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Trial registered on ANZCTR


Registration number
ACTRN12619001621101
Ethics application status
Approved
Date submitted
30/10/2019
Date registered
22/11/2019
Date last updated
19/03/2020
Date data sharing statement initially provided
22/11/2019
Date results information initially provided
19/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Games for Health: A feasibility study assessing the recruitment method for a randomised controlled trial investigating the use of interactive video games for improving health and diabetes-specific knowledge in children (9-16 years) at risk for type 2 diabetes.
Scientific title
Games for Health: A feasibility study assessing the recruitment method for a three-arm, parallel, randomised controlled trial investigating the use of interactive video games for improving health and diabetes-specific knowledge in children (9-16 years) who are at risk for type 2 diabetes
Secondary ID [1] 299666 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow up to ACTRN12619000380190 which was stopped early due to recruitment issues. It was determined that the eligibility criteria were too strict so the requirement of having access to an Android device was removed. This new study is determining the feasibility of this new design.

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 315004 0
Overweight/Obese 315005 0
Condition category
Condition code
Public Health 313341 313341 0 0
Health promotion/education
Diet and Nutrition 313342 313342 0 0
Obesity
Metabolic and Endocrine 313343 313343 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.
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.

Baseline Session: During one 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, and a questionnaire about their attitudes and preferences for the video games will be assessed.
Follow up Session: Participants will be assessed for knowledge of healthy lifestyles via a survey emailed to them/their parents 4 weeks after the clinic type setting. Apart from these two time points, there is no other contact or intervention for the participants.

The primary endpoint will be feasibility of the recruitment method, defined as recruitment and randomisation of 40 participants within a 1-month period. Participants will also be assessed for a change in knowledge of healthy lifestyles 15 min +/- 5 min after being given the game to play and at 4 weeks, as well as their attitudes and preferences regarding video game 15 min +/- 5 min after being given the game to play.

Adherence to the intervention will be monitored by android game data from the device at baseline, time stamps on the surveys, and participant feedback on the games.
Intervention code [1] 315928 0
Lifestyle
Intervention code [2] 315996 0
Treatment: Devices
Intervention code [3] 315997 0
Behaviour
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] 321820 0
The primary endpoint will be feasibility of the recruitment method, defined as recruitment and randomisation of 40 participants within a 1-month period.
Timepoint [1] 321820 0
One month after going live with recruitment
Secondary outcome [1] 376346 0
Participants knowledge of healthy lifestyles measured by a self-report survey specifically designed for this study.
Timepoint [1] 376346 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] 376347 0
Attitudes and preferences regarding video game measured by a self-report survey specifically designed for the game.
Timepoint [2] 376347 0
15 min +/- 5 min after receiving the game to play (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.
Minimum age
9 Years
Maximum age
16 Years
Gender
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 40 participants over a 1-month, which we believe will provide sufficient evidence regarding the feasibility of recruitment using this study design.
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21968 0
New Zealand
State/province [1] 21968 0
Auckland

Funding & Sponsors
Funding source category [1] 304142 0
Government body
Name [1] 304142 0
Health Research Council
Address [1] 304142 0
Health Research Council of New Zealand, PO Box 5541, Wellesley St, Auckland 1141, New Zealand
Country [1] 304142 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] 304372 0
None
Name [1] 304372 0
Address [1] 304372 0
Country [1] 304372 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304622 0
University of Auckland Human Ethics Committee
Ethics committee address [1] 304622 0
The University of Auckland
Private Bag 92019
Auckland, New Zealand
Level 11, 49 Symonds Street
Ethics committee country [1] 304622 0
New Zealand
Date submitted for ethics approval [1] 304622 0
18/07/2018
Approval date [1] 304622 0
19/02/2019
Ethics approval number [1] 304622 0
022616

Summary
Brief summary
This feasibility study will investigate the recruitment method for a three-arm, parallel, randomised controlled trial investigating the use of interactive video games for improving health and diabetes-specific knowledge in children at risk for type 2 diabetes. A feasible recruitment method for this new study design is defined as recruitment and randomisation of 40 participants within a 1-month period. We hypothesise that participants who are randomised to play one of two games designed to improve health knowledge will result in greater knowledge of healthy lifestyles and type two diabetes compared to those who are randomised to a control game, which is a similar game without the health information.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97622 0
Prof Ralph Maddison
Address 97622 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 97622 0
New Zealand
Phone 97622 0
+6493737599
Fax 97622 0
Email 97622 0
r.maddison@auckland.ac.nz
Contact person for public queries
Name 97623 0
Dr Amanda Calder
Address 97623 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 97623 0
New Zealand
Phone 97623 0
+6493737599
Fax 97623 0
Email 97623 0
gamesforhealth@auckland.ac.nz
Contact person for scientific queries
Name 97624 0
Prof Ralph Maddison
Address 97624 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 97624 0
New Zealand
Phone 97624 0
+6493737599
Fax 97624 0
Email 97624 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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
The aim of this study was to assess the feasibility of recruiting a total of 40 participants (~13 per group) to complete a randomised controlled pilot trial to determine the effectiveness of two health-related video games to help adolescents and young people at risk of Type 2 Diabetes (T2D) to improve knowledge related to healthy lifestyles and prevention of the disease. Additional aims included to determine whether there was a change in healthy lifestyle and T2D knowledge, and young people’s attitudes toward the games.
The main study involved a 1-hour baseline session where eligible young people (aged 9-13 years considered at risk of T2D, living in the greater Auckland area, who could read and understand English) answered questions about healthy lifestyles, and diabetes then randomised to play one of three games. Lifestyle knowledge and diabetes knowledge were measured at baseline, immediately after playing the game, and after four weeks.
Despite considerable efforts we were only able to recruit a total of four participants, thus it was not considered feasible as defined by our primary outcome. No further analyses were conducted.