NCT06296355

Brief Summary

Purpose: The overall purpose of this study is to identify the impacts of an ultra-processed (UPF) health warning label and UPF identify warning label compared to a control label (i.e., a barcode). Participants: \~4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency, recruited from a Latino-focused panel company. Procedures: Participants will be randomly assigned to view food products with one of three label types: health warning labels, identity labels, or barcode control labels. Participants will be asked a series of questions about the products and the label they were assigned.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 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

February 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 9, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

February 28, 2024

Last Update Submit

October 14, 2024

Conditions

Keywords

front-of-package labelsultra-processed foodfood and beverage purchases

Outcome Measures

Primary Outcomes (1)

  • Identification of a product as ultra-processed

    Correct identification of a product as ultra-processed. Measured with the question, "Do you think this product is ultra-processed?" Response options are Yes, No, and I'm not sure.

    Immediately after exposure to intervention, assessed during 1-time online study visit.

Secondary Outcomes (3)

  • Perceived product healthfulness of ultra-processed products

    Immediately after exposure to intervention, assessed during 1-time online study visit.

  • Intentions to purchase ultra-processed products

    Immediately after exposure to intervention, assessed during 1-time online study visit.

  • Perceived message effectiveness

    Immediately after exposure to intervention, assessed during 1-time online study visit.

Study Arms (3)

Health Warning Label

EXPERIMENTAL

Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) each with a health warning label displayed on the front of package.

Behavioral: Health Warning Label

Identity Warning Label

EXPERIMENTAL

Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) each with an identity warning label displayed on the front of package.

Behavioral: Identity Warning Label

Barcode Label

OTHER

Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) each with a barcode control label displayed on the front of package.

Other: Barcode Label

Interventions

Message displayed on warning label is: "WARNING: Consuming ultra-processed food and drinks can cause weight gain, which increases the risk of obesity and type 2 diabetes."

Health Warning Label

Message displayed on warning label is: "WARNING: Ultra-processed food".

Identity Warning Label

Barcode is displayed.

Barcode Label

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Identifying as Latino or Hispanic
  • Ages 18-55 years old
  • Currently resides in the United States

You may not qualify if:

  • Not identifying as Latino or Hispanic
  • Less than 18 or greater than 55 years old
  • Not residing in the United States

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Carolina Population Center

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lindsey Smith Taillie, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 6, 2024

Study Start

August 9, 2024

Primary Completion

September 11, 2024

Study Completion

September 11, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

A deidentified dataset and the corresponding survey codebook will be shared beginning 9 months and continuing for 36 months after publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. The study protocol, statistical analysis plan, and informed consent form will be published alongside as supplementary material.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
beginning 9 and continuing for 36 months following publication of study results.
Access Criteria
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations