NCT04156919

Brief Summary

Pediatric obesity is one of the most serious public health challenges of the 21st century. It is a serious problem that is expected to create lifelong health challenges and potentially overwhelm the ability of healthcare providers to manage the consequences. While many factors contribute to pediatric obesity, dietary choices are the leading cause. A key concern is how to inculcate healthy dietary habits early among young children. Over the past 20 years, there has been significant scientific interest in examining the potential learning consequences of playing video games given children's interests in such games. This study investigates the impact of a health video game on children's nutritional knowledge and dietary choices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

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

First Submitted

Initial submission to the registry

November 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

November 12, 2019

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

18 days

First QC Date

November 6, 2019

Last Update Submit

December 13, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Dietary Choice

    After each experiment, participants will be asked to choose between six actual food items under the pretext of a parting gift. Of these six, three will be healthy: orange, apple and banana, and three will be unhealthy: potato chips, biscuits and master pop juice. Following prior literature, the gift selection will serve as the onsite objective measure of behavior. We will make sure that the choices are a single small serving so as not to contribute to the problem of unhealthy dietary habits.

    1 day

  • Objective Nutrition Knowledge (ONK)

    ONK will be captured using the children's identification of healthy foods measure (Tatlow-Golden et al. 2013). Correct answers will be summed to create this formative measure.

    1 day

  • Subjective Nutrition Knowledge (SNK)

    The SNK measure will be adapted from prior research (Moorman et al. 2004). SNK will be will be assessed using three items: 1) I am able to understand product information on food labels; 2) I know the difference between healthy snacks and unhealthy snacks; 3) I know the difference between healthy drinks and unhealthy drinks. Response options will range from 1=totally disagree to 5=totally agree.

    1 day

  • Subjective Experiences of Discrete Emotions

    To capture subjective discrete emotions, we will adopt the child version of the positive and negative affect scale, the PANAS-C (Laurent et al. 1999). We select emotions that are relevant to our context (Liu et al. 2017). We will capture six discrete emotions. Of the six, three are positive (excited, joyful, and energetic), and three are negative (upset, nervous, and gloomy).

    1 day

Secondary Outcomes (2)

  • Health locus of control

    1 day

  • Dietary Intention

    1 day

Study Arms (3)

Playful condition

EXPERIMENTAL

Children in the playful and non-playful conditions will receive the fooya! intervention but will be varied in the psychological state of playfulness. Children in the playful condition will play a health game called fooya! Drawing on the playfulness literature, we will manipulate four dimensions of play. First, to manipulate the voluntariness of tasks, children in the playful condition will be asked/invited to participate in the study. Second, to manipulate adult presence, there will be little to no teacher involvement in the playful condition. Third, to manipulate the timing of the activity, children in the playful condition will be given an option to play anytime, including after school hours. Fourth, to manipulate the goal perception, the children in the playful condition will be told that their activity is not graded-i.e., autotelic.

Behavioral: fooya!™

Non-playful condition

EXPERIMENTAL

As mentioned earlier, we will manipulate four dimensions of play. First, participation will be mandatory for children in the non-playful condition. Second, teacher presence will be more salient in this condition. Third, children in the non-playful condition will participate during school hours. Fourth, the children in the non-playful condition will be told that their activity is graded.

Behavioral: fooya!™

Control condition

ACTIVE COMPARATOR

Children in the control condition will play a video game unrelated to diet and lifestyle called Wordsearch.

Other: WordSearch

Interventions

fooya!™BEHAVIORAL

fooya!™ is a science/evidence-based AI-enabled neuromodulation and Cognitive Behavior Therapy (CBT) technology. fooya!™ has been shown to deliver statistically significant outcomes concerning food choices during randomized-controlled clinical trials conducted at the Baylor College of Medicine's Children's Nutrition Research in the United States of America as well as India. In the game, children make several decisions with split-second timing, such as food choices, destroying bad/unhealthy food robots using the bad foods that are thrown at the player, and saving themselves. If the children collect good/healthy foods, they are in fit-zone for a while, which shields them from bad food robots.

Non-playful conditionPlayful condition

We will have an active control group that will play a WordSearch game. The intention is to have the children play a familiar video game through the same modality (IPAD) that is unrelated to diet or lifestyle choices.

Control condition

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children in primary level 4 between the ages of 8-11
  • children fluent in English
  • children who have a parent fluent in English who is willing to participate in the study

You may not qualify if:

  • children with a history of photosensitive epilepsy
  • children with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators
  • underweight children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tati Siding Primary School

Tati Siding, North-East District, P O Box 3, Botswana

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 8, 2019

Study Start

November 12, 2019

Primary Completion

November 30, 2019

Study Completion

December 31, 2019

Last Updated

December 14, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations