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Front-of-Package Nutrition Labels

NCT ID: NCT06516627

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5638 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2024-11-21

Brief Summary

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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.

Detailed Description

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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

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Nutrition Food Selection Food Preferences Dietary Habits Healthy Diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Positive Labels

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.

Group Type EXPERIMENTAL

Positive Labels

Intervention Type 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").

Spectrum Labels

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.

Group Type EXPERIMENTAL

Spectrum Labels

Intervention Type 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").

FDA High In Labels

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.

Group Type EXPERIMENTAL

FDA High In Labels

Intervention Type 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 Traffic Light Labels

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.

Group Type EXPERIMENTAL

FDA Traffic Light Labels

Intervention Type 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 High In Labels Plus Positive Labels

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.

Group Type EXPERIMENTAL

Positive Labels

Intervention Type 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

Intervention Type 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 Traffic Light Labels Plus Positive Labels

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.

Group Type EXPERIMENTAL

Positive Labels

Intervention Type 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 Traffic Light Labels

Intervention Type 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.

Interventions

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Positive Labels

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").

Intervention Type BEHAVIORAL

Spectrum Labels

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").

Intervention Type BEHAVIORAL

FDA High In Labels

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.

Intervention Type BEHAVIORAL

FDA Traffic Light Labels

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Harvard Pilgrim Health Care

OTHER

Sponsor Role lead

Responsible Party

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Jason Block

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason P. Block, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Pilgrim Health Care

Anna H. Grummon, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Harvard Pilgrim Health Care Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 41105412 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R01DK115492

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1938853

Identifier Type: -

Identifier Source: org_study_id