NCT05432271

Brief Summary

The aim of this study is to compare the impact of 5 different types of front of package (FOP) food and beverage labels: 1) calorie labels \[control\], 2) green labels on healthy foods, 3) red/yellow/green labels on less healthy/moderately healthy/healthy foods, 4) physical activity calorie equivalent labels, and 5) "High in" nutrient warning labels) on consumers' beverage and snack selections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

November 16, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 20, 2023

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

17 days

First QC Date

June 15, 2022

Results QC Date

November 30, 2023

Last Update Submit

December 18, 2023

Conditions

Keywords

food labelingsugar-sweetened beverageseatingdrinkingchoice behavior

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Purchasing Beverages With Calories

    Participants will select a beverage to purchase from the online vending machine. Outcome is binary: purchased a beverage with calories or not.

    The survey will take up to 20 minutes.

  • Calories Purchased From Beverages, if Beverage With Calories Chosen

    Participants will select a beverage to purchase from the online vending machine. Outcome is calories in beverage chosen to purchase - only for those participants who chose a beverage with calories.

    The survey will take up to 20 minutes.

  • Calories Purchased From Snacks

    Participants will select a snack to purchase from the online vending machine. Outcome is calories in snacks chosen to purchase.

    The survey will take up to 20 minutes.

Secondary Outcomes (33)

  • Likelihood of Selecting a Healthy Beverage

    The survey will take up to 20 minutes.

  • Likelihood of Selecting a Moderately Healthy Beverage

    The survey will take up to 20 minutes.

  • Likelihood of Selecting a Less Healthy Beverage

    The survey will take up to 20 minutes.

  • Likelihood of Selecting a Healthy Snack

    The survey will take up to 20 minutes.

  • Likelihood of Selecting a Moderately Healthy Snack

    The survey will take up to 20 minutes.

  • +28 more secondary outcomes

Study Arms (5)

Control

ACTIVE COMPARATOR

Calorie labels shown on front of product packaging

Behavioral: Exposure to calorie information

Green labels

EXPERIMENTAL

Green label added to front of product packaging for healthy products; no additional labels shown for "less healthy" products

Behavioral: Exposure to calorie informationBehavioral: Exposure to healthy labels only

Traffic light labels

EXPERIMENTAL

Red/yellow/green labels added to front of product packaging for less healthy/moderately healthy/healthy products, respectively

Behavioral: Exposure to calorie informationBehavioral: Exposure to healthiness information

Physical activity calorie equivalent labels

EXPERIMENTAL

Labels added to front of product packaging that display products' calorie content in terms of physical activity required to burn those calories

Behavioral: Exposure to calorie informationBehavioral: Exposure to physical activity equivalents

"High in" nutrient warning labels

EXPERIMENTAL

Labels added to front of product packaging that signal when the product exceeds thresholds for sugar, sodium, saturated fat, or calorie content

Behavioral: Exposure to calorie informationBehavioral: Exposure to "high in" nutrient warning labels

Interventions

Calories for all beverages and foods

"High in" nutrient warning labelsControlGreen labelsPhysical activity calorie equivalent labelsTraffic light labels

Green labels only for beverages and foods scored as healthy

Green labels

All beverages and foods labeled as either healthy (green), moderately healthy (yellow), or less healthy (red)

Traffic light labels

All beverages and foods labeled with physical activity required to burn their calories

Physical activity calorie equivalent labels

Warning labels only for beverages and foods that exceed the thresholds for sugar, sodium, saturated fat, or calorie content

"High in" nutrient warning labels

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be US adults
  • Ages 18 or older
  • With an over-sample of adults with lower educational attainment (some college or less)

You may not qualify if:

  • Younger than 18
  • Non-US
  • Educational quota filled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Grummon AH, Gibson LA, Musicus AA, Stephens-Shields AJ, Hua SV, Roberto CA. Effects of 4 Interpretive Front-of-Package Labeling Systems on Hypothetical Beverage and Snack Selections: A Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2333515. doi: 10.1001/jamanetworkopen.2023.33515.

MeSH Terms

Conditions

Food PreferencesObesityWeight Gain

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
Dr. Laura Gibson
Organization
University of Pennsylvania

Study Officials

  • Christina A Roberto, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to 1 of 5 front-of-package labeling arms with equal probability: Participants will complete two vending machine choice tasks with their assigned labels shown (one for beverages, one for snack foods, in random order). For each choice task, participants will be asked to select 1 item they most wish to purchase. We will incentivize truthful responding by instructing participants that they could be randomly selected to have their choice delivered to them. We will record participants' selections and match these to nutrition information.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 27, 2022

Study Start

November 16, 2022

Primary Completion

December 3, 2022

Study Completion

December 3, 2022

Last Updated

December 20, 2023

Results First Posted

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

In the consenting process, participants agreed that de-identified data produced from this project may be distributed for future research studies without additional informed consent. After analysis, we will upload the de-identified data to ResearchBox for public sharing.

Shared Documents
SAP
Time Frame
Starting 6 months after publication
Access Criteria
Public

Locations