Clinical trial NCT06666725: Effect of Added-sugar Menu Labels
Official title: Restaurant Menu Labeling: Added-sugar Labels and Labeling Thresholds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Knowledge
Dietary Behaviour
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 11275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: To compare two added-sugar menu label--(1) red, icon-only, 150% of the menu text height and (2) black, icon-plus-text, 100% of the menu text height--to a no-label control on grams of added sugar ordered using two different added-sugar labeling thresholds: (1) ≥50% of Daily Value for added sugar (equivalent to ≥25g) and (2) ≥100% of Daily Value for added sugar (equivalent to ≥50g)

Detailed description: The main goal of this study is to compare two added-sugar menu labels--(1) red, icon-only, 150% of the menu text height and (2) black, icon-plus-text, 100% of the menu text height--to a no-label control on grams of added sugar ordered using two different added-sugar labeling thresholds: (1) ≥50% of Daily Value for added sugar (equivalent to ≥25g) and (2) ≥100% of Daily Value for added sugar (equivalent to ≥50g). This results in 5 conditions: (1) icon-only at 50% threshold, (2) icon-plus-text at 50% threshold, (3) icon-only at 100% threshold, (4) icon-plus-text at 100% threshold, and (5) no-label control.

The two primary outcomes are (1) grams of added sugar ordered averaged across a fast-food and full-service restaurant menus and (2) grams of added sugar ordered from a café menu. The secondary outcomes are (1) noticing a high added sugar nutrition label and (2) knowledge of items' added sugar content.

For continuous outcomes (e.g., grams of added sugar, knowledge), linear regression models regressing the outcome on an indicator for experimental condition will be used. If the outcomes are not normally distributed, alternative modeling approaches or data transformations will be explored. For dichotomous outcomes (e.g., noticing the added-sugar label), the probability ratio will be modeled using Poisson regression with a robust error variance, regressing the outcome on an indicator for experimental condition.

Exploration of effect modification of the labels on primary outcomes by type 2 diabetes status and sociodemographic variables important for health equity will be conducted using interaction terms and stratified models.

Exploratory process outcomes include (1) selection of at least one item that contains ≥50% of the Daily Value of added sugar and (2) selection of at least one item that contains ≥100% of Daily Value of added sugar. Other exploratory outcomes include the perception that the labels grabbed attention and support for an added sugars warning label policy. Additionally, differences in the primary outcomes between each of the 5 unique conditions will be examined. If there is evidence of interactions, the modeling approach will be modified.

Eligibility criteria: 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 American Community Survey 5-year estimates for sex, 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

Primary outcomes:
measure: Grams of added sugar ordered averaged across fast-food and full-service menus
timeFrame: Within approximately 2 minutes of intervention exposure
measure: Grams of added sugar ordered from a cafe menu
timeFrame: Within approximately 2 minutes of intervention exposure
Secondary outcomes:
measure: Noticing and recall of added-sugar nutrient label - dichotomous variable "Correct" (Answered "Yes" to noticing, answered "Added sugars" to recall, and answered "high" for high low recall question) or "Incorrect" (otherwise)
timeFrame: Within approximately 10 minutes of intervention exposure
measure: Knowledge of menu items high in added sugar
timeFrame: Within approximately 10 minutes of intervention exposure
Other outcomes:
measure: Selection of at least one item that has ≥50% of the Daily Value of added sugar
timeFrame: Within approximately 10 minutes of intervention exposure
measure: Selection of at least one item that has ≥100% of Daily Value of added sugar
timeFrame: Within approximately 10 minutes of intervention exposure
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Jennifer Falbe, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References: