NCT05958888

Brief Summary

The goal of this study is to examine attention elicited by icon, text-only, and control front-of-package food labels. The study also aims to explore whether English language proficiency moderates the impact of icon vs. text-only labels on attention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

August 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

July 12, 2023

Results QC Date

July 8, 2024

Last Update Submit

August 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Amount of Time Spent Looking at the Front-of-package Sodium Label (i.e., Dwell Time)

    This outcome will be measured using eye tracking technology.

    During ~5-minute eye tracking task, as part of a one-time study visit lasting ~30 minutes

Secondary Outcomes (6)

  • Number of Times Looking at the Front-of-package Sodium Label (i.e., Fixation Count)

    During ~5-minute eye tracking task, as part of a one-time study visit lasting ~30 minutes

  • Time to First Fixation on the Front-of-package Sodium Label

    During ~5-minute eye tracking task, as part of a one-time study visit lasting ~30 minutes

  • Dwell Time on "Natural" Claim

    During ~5-minute eye tracking task, as part of a one-time study visit lasting ~30 minutes

  • Self-reported Attention to the Front-of-package Sodium Label

    During ~10 minute online survey, as part of one-time study visit lasting ~30 minutes

  • Perceived Message Effectiveness of the Front-of-package Sodium Label

    During ~10 minute online survey, as part of one-time study visit lasting ~30 minutes

  • +1 more secondary outcomes

Study Arms (1)

Front of package food label

EXPERIMENTAL

4 labels (3 sodium labels, 1 control barcode label) are shown on an image of a soup can

Behavioral: Text only sodium labelBehavioral: Icon sodium labelBehavioral: Pictorial sodium labelBehavioral: Barcode label

Interventions

"Warning: High in sodium." is shown in a black square label on the can of soup.

Front of package food label

"Warning: High in sodium." is shown beneath a yellow triangle icon with an exclamation mark all in a black square label on the can of soup.

Front of package food label

"Warning: High in sodium." is shown beneath an image of a spilled salt shaker, all in a black square label on the can of soup.

Front of package food label
Barcode labelBEHAVIORAL

Barcode is shown in white square label on the can of soup

Front of package food label

Eligibility Criteria

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

You may qualify if:

  • Adult aged 18 or older
  • Self-identifies as Hispanic or Latino

You may not qualify if:

  • Less than 18 years old
  • Does not identify as Hispanic or Latino
  • Has one of the following conditions: (Wears bifocals, glaucoma, permanently dilated pupils, eye implants \[artificial lenses, not contact lenses\], less than 2 eyes, or blindness)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Marissa Hall, PhD
Organization
University of North Carolina at Chapel Hill

Study Officials

  • Marissa Hall, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All participants will see the same 4 labels (3 sodium labels \[text only, text + icon, and text + pictorial\] and a control bar code label) in a random order.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 25, 2023

Study Start

August 2, 2023

Primary Completion

September 29, 2023

Study Completion

September 29, 2023

Last Updated

August 13, 2024

Results First Posted

August 13, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Deidentified individual data that supports the results will be shared beginning 9 months following 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 the University of North Carolina (UNC).

Shared Documents
SAP, ANALYTIC CODE
Time Frame
Data will be available 9 months after and up to 10 years following publication.
Access Criteria
The investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations