NCT06227507

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,052

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

May 9, 2024

Status Verified

January 1, 2024

Enrollment Period

29 days

First QC Date

January 8, 2024

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Identification of healthiest product - dichotomous variable "Correct" (Selected product that is high in only 1 nutrient of concern) or "Incorrect" (otherwise)

    Measured with: "Which of the products below is the healthiest in terms of added sugars, sodium, and saturated fat content? The U.S. Food and Drug Administration (FDA) recommends limiting consumption of added sugars, sodium, and saturated fat." There is no formal name for this measure/scale.

    During a ~10 minute online survey

Secondary Outcomes (5)

  • Identification of least healthy product - dichotomous variable "Correct" (Selected product that is high in all 3 nutrients of concern) or "Incorrect" (otherwise)

    During a ~10 minute online survey

  • Identification of high-sodium product(s) - dichotomous variable "Correct" (Selected all products that are high in sodium) or "Incorrect" (otherwise)

    During a ~10 minute online survey

  • Identification of high-saturated-fat product(s) - dichotomous variable "Correct" (Selected all products that are high in saturated fat) or "Incorrect" (otherwise)

    During a ~10 minute online survey

  • Identification of high-added-sugars product(s) - dichotomous variable "Correct" (Selected all products that are high in added sugars) or "Incorrect" (otherwise)

    During a ~10 minute online survey

  • Perceived Message Effectiveness of label: Discouragement - continuous variable from a 3-item scale in which each item uses a 1-5 response scale

    During a ~10 minute online survey

Other Outcomes (1)

  • Nutrition literacy

    During a ~10 minute online survey

Study Arms (5)

No icon

EXPERIMENTAL

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.

Behavioral: Front-of-package label

Magnifying glass

EXPERIMENTAL

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.

Behavioral: Front-of-package label

Exclamation Mark

EXPERIMENTAL

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.

Behavioral: Front-of-package label

Exclamation Mark with multiple labels

EXPERIMENTAL

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.

Behavioral: Front-of-package label

Exclamation Mark with Black Background

EXPERIMENTAL

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.

Behavioral: Front-of-package label

Interventions

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

Exclamation MarkExclamation Mark with Black BackgroundExclamation Mark with multiple labelsMagnifying glassNo icon

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Failing the attention check question
  • Completing the survey in less than 33% of the median completion time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

Study Officials

  • Jennifer Falbe, ScD, MPH

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 29, 2024

Study Start

February 15, 2024

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

May 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations