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OpenTrials
Completed

NCT Number: NCT06227507

High in Front-of-package Label Pretest

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).

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Davis, California, 95616, United States

About this study

The objective of this aim is to assess which of five "High In" front-of-package label (FOPL) 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). The investigators will use a between-subjects randomized experiment to assess the primary outcome. Participants will be randomized to one of five label conditions modeled after the U.S. Food and Drug Administration's draft "High In" FOPL designs: 1) No Icon; 2) Magnifying Glass; 3) Exclamation Mark; 4) Exclamation Mark with multiple labels; 5) Exclamation Mark with Black Background.

The primary outcome is correct identification of the healthiest product, defined as the product that is high in the fewest nutrients of concern, including added sugars, sodium, and saturated fat (percent correct for each condition). Secondary outcomes include correct identification of which product is least healthy; which product(s) are high in added sugars, saturated fat, and sodium (3 separate questions); and perceived message effectiveness (PME) of the different labels.

Logit models will be used to compare proportions in each condition that correctly identified the items (each condition compared to every other condition). For continuous outcomes (e.g., knowledge, PME scale), the investigators will use linear regression models regressing the outcome on an indicator for experimental condition. A critical alpha 0.05 will be used, and statistical tests will be two-tailed. The Bonferroni Holm correction will be used for analyses comparing conditions 2-5 to each other for each outcome (6 comparisons).

The investigators will also measure nutrition literacy, and assess moderation on the primary outcome by nutrition literacy (continuous) and highest education attainment (Bachelor's Degree or higher vs. less than Bachelor's Degree).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Front-of-package label

Behavioral

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

Primary outcomes

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

    Time frame: During a ~10 minute online survey

    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.

Secondary outcomes

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

    Time frame: During a ~10 minute online survey

    Measured with: "Which of the products below is the least healthy 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."

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

    Time frame: During a ~10 minute online survey

    Measured with: "Which product(s) below are high in sodium? Select all that apply."

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

    Time frame: During a ~10 minute online survey

    Measured with: "Which product(s) below are high in saturated fat? Select all that apply."

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

    Time frame: During a ~10 minute online survey

    Measured with: "Which product(s) below are high in added sugars? Select all that apply."

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

    Time frame: During a ~10 minute online survey

    Measured with discouragement item from University of North Carolina Perceived Message Effectiveness Scale: How much does this label discourage you from wanting to eat this product? Response options include Not at all, A little bit, Somewhat, Quite a bit, and A great deal.

Other outcomes

  1. Nutrition literacy

    Time frame: During a ~10 minute online survey

    Measured with: "How confident are you that you understand Nutrition Facts labels? Below is an example of a Nutrition Facts label. [Nutrition Facts label displayed]". Response options include Not at all confident, A little confident, Somewhat confident, Very confident, and Extremely confident

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

FDA Front-of-package Pretest: High In Labels

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2024
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.