NCT05025995

Brief Summary

Background: Currently the dietary intake patterns of children do not meet the prescribed dietary guidelines. Consequently childhood obesity is one of the most serious health concerns. Therefore, innovative methods need to be developed and tested in order to effectively improve the dietary intake of children. Learning children how to cope with the overwhelming number of unhealthy food cues could be conducted effectively by serious health games. Objective: The main aim of this study was to examine the effect of a serious health computer game on young children's eating behavior and attitudes towards healthy and unhealthy foods. Methods: A cluster-randomized controlled trial with a between-subject design was conducted (N=157; 8-12 years), whereby children played a game that promoted a healthy lifestyle or were in the control condition. Children in the control condition attended regular classes and did not play a game. The game was designed in collaboration with researchers and pilot-tested before conducting the experiment among a group of children repeatedly. After one week of playing, attitudes towards food snacks and actual intake was assessed, whereby children could eat at libitum from fruits or energy-dense snacks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

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

Study Start

First participant enrolled

April 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

August 3, 2021

Last Update Submit

August 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • calorie intake of energy dense snacks (candy) and fruits (bananas and apples)

    Energy dense snacks and fruits

    1 week after treatment

Study Arms (2)

Serious health game

EXPERIMENTAL

Children played a serious health game with Garfield promoting health behavior, such as less intake of energy dense snacks, drink more water, and exercise more often.

Behavioral: Serious health game

control

EXPERIMENTAL

Children in this condition did not play a serious health game and were in control condition.

Behavioral: Serious health game

Interventions

Serious health game

Serious health gamecontrol

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • primary school between group 5 and 8

You may not qualify if:

  • n.a.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tilburg School of Humanities and Digital Sciences

Tilburg, Netherlands

Location

Related Publications (1)

  • Folkvord F, Haga G, Theben A. The Effect of a Serious Health Game on Children's Eating Behavior: Cluster-Randomized Controlled Trial. JMIR Serious Games. 2021 Sep 2;9(3):e23050. doi: 10.2196/23050.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 30, 2021

Study Start

April 1, 2018

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations