NCT03482336

Brief Summary

Regulated nutrition information is complex, using decimal places and percentages. Front of pack (FOP) labels provide simplified nutrition information on the front of packages. It has been suggested that the traditional approach to nutrition labeling is difficult for children to use; this is unfortunate as childhood is a critical time for developing long-lasting eating habits and children influence purchase decisions. Materials and Methods Children aged 6-10 played a video game in which participants fed "Munchy Monster" the healthier of two cereal products presented on a computer screen. Across trials the FOP format varied in a 2 (color/no color) x 2 (facial emotion icon/no facial icon) factorial design. Within a trial both cereals presented the same FOP format, with one cereal healthier than the other. Results Data suggest that color coding and/or facial icon significantly benefits selection accuracy and speed, particularly for the youngest children. Minimal training (awareness of the FOPs existence and that it might contain nutrition information) further improved accuracy and speed of responses. Conclusions FOPs that leverage visual indicators assist even young children in assessing the nutritional value of a product.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

September 18, 2017

Last Update Submit

March 22, 2018

Conditions

Keywords

labelingFront of packnutritionnutrition facts panel

Outcome Measures

Primary Outcomes (1)

  • Proportion of Correct selections

    The correct selection of the healthier stimulus

    During the one hour test period

Secondary Outcomes (1)

  • Time to correct selection

    During the one hour test period

Study Arms (2)

Uninstructed Group

OTHER

For the first block of participants recruited (39, one of which withdrew from boredom), no overt reference was made regarding the FOP labels that were present on the images that participants viewed during the course of the video game. Participants comprising this block were referred to as "uninstructed."

Other: Four FOP label designs

Minimally trained

OTHER

Realizing that subjects might not use the FOP during decision making when not informed that it contained nutrition information, we conducted a second experiment (N= 41) which provided minimal information about the FOP. These subjects (the "minimally instructed" group) were provided with further instruction. At the beginning of the experiment, in addition to being shown the basic premise of the game and told that Munchy preferred to eat healthy options, the researcher pointed to one of the FOPs and told children "this information might be helpful when you decide what's healthy."

Other: Four FOP label designs

Interventions

Color (present and absent) were crossed with facial icon (present and absent) for a total of four FOP label treatments. For each trial, both packages had the same FOP treatment, but one appeared at a "healthy level" while the second "unhealthy." Subjects were asked to choose the healthier option as quickly as possible. Accuracy and speed to correct selection both served as dependent variables.

Also known as: color plus facial icon, no color plus facial icon, color plus no facial icon, no color plus no facial icon
Minimally trainedUninstructed Group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • Legally sighted
  • have parent or legal guardian present (written consent of parent)
  • have transportation to the test site
  • be willing to share contact information for reminders be willing to have deidentified data stored provide written or verbal assent (depending on the age of the child)

You may not qualify if:

  • legally blind
  • no assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Packaging

East Lansing, Michigan, 48824, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Color

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LightOptical PhenomenaPhysical Phenomena

Study Officials

  • Mark Becker, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Participants were handled differently in the methods. For the first block of participants, the FOP was not pointed out. For the second block, researchers merely pointed to the FOP and indicated that it might be helpful in decision making.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two blocks of participants were recruited. One block received no information regarding the FOP; for the second block, researchers pointed to an FOP and suggested that the information might be helpful in deciding which product was healthier.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 18, 2017

First Posted

March 29, 2018

Study Start

February 2, 2016

Primary Completion

April 12, 2016

Study Completion

April 12, 2016

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

deidenitified file will be shared as supplemental file when published

Shared Documents
ANALYTIC CODE
Time Frame
Indefinitely upon publication
Access Criteria
will be shared as deidentified file upon publication

Locations