High in Front-of-package Label Pretest

NCT ID: NCT06227507

Last Updated: 2024-05-09

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

4052 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2024-03-15

Brief Summary

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The goal of this trial is to understand which of five "High In" front-of-package label designs is most effective at helping consumers identify the healthiest products (i.e., products that are high in the fewest number of nutrients of concern: added sugar, sodium, and saturated fat).

Detailed Description

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The objective of this aim is to assess which of five "High In" front-of-package label (FOPL) designs is most effective at helping consumers identify the healthiest products (i.e., products that are high in the fewest number of nutrients of concern: added sugar, sodium, and saturated fat). The investigators will use a between-subjects randomized experiment to assess the primary outcome. Participants will be randomized to one of five label conditions modeled after the U.S. Food and Drug Administration's draft "High In" FOPL designs: 1) No Icon; 2) Magnifying Glass; 3) Exclamation Mark; 4) Exclamation Mark with multiple labels; 5) Exclamation Mark with Black Background.

The primary outcome is correct identification of the healthiest product, defined as the product that is high in the fewest nutrients of concern, including added sugars, sodium, and saturated fat (percent correct for each condition). Secondary outcomes include correct identification of which product is least healthy; which product(s) are high in added sugars, saturated fat, and sodium (3 separate questions); and perceived message effectiveness (PME) of the different labels.

Logit models will be used to compare proportions in each condition that correctly identified the items (each condition compared to every other condition). For continuous outcomes (e.g., knowledge, PME scale), the investigators will use linear regression models regressing the outcome on an indicator for experimental condition. A critical alpha 0.05 will be used, and statistical tests will be two-tailed. The Bonferroni Holm correction will be used for analyses comparing conditions 2-5 to each other for each outcome (6 comparisons).

The investigators will also measure nutrition literacy, and assess moderation on the primary outcome by nutrition literacy (continuous) and highest education attainment (Bachelor's Degree or higher vs. less than Bachelor's Degree).

Conditions

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Understanding of Food Nutrient Content

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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No icon

Participants will be shown 3 frozen meals at once; each product will be high in 1, 2, or 3 nutrients of concern (added sugar, sodium, and/or saturated fat) and will be labeled as such with a rectangular "high in" front-of-package label. The label will solely contain "high in" and nutrient text with no icon.

Group Type EXPERIMENTAL

Front-of-package label

Intervention Type BEHAVIORAL

Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.

Magnifying glass

Participants will be shown 3 frozen meals at once; each product will be high in 1, 2, or 3 nutrients of concern (added sugar, sodium, and/or saturated fat) and will be labeled as such with a rectangular "high in" front-of-package label. The label will contain "high in" and nutrient text, along with a magnifying glass icon.

Group Type EXPERIMENTAL

Front-of-package label

Intervention Type BEHAVIORAL

Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.

Exclamation Mark

Participants will be shown 3 frozen meals at once; each product will be high in 1, 2, or 3 nutrients of concern (added sugar, sodium, and/or saturated fat) and will be labeled as such with a rectangular "high in" front-of-package label. The label will contain "high in" and nutrient text, along with an exclamation mark icon.

Group Type EXPERIMENTAL

Front-of-package label

Intervention Type BEHAVIORAL

Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.

Exclamation Mark with multiple labels

Participants will be shown 3 frozen meals at once; each product will be high in 1, 2, or 3 nutrients of concern (added sugar, sodium, and/or saturated fat) and will be labeled as such with 1, 2, or 3 rectangular "high in" front-of-package labels, one for each specific nutrient of concern. Each label will contain "high in" and nutrient text, along with an exclamation mark icon.

Group Type EXPERIMENTAL

Front-of-package label

Intervention Type BEHAVIORAL

Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.

Exclamation Mark with Black Background

Participants will be shown 3 frozen meals at once; each product will be high in 1, 2, or 3 nutrients of concern (added sugar, sodium, and/or saturated fat) and will be labeled as such with a rectangular "high in" front-of-package label. The label will contain "high in" and nutrient text, along with an exclamation mark icon. The background of the "high in" text will be black, and the "high in" text will be white.

Group Type EXPERIMENTAL

Front-of-package label

Intervention Type BEHAVIORAL

Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.

Interventions

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Front-of-package label

Participants will identify the healthfulness of three packaged foods, each displayed with front-of-package labels as specified by their assigned group.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Equal or greater than 18 years of age
* Less than 100 years of age
* English-speaking
* U.S. residents
* Participants will reflect the U.S. Census Bureau's 2021 American Community Survey 5-year estimates for gender, race/ethnicity, educational attainment, and age

Exclusion Criteria

* Failing the attention check question
* Completing the survey in less than 33% of the median completion time
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Falbe, ScD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis

Davis, California, United States

Site Status

Countries

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United States

Other Identifiers

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1641776-7

Identifier Type: -

Identifier Source: org_study_id

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