Front-of-Package Nutrition Labels

NCT06516627 | Completed

• 2 other identifiers: 1938853R01DK115492
• Study Type: interventional
• Target: 5,638
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutrition; Food Selection; Food Preferences; Dietary Habits; Healthy Diet

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed from enrollment to end of one-time, 30-minute online study survey

Secondary Outcomes (25)

• Guiding Stars scores of participants' grocery selections

  Assessed from enrollment to end of one-time, 30-minute online study survey

• Number of items selected that are high in ≥1 nutrient of concern

  Assessed from enrollment to end of one-time, 30-minute online study survey

• Calorie density of participants' grocery selections

  Assessed from enrollment to end of one-time, 30-minute online study survey

• Sugar density of participants' grocery selections

  Assessed from enrollment to end of one-time, 30-minute online study survey

• Sodium density of participants' grocery selections

  Assessed from enrollment to end of one-time, 30-minute online study survey

Study Arms (6)

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.

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.

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.

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.

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.

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.

Behavioral: Positive Labels; Behavioral: FDA Traffic Light Labels

Interventions

Positive Labels BEHAVIORAL

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").

FDA High In Labels Plus Positive Labels; FDA Traffic Light Labels Plus Positive Labels; Positive Labels

Spectrum Labels BEHAVIORAL

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").

Spectrum Labels

FDA High In Labels BEHAVIORAL

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 High In Labels; FDA High In Labels Plus Positive Labels

FDA Traffic Light Labels BEHAVIORAL

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.

FDA Traffic Light Labels; FDA Traffic Light Labels Plus Positive Labels

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• Stanford University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Harvard Pilgrim Health Care Institute

Boston, Massachusetts, 02215-3325, United States

Location

Related Publications (2)

• Huang Y, O'Sullivan K, Block JP, Petimar J, Lee CJY, Grummon AH. Impact of FDA's proposed front-of-package label and alternative designs on consumer understanding: A randomized experiment. Am J Prev Med. 2025 Dec 13:108222. doi: 10.1016/j.amepre.2025.108222. Online ahead of print.

  PMID: 41397534 DERIVED

• 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.

  PMID: 41105412 DERIVED

MeSH Terms

Conditions

Food Preferences; Feeding Behavior

Interventions

Product Labeling

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal

Intervention Hierarchy (Ancestors)

Product Packaging; Industry; Technology, Industry, and Agriculture

Study Officials

• Jason P. Block, MD

  Harvard Pilgrim Health Care

  PRINCIPAL INVESTIGATOR

• Anna H. Grummon, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 24, 2024
• Study Start: October 31, 2024
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Investigators will post IDP within 6 months of publication of manuscripts associated with the data generated in this study.
• Access Criteria: Data and code will be made publicly available.

Locations

US (1)