NCT06666725

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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11,275

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2024

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

October 17, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 23, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2025

Completed
Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

October 17, 2024

Last Update Submit

May 6, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Grams of added sugar ordered averaged across fast-food and full-service menus

    Continuous variable. Average grams of added sugar in foods and beverages selected, averaged across fast-food and full-service menus, analyzed using linear regression to examine differences between factor levels

    Within approximately 2 minutes of intervention exposure

  • Grams of added sugar ordered from a cafe menu

    Continuous variable. Total grams of added sugar in menu items selected from a cafe menu, analyzed using linear regression to examine differences between factor levels

    Within approximately 2 minutes of intervention exposure

Secondary Outcomes (2)

  • 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)

    Within approximately 10 minutes of intervention exposure

  • Knowledge of menu items high in added sugar

    Within approximately 10 minutes of intervention exposure

Other Outcomes (2)

  • Selection of at least one item that has ≥50% of the Daily Value of added sugar

    Within approximately 10 minutes of intervention exposure

  • Selection of at least one item that has ≥100% of Daily Value of added sugar

    Within approximately 10 minutes of intervention exposure

Study Arms (5)

Control

NO INTERVENTION

Participant will order food and beverages from three menus. The menus will not contain any added sugar labels.

Large, red, icon-only label, 50% daily value

EXPERIMENTAL

Participant will order food and beverages from three menus containing labels next to items that contain equal to or higher than half the daily value of added sugar (greater than or equal to 25 grams). The label will be on the right of the item, colored red, icon only design, and height that is 150% of size of the menu text height.

Other: Menu label

Large, red, icon-only label, 100% daily value

EXPERIMENTAL

Participant will order food and beverages from three menus containing labels next to items that contain equal to or higher than the total daily value of added sugar (greater than or equal to 50 grams). The label will be on the right of the item, colored red, icon only design, and height that is 150% of size of the menu text height.

Other: Menu label

Small, black, icon-plus-text label, 50% daily value

EXPERIMENTAL

Participant will order food and beverages from three menus containing labels next to items that contain equal to or higher than half the daily value of added sugar (greater than or equal to 25 grams). The label will be on the right of the item, colored black, icon plus text design, and height that is 100% of size of the menu text height.

Other: Menu label

Small, black, icon-plus-text label, 100% daily value

EXPERIMENTAL

Participant will order food and beverages from three menus containing labels next to items that contain equal to or higher than the total daily value of added sugar (greater than or equal to 50 grams). The label will be on the right of the item, colored black, icon plus text design, and height that is 100% of size of the menu text height.

Other: Menu label

Interventions

Participants will select food items from three restaurant menus, displayed with labels as specified by their assigned group

Large, red, icon-only label, 100% daily valueLarge, red, icon-only label, 50% daily valueSmall, black, icon-plus-text label, 100% daily valueSmall, black, icon-plus-text label, 50% daily value

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

Study Officials

  • Jennifer Falbe, ScD, MPH

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 17, 2024

First Posted

October 31, 2024

Study Start

December 23, 2024

Primary Completion

February 13, 2025

Study Completion

February 13, 2025

Last Updated

May 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

All variables used in the results of this study (experimental condition and individual level data on reactions to, perceptions of, and hypothetical behaviors in response to added-sugar menu label designs).

Time Frame
The IPD will be available no later than 6 months post-publication of all related research or 18 months from the end date of the award funding this work. The IPD will be available for approximately 5 years (depending constraints of the repository).
Access Criteria
Data will be deposited in an NIH-supported repository, access to which will be described on the principal investigator's website. A data sharing agreement will be required to ensure that the data will only be used for non-commercial research purposes.

Locations