Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03482336
Other study ID # 13-678
Secondary ID
Status Completed
Phase N/A
First received September 18, 2017
Last updated March 22, 2018
Start date February 2, 2016
Est. completion date April 12, 2016

Study information

Verified date March 2018
Source Michigan State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Background It has been estimated that only two percent of children eat a diet that is consistent with the Food Guide pyramid, consuming diets that are too high in fat, saturated fat and sodium, and too low in fiber. Furthering concerns associated with these statistics is the fact that childhood is a determinant phase in the establishment of eating habits, and that developing healthy eating practices as a child has long-term health benefits.

That said, children are an attractive segment for food marketers. Children are not only represent a primary market with growing access to discretionary income, children also have significant power to influence decisions and are a promising future market. As such, kids represent an attractive target for marketers, and research suggests vulnerability to the messages which target them.

It has been suggested that directing messages to children "increases children's preferences for the foods advertised and increases their requests to parents for those foods." Recognizing this, packaging plays an important role in the marketing mix. The US Federal Trade Commission (FTC) has estimated that 12% of all youth marketing expenditures are spent on packaging and in-store in store display materials. This is because of packaging's ability to influence purchase within retail spaces, at the point where purchasing decisions are made; something researchers have referred to as the "nag factor."

Clearly, the idea of presenting information directed at children using packaging for the purpose of motivating sales is utilized; however, the idea of presenting regulated information (e.g. nutritional information) in a format that might be readily understood by this vulnerable audience has not been widely explored. A major goal of nutritional labeling on food packages is to help consumers make appropriate choices. However, the current approach to nutritional labeling is targeted at adults, rather than children.

Although children as young as age four are capable of classifying familiar foods (e.g. ice cream vs. broccoli) as healthy or unhealthy, the investigators are the first to examine whether children can use visual cues from Front of Pack (FOP) labels to compare and evaluate food products from the same category (cereal). FOP labels appear on the front of packages and provide truncated information about nutrients that tend to be associated with disease (e.g. fats, trans fats, sugar and sodium).

Two semi-directive overlays, namely, color (2 levels present/absent) and facial icon (present and absent) were crossed, for a total of four FOP treatments. The study investigated color because it represents the traffic light system, which is a standard FOP design in the United Kingdom (UK), and its use is a topic of significant debate globally. Investigators also tested the efficacy of schematic facial expressions representing relatively high, medium, and low values for nutrients (i.e. frowning for high; straight face for moderate and a smile for those low). Overwhelming evidence indicates that face stimuli are given extremely high attentional priority and that the processing of facial expressions of emotion requires very few cognitive resources. These findings suggest that a face stimulus might be a particularly effective stimulus for drawing attention to the FOP nutritional panel and conveying relative qualitative information about the nutritional value of a product. As such, study investigators postulated that FOP utilizing faces would be particularly well-suited for use with children. Faces are known for garnering increased attention in infants and children as young as age 4 can reliably identify facial expressions of emotion. In fact, developmental research often exploits children's ease of comprehending iconic faces to measure children's judgments of stimuli or situations.

Materials and Methods Investigators leverage these fundamental insights in work presented here, such insights can be used in ways that positively enhance attention to and understanding of nutrition information in a vulnerable audience, children aged 6 to 10.

Children were seated at a computer and given a brief overview of the game. The program began with an instruction scene in which a purple monster character (Munchy) said

"Hi my name is Munchy. I like to eat, but only healthy foods. Will you please feed me? In the game, you will see two cereal boxes. One is healthier than the other. To feed me please press the button on the side with the healthy cereal. If you select the healthy one I will eat it and you will get points. If you select the unhealthy one I will refuse to eat and you will not get any points. I am really hungry so please choose the healthy one as fast as you can. Do you have any questions?"

For each trial, both cereals had the same FOP treatment. However, one package contained "healthy levels" of key nutrients (e.g. for colored FOP three or more nutrients at "green levels") while the other contained "unhealthy levels" (three or more nutrients at "red levels"). Nutrients were categorized into high, moderate and low levels based on Traffic Light Label Guidelines released by the Food Standards Agency. The appearance of the brand and the position of the package (right or left side of screen) were randomized; additionally, a second randomization was done with the healthfulness level of the nutrition information such that the positioning (right side of screen or left) was randomized. As a result, for one subject brand X might appear as healthy, while for another it might be presented with unhealthy information. Each participant completed 80 trials, with each of the four FOP designs appearing in 20 trials per participant by the conclusion of the game. The time it took for the participant to make a correct choice was recorded along with a binary response of correct choice (yes or no).

Two blocks of participants were recruited. In the first block, no reference was made to the FOP labeling. For the second block of participants, 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."


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 12, 2016
Est. primary completion date April 12, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 10 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States School of Packaging East Lansing Michigan

Sponsors (2)

Lead Sponsor Collaborator
Michigan State University United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Correct selections The correct selection of the healthier stimulus During the one hour test period
Secondary Time to correct selection The amount of time it takes to make a correct selection During the one hour test period
See also
  Status Clinical Trial Phase
Recruiting NCT06185413 - Children's Cooperation Denmark: a 3-year System Dynamics Trial N/A
Enrolling by invitation NCT05166629 - Eatable Alphabet as a Nutrition Education Tool N/A
Recruiting NCT05140070 - Fruit and Vegetable Products Enriched With Fibre From Potato Starch With Prebiotic Properties for Children and Youth N/A
Recruiting NCT06108128 - Food for Thought: Executive Functioning Around Eating Among Children N/A
Completed NCT04042467 - Greenlight Plus Study: Approaches to Early Childhood Obesity Prevention N/A
Not yet recruiting NCT06463223 - HIBOC = Hepatic Imaging Biomarkers in Obese Children
Completed NCT01974102 - Family Based Mindfulness Intervention N/A
Recruiting NCT05403658 - Attrition in Pediatric Obesity Management N/A
Completed NCT04315220 - Corestability Training in Overweight Children N/A
Recruiting NCT05570396 - Long-term Follow-up on Childhood Adiposity - The FitKids Study
Recruiting NCT03643341 - Family Healthy Living Early Intervention Program N/A
Completed NCT03219658 - STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity N/A
Recruiting NCT05540678 - The FibreGum Study - Changing the Course of Obesity in Children N/A
Completed NCT04459130 - Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years N/A
Completed NCT05019339 - HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity in SNAP-Education N/A
Active, not recruiting NCT03950453 - Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention N/A
Completed NCT03982511 - Improving Parent-Child Interactions to Enhance Child Health N/A
Active, not recruiting NCT06317883 - Childhood Obesity Risk Assessment Longitudinal Study
Completed NCT02206529 - Enhancing Family Based Treatment of Childhood Obesity Through Social Networks N/A
Recruiting NCT06341179 - Effect of Sleep Extension on Overweight and Learning in Children N/A