Clinical trial NCT06516627: Front-of-Package Nutrition Labels
Official title: Online Randomized Experiment Evaluating Front-of-Package Nutrition Labeling Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition
Food Selection
Food Preferences
Dietary Habits
Healthy Diet
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Stanford University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-07-24
Enrollment: 5638
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This study aims to determine whether certain front-of-package food labeling systems improve the healthfulness of consumers' grocery selections. The survey research company Cloud Research will recruit a sample of approximately 5,610 US adults ages 18+ who read and speak English and who are their households' primary grocery shopper.

Participants will complete a between-subjects online randomized experiment. They will be randomized to 1 of 6 front-of-package labeling systems: 1) positive labels, 2) spectrum labels, 3) Food and Drug Administration (FDA) high in labels, 4) FDA traffic light labels, 5) FDA high in labels plus positive labels, or 6) FDA traffic light labels plus positive labels. Participants will complete a shopping task in a naturalistic online grocery store. Participants will be instructed to shop as they usually would for items in the following categories: non-alcoholic beverages (e.g., juice, coffee, tea, soda, sports drinks, water), breads and baked goods, breakfast cereals, soups, boxed and frozen meals, and snacks (e.g., chips, crackers, nuts, applesauce, dried fruit). They will be given a budget based on average spending in these categories in a large supermarket chain. The store will record participants' selections. After completing the shopping task, participants will complete an online survey.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Reside in the US
* Can read and speak English
* Are their household's primary shopper (do 50% or more of the grocery shopping for their household)

Exclusion Criteria:

* Under the age of 18
* Reside outside of the United States
* Unable to complete a survey in English
* Are not their household's primary shopper (do \<50% of the grocery shopping for their household)

Primary outcomes:
measure: Healthfulness of participants' grocery selections
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
Secondary outcomes:
measure: Guiding Stars scores of participants' grocery selections
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Number of items selected that are high in ≥1 nutrient of concern
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Calorie density of participants' grocery selections
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Sugar density of participants' grocery selections
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Sodium density of participants' grocery selections
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Saturated fat density of participants' grocery selections
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Fiber density of participants' grocery selections
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Protein density of participants' grocery selections
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Total calories selected
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Total sugar selected
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Total sodium selected
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Total saturated fat selected
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Total fiber selected
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Total protein selected
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Total number of items selected
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Total spending on participants' grocery selections
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Correct identification of healthier items
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Noticing of front-of-package labeling systems
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Use of front-of-package labeling systems
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Thinking about health
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Negative emotional reactions
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Perceived helpfulness of the front-of-package labeling system
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Perceived understandability of the front-of-package labeling system
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Perceived trustworthiness of the front-of-package labeling system
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
measure: Public support for front-of-package labeling system
timeFrame: Assessed from enrollment to end of one-time, 30-minute online study survey
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Pilgrim Health Care Institute
state: Massachusetts
Study officials:
affiliation: Harvard Pilgrim Health Care
name: Jason P. Block, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Anna H. Grummon, PhD
role: PRINCIPAL_INVESTIGATOR
References: