An Online RCT Testing Added-Sugars Warning Label Public Service Announcements Among U.S. Hispanic Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 主要终点
- Noticing, recall, and understanding of the added sugar menu label
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Safe Driving PSA
Viewing safe driving PSAs from a hypothetical state public health department.
干预措施: Safe Driving (control) (Behavioral)
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.)
干预措施: Negative health outcomes (Behavioral)
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.)
干预措施: Labels are coming soon (Behavioral)
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.)
干预措施: Hidden sugars in restaurant foods (Behavioral)
结局指标
主要结局
Noticing, recall, and understanding of the added sugar menu label
时间窗: 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.
Grams of added sugar ordered
时间窗: 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.
次要结局
- 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)
- Perceived trust of a PSA(Within approximately 10 minutes of intervention exposure)
- Correct Identification of menu items high in added sugars(Within approximately 10 minutes of intervention exposure)
- Anticipated social interaction about PSA(Within approximately 10 minutes of intervention exposure)
- Selection of two PSAs perceived as most effective in discouraging the consumption of added sugars(Within approximately 10 minutes of intervention exposure)
- Perceived PSA weight stigmatization of people with obesity(Within approximately 5 minutes of intervention exposure)
- Support for the use of the added-sugars label in the community(Within approximately 10 minutes of intervention exposure)
研究者
Jennifer Falbe
Associate Professor
University of California, Davis
