Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/05/2017
Date assigned
28/06/2017
Last edited
26/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The global prevalence of being overweight or obese has reached an all-time high. Generally, the diet leading to obesity consists of too many energy-dense products (such as junk food or food that is high in sugar and low in nutrients) and too few fruits and vegetables. Eating very little fruits and vegetables is associated with health risks such as cardiovascular (heart) disease. Increasing the amount of fruits and vegetables eaten in a diet might be helpful, especially when energy-dense products are replaced by fruit and vegetables. The goal of this study is to investigate whether a newly-developed videogame can be used to positively affect eating behavior. This study uses a health game employing the mechanism of a Go/No-Go (GNG) paradigm, targeting impulse inhibition towards food, which has been shown to induce more healthful behaviour to see if this can help improve diets. Suggested mechanisms for this effect are learning through modification of the stimulus-response association (in this case association with a stop signal) and an influence on implicit liking. The aim of this study is to evaluate the effectiveness of a health game based on a Go/No-Go (GNG) paradigm compared to a GNG control game and a double control game on (young) adults’ impulse inhibition and eating behaviour.

Who can participate?
Adults aged 18 or older

What does the study involve?
Participants are randomly allocated to one of three conditions, but matched for gender. Their baseline impulse inhibition is assessed with a GNG task, after which they play a game for ten minutes. Those who are assigned to the first condition play a game that features food stimuli. Those who are assigned to the second condition play an identical game as the first group but the stimuli are soft and fluffy objects versus heavy and dense objects and does not include food. Those in the third condition play a card-sorting game that does not include a GNG principle nor food. After the game, impulse inhibition is assessed again. Participants then undergo a bogus taste test where they rate and compare two types of apples and two types of cookies.

What are the possible benefits and risks of participating?
The game is intended to train impulse inhibition to energy-dense food products to increase healthful eating behaviour. Even though the impulse inhibition effects of this game may be attenuated due to the second GNG measurement session, some (residual) inhibitory effects might still be present after conclusion of the study. Other than that, there are no notable benefits or risks with participating.

Where is the study run from?
Radboud University, Behavioural Science Institute (Netherlands)

When is the study starting and how long is it expected to run for?
November 2013 to December 2017

Who is funding the study?
Radboud University Behavioural Science Institute (Netherlands)

Who is the main contact?
Miss Eva Alblas

Trial website

Contact information

Type

Public

Primary contact

Miss Eva Alblas

ORCID ID

Contact details

Radboud University
Behavioural Science Institute
Postbus 9104
Nijmegen
6500 HE
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Game On project, Study 3. Radboud University, Behavioural Science Institute

Study information

Scientific title

Investigating the impact of a Go/No-Go health game targeting young adults’ impulse inhibition towards food and eating behaviour

Acronym

Study hypothesis

Study aim:
The aim of this study is to evaluate the effectiveness of a health game based on a Go/No-Go (GNG) paradigm compared to a GNG control game and a double control game on (young) adults’ impulse inhibition and eating behaviour.

Hypotheses:
1. It is expected that participants in the intervention condition will show increased impulse inhibition towards energy-dense food after playing the health game compared to those in the control conditions
2. Impulse inhibition at baseline is expected to moderate the effect of condition on impulse inhibition
3. The participants in the intervention condition are expected to eat healthier compared to those in the control conditions
4. Impulse inhibition at baseline is expected to moderate the effect of condition on eating behaviour

Ethics approval

Radboud University Ethical Committee, 10/07/2015, ref: ECSW2015-2206-324

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Not Specified

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

A change over time in impulse inhibition towards energy-dense food (a possible precursor of
eating behaviour), and direct eating behaviour

Intervention

The participants are semi-randomly assigned to one of three conditions, matched on gender.

Condition 1 Go/No-Go (GNG) food game ‘Castle Invaders Food’:
This game is based on a GNG paradigm and features food stimuli.

Condition 2 GNG non-food game ‘Castle Invaders Control’:
This game is identical to ‘Castle Invaders Food’, but then instead of food stimuli, images of soft and fluffy versus heavy and dense objects are used.

Condition 3 Non-GNG non-food game ‘Patience Solitaire’:
This is a card-sorting game with no GNG principle nor food stimuli.

Each participant first starts with a few questions to assess hunger and thirst, masked with questions about fatigue and alertness. Then baseline impulse inhibition is assessed using a GNG task. After this, one of the three games starts with a 10-minute fixed playtime. Immediately after the game, the post-test impulse inhibition is assessed. Then a bogus taste test will commence, where participants get eight minutes to rate and compare two types of apples and two types of chocolate chip cookies. The study concludes with questions about the game, gaming experience and demographic information. The duration of the study is approximately 35 minutes.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Impulse inhibition is measured using a modified Go/No-Go paradigm at baseline and post-test, which is immediately after game-play.

Secondary outcome measures

1. Snack consumption is assessed at post-test, after the second assessment of impulse inhibition, using a bogus taste test with apples and chocolate chip cookies. Before and after the taste test, the food products are inconspicuously weighted and calorie intake is calculated for both products and compared between the groups.
1.1. Nutrient dense snack consumption is measured by subtracting weight after taste test from start weight of the two bowls of apples
1.2. Energy-dense snack consumption is measured by subtracting weight after taste test from start weight of the two bowls of chocolate chip cookies

Overall trial start date

11/11/2013

Overall trial end date

12/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Adults aged 18 and older

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

125

Participant exclusion criteria

No informed consent

Recruitment start date

17/05/2016

Recruitment end date

06/08/2016

Locations

Countries of recruitment

Netherlands

Trial participating centre

Radboud University, Behavioural Science Institute
Nijmegen
6525 GD
Netherlands

Sponsor information

Organisation

Radboud University

Sponsor details

Behavioural Science Institute
Montessorilaan 3
A.08.29
Nijmegen
6525 HR
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Radboud University Behavioural Science Institute

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Eva Alblas, MSc at E.alblas@bsi.ru.nl

Intention to publish date

12/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes