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Dietary BehaviourNCT07791511

Added-Sugars Warning Label PSAs

A study testing Labels are coming soon, Hidden sugars in restaurant foods and Negative health outcomes in people with Dietary Behaviour and Nutrition Knowledge, run by University of California, Davis.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 yearsHealthy volunteers can take part
What is being tested?
Labels are coming soon, Hidden sugars in restaurant foods and Negative health outcomes
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,000 participants
Where
No sites listed yet
Study dates
Dec 2026to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 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

Who cannot join

  • 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)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jennifer Falbe, ScD, MPH contact

530-752-9653

jfalbe@ucdavis.edu

Andrea M Gil, BS contact

amgil@ucdavis.edu

About this study

Official title: An Online RCT Testing Added-Sugars Warning Label Public Service Announcements Among U.S. Hispanic Adults

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.

Read the detailed description

This online randomized controlled trial (RCT) will assess if 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 investigators will recruit a sample of 2,000 U.S. Hispanic/Latino adults, oversampling such that approximately 50% prefer Spanish. Participants will be assigned to either an experimental PSA arm or a control PSA arm using a 2:1 ratio. Within the experimental PSA arm, participants will be randomized using a 1:1:1 ratio to one of three interventions, each with different PSA themes: (1) Labels are coming (i.e., informing consumers that added-sugars menu warning labels are coming soon), (2) Hidden sugars (i.e., informing consumers that added sugars are hidden in many common restaurant foods), and (3), Health outcomes (i.e., informing consumers that added sugars increase the risk of getting type 2 diabetes, cardiovascular disease, and tooth decay). Within the control PSA arm, all participants will be exposed to the same PSA intervention theme: Safe driving (i.e., informing consumers that using a phone while driving is dangerous). For each PSA intervention theme, participants will view two PSAs (e.g., two PSAs about hidden sugars).

This RCT will be administered using an online survey for which participants will select a language (i.e., English, Spanish) for survey navigation. Then, after randomization to a study arm and intervention, they will view their two assigned (and language-matched) PSAs in random order within the context of four mock advertisements, presented in identical order in each arm and condition. These mock advertisements will be the same for each intervention and will promote car insurance, a food delivery service, a music streaming platform, and a credit card to simulate a realistic advertising environment. After exposure to the experimental or control PSAs and advertisements, participants will place hypothetical meal orders from two realistic chain-restaurant menus, one fast-food menu and one full-service menu, shown in random order. The menus will display an added-sugars warning label next to items containing ≥100% Daily Value for added sugars and a disclosure statement explaining the label's meaning. After completion of the ordering tasks, participants will answer additional questions.

In both study arms, if the participant's language preference is Spanish, they will be shown the PSAs and mock advertisement graphics in Spanish. Otherwise, they will view the PSAs and mock advertisement graphics in English. Explanations of the added-sugars warning label on the restaurant menus and the menus for the ordering task will always be in English to simulate a realistic U.S. environment.

Primary outcomes for this study include: (1) noticing, recall, understanding of the added-sugars menu label; and (2) grams of added sugars ordered. Secondary outcomes include: (1) noticing, recall, understanding the PSAs; (2) reported use of the added-sugars label when selecting food items; (3) selection of a food item high in added sugars for themselves; (4) perceived message effectiveness of the label; (5) perceived message effectiveness of a PSA; (6) Perceived trust of a PSA; (7) correct identification of menu items high in added sugars; (8) anticipated social interaction about a PSA; (9) selection of 2 PSAs perceived as most effective in discouraging the consumption of added sugars; (10) perceived PSA weight stigmatization of people with obesity; and (11) support for the use of the added-sugars label in the community.

The primary analysis will compare label understanding between the intervention and control arms on 1) noticing and 2) added sugars ordered. All statistical analyses will use two-tailed tests with a significance level of alpha < 0.05. For continuous outcomes, linear regression models will be used, but if there is evidence of non-normality, necessarily transformations or alternative modeling approaches will be used. For dichotomous outcomes, risk ratios (or probability ratios) will be estimated using modified Poisson regression with robust standard errors. Results will report means and proportions in each condition and differences between groups. All models comparing labels will be bivariate, regressing outcomes on an indicator variable for assignment to the experimental arm. Sensitivity analyses will examine primary outcomes by chain-restaurant menu (i.e., fast-food and full-service). Exploratory analyses will compare the efficacy of each experimental PSA theme to the control and to one another. These models will regress outcomes on indicators for each experimental PSA and use post-regression pairwise comparisons. Effect modification of the PSAs on primary outcomes will be explored for sociodemographic variables using interaction terms and stratified models.

A soft launch of approximately 100 completed surveys will be conducted to verify that the online survey is functioning as intended and to detect any programming errors. There may be another soft launch if any corrections are needed. The analytic sample will include participants with complete data on the primary outcomes.

Being tested
Labels are coming soon, Hidden sugars in restaurant foods, Negative health outcomes, Safe Driving (control)
Keywords
added sugars, nutrient labeling, food labels

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Labels are coming soonBehavioural

    Also called Labels soon

    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.

  • Hidden sugars in restaurant foodsBehavioural

    Also called Hidden sugars

    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.

  • Negative health outcomesBehavioural

    Also called Health outcomes

    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.

  • Safe Driving (control)Behavioural

    Also called Safe Driving, Control

    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.

Study groups in NCT07791511
Study groupRoleWhat they receive
Safe Driving PSAPlacebo comparatorViewing safe driving PSAs from a hypothetical state public health department.
Receives: Behavioral: Safe Driving (control)
Added-sugars label PSAExperimentalViewing 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.)
Receives: Behavioral: Labels are coming soon; Behavioral: Hidden sugars in restaurant foods; Behavioral: Negative health outcomes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within approximately 5 minutes of intervention exposure

  2. 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.

    Measured: Within approximately 5 minutes of intervention exposure

Secondary outcomes (11)
  1. Noticing, recall, and understanding the PSAs

    Noticing, recall, and understanding (hereafter, "noticing") of added-sugars PSAs where participants will be asked if they noticed any PSAs with response options "yes", "no", or "not sure". Then, participants will be asked what the previously viewed PSAs told them about. Response options include safe driving, covid-19 testing, labels for added sugars, calories labels, fruits and vegetables, exercise, how to filter water, labels indicating healthy food, "none of these options", or "I do not recall seeing a public service announcement (PSA)". If answers are "yes" and "labels for added sugars", respectively, the variable would be coded as correct and otherwise, incorrect. Analysis will use Poisson regression with robust standard errors. Adapted from doi: 10.1016/j.amepre.2025.108038.

    Measured: Within approximately 5 minutes of intervention exposure

  2. Reported use of added-sugars label when selecting food items

    If participants answer "yes" to the label noticing measure and correctly recall the nutrition label, they will be asked, "Did you use the label when deciding which food to select?" Response options will be "yes" or "no". The dichotomous outcome of reported use will be analyzed using Poisson regression with robust standard errors. Adapted from doi: 10.1016/S2468-2667(26)00027-7.

    Measured: Within approximately 5 minutes of intervention exposure

  3. Selection of a food item high in added sugars for themselves

    In a hypothetical menu ordering task, participants will select a food they would purchase for themselves. A dichotomous outcome (ordered high added-sugars item vs. did not order high added-sugars item) will be used. Analysis will use Poisson regression with robust standard errors. Adapted from doi: 10.1016/S2468-2667(26)00027-7.

    Measured: Within approximately 5 minutes of intervention exposure

  4. Perceived message effectiveness of label

    Adapted 1-item UNC PME scale specifically regarding the added-sugars warning label (i.e., discourage) with a 5-point scale from 1= not at all to 5= a great deal [the higher the score, the higher the perceived effectiveness]. Responses will be treated as a continuous outcome in linear regression. Adapted from doi: 10.1093/abm/kay080.

    Measured: Within approximately 10 minutes of intervention exposure

  5. Perceived message effectiveness of PSA

    Adapted 3-item UNC PME scale for the PSA each participant views (i.e., each item--concern, discourage, unpleasant) with a 5-point scale from 1= not at all to 5= a great deal. All item scores are averaged for the overall PME score [the higher the score, the higher the perceived effectiveness].) Responses will be treated as a continuous outcome in linear regression. Adapted from doi: 10.1093/abm/kay080.

    Measured: Within approximately 10 minutes of intervention exposure

  6. Perceived trust of a PSA

    Participants will be asked how much they trust the information on the PSA. Participants will select a response option which will range from 1= not at all to 5= a great deal. Responses will be treated as a continuous outcome in linear regression. Adapted from doi 10.1016/j.amepre.2025.107966.

    Measured: Within approximately 10 minutes of intervention exposure

  7. Correct Identification of menu items high in added sugars

    Participants will be asked to click on all the menu items (5) out of 9 items that have the daily limit of added sugars or more. A continuous outcome variable for the percentage correctly identified will be analyzed using linear regression. Adapted from doi: 10.1016/j.ypmed.2022.107090.

    Measured: Within approximately 10 minutes of intervention exposure

  8. Anticipated social interaction about PSA

    Participants will be asked how likely they are to talk about one of the PSAs they were assigned to (using a 5-point scale from 1=not at all likely to 5=extremely likely). Dichotomous outcomes will be analyzed using Poisson regression with robust standard errors. Adapted from doi: 10.3390/ijerph121013195.

    Measured: Within approximately 10 minutes of intervention exposure

  9. Selection of two PSAs perceived as most effective in discouraging the consumption of added sugars

    Participants will view all six experimental PSAs and be asked to select the top two PSAs that are most effective in discouraging the consumption of added sugars. Results will be reported descriptively.

    Measured: Within approximately 10 minutes of intervention exposure

  10. Perceived PSA weight stigmatization of people with obesity

    Adapted 3-item scale regarding the extent to which participants believe one of the PSAs stigmatizes people with obesity, promotes negative stereotypes, and portrays people with obesity in a disrespectful manner (using a 5 point scale from 1= not at all to 5= a great deal). All item scores will be averaged for the overall perceived weight stigmatization score. Responses will be treated as a continuous outcome in linear regression. Adapted from doi: 10.1016/j.ypmed.2022.107090.

    Measured: Within approximately 5 minutes of intervention exposure

  11. Support for the use of the added-sugars label in the community

    Participants will be asked if they would support displaying the added-sugars label next to menu items high in added sugars on chain restaurant menus (using a 5-point scale from 1=strongly oppose to 5=strongly support). Data will be analyzed after dichotomizing the outcome (oppose vs. support) using Poisson regression with robust standard errors. Adapted from doi: 10.1016/j.ypmed.2022.107090.

    Measured: Within approximately 10 minutes of intervention exposure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07791511
Sponsor's protocol ID
1641776-10
Other IDs
11-22-ICTSN-07
Status last verified
Sep 2026
First submitted
23 Aug 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Questions about this trial

What is this clinical trial studying?

A study testing Labels are coming soon, Hidden sugars in restaurant foods and Negative health outcomes in people with Dietary Behaviour and Nutrition Knowledge, run by University of California, Davis.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Falbe, ScD, MPH (530-752-9653, jfalbe@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Noticing, recall, and understanding of the added sugar menu label (time frame: Within approximately 5 minutes of intervention exposure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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