stars' criteria for earning 1 or more Guiding Star will display labels indicating their healthfulness using star ratings: 1 star ("Good"), 2 stars ("Better"), or 3 stars ("Best").
Spectrum LabelsBehavioural
All products will display an expanded Guiding Stars label that show an overall rating indicating their healthfulness using star ratings: 1 star ("Poor"), 2 stars ("Fair"), 3 stars ("Good"), 4 stars ("Better"), or 5 stars ("Best").
FDA High In LabelsBehavioural
Products that contain high levels (i.e., ≥20% DV per serving) of saturated fat, sodium, or added sugars will display a label indicating which of these nutrients the product is high in.
FDA Traffic Light LabelsBehavioural
All products will display a "Nutrition Info" label showing whether the amount of saturated fat, sodium, and added sugars in 1 serving of the product is low (<5% DV), medium (≥5 to <20% DV), or high (≥20% DV). "Low" will be shown in green, "Medium" in yellow, and "High" in red.

Study groups in NCT06516627
Study group	Role	What they receive
Positive Labels	Experimental	Products that meet Guiding Stars' criteria for earning 1 or more Guiding Star will display labels indicating their healthfulness using star ratings: 1 star ("Good"), 2 stars ("Better"), or 3 stars ("Best"). The Guiding Stars rating system uses a patented algorithm to rate foods based on their nutrients and ingredients per 100-calorie serving of the food. Products that do not meet Guiding Stars' criteria for earning stars will not display any new front-of-package label. Receives: Behavioral: Positive Labels
Spectrum Labels	Experimental	All products will display an expanded Guiding Stars label that shows an overall rating indicating their healthfulness using star ratings: 1 star ("Poor"), 2 stars ("Fair"), 3 stars ("Good"), 4 stars ("Better"), or 5 stars ("Best"). The Guiding Stars rating system uses a patented algorithm to rate foods based on their nutrients and ingredients per 100-calorie serving of the food. Products that display 1-, 2-, or 3-star labels in the Positive Labels arm will display 3-, 4-, or 5-star labels, respectively, in the Spectrum Labels arm. The remaining products that do not earn stars in the Positive Labels arm will be divided in half based on their underlying Guiding Stars scores; the bottom half of these products will display 1-star labels and the top half of these products will display 2-star labels. Receives: Behavioral: Spectrum Labels
FDA High In Labels	Experimental	Products that contain high levels (i.e., ≥20% DV per serving) of saturated fat, sodium, or added sugars will display a label indicating which of these nutrients the product is high in. The investigators will use DVs of 20g for saturated fat, 2,300mg for sodium, and 50g for added sugars per FDA definitions. Receives: Behavioral: FDA High In Labels
FDA Traffic Light Labels	Experimental	All products will display a "Nutrition Info" label showing whether the amount of saturated fat, sodium, and added sugars in 1 serving of the product is low (<5% DV), medium (≥5 to <20% DV), or high (≥20% DV). "Low" will be shown in green, "Medium" in yellow, and "High" in red. The investigators will use DVs of 20g for saturated fat, 2,300mg for sodium, and 50g for added sugars per FDA definitions. Receives: Behavioral: FDA Traffic Light Labels
FDA High In Labels Plus Positive Labels	Experimental	Products that contain high levels (i.e., ≥20% DV per serving) of saturated fat, sodium, or added sugars will display a label indicating which of these nutrients the product is high in. The investigators will use DVs of 20g for saturated fat, 2,300mg for sodium, and 50g for added sugars per FDA definitions. Additionally, products that meet Guiding Stars' criteria for earning 1 or more Guiding Star will display labels indicating their healthfulness using star ratings: 1 star ("Good"), 2 stars ("Better"), or 3 stars ("Best"). The Guiding Stars rating system uses a patented algorithm to rate foods based on their nutrients and ingredients per 100-calorie serving of the food. Receives: Behavioral: Positive Labels; Behavioral: FDA High In Labels
FDA Traffic Light Labels Plus Positive Labels	Experimental	All products will display a "Nutrition Info" label showing whether the amount of saturated fat, sodium, and added sugars in 1 serving of the product is low (<5% DV), medium (≥5 to <20% DV), or high (≥20% DV). "Low" will be shown in green, "Medium" in yellow, and "High" in red. The investigators will use DVs of 20g for saturated fat, 2,300mg for sodium, and 50g for added sugars per FDA definitions. Additionally, products that meet Guiding Stars' criteria for earning 1 or more Guiding Star will display labels indicating their healthfulness using star ratings: 1 star ("Good"), 2 stars ("Better"), or 3 stars ("Best"). The Guiding Stars rating system uses a patented algorithm to rate foods based on their nutrients and ingredients per 100-calorie serving of the food. Receives: Behavioral: Positive Labels; Behavioral: FDA Traffic Light Labels

What is being measured

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

Healthfulness of Participants' Grocery Selections
The study will assess healthfulness of participants' grocery selections as the weighted average Ofcom Nutrient Profiling Model score of the products the participants select in the shopping task, weighted by the number of servings in each product. Ofcom Nutrient Profiling Model scores will be calculated for each product participants select. Products receive higher Ofcom scores when they contain lower calorie, saturated fat, sodium, and sugar density, higher protein and fiber density, and more fruits, vegetables, legumes, and nuts. The investigators will calculate the weighted average score across participants' selections, weighting by the number of servings participants select of that product. The Ofcom Nutrient Profiling Model score ranges from 0 to 100, where higher scores indicate healthier products.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes

Secondary outcomes (25)

Guiding Stars Scores
The study will assess Guiding Stars scores of participants' grocery selections as the weighted average Guiding Stars score of the products the participants select in the shopping task, weighted by the number of servings in each product. Products receive higher Guiding Stars scores when they contain more healthier nutrients and ingredients including vitamins, minerals, fiber, whole grains, and omega-3s and fewer unhealthy nutrients and ingredients including saturated fat, trans fat, added sodium, added sugars, and certain additives. Higher scores indicate healthier products. Raw Guiding Stars score are at the product level and have a range from +3 (most healthy) to -11 (least healthy).
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Number of Items Selected That Are High in ≥1 Nutrient of Concern
The study will assess the number of items participants select that contain ≥20% DV of saturated fat, sodium, or added sugars. The investigators will use DVs of 20g for saturated fat, 2,300mg for sodium, and 50g for added sugars per FDA definitions. Higher counts will indicate a larger number of products selected were high in nutrients of concern.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Calorie Density of Participants' Grocery Selections
The study will assess the weighted average calorie density of participants' grocery selections, calculated as the average kcal per 100g of the selected products, weighted by the number of servings in each product. Higher values will indicate higher calorie density.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Sugar Density of Participants' Grocery Selections
The study will assess the weighted average sugar density of participants' grocery selections, calculated as the average grams of sugar per 100g of the selected products, weighted by the number of servings in each product. Higher values will indicate higher sugar density.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Sodium Density of Participants' Grocery Selections
The study will assess the weighted average sodium density of participants' grocery selections, calculated as the average milligrams of sodium per 100g of the selected products, weighted by the number of servings in each product. Higher values will indicate higher sodium density.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Saturated Fat Density of Participants' Grocery Selections
The study will assess the weighted average saturated fat density of participants' grocery selections, calculated as the average grams of saturated fat per 100g of the selected products, weighted by the number of servings in each product. Higher values will indicate higher saturated fat density.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Fiber Density of Participants' Grocery Selections
The study will assess the weighted average fiber density of participants' grocery selections, calculated as the average grams of fiber per 100g of the selected products, weighted by the number of servings in each product. Higher values will indicate fiber saturated fat density.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Protein Density of Participants' Grocery Selections
The study will assess the weighted average protein density of participants' grocery selections, calculated as the average grams of protein per 100g of the selected products, weighted by the number of servings in each product. Higher values will indicate higher protein density.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Calories Selected
The study will assess the total number of calories in participants' grocery selections, calculated as the sum of calories across all products selected. Higher values will indicate more calories selected.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Sugar Selected
The study will assess the total amount of sugar in participants' grocery selections, calculated as the sum of sugar selected across all products selected. Higher values will indicate more sugar selected.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Sodium Selected
The study will assess the total amount of sodium in participants' grocery selections, calculated as the sum of sodium selected across all products selected. Higher values will indicate more sodium selected.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Saturated Fat Selected
The study will assess the total amount of saturated fat in participants' grocery selections, calculated as the sum of saturated fat selected across all products selected. Higher values will indicate more saturated fat selected.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Fiber Selected
The study will assess the total amount of fiber in participants' grocery selections, calculated as the sum of fiber selected across all products selected. Higher values will indicate more fiber selected.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Protein Selected
The study will assess the total amount of protein in participants' grocery selections, calculated as the sum of protein selected across all products selected. Higher values will indicate more protein selected.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Number of Items Selected
The study will assess the total number of items participants select. Higher values will indicate more items selected.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Spending on Participants' Grocery Selections
The study will assess the total amount participants spent on their grocery selections in USD. Higher values will indicate greater spending.
Measured: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Correct Identification of Healthier Items
The study will assess the likelihood that participants correctly identify which of a pair of products is healthier with 6 items (1 for each of 6 product categories: bread, beverages, cereal, meals, snacks, and soups). Responses will be coded as correct (1) if participants select the product with the higher Ofcom Nutrient Profiling Model score and incorrect (0) otherwise.
Measured: Assessed from enrollment to end of one-time, 30-minute online study survey
Noticing of Front-of-package Labeling Systems
The study will assess noticing of the front-of-package labeling systems with 1 item: "When you were selecting foods and beverages in the shopping task, did you notice any other nutrition labels next to the products, besides the Nutrition Facts Panel?" Response options will be "yes," "no," and "not sure." Responses will be coded as noticed (1) if participants select "yes" and not noticed (0) otherwise.
Measured: Assessed from enrollment to end of one-time, 30-minute online study survey
Use of Front-of-package Labeling Systems
The study will assess use of the front-of-package labeling systems with 1 item: "While you were shopping, did you use these other nutrition labels to decide foods and beverages to select?" Response options will be "yes" (coded as 1) and "no" (coded as 0).
Measured: Assessed from enrollment to end of one-time, 30-minute online study survey
Thinking About Health
The study will assess thinking about health using 1 item: "When you were selecting foods and beverages in the shopping task, how much did you think about the overall healthfulness of the product? Response options range from not at all (1) to a great deal (5).
Measured: Assessed from enrollment to end of one-time, 30-minute online study survey
Negative Emotional Reactions
The study will assess negative emotional reactions using 5 items: "How much does this label make you feel…" "worried", "scared," "guilty," "ashamed", and "sad"? Response options range from not at all (1) to a great deal (5). The investigators will average the 5 items; higher average scores indicate stronger negative emotional reactions.
Measured: Assessed from enrollment to end of one-time, 30-minute online study survey
Perceived Helpfulness of the Front-of-package Labeling System
The study will assess perceived helpfulness with 1 item: "How much do you agree or disagree with the following statement: These labels would help me choose healthier foods and beverages." Response options range from strongly disagree (1) to strongly agree (5).
Measured: Assessed from enrollment to end of one-time, 30-minute online study survey
Perceived Understandability of the Front-of-package Labeling System
The study will assess perceived understandability with 1 item: "How much do you agree or disagree with the following statement: It is easy to understand the information in these labels." Response options range from strongly disagree (1) to strongly agree (5).
Measured: Assessed from enrollment to end of one-time, 30-minute online study survey
Perceived Trustworthiness of the Front-of-package Labeling System
The study will assess perceived trustworthiness with 1 item: "How much do you trust or distrust the information in these labels?" Response options range from completely distrust (1) to completely trust (5).
Measured: Assessed from enrollment to end of one-time, 30-minute online study survey
Public Support for Front-of-package Labeling System
The study will assess public support for the front-of-package labeling systems with 1 item: "Would you oppose or support a policy requiring these labels on foods and beverages?" Response options range from strongly oppose (1) to strongly support (5).
Measured: Assessed from enrollment to end of one-time, 30-minute online study survey

Timeline

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

31 Oct 202421 Nov 2024

First posted24 Jul 2024
Study start31 Oct 2024
Primary completion21 Nov 2024
Study completion21 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for NutritionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: None (open label)
Enrolment: 6,002 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06516627
Sponsor's protocol ID: 1938853
Other IDs: R01DK115492
Status last verified: Sep 2026
First submitted: 17 Jul 2024
Last updated: 8 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Investigators will post de-identified individual participant data in a public repository.

Publications

Huang Y, O'Sullivan K, Block JP, Petimar J, Lee CJY, Grummon AH. Impact of the Food and Drug Administration's Proposed Front-of-Package Label and Alternative Designs on Consumer Understanding: A Randomized Experiment. Am J Prev Med. 2026 May;70(5):108222. doi: 10.1016/j.amepre.2025.108222. Epub 2025 Dec 13.
PubMed 41397534
Grummon AH, O'Sullivan K, Petimar J, Lee CJY, Zeitlin AB, Cleveland LP, Collis C, Musicus AA, Tiefenbeck V, Fleisch E, Block JP. Nutrition Info and Other Front-of-Package Labels and Simulated Food and Beverage Purchases: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2537389. doi: 10.1001/jamanetworkopen.2025.37389.
PubMed 41105412

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Online Randomized Experiment Evaluating Front-of-Package Nutrition Labeling Systems
ClinicalTrials.gov ID: NCT06516627
Acronym / sponsor ID: 1938853
Conditions: Nutrition, Food Selection, Food Preferences, Dietary Habits, Healthy Diet
Study type: Interventional
Recruitment status: Completed
Enrolment: 6,002 participants (actual)
Lead sponsor: Harvard Pilgrim Health CareUniversity, hospital or other
Collaborators: Stanford University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 31 Oct 2024 (actual)
Primary completion: 21 Nov 2024 (actual)
Study completion: 21 Nov 2024 (actual)
First posted: 24 Jul 2024 (actual)
Results: Posted 8 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Positive Labels	Experimental	Behavioral: Positive LabelsProducts that meet Guiding Stars' criteria for earning 1 or more Guiding Star will display labels indicating their healthfulness using star ratings: 1 star ("Good"), 2 stars ("Better"), or 3 stars ("Best"). The Guiding Stars rating system uses a patented algorithm to rate foods based on their nutrients and ingredients per 100-calorie serving of the food. Products that do not meet Guiding Stars' criteria for earning stars will not display any new front-of-package label.
Spectrum Labels	Experimental	Behavioral: Spectrum LabelsAll products will display an expanded Guiding Stars label that shows an overall rating indicating their healthfulness using star ratings: 1 star ("Poor"), 2 stars ("Fair"), 3 stars ("Good"), 4 stars ("Better"), or 5 stars ("Best"). The Guiding Stars rating system uses a patented algorithm to rate foods based on their nutrients and ingredients per 100-calorie serving of the food. Products that display 1-, 2-, or 3-star labels in the Positive Labels arm will display 3-, 4-, or 5-star labels, respectively, in the Spectrum Labels arm. The remaining products that do not earn stars in the Positive Labels arm will be divided in half based on their underlying Guiding Stars scores; the bottom half of these products will display 1-star labels and the top half of these products will display 2-star labels.
FDA High In Labels	Experimental	Behavioral: FDA High In LabelsProducts that contain high levels (i.e., ≥20% DV per serving) of saturated fat, sodium, or added sugars will display a label indicating which of these nutrients the product is high in. The investigators will use DVs of 20g for saturated fat, 2,300mg for sodium, and 50g for added sugars per FDA definitions.
FDA Traffic Light Labels	Experimental	Behavioral: FDA Traffic Light LabelsAll products will display a "Nutrition Info" label showing whether the amount of saturated fat, sodium, and added sugars in 1 serving of the product is low (<5% DV), medium (≥5 to <20% DV), or high (≥20% DV). "Low" will be shown in green, "Medium" in yellow, and "High" in red. The investigators will use DVs of 20g for saturated fat, 2,300mg for sodium, and 50g for added sugars per FDA definitions.
FDA High In Labels Plus Positive Labels	Experimental	Behavioral: Positive Labels, Behavioral: FDA High In LabelsProducts that contain high levels (i.e., ≥20% DV per serving) of saturated fat, sodium, or added sugars will display a label indicating which of these nutrients the product is high in. The investigators will use DVs of 20g for saturated fat, 2,300mg for sodium, and 50g for added sugars per FDA definitions. Additionally, products that meet Guiding Stars' criteria for earning 1 or more Guiding Star will display labels indicating their healthfulness using star ratings: 1 star ("Good"), 2 stars ("Better"), or 3 stars ("Best"). The Guiding Stars rating system uses a patented algorithm to rate foods based on their nutrients and ingredients per 100-calorie serving of the food.
FDA Traffic Light Labels Plus Positive Labels	Experimental	Behavioral: Positive Labels, Behavioral: FDA Traffic Light LabelsAll products will display a "Nutrition Info" label showing whether the amount of saturated fat, sodium, and added sugars in 1 serving of the product is low (<5% DV), medium (≥5 to <20% DV), or high (≥20% DV). "Low" will be shown in green, "Medium" in yellow, and "High" in red. The investigators will use DVs of 20g for saturated fat, 2,300mg for sodium, and 50g for added sugars per FDA definitions. Additionally, products that meet Guiding Stars' criteria for earning 1 or more Guiding Star will display labels indicating their healthfulness using star ratings: 1 star ("Good"), 2 stars ("Better"), or 3 stars ("Best"). The Guiding Stars rating system uses a patented algorithm to rate foods based on their nutrients and ingredients per 100-calorie serving of the food.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Aged 18 years or older
Reside in the US
Can read and speak English
Are their household's primary shopper (do 50% or more of the grocery shopping for their household)

Key exclusion criteria (4 listed)

Under the age of 18
Reside outside of the United States
Unable to complete a survey in English
Are not their household's primary shopper (do <50% of the grocery shopping for their household)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Positive LabelsProducts that meet Guiding Stars' criteria for earning 1 or more Guiding Star will display labels indicating their healthfulness using star ratings: 1 star ("Good"), 2 stars ("Better"), or 3 stars ("Best").	Behavioural	FDA High In Labels Plus Positive Labels, FDA Traffic Light Labels Plus Positive Labels, Positive Labels
Spectrum LabelsAll products will display an expanded Guiding Stars label that show an overall rating indicating their healthfulness using star ratings: 1 star ("Poor"), 2 stars ("Fair"), 3 stars ("Good"), 4 stars ("Better"), or 5 stars ("Best").	Behavioural	Spectrum Labels
FDA High In LabelsProducts that contain high levels (i.e., ≥20% DV per serving) of saturated fat, sodium, or added sugars will display a label indicating which of these nutrients the product is high in.	Behavioural	FDA High In Labels, FDA High In Labels Plus Positive Labels
FDA Traffic Light LabelsAll products will display a "Nutrition Info" label showing whether the amount of saturated fat, sodium, and added sugars in 1 serving of the product is low (<5% DV), medium (≥5 to <20% DV), or high (≥20% DV). "Low" will be shown in green, "Medium" in yellow, and "High" in red.	Behavioural	FDA Traffic Light Labels, FDA Traffic Light Labels Plus Positive Labels

Primary outcome

Healthfulness of Participants' Grocery Selections
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
The study will assess healthfulness of participants' grocery selections as the weighted average Ofcom Nutrient Profiling Model score of the products the participants select in the shopping task, weighted by the number of servings in each product. Ofcom Nutrient Profiling Model scores will be calculated for each product participants select. Products receive higher Ofcom scores when they contain lower calorie, saturated fat, sodium, and sugar density, higher protein and fiber density, and more fruits, vegetables, legumes, and nuts. The investigators will calculate the weighted average score across participants' selections, weighting by the number of servings participants select of that product. The Ofcom Nutrient Profiling Model score ranges from 0 to 100, where higher scores indicate healthier products.

25 secondary outcomes

Guiding Stars Scores
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Number of Items Selected That Are High in ≥1 Nutrient of Concern
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Calorie Density of Participants' Grocery Selections
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Sugar Density of Participants' Grocery Selections
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Sodium Density of Participants' Grocery Selections
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Saturated Fat Density of Participants' Grocery Selections
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Fiber Density of Participants' Grocery Selections
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Protein Density of Participants' Grocery Selections
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Calories Selected
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Sugar Selected
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Sodium Selected
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Saturated Fat Selected
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Fiber Selected
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Protein Selected
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Number of Items Selected
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Total Spending on Participants' Grocery Selections
Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes
Correct Identification of Healthier Items
Time frame: Assessed from enrollment to end of one-time, 30-minute online study survey
Noticing of Front-of-package Labeling Systems
Time frame: Assessed from enrollment to end of one-time, 30-minute online study survey
Use of Front-of-package Labeling Systems
Time frame: Assessed from enrollment to end of one-time, 30-minute online study survey
Thinking About Health
Time frame: Assessed from enrollment to end of one-time, 30-minute online study survey
Negative Emotional Reactions
Time frame: Assessed from enrollment to end of one-time, 30-minute online study survey
Perceived Helpfulness of the Front-of-package Labeling System
Time frame: Assessed from enrollment to end of one-time, 30-minute online study survey
Perceived Understandability of the Front-of-package Labeling System
Time frame: Assessed from enrollment to end of one-time, 30-minute online study survey
Perceived Trustworthiness of the Front-of-package Labeling System
Time frame: Assessed from enrollment to end of one-time, 30-minute online study survey
Public Support for Front-of-package Labeling System
Time frame: Assessed from enrollment to end of one-time, 30-minute online study survey

Results and safety

Results posted to the registry on 8 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Positive Labels	995	937
Spectrum Labels	1,002	944
FDA High In Labels	1,007	946
FDA Traffic Light Labels	998	935
FDA High In Labels Plus Positive Labels	1,001	934
FDA Traffic Light Labels Plus Positive Labels	999	940

Primary outcome: Healthfulness of Participants' Grocery Selections

Time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes. Mean (Standard Error). Unit: Units on a scale, 0 to 100

Measure	Positive Labels n = 937	Spectrum Labels n = 944	FDA High In Labels n = 946	FDA Traffic Light Labels n = 935	FDA High In Labels Plus Positive Labels n = 934	FDA Traffic Light Labels Plus Positive Labels n = 940
Value	58.5 (0.3)	60.9 (0.3)	58.9 (0.3)	58.5 (0.3)	59.1 (0.3)	59.0 (0.3)

25 secondary outcomes are reported in the full results.

Adverse events

Time frame: This study included a one-time shopping task that lasted for approximately 30 minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Positive Labels	0 of 937 (0%)	0 of 937 (0%)	0 of 937
Spectrum Labels	0 of 944 (0%)	0 of 944 (0%)	0 of 944
FDA High In Labels	0 of 946 (0%)	0 of 946 (0%)	0 of 946
FDA Traffic Light Labels	0 of 935 (0%)	0 of 935 (0%)	0 of 935
FDA High In Labels Plus Positive Labels	0 of 934 (0%)	0 of 934 (0%)	0 of 934
FDA Traffic Light Labels Plus Positive Labels	0 of 940 (0%)	0 of 940 (0%)	0 of 940

Limitations and caveats (from the sponsor): Limitations include that participants had a single exposure to the labels in the context of an online store; effects after repeated exposures and in brick-and-mortar settings remain unknown. Second, we recruited a convenience sample, although randomized clinical trials conducted with convenience samples generally replicate in representative samples. Several other limitations are described in the published paper: https://doi.org/10.1001/jamanetworkopen.2025.37389.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41397534Huang Y, O'Sullivan K, Block JP, Petimar J, Lee CJY, Grummon AH. Impact of the Food and Drug Administration's Proposed Front-of-Package Label and Alternative Designs on Consumer Understanding: A Randomized Experiment. Am J Prev Med. 2026 May;70(5):108222. doi: 10.1016/j.amepre.2025.108222. Epub 2025 Dec 13.
Derived from this study: PubMed 41105412Grummon AH, O'Sullivan K, Petimar J, Lee CJY, Zeitlin AB, Cleveland LP, Collis C, Musicus AA, Tiefenbeck V, Fleisch E, Block JP. Nutrition Info and Other Front-of-Package Labels and Simulated Food and Beverage Purchases: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2537389. doi: 10.1001/jamanetworkopen.2025.37389.
Individual participant dataSharing planned: Yes. Investigators will post de-identified individual participant data in a public repository.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason P. Block, MD principal investigator

Harvard Pilgrim Health Care

Anna H. Grummon, PhD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Positive Labels, Spectrum Labels and FDA High In Labels in people with Nutrition and Food Selection, run by Harvard Pilgrim Health Care 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 8 Oct 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. 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?

Yes. Results are posted in the registry (first posted 8 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healthfulness of Participants' Grocery Selections (time frame: Assessed during a one-time online shopping task that lasted for approximately 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06516627, which also lists 2 linked publications.

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 8 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.