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Trial registered on ANZCTR


Registration number
ACTRN12619000380190
Ethics application status
Approved
Date submitted
5/03/2019
Date registered
11/03/2019
Date last updated
6/04/2020
Date data sharing statement initially provided
11/03/2019
Date results provided
13/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Games for Health: A trial to determine whether using interactive video games can improve healthy-lifestyle and diabetes specific knowledge in youth (9-16years) who are at risk for type 2 diabetes.
Scientific title
Games for Health: A three-arm, parallel, randomised control feasibility trial investigating the use of two interactive video games on improving healthy-lifestyle and diabetes knowledge with in youth (9-16 years) who are at risk of type 2 diabetes.
Secondary ID [1] 297609 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 311871 0
Overweight/Obese 311872 0
Condition category
Condition code
Public Health 310463 310463 0 0
Health promotion/education
Diet and Nutrition 310464 310464 0 0
Obesity
Metabolic and Endocrine 310526 310526 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This three-arm, parallel, randomised controlled feasibility trial will compare the effect of two different interactive video games on children engagement with interactive serious games, their preferences and attitudes to serious games, and whether playing these games impact on knowledge of healthy lifestyle behaviours. In order to participate, children will need to be classified as being at-risk for type 2 diabetes. This means they must either have been told by their doctor that they are at-risk for type 2 diabetes, or they are overweight/obese, or they have a family history of type 2 diabetes. This classification of being ‘at-risk for type 2 diabetes’ was based on professional opinion and recommended guidelines.

Participants will be randomised to receive one of two interactive serious video designed to improve health knowledge or a control game, which is a similar game without the health information. Preferences and attitudes to the games (active groups only), impact on healthy lifestyle behaviours and diabetic knowledge will be assessed. Participants will play the game for 15-min +/- 5 min during a 1-hour clinic session and will be invited to take the game home for 4 weeks.

During a 15-min +/- 5 min clinic type setting with a research assistant, participants will complete a healthy lifestyle and diabetes knowledge questionnaire. Participant's height and weight will be measured and they will then be given the instructions for one of the two health games or the control game by the research assistant and be invited to play the game for 15-min +/- 5 min. After playing, the participants will repeat the healthy lifestyle and diabetes knowledge questionnaire. Participants in the active groups will then be invited to take the game home for 4 weeks to play or not play at their discretion to determine sustained use.
Two games have been developed, which aim to educate children at risk of diabetes:
Arm 1- Ari and Friends: The game can be played on an Android phone or tablet. The main character of the game, named Ari, has to watch what he eats, how much he exercises and the amount of sleeps he gets on his way to save the princess who is locked in a castle. Thus, the health challenges faced by Ari become the health challenges to be solved by the player. To achieve the goal and progress to next level, Ari needs to manage his energy levels (shown at the top of the game) while fighting against a variety of evil guards during multiple stages of the game. Ari's energy level changes depending on food choices the player makes. The player has to answer some multiple-choice health related questions as well throughout the game and immediate feedback on their answers will be provided. It is expected that, as children progress through stages of the game, they will gradually learn the skills to remain healthy by choosing appropriate food options, and being physically active.

Arm 2 - Diabetic Jumper: The concepts we are trying to teach on healthy lifestyle are similar to Ari and Friends in this game, and it can be played on Android phones/tablets. Diabetic Jumper consists of two main screens, the menu screen and the play screen. The menu screen is the entry point for each participant where the setting of the game can be modified (theme, music on/off, gender of the character F/M/Neutral and colour of the background) a demo can be accessed for beginners. The goal of the game is to jump to the top of the level by steering the character/jumper from platform to platform, gradually gaining height and collecting coins and making food, sleep and exercise choices on the way up (the icons appear along the way). Similar to Ari and Friends, energy level of the jumper is displayed at the top and some multiple choice health related questions will be displayed from time to time (immediate feedback will be displayed to children). The jumping is done automatically and cannot be stopped by the participant, who can only give the jumper a direction to the left or right by tilting the tablet devices we use for the experiment. With an increasing height, the jumper will face flying enemies that move from side to side and that will end the game for children immediately, once it is touched by the jumper or if the jumper falls off a platform.

A key feature of the games is that the software records when children play the game, the duration, and the game-playing activities (e.g. amount of character food consumption).

Participants will be assessed for knowledge of healthy lifestyles, video game play (active groups only), as well as attitudes and preferences for the video games (active groups only) via a survey emailed to them/their parents 4 weeks after receiving the game to take home.
Intervention code [1] 313841 0
Lifestyle
Comparator / control treatment
Arm 3 - the control group will receive a video game similar to the above games but without the health information.
Control group
Active

Outcomes
Primary outcome [1] 319330 0
The primary endpoint will be number of hours played over a 4-week period. Data will be directly extracted from the video games for this outcome and will include frequency and duration of video game play, levels achieved, skill level etc.
Timepoint [1] 319330 0
4 weeks after receiving the games.
Secondary outcome [1] 367789 0
Participants knowledge of healthy lifestyles measured by a self-report survey specifically designed for this study.
Timepoint [1] 367789 0
15 min +/- 5 min after being given the game to play and at 4 weeks (controlled for at Baseline and compared to the control group)
Secondary outcome [2] 367790 0
Attitudes and preferences regarding video game measured by a self-report survey specifically designed for the game.
Timepoint [2] 367790 0
15 min +/- 5 min after receiving the game to play and at 4 weeks (controlled for at Baseline and compared to the control group)

Eligibility
Key inclusion criteria
Young people aged 9-16 years at-risk of type 2 diabetes.
In order to be classified as being at-risk for diabetes mellitus they must either have been told by their doctor that they are at-risk for type 2 diabetes, or they are overweight/obese, or they have a family history of type 2 diabetes.
Children will also need to be living in the greater Auckland area and must be able to read and understand English.
Access to an Android device to play the game.
Minimum age
9 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to understand and/or comply with study protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a feasibility study, no formal power calculation has been conducted. We intend to recruit approximately 60 participants (20 per arm), which we feel will provide sufficient trend data and information regarding video game play, lifestyle knowledge.
All statistical tests will be two-tailed and a 5% significance level maintained throughout the analyses. Baseline characteristics will be summarised using descriptive statistics. Continuous variables will be described as numbers of observed and missing values, mean, standard deviation, median, minimum and maximum. Categorical variables will be described as frequencies and percentages. T -tests will be used to examine change in knowledge and game play time

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/04/2019
Actual
22/05/2019
Date of last participant enrolment
Anticipated
12/06/2019
Actual
16/09/2019
Date of last data collection
Anticipated
12/07/2019
Actual
25/09/2019
Sample size
Target
60
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 21328 0
New Zealand
State/province [1] 21328 0
Auckland

Funding & Sponsors
Funding source category [1] 302152 0
Government body
Name [1] 302152 0
Health Research Council
Country [1] 302152 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland
Private Bag 92019
Auckland 1142,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 301991 0
None
Name [1] 301991 0
Address [1] 301991 0
Country [1] 301991 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302834 0
University of Auckland Human Ethics Committee
Ethics committee address [1] 302834 0
Ethics committee country [1] 302834 0
New Zealand
Date submitted for ethics approval [1] 302834 0
18/02/2019
Approval date [1] 302834 0
19/02/2019
Ethics approval number [1] 302834 0
022616

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91550 0
Prof Ralph Maddison
Address 91550 0
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 91550 0
New Zealand
Phone 91550 0
+6493737599
Fax 91550 0
Email 91550 0
r.maddison@auckland.ac.nz
Contact person for public queries
Name 91551 0
Amanda Calder
Address 91551 0
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 91551 0
New Zealand
Phone 91551 0
+6493737599
Fax 91551 0
Email 91551 0
gamesforhealth@auckland.ac.nz
Contact person for scientific queries
Name 91552 0
Ralph Maddison
Address 91552 0
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 91552 0
New Zealand
Phone 91552 0
+6493737599
Fax 91552 0
Email 91552 0
r.maddison@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.