FDA Front-of-package Pretest: High In Labels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,052
- 试验地点
- 2
- 主要终点
- Identification of healthiest product - dichotomous variable "Correct" (Selected product that is high in only 1 nutrient of concern) or "Incorrect" (otherwise)
研究概览
简要总结
The goal of this trial is to understand which of five "High In" front-of-package label designs is most effective at helping consumers identify the healthiest products (i.e., products that are high in the fewest number of nutrients of concern: added sugar, sodium, and saturated fat).
详细描述
The objective of this aim is to assess which of five "High In" front-of-package label (FOPL) designs is most effective at helping consumers identify the healthiest products (i.e., products that are high in the fewest number of nutrients of concern: added sugar, sodium, and saturated fat). The investigators will use a between-subjects randomized experiment to assess the primary outcome. Participants will be randomized to one of five label conditions modeled after the U.S. Food and Drug Administration's draft "High In" FOPL designs: 1) No Icon; 2) Magnifying Glass; 3) Exclamation Mark; 4) Exclamation Mark with multiple labels; 5) Exclamation Mark with Black Background.
The primary outcome is correct identification of the healthiest product, defined as the product that is high in the fewest nutrients of concern, including added sugars, sodium, and saturated fat (percent correct for each condition). Secondary outcomes include correct identification of which product is least healthy; which product(s) are high in added sugars, saturated fat, and sodium (3 separate questions); and perceived message effectiveness (PME) of the different labels.
Logit models will be used to compare proportions in each condition that correctly identified the items (each condition compared to every other condition). For continuous outcomes (e.g., knowledge, PME scale), the investigators will use linear regression models regressing the outcome on an indicator for experimental condition. A critical alpha 0.05 will be used, and statistical tests will be two-tailed. The Bonferroni Holm correction will be used for analyses comparing conditions 2-5 to each other for each outcome (6 comparisons).
The investigators will also measure nutrition literacy, and assess moderation on the primary outcome by nutrition literacy (continuous) and highest education attainment (Bachelor's Degree or higher vs. less than Bachelor's Degree).
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Equal or greater than 18 years of age
- •Less than 100 years of age
- •English-speaking
- •U.S. residents
- •Participants will reflect the U.S. Census Bureau's 2021 American Community Survey 5-year estimates for gender, race/ethnicity, educational attainment, and age
排除标准
- •Failing the attention check question
- •Completing the survey in less than 33% of the median completion time
结局指标
主要结局
Identification of healthiest product - dichotomous variable "Correct" (Selected product that is high in only 1 nutrient of concern) or "Incorrect" (otherwise)
时间窗: During a ~10 minute online survey
Measured with: "Which of the products below is the healthiest in terms of added sugars, sodium, and saturated fat content? The U.S. Food and Drug Administration (FDA) recommends limiting consumption of added sugars, sodium, and saturated fat." There is no formal name for this measure/scale.
次要结局
- Identification of least healthy product - dichotomous variable "Correct" (Selected product that is high in all 3 nutrients of concern) or "Incorrect" (otherwise)(During a ~10 minute online survey)
- Identification of high-sodium product(s) - dichotomous variable "Correct" (Selected all products that are high in sodium) or "Incorrect" (otherwise)(During a ~10 minute online survey)
- Identification of high-saturated-fat product(s) - dichotomous variable "Correct" (Selected all products that are high in saturated fat) or "Incorrect" (otherwise)(During a ~10 minute online survey)
- Identification of high-added-sugars product(s) - dichotomous variable "Correct" (Selected all products that are high in added sugars) or "Incorrect" (otherwise)(During a ~10 minute online survey)
- Perceived Message Effectiveness of label: Discouragement - continuous variable from a 3-item scale in which each item uses a 1-5 response scale(During a ~10 minute online survey)
