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Added-Sugars Warning Label PSAs

2026年9月9日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

2000

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Jennifer Falbe, ScD, MPH
  • 電話番号:530-752-9653
  • メール:jfalbe@ucdavis.edu

研究連絡先のバックアップ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター: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.
他の名前:
  • コントロール
  • Safe Driving
実験的: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.
他の名前:
  • 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.
他の名前:
  • 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.
他の名前:
  • Health outcomes

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Noticing, recall, and understanding of the added sugar menu label
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Noticing, recall, and understanding the PSAs
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Jennifer Falbe, ScD, MPH、University of California, Davis

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年12月1日

一次修了 (推定)

2027年1月1日

研究の完了 (推定)

2027年1月1日

試験登録日

最初に提出

2026年8月23日

QC基準を満たした最初の提出物

2026年8月27日

最初の投稿 (実際)

2026年8月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月11日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 1641776-10
  • 11-22-ICTSN-07 (その他の助成金/資金番号:American Diabetes Association (ADA))

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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).

IPD 共有時間枠

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).

IPD 共有アクセス基準

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.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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