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Added-Sugars Warning Label PSAs

9 settembre 2026 aggiornato da: University of California, Davis

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

2000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Jennifer Falbe, ScD, MPH
  • Numero di telefono: 530-752-9653
  • Email: jfalbe@ucdavis.edu

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Safe Driving PSA
Viewing safe driving PSAs from a hypothetical state public health department.
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.
Altri nomi:
  • Controllo
  • Safe Driving
Sperimentale: Added-sugars label PSA
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.)
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.
Altri nomi:
  • Labels soon
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.
Altri nomi:
  • Hidden sugars
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.
Altri nomi:
  • Health outcomes

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Noticing, recall, and understanding of the added sugar menu label
Lasso di tempo: Within approximately 5 minutes of intervention exposure
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
Lasso di tempo: Within approximately 5 minutes of intervention exposure
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Noticing, recall, and understanding the PSAs
Lasso di tempo: Within approximately 5 minutes of intervention exposure
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.
Within approximately 5 minutes of intervention exposure
Reported use of added-sugars label when selecting food items
Lasso di tempo: Within approximately 5 minutes of intervention exposure
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.
Within approximately 5 minutes of intervention exposure
Selection of a food item high in added sugars for themselves
Lasso di tempo: Within approximately 5 minutes of intervention exposure
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.
Within approximately 5 minutes of intervention exposure
Perceived message effectiveness of label
Lasso di tempo: Within approximately 10 minutes of intervention exposure
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.
Within approximately 10 minutes of intervention exposure
Perceived message effectiveness of PSA
Lasso di tempo: Within approximately 10 minutes of intervention exposure
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.
Within approximately 10 minutes of intervention exposure
Perceived trust of a PSA
Lasso di tempo: Within approximately 10 minutes of intervention exposure
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.
Within approximately 10 minutes of intervention exposure
Correct Identification of menu items high in added sugars
Lasso di tempo: Within approximately 10 minutes of intervention exposure
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.
Within approximately 10 minutes of intervention exposure
Anticipated social interaction about PSA
Lasso di tempo: Within approximately 10 minutes of intervention exposure
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.
Within approximately 10 minutes of intervention exposure
Selection of two PSAs perceived as most effective in discouraging the consumption of added sugars
Lasso di tempo: Within approximately 10 minutes of intervention exposure
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.
Within approximately 10 minutes of intervention exposure
Perceived PSA weight stigmatization of people with obesity
Lasso di tempo: Within approximately 5 minutes of intervention exposure
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.
Within approximately 5 minutes of intervention exposure
Support for the use of the added-sugars label in the community
Lasso di tempo: Within approximately 10 minutes of intervention exposure
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.
Within approximately 10 minutes of intervention exposure

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Jennifer Falbe, ScD, MPH, University of California, Davis

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

23 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 agosto 2026

Primo Inserito (Effettivo)

28 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 1641776-10
  • 11-22-ICTSN-07 (Altro numero di sovvenzione/finanziamento: American Diabetes Association (ADA))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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).

Periodo di condivisione IPD

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).

Criteri di accesso alla condivisione IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .