Comparing Front-of-package Nutrient Labels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15,582
- 试验地点
- 2
- 主要终点
- Correct identification of healthiest profile
研究概览
简要总结
The goal of this study is to compare front-of-package labels to a no-label control and to one another: 1.) FDA's Nutrition Info with %DV, 2.) Nutrition Info with red "high", 3.) FDA's High In, 4.) multiple High In labels-one for each nutrient and 5.) a no-label control. Primary outcomes include 1.) correct identification of foods and beverages with the healthiest and least healthy overall nutrient profiles, 2.) perceived healthfulness of products low in two nutrients of concern, and 3.) correct identification of foods and beverages as high in saturated fat, sodium, and added sugars.
详细描述
The overall goal of this online randomized controlled trial is to compare the performance of FDA's Nutrition Info %DV front-of-package label (FOPL) to a no-label control and other FOPL designs, including the Nutrition Info label without the %DV and with red color for "high in" nutrients, the FDA's High In label, and multiple black box High In labels-one for each nutrient.
The primary outcomes are: 1.) correct identification of foods and beverages with the healthiest and least healthy overall nutrient profiles, 2.) perceived healthfulness of products low in two nutrients of concern, and 3.) correct identification of foods and beverages as high in saturated fat, sodium, and added sugars. Secondary outcomes include: 1.) noticing the nutrition label, 2.) recalling the label's content, 3.) reported use of label when selecting food items, 4.) perceived healthfulness of i.) products not high in any nutrients of concern and ii.) products with different nutrient levels for each nutrient of concern, 5.) selection of a food item high in at least one nutrient of concern for themselves, 6.) selection of a food item high in at least one nutrient of concern for their youngest child (at least 2 years old), 7.) perceived message effectiveness of label for discouraging consumption of foods high in saturated fat, sodium, and added sugars, 8.) time spent on identifying healthiest and least healthy overall nutrient profiles, and 9.) time spent on identifying foods and beverages as high in saturated fat, sodium, and added sugars.
Repeated dichotomous outcomes (e.g., correct selection of healthiest profile, correct selection of least healthy profile, correct identification of product high in nutrients of concern) will be analyzed in mixed effects Poisson regression with robust standard errors. Single dichotomous outcomes (e.g., noticing, use of label, selection of at least one item high in one nutrient of concern) will be analyzed in Poisson regression with robust standard errors. Results will report proportions in each condition and absolute (i.e., percentage point) and relative differences (i.e., probability ratios). Continuous outcomes (e.g., perceived healthfulness, time spent) will be used in linear regression. All regression models will regress the outcome on an indicator for experimental condition. results will report averages by condition and average differential effects between conditions. Analyses will use a two-sided critical alpha of 0.05 to conduct all statistical tests. All confidence intervals presented will be 95% and two-sided. Given the preliminary nature of this study, which is comparing novel FOPLs for the first time, no p-value adjustments for multiple comparisons are planned.
In moderation analyses using interaction terms and stratified models, effect modification of label design on the primary outcomes will be examined by participant nutrition literacy, education, grocery shopping frequency, having children, and type of device used to take the survey.
Additionally, differences in all outcomes between each of the 5 unique conditions will be examined. The modeling approach may be modified if assumptions are not met.
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
- •English-speaking
- •U.S. residents
排除标准
- •Failing the attention check question
- •Completing the survey in less than one-third of the median completion time (median time calculated when 90% of responses are collected and will be based on the median time of completed questionnaires)
结局指标
主要结局
Correct identification of healthiest profile
时间窗: Within approximately 5 minutes of intervention exposure
Participants will view 4 series of 3 products on the same screen, with each product having a nutrient profile. They will be instructed, "Choose the food \[beverage\] that has the healthiest overall nutrient profile. Consider saturated fat, sodium, and added sugars." Outcome for each series will be dichotomized (1 = correct, 0 = incorrect), and the multiple outcomes will be used in mixed effects Poisson regression with robust standard errors.
Correct identification of least healthy profile
时间窗: Within approximately 5 minutes of intervention exposure
Participants will view approximately 4 series of 3 products side-by-side, showing different nutrient profiles. They will be asked "Choose the food \[or beverage\] with the least healthy overall nutrient profile. Consider saturated fat, sodium, and added sugars." Outcome for each series will be dichotomized (1 = correct, 0 = incorrect) and the multiple outcomes will be used in mixed effects Poisson regression with robust standard errors.
Correct identification of "high" nutrients
时间窗: Within approximately 5 minutes of intervention exposure
Participants will view 5 foods and indicate whether each food is high in each of saturated fat, sodium, and added sugars. A "correct" response is identifying a high-in product as high in the corresponding nutrient and identifying a not high-in product as not high in the corresponding nutrient; otherwise the response is "incorrect". The 15 (3 nutrients across 5 products) dichotomous responses will be analyzed in a mixed model, accounting for within subject correlation.
Perceived healthfulness of items low in two nutrients of concern
时间窗: Within approximately 5 minutes of intervention exposure
Participants will provide a healthfulness score (response scale from 1-7 ranging from very unhealthy to very healthy) for 4 different products. The score for each product will be used as a continuous outcome in linear regression models.
次要结局
- Time spent on identifying foods and beverages as high in saturated fat, sodium, and added sugars.(Within approximately 5 minutes of intervention exposure)
- Noticing the label(Within approximately 5 minutes of intervention exposure)
- Recalling the label's content(Within approximately 5 minutes of intervention exposure)
- Selection of a product high in a nutrient of concern for themselves(Within approximately 5 minutes of intervention exposure)
- Reported use of label(Within approximately 5 minutes of intervention exposure)
- Perceived healthfulness of (i) items not high in any nutrient of concern and (ii) items with different nutrient levels for each nutrient of concern(Within approximately 5 minutes of intervention exposure)
- Selection of a product high in a nutrient of concern for their child(Within approximately 5 minutes of intervention exposure)
- Perceived message effectiveness(Within approximately 5 minutes of intervention exposure)
- Time spent on identifying healthiest and least healthy overall nutrient profiles(Within approximately 5 minutes of intervention exposure)
研究者
Jennifer Falbe
Associate Professor
University of California, Davis
