NCT07791511

Brief Summary

The purpose of this study is to determine if exposure to language-matched English-Spanish public service announcements (PSAs) can increase the understanding of and response to added-sugars menu warning labels among U.S. Hispanic adults. The hypothesis is that the experimental PSAs educating consumers about a new added-sugars menu label will significantly improve understanding of the label and reduce grams of added sugars in meals ordered from menus displaying the label. Participants will be recruited and randomized to one of two arms: (1) Control Arm: Viewing PSAs stating that using a phone while driving is dangerous or (2) Intervention Arm: Viewing PSAs informing participants about new added-sugars menu labels. Within the intervention arm, participants will be randomized to view one of three PSA themes.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Study Progress48%
Aug 2026Oct 2026

Study Start

First participant enrolled

August 1, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 23, 2026

Last Update Submit

August 27, 2026

Conditions

Keywords

added sugarsnutrient labelingfood labels

Outcome Measures

Primary Outcomes (2)

  • Noticing, recall, and understanding of the added sugar menu label

    Noticing, recall, and understanding (hereafter, "noticing") of an added-sugars nutrient label where participants will be asked if they noticed any menu labels. If "Yes", participants would be asked what the warning label told them about (e.g., added sugars), and if answered "added sugars", what about added sugars (e.g., high amount of added sugars). If the three answers were "Yes", "Added sugars", and "high amount of added sugars", the dichotomous variable would be correct. Otherwise, the variable would be classified as incorrect. This outcome will be compared between the experimental PSA arm and the control PSA arm and between each of the three PSA intervention themes. Analysis will use Poisson regression with robust standard errors. Adapted from doi: 10.1016/j.amepre.2025.108038.

    Within approximately 5 minutes of intervention exposure

  • Grams of added sugar ordered

    After the intervention, participants will place hypothetical meal orders from 2 realistic menus, shown in random order, that display an added-sugars warning label next to items containing ≥100% of the Daily Value for added sugars and a disclosure statement explaining the label's meaning. Added-sugars data will be estimated using restaurant website nutritional information. Analyses will use linear regression. Adapted from doi: 10.1016/j.amepre.2025.108038.

    Within approximately 5 minutes of intervention exposure

Secondary Outcomes (11)

  • Noticing, recall, and understanding the PSAs

    Within approximately 5 minutes of intervention exposure

  • Reported use of added-sugars label when selecting food items

    Within approximately 5 minutes of intervention exposure

  • Selection of a food item high in added sugars for themselves

    Within approximately 5 minutes of intervention exposure

  • Perceived message effectiveness of label

    Within approximately 10 minutes of intervention exposure

  • Perceived message effectiveness of PSA

    Within approximately 10 minutes of intervention exposure

  • +6 more secondary outcomes

Study Arms (2)

Safe Driving PSA

PLACEBO COMPARATOR

Viewing safe driving PSAs from a hypothetical state public health department.

Behavioral: Safe Driving (control)

Added-sugars label PSA

EXPERIMENTAL

Viewing added-sugars PSAs from a hypothetical state public health department. (Participants in this arm will be randomly assigned to view only one of the three interventions.)

Behavioral: Labels are coming soonBehavioral: Hidden sugars in restaurant foodsBehavioral: Negative health outcomes

Interventions

Viewing 2 PSAs with a "labels are coming soon" theme that contain an added-sugars warning label and a statement stating that chain restaurant menus must place warning labels on items that contain or exceed the recommended daily limit of added sugars.

Also known as: Labels soon
Added-sugars label PSA

Viewing 2 PSAs with a "hidden sugars in restaurant foods" theme that contain an added-sugars warning label and a statement stating that chain restaurant menus must place warning labels on items that contain or exceed the recommended daily limit of added sugars.

Also known as: Hidden sugars
Added-sugars label PSA

Viewing 2 PSAs with a "negative health outcomes" theme that contain an added-sugars warning label and a statement stating that chain restaurant menus must place warning labels on items that contain or exceed the recommended daily limit of added sugars.

Also known as: Health outcomes
Added-sugars label PSA

Viewing 2 PSAs with a "safe driving" theme that contain a statement stating that using a phone while driving is a distraction and puts lives at risk.

Also known as: Safe Driving, Control
Safe Driving PSA

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Residence in the United States
  • Hispanic ethnicity
  • Ability to read English and/or Spanish
  • Purchased food from a restaurant at least once per month

You may not qualify if:

  • Failing attention check question
  • Speeding (finishing survey in \<33% of the median completion time, which is calculated based on survey times from those who completed the survey and did not fail the attention check once 90% of the target sample has been recruited)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Outcome Assessment, Health Care

Intervention Hierarchy (Ancestors)

Outcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • Jennifer Falbe, ScD, MPH

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Falbe, ScD, MPH

CONTACT

Andrea M Gil, BS

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 23, 2026

First Posted

August 28, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 28, 2026

Record last verified: 2026-08

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-sugars 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 on constraints of the repository).
Access Criteria
Data will be deposited in a 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.