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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL147713 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
In this study, participants will attend one in-person visit, lasting approximately 15 minutes after signing informed consent. First participants will complete an eye tracking task where their attention to study stimuli is measured objectively via an eye tracker (i.e., eye tracking task). The eye tracking task will take ~5 minutes. Then, participants will complete a brief ~10 minute self-administered survey on a computer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Front of package food label | Experimental | 4 labels (3 sodium labels, 1 control barcode label) are shown on an image of a soup can |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text only sodium label | Behavioral | "Warning: High in sodium." is shown in a black square label on the can of soup. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Times Looking at the Front-of-package Sodium Label (i.e., Fixation Count) | 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 |
| Time to First Fixation on the Front-of-package Sodium Label |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marissa Hall, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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).
Data will be available 9 months after and up to 10 years following publication.
The investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Front of Package Food Label | Participants view 4 labels (3 sodium labels, 1 control barcode label) on a soup can image in a random order with a washout in between each label viewing. The washout includes instructions to click forward at participants' own pace to view the next label. Text only sodium label: "Warning: High in sodium." is shown in a black square label on the can of soup. Icon sodium 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. Pictorial sodium 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. Barcode label: Barcode is shown in white square label on the can of soup |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Label Viewing (Self-paced) |
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| Washout (Self-paced) |
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| Second Label Viewing (Self-paced) |
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| Washout (Self Paced) |
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| Third Label Viewing (Self-paced) |
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| Washout (Self Paced) |
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| Fourth Label Viewing (Self-paced) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Front of Package Food Label | 4 labels (3 sodium labels, 1 control barcode label) are shown on an image of a soup can Text only sodium label: "Warning: High in sodium." is shown in a black square label on the can of soup. Icon sodium 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. Pictorial sodium 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. Barcode label: Barcode is shown in white square label on the can of soup |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | seconds | During ~5-minute eye tracking task, as part of a one-time study visit lasting ~30 minutes |
|
From the time of signing informed consent, through study completion, a total of up to 30 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Text Only Sodium Label | Participants are shown on an image of a soup can bearing a text only sodium label: "Warning: High in sodium." is shown in a black square label on the can of soup. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marissa Hall, PhD | University of North Carolina at Chapel Hill | (919) 445-1310 | mghall@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2024 | Jul 8, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2023 | Oct 12, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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.
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| Icon sodium label | Behavioral | "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. |
|
| Pictorial sodium label | Behavioral | "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. |
|
| Barcode label | Behavioral | Barcode is shown in white square label on the can of soup |
|
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 |
| Dwell Time on "Natural" Claim | 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 |
| Self-reported Attention to the Front-of-package Sodium Label | Assessed with 1 item for each label type. Response options will range from 1 to 5. Higher scores indicate more attention. | 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 | Assessed with 3 items for each label type. Response options will range from 1 to 5. Higher scores indicate greater perceived message effectiveness. | During ~10 minute online survey, as part of one-time study visit lasting ~30 minutes |
| Understandability of Front-of-package Sodium Label | 1 item for each label type. Response options will range from 1 to 5. Higher scores indicate more understandability. | During ~10 minute online survey, as part of one-time study visit lasting ~30 minutes |
| Pictorial Sodium Label |
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| Barcode Label |
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| COMPLETED |
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| NOT COMPLETED |
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| Pictorial Sodium Label |
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| Barcode Label |
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| COMPLETED |
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| NOT COMPLETED |
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| Pictorial Sodium Label |
|
| Barcode Label |
|
| COMPLETED |
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| NOT COMPLETED |
|
| Pictorial Sodium Label |
|
| Barcode Label |
|
| COMPLETED |
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| NOT COMPLETED |
|
| Pictorial Sodium Label |
|
| Barcode Label |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Pictorial Sodium Label |
|
| Barcode Label |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex/Gender, Customized | Reporting of gender was optional and 1 participant did not provide. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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|
|
|
| Secondary | Number of Times Looking at the Front-of-package Sodium Label (i.e., Fixation Count) | This outcome will be measured using eye tracking technology. | Posted | Mean | Standard Deviation | fixation | During ~5-minute eye tracking task, as part of a one-time study visit lasting ~30 minutes |
|
|
|
|
| Secondary | Time to First Fixation on the Front-of-package Sodium Label | This outcome will be measured using eye tracking technology. | There were missing data for 1 participant. | Posted | Mean | Standard Deviation | seconds | During ~5-minute eye tracking task, as part of a one-time study visit lasting ~30 minutes |
|
|
|
|
| Secondary | Dwell Time on "Natural" Claim | This outcome will be measured using eye tracking technology. | Posted | Mean | Standard Deviation | seconds | During ~5-minute eye tracking task, as part of a one-time study visit lasting ~30 minutes |
|
|
|
|
| Secondary | Self-reported Attention to the Front-of-package Sodium Label | Assessed with 1 item for each label type. Response options will range from 1 to 5. Higher scores indicate more attention. | Posted | Mean | Standard Deviation | score on a scale | During ~10 minute online survey, as part of one-time study visit lasting ~30 minutes |
|
|
|
|
| Secondary | Perceived Message Effectiveness of the Front-of-package Sodium Label | Assessed with 3 items for each label type. Response options will range from 1 to 5. Higher scores indicate greater perceived message effectiveness. | Posted | Mean | Standard Deviation | score on a scale | During ~10 minute online survey, as part of one-time study visit lasting ~30 minutes |
|
|
|
|
| Secondary | Understandability of Front-of-package Sodium Label | 1 item for each label type. Response options will range from 1 to 5. Higher scores indicate more understandability. | Posted | Mean | Standard Deviation | score on a scale | During ~10 minute online survey, as part of one-time study visit lasting ~30 minutes |
|
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | Icon Sodium Label | Participants are shown on an image of a soup can bearing an icon sodium 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. | 0 | 63 | 0 | 63 | 0 | 63 |
| EG002 | Pictorial Sodium Label | Participants are shown on an image of a soup can bearing a pictorial sodium 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. | 0 | 63 | 0 | 63 | 0 | 63 |
| EG003 | Barcode Label | Participants are shown on an image of a soup can bearing a barcode label: Barcode is shown in white square label on the can of soup | 0 | 63 | 0 | 63 | 0 | 63 |
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| Title | Measurements |
|---|---|
|
| Graphic |
|
Icon vs. Control |
| Mixed Models Analysis |
| <.001 |
p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. |
| Mean Difference (Final Values) |
| 6 |
| Standard Error of the Mean |
| .85 |
| 2-Sided |
| Superiority |
| Graphic vs. Control | Mixed Models Analysis | <.001 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | 8 | Standard Error of the Mean | .85 | 2-Sided | Superiority |
| Icon vs. Text | Mixed Models Analysis | .12 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | 1 | Standard Error of the Mean | .85 | 2-Sided | Superiority |
| Graphic vs. Text | Mixed Models Analysis | <.001 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | 3 | Standard Error of the Mean | .85 | 2-Sided | Superiority |
| Graphic vs. Icon | Mixed Models Analysis | .04 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | 2 | Standard Error of the Mean | .85 | 2-Sided | Superiority |
| Title | Measurements |
|---|---|
|
| Graphic |
|
Icon vs. Control |
| Mixed Models Analysis |
| .23 |
p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. |
| Mean Difference (Final Values) |
| -.35 |
| Standard Error of the Mean |
| .19 |
| 2-Sided |
| Superiority |
| Graphic vs. Control | Mixed Models Analysis | .01 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | -.59 | Standard Error of the Mean | .19 | 2-Sided | Superiority |
| Icon vs. Text | Mixed Models Analysis | .58 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | .21 | Standard Error of the Mean | .19 | 2-Sided | Superiority |
| Graphic vs. Text | Mixed Models Analysis | .85 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | -.03 | Standard Error of the Mean | .19 | 2-Sided | Superiority |
| Graphic vs. Icon | Mixed Models Analysis | .58 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | -.24 | Standard Error of the Mean | .19 | 2-Sided | Superiority |
| Title | Measurements |
|---|---|
|
| Graphic |
|
Icon vs. Control |
| Mixed Models Analysis |
| >.99 |
p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. |
| Mean Difference (Final Values) |
| -.03 |
| Standard Error of the Mean |
| .10 |
| 2-Sided |
| Superiority |
| Graphic vs. Control | Mixed Models Analysis | .47 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | -.16 | Standard Error of the Mean | .10 | 2-Sided | Superiority |
| Icon vs. Text | Mixed Models Analysis | >.99 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | -.04 | Standard Error of the Mean | .10 | 2-Sided | Superiority |
| Graphic vs. Text | Mixed Models Analysis | .45 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | -.17 | Standard Error of the Mean | .10 | 2-Sided | Superiority |
| Graphic vs. Icon | Mixed Models Analysis | .70 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | -.13 | Standard Error of the Mean | .10 | 2-Sided | Superiority |
| Title | Measurements |
|---|---|
|
| Graphic |
|
Icon vs. Control |
| Mixed Models Analysis |
| <.001 |
p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. |
| Mean Difference (Final Values) |
| 1.76 |
| Standard Error of the Mean |
| .17 |
| 2-Sided |
| Superiority |
| Graphic vs. Control | Mixed Models Analysis | <.001 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | 1.70 | Standard Error of the Mean | .17 | 2-Sided | Superiority |
| Icon vs. Text | Mixed Models Analysis | <.001 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | .87 | Standard Error of the Mean | .17 | 2-Sided | Superiority |
| Graphic vs. Text | Mixed Models Analysis | <.001 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | .81 | Standard Error of the Mean | .17 | 2-Sided | Superiority |
| Graphic vs. Icon | Mixed Models Analysis | .72 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | -.06 | Standard Error of the Mean | .17 | 2-Sided | Superiority |
| Title | Measurements |
|---|---|
|
| Graphic |
|
Icon vs. Control |
| Mixed Models Analysis |
| <.001 |
p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. |
| Mean Difference (Final Values) |
| 2.39 |
| Standard Error of the Mean |
| .14 |
| 2-Sided |
| Superiority |
| Graphic vs. Control | Mixed Models Analysis | <.001 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | 2.11 | Standard Error of the Mean | .14 | 2-Sided | Superiority |
| Icon vs. Text | Mixed Models Analysis | <.001 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | .66 | Standard Error of the Mean | .14 | 2-Sided | Superiority |
| Graphic vs. Text | Mixed Models Analysis | .01 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | .38 | Standard Error of the Mean | .14 | 2-Sided | Superiority |
| Graphic vs. Icon | Mixed Models Analysis | .04 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | -.28 | Standard Error of the Mean | .14 | 2-Sided | Superiority |
| Title | Measurements |
|---|---|
|
| Graphic |
|
Icon vs. Control |
| Mixed Models Analysis |
| <.001 |
p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. |
| Mean Difference (Final Values) |
| .81 |
| Standard Error of the Mean |
| .15 |
| 2-Sided |
| Superiority |
| Graphic vs. Control | Mixed Models Analysis | <.001 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | .71 | Standard Error of the Mean | .15 | 2-Sided | Superiority |
| Icon vs. Text | Mixed Models Analysis | .43 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | .22 | Standard Error of the Mean | .15 | 2-Sided | Superiority |
| Graphic vs. Text | Mixed Models Analysis | .81 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | .13 | Standard Error of the Mean | .15 | 2-Sided | Superiority |
| Graphic vs. Icon | Mixed Models Analysis | .81 | p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p<0.05. | Mean Difference (Final Values) | -.10 | Standard Error of the Mean | .15 | 2-Sided | Superiority |