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Trial record 11 of 30 for:    fop

Using Video Gaming to Evaluate Front of Pack Labeling With Children

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ClinicalTrials.gov Identifier: NCT03482336
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
Laura Bix, Michigan State University

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.


Condition or disease Intervention/treatment Phase
Child Obesity Other: Four FOP label designs Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Munchy Monster: Using Video Gaming to Objectively Evaluate Front of Pack Labeling Strategies for School-aged Children
Actual Study Start Date : February 2, 2016
Actual Primary Completion Date : April 12, 2016
Actual Study Completion Date : April 12, 2016

Arm Intervention/treatment
Uninstructed Group
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
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.
Other Names:
  • color plus facial icon
  • no color plus facial icon
  • color plus no facial icon
  • no color plus no facial icon

Minimally trained
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
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.
Other Names:
  • color plus facial icon
  • no color plus facial icon
  • color plus no facial icon
  • no color plus no facial icon




Primary Outcome Measures :
  1. Proportion of Correct selections [ Time Frame: During the one hour test period ]
    The correct selection of the healthier stimulus


Secondary Outcome Measures :
  1. Time to correct selection [ Time Frame: During the one hour test period ]
    The amount of time it takes to make a correct selection



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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 6-10 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)

Exclusion Criteria:

  • legally blind
  • no assent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482336


Locations
United States, Michigan
School of Packaging
East Lansing, Michigan, United States, 48824
Sponsors and Collaborators
Michigan State University
United States Department of Agriculture (USDA)
Investigators
Principal Investigator: Mark Becker, PhD Michigan State University

Responsible Party: Laura Bix, Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT03482336     History of Changes
Other Study ID Numbers: 13-678
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: deidenitified file will be shared as supplemental file when published
Supporting Materials: Analytic Code
Time Frame: Indefinitely upon publication
Access Criteria: will be shared as deidentified file upon publication
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laura Bix, Michigan State University:
labeling
Front of pack
nutrition
nutrition facts panel

Additional relevant MeSH terms:
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms