Front-of-Package Nutrition Labels
NCT Number: NCT06516627
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nutrition|Food Selection|Food Preferences|Dietary Habits|Healthy Diet
Interventions: BEHAVIORAL: Positive Labels|BEHAVIORAL: Spectrum Labels|BEHAVIORAL: FDA High In Labels|BEHAVIORAL: FDA Traffic Light Labels
Sponsor: Harvard Pilgrim Health Care
Collaborators: Stanford University|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5610
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2024-09
Locations: Harvard Pilgrim Health Care Institute, Boston, Massachusetts, 02215-3325, United States

Summary:
The goal of this study is to determine whether certain front-of-package food labeling systems improve the healthfulness of consumers' grocery selections. US adults who are their households' primary shoppers will complete a shopping task in a naturalistic online grocery store. They will be exposed to different front-of-package food labeling systems and asked to shop for groceries. The online store will record participants' selections. Participants will also be asked to complete survey measures.

Primary Outcome Measures: Healthfulness of participants' grocery selections, The study will assess healthfulness of participants' grocery selections as the weighted average Ofcom Nutrient Profiling Model score of the products the participants select in the shopping task, weighted by the number of servings in each product. Ofcom Nutrient Profiling Model scores will be calculated for each product participants select. Products receive higher Ofcom scores when they contain lower calorie, saturated fat, sodium, and sugar density, higher protein and fiber density, and more fruits, vegetables, legumes, and nuts. The investigators will calculate the weighted average score across participants' selections, weighting by the number of servings participants select of that product. The Ofcom Nutrient Profiling Model score ranges from 0 to 100, where higher scores indicate healthier products., Assessed from enrollment to end of one-time, 30-minute online study survey
Secondary Outcome Measures: Guiding Stars scores of participants' grocery selections, The study will assess Guiding Stars scores of participants' grocery selections as the weighted average Guiding Stars score of the products the participants select in the shopping task, weighted by the number of servings in each product. Products receive higher Guiding Stars scores when they contain more healthier nutrients and ingredients including vitamins, minerals, fiber, whole grains, and omega-3s and fewer unhealthy nutrients and ingredients including saturated fat, trans fat, added sodium, added sugars, and certain additives. Higher scores indicate healthier products., Assessed from enrollment to end of one-time, 30-minute online study survey|Number of items selected that are high in ≥1 nutrient of concern, The study will assess the number of items participants select that contain ≥20% DV of saturated fat, sodium, or added sugars. The investigators will use DVs of 20g for saturated fat, 2,300mg for sodium, and 50g for added sugars per FDA definitions. Higher counts will indicate a larger number of products selected were high in nutrients of concern., Assessed from enrollment to end of one-time, 30-minute online study survey|Calorie density of participants' grocery selections, The study will assess the weighted average calorie density of participants' grocery selections, calculated as the average kcal per 100g of the selected products, weighted by the number of servings in each product. Higher values will indicate higher calorie density., Assessed from enrollment to end of one-time, 30-minute online study survey|Sugar density of participants' grocery selections, The study will assess the weighted average sugar density of participants' grocery selections, calculated as the average grams of sugar per 100g of the selected products, weighted by the number of servings in each product. Higher values will indicate higher sugar density., Assessed from enrollment to end of one-time, 30-minute online study survey|Sodium density of participants' grocery selections, The study will assess the weighted average sodium density of participants' grocery selections, calculated as the average milligrams of sodium per 100g of the selected products, weighted by the number of servings in each product. Higher values will indicate higher sodium density., Assessed from enrollment to end of one-time, 30-minute online study survey|Saturated fat density of participants' grocery selections, The study will assess the weighted average saturated fat density of participants' grocery selections, calculated as the average grams of saturated fat per 100g of the selected products, weighted by the number of servings in each product. Higher values will indicate higher saturated fat density., Assessed from enrollment to end of one-time, 30-minute online study survey|Fiber density of participants' grocery selections, The study will assess the weighted average fiber density of participants' grocery selections, calculated as the average grams of fiber per 100g of the selected products, weighted by the number of servings in each product. Higher values will indicate fiber saturated fat density., Assessed from enrollment to end of one-time, 30-minute online study survey|Protein density of participants' grocery selections, The study will assess the weighted average protein density of participants' grocery selections, calculated as the average grams of protein per 100g of the selected products, weighted by the number of servings in each product. Higher values will indicate higher protein density., Assessed from enrollment to end of one-time, 30-minute online study survey|Total calories selected, The study will assess the total number of calories in participants' grocery selections, calculated as the sum of calories across all products selected. Higher values will indicate more calories selected., Assessed from enrollment to end of one-time, 30-minute online study survey|Total sugar selected, The study will assess the total amount of sugar in participants' grocery selections, calculated as the sum of sugar selected across all products selected. Higher values will indicate more sugar selected., Assessed from enrollment to end of one-time, 30-minute online study survey|Total sodium selected, The study will assess the total amount of sodium in participants' grocery selections, calculated as the sum of sodium selected across all products selected. Higher values will indicate more sodium selected., Assessed from enrollment to end of one-time, 30-minute online study survey|Total saturated fat selected, The study will assess the total amount of saturated fat in participants' grocery selections, calculated as the sum of saturated fat selected across all products selected. Higher values will indicate more saturated fat selected., Assessed from enrollment to end of one-time, 30-minute online study survey|Total fiber selected, The study will assess the total amount of fiber in participants' grocery selections, calculated as the sum of fiber selected across all products selected. Higher values will indicate more fiber selected., Assessed from enrollment to end of one-time, 30-minute online study survey|Total protein selected, The study will assess the total amount of protein in participants' grocery selections, calculated as the sum of protein selected across all products selected. Higher values will indicate more protein selected., Assessed from enrollment to end of one-time, 30-minute online study survey|Total number of items selected, The study will assess the total number of items participants select. Higher values will indicate more items selected., Assessed from enrollment to end of one-time, 30-minute online study survey|Total spending on participants' grocery selections, The study will assess the total amount participants spent on their grocery selections in USD. Higher values will indicate greater spending., Assessed from enrollment to end of one-time, 30-minute online study survey|Correct identification of healthier items, The study will assess the likelihood that participants correctly identify which of a pair of products is healthier with 6 items (1 for each of 6 product categories: bread, beverages, cereal, meals, snacks, and soups). Responses will be coded as correct (1) if participants select the product with the higher Ofcom Nutrient Profiling Model score and incorrect (0) otherwise., Assessed from enrollment to end of one-time, 30-minute online study survey|Noticing of front-of-package labeling systems, The study will assess noticing of the front-of-package labeling systems with 1 item: "When you were selecting foods and beverages in the shopping task, did you notice any other nutrition labels next to the products, besides the Nutrition Facts Panel?" Response options will be "yes," "no," and "not sure." Responses will be coded as noticed (1) if participants select "yes" and not noticed (0) otherwise., Assessed from enrollment to end of one-time, 30-minute online study survey|Use of front-of-package labeling systems, The study will assess use of the front-of-package labeling systems with 1 item: "While you were shopping, did you use these other nutrition labels to decide foods and beverages to select?" Response options will be "yes" (coded as 1) and "no" (coded as 0)., Assessed from enrollment to end of one-time, 30-minute online study survey|Thinking about health, The study will assess thinking about health using 1 item: "When you were selecting foods and beverages in the shopping task, how much did you think about the overall healthfulness of the product? Response options range from not at all (1) to a great deal (5)., Assessed from enrollment to end of one-time, 30-minute online study survey|Negative emotional reactions, The study will assess negative emotional reactions using 5 items: "How much does this label make you feel..." "worried", "scared," "guilty," "ashamed", and "sad"? Response options range from not at all (1) to a great deal (5). The investigators will average the 5 items; higher average scores indicate stronger negative emotional reactions., Assessed from enrollment to end of one-time, 30-minute online study survey|Perceived helpfulness of the front-of-package labeling system, The study will assess perceived helpfulness with 1 item: "How much do you agree or disagree with the following statement: These labels would help me choose healthier foods and beverages." Response options range from strongly disagree (1) to strongly agree (5)., Assessed from enrollment to end of one-time, 30-minute online study survey|Perceived understandability of the front-of-package labeling system, The study will assess perceived understandability with 1 item: "How much do you agree or disagree with the following statement: It is easy to understand the information in these labels." Response options range from strongly disagree (1) to strongly agree (5)., Assessed from enrollment to end of one-time, 30-minute online study survey|Perceived trustworthiness of the front-of-package labeling system, The study will assess perceived trustworthiness with 1 item: "How much do you trust or distrust the information in these labels?" Response options range from completely distrust (1) to completely trust (5)., Assessed from enrollment to end of one-time, 30-minute online study survey|Public support for front-of-package labeling system, The study will assess public support for the front-of-package labeling systems with 1 item: "Would you oppose or support a policy requiring these labels on foods and beverages?" Response options range from strongly oppose (1) to strongly support (5)., Assessed from enrollment to end of one-time, 30-minute online study survey