- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06673706
Assessing the Impact of Front-of-package Nutrient Labels
Assessing the Impact of Front-of-package Nutrient Labels on Consumer Understanding and Behavior
Study Overview
Status
Intervention / Treatment
Detailed Description
This study aims to compare different front-of-package label designs, using two schemes: (1) High In and (2) Nutrition Info. The labels will have variations, such as color, and will be compared to a no-label control and one another. There will be a total of 6 experimental conditions: 1) High In label with color; 2) High In label in black and white; 3) Nutrition Info label with color; 4) Nutrition Info in black and white; 5) Nutrition Info label in black and white with percent Daily Value listed; and 6) a no-label control.
Participants will view a series of food-and-beverage products labeled (or not) according to condition. The three primary outcomes are: (1) correct assessment of high nutrient contents in food-and-beverage products, (2) perceived healthfulness of packaged foods and beverages, and (3) selection of at least one item high in at least one nutrient of concern (saturated fat, sodium, added sugar) in a shopping task. Perceived message effectiveness will be examined as a secondary outcome.
All statistical analyses will use two-tailed tests with a significance level of <0.05. Per CONSORT Guidelines, all models comparing labels will be bivariate, regressing outcomes on indicators for labeling condition. For continuous outcomes, linear regression models will be used, and for dichotomous outcomes, risk ratios (or probability ratios) will be estimated using Poisson regression with a robust error variance.
Effect modification of the labels on primary outcomes will be explored for type 2 diabetes status and sociodemographic variables important for health equity using interaction terms and stratified models.
Additionally, differences in the primary outcomes between each of the 6 unique conditions will be explored.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
California
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Davis, California, United States, 96516
- University of California, Davis
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Equal or greater than 18 years of age
- English-speaking
- U.S. residents
- Have eaten restaurant food at least once in the last month
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No-label Control
Participants will see packaged food-and-beverage items with no front-of-package labels (other than any posted by the manufacturer).
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|
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Experimental: High-In with color
Participants will see packaged food-and-beverage items displaying front-of-package labels that say, "High In [nutrient]" (nutrients: saturated fat, sodium, or added sugar) if the item contains 20% or more of the daily recommended limit per serving for each nutrient. The nutrients will be highlighted in red. If the item is not high in 1 or 2 of the nutrients, the nutrient(s) will not be on the label. If the item is not high in any of the 3 nutrients, the product will not display this label. |
Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group
|
|
Experimental: High-In black and white
Participants will see packaged food-and-beverage items displaying front-of-package labels that say, "High In [nutrient]" (nutrients: saturated fat, sodium, or added sugar) if the item contains 20% or more of the daily recommended limit per serving for each nutrient. The label will have a white background and black text. If the item is not high in 1 or 2 of the nutrients, the nutrient(s) will not be on the label. If the item is not high in any of the 3 nutrients, the product will not display this label. |
Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group
|
|
Experimental: Nutrition Info with color
Participants will see packaged food-and-beverage items displaying front-of-package labels that list "high", "medium", or "low" for saturated fat, sodium, and added sugars.
"High" is defined as 20% or more of the daily recommended limit per serving, "medium" as 6-19%, and "low" as 5% or less.
The word "high" will be highlighted red; the word "medium" will be highlighted yellow; and the word "low" will be highlighted green.
|
Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group
|
|
Experimental: Nutrition Info black and white
Participants will see packaged food-and-beverage items displaying front-of-package labels that list "high", "medium", or "low" for saturated fat, sodium, and added sugars.
"High" is defined as 20% or more of the daily recommended limit per serving, "medium" as 6-19%, and "low" as 5% or less.
The label will have a white background and black text.
|
Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group
|
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Experimental: Nutrition Info without color, with percent Daily Value
Participants will see packaged food-and-beverage items displaying front-of-package labels that list "high", "medium", or "low" for saturated fat, sodium, and added sugars.
"High" is defined as 20% or more of the daily recommended limit per serving, "medium" as 6-19%, and "low" as 5% or less.
The label will also list the exact percent of the daily recommended limit (i.e., daily value) for each nutrient per serving.
The label will have a white background and black text.
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Participants will see packaged food-and-beverage items displayed with labels as specified by their assigned group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived healthfulness
Time Frame: Within approximately 5 minutes of intervention exposure
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Participants will provide a healthfulness score (response scale from 1-7) for up to 6 different products.
The average score across products will be used as a continuous outcome in linear regression models.
In sensitivity analyses, scores will be examined by product and product grouping.
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Within approximately 5 minutes of intervention exposure
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Selection of a product high in a nutrient of concern
Time Frame: Within approximately 5 minutes of intervention exposure
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Participants will select a food and beverage they would purchase for themselves from hypothetical grocery store shelves displaying foods and beverages.
The dichotomous outcome is selection of an item that is high in at least one nutrient of concern (compared to not selecting an item high in at least one nutrient of concern), examined overall and separately for foods and beverages.
Analyzed in Poisson regression with robust SE to directly estimate risk ratios.
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Within approximately 5 minutes of intervention exposure
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Correct assessment of "high" nutrients
Time Frame: Within approximately 5 minutes of intervention exposure
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Participants will view 4 foods and indicate whether each food is high in each of saturated fat, sodium, and added sugar.
A "correct" response is identifying a high-in product as high in the corresponding nutrient and identifying a not high-in product as not high in the corresponding nutrient; otherwise the response is "incorrect".
Participants will provide 12 responses (3 nutrients across 4 foods), and the percent correct for each participant will be used as a continuous outcome in linear regression.
If the distribution of percent correct is skewed, analysis may use all 12 dichotomous responses in a mixed model, accounting for within subject correlation.
In sensitivity analyses, this outcome will be (1) examined by nutrient and (2) dichotomized as correct assessment of all nutrients in each meal.
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Within approximately 5 minutes of intervention exposure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived message effectiveness
Time Frame: Within approximately 5 minutes of intervention exposure
|
Measured with one item from the validated 3-item University of North Carolina perceived message effectiveness scale: "How much does this label discourage you from wanting to consume products high in sodium, saturated fat, and added sugar?" Response options include 1-5 where higher values represent higher perceived discouragement.
Analyzed as a continuous outcome in linear regression.
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Within approximately 5 minutes of intervention exposure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Falbe, ScD, MPH, University of California, Davis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1641776-8B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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