Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000668707
Ethics application status
Approved
Date submitted
12/04/2022
Date registered
6/05/2022
Date last updated
6/05/2022
Date data sharing statement initially provided
6/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a comprehensive Precision Health application on markers of Type 2 Diabetes
Scientific title
The efficacy of a Precision Health Application for Type 2 Diabetes: a randomised-controlled trial.
Secondary ID [1] 306924 0
Nil
Universal Trial Number (UTN)
U1111-1277-1190
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 326030 0
Condition category
Condition code
Metabolic and Endocrine 323337 323337 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants receive access to 1) the Shae application and 2) a learning management software that supports their journey and completion of milestones throughout the 24 week process, and 3) access to a facebook group for all active participants to share their experience and support one another - facilitated and moderated by the research manager.
Once recruited, they will receive documentation to explain the study to their health and medical practitioners as well as the timings for their intervention.

All documentation both provided to the participants and received from them will be electronic.
Participants will be asked to complete surveys and blood tests at Week 0, 6, 12 and 24 of the active intervention arm. They will be provided instructions and documentation to assist with this.

Materials for the intervention:
Shae app technology: The Shae app is a tool that provides guidance and suggestions based on an individual’s profile. The participant will onboard and orient to the application and the initial 6 week protocol, and ongoing suggestions found within it. The onboarding process requires setting goals, identifying a start date and deciding on what metrics to track. Once complete, the platform will prompt the user based on their best strategies for the 6 weeks, and provide information to guide specific:
Food choices: These are determined through understanding the phenotype of an individual (body composition, current health state), and then recommended based on baseline nutrient requirements, chrononutrition and food timing principles, low GI, specific fibre and antioxidant components known to support metabolic health
Exercise type and timing: Recommendations will include light to moderate intensity exercise, with the aim of building up to >150min per week collectively. Exercise timing will be recommended based on an individuals chronotype. Guidelines will be provided to support participants repetitions and sets - depending on the individual, the program may involved 2-3 sets of 15-20 repetitions through to 3-4 sets of 8-15 repetitions. The prescription will vary based on the phenotype assessment outcome. The individuals will also be provided optimised stretching exercises based on their biomechanics and predispositions calculated by the phenotype assessment.

In addition, resources will be made available to support the participants learning of metabolic syndrome and diabetes health, how it relates to them, and how they can support themselves.

The Shae app utilises an innovative phenotype assessment that through a 30-40min onboarding taking into account anthropometrics, disease and medical history, hair, skin, eye colour variations, current lifestyle and current environment and through a proprietary algorithm provides personalised guidance to the individual in-app. Over the course of the program, participants will become more familiar with their profile and how to use it and implement behaviours based on its recommendations.

Behaviours will be monitored through weekly exercise and food tracking, monthly anthropometric updates and through completion of milestones in the LMS

The group coaching sessions will be conducted by allied health professionals specialising in exercise physiology, nutrition and dietetics, and behavioural change. The sessions will run for approximately 30min and will cover information on the application and how it supports metabolic health, strategies and tips to implement the insights from the platform, and group based coaching that supports participants’ sustained motivation and behaviour change through goal setting, self-efficacy, obstacles and outcomes, all tailored to meet the demands of the different participants based on their biological behavioural tendencies.
There will be an onboarding session, then weekly sessions for 6 weeks from the start of the intervention, then one at 12 weeks into the intervention. These are the same as the weekly webinars
Individuals will be supported by the trial manager (allied health qualified) to complete the study milestones and gather any feedback or questions that the research allied health team can field based on scope of the practitioner.

Ph360 metabolic health community: during the active intervention, each participant will be invited to and encouraged to participate in the group forum where the health professional team can facilitate questions and answers from the group in between sessions, post resources, and have the participants post milestones as they progress through the program.

Participants that do not participate each week will be encouraged to do so, i.e. recommended to post a win, challenge or insight they have had this week. On each contact as part of the webinars, participants will be encouraged to visit the group at least 2 times per week to ensure they are receiving continual positive input and encouragement

Access to the community group will continue during and after the program and form part of the long term accountability and adherence to the recommended suggestions.

Adherence and attendance tracking: all participants will be given access to the program’s resources through a learning management software, Teachable. Once logged in, the participant will be given access to the relevant information and be notified of survey/assessment milestones. Their progress through this content will be tracked by the program coordinator.
Each week, the program coordinator will contact each participant as needed to support adherence and attendance. If an individual has not met a milestone at the appropriate time, they will be contacted and supported to ensure that it is completed in a timely manner, with higher frequency of contact provided to ensure future success in meeting milestones. Milestones include diet, exercise and sleep diaries, ph360 measurements and attendance to weekly webinars/watching of replays.

The relevant procedures during the trial include:
Blood tests through pre-arranged clinical laboratories
Survey completion in-app and through the learning management software (LMS) (completed on computer or phone)
There will be 10 x 30min group webinars over the 12 weeks (weekly for 2 weeks of onboarding, then weekly for 6 weeks of active intervention, then at week 9 and week 12). These will be accessed via recording in the LMS.
All other protocols will be delivered in the app relating to the health intervention as described above.

The intervention will assess individuals over a ~6 month (24 wk) period with a 2 week onboarding period. This intervention period will be run twice over a 12-15 month period, once for the initial active intervention group, and once for the wait-list control group (following their waiting period), plus any new participants randomised to the active intervention arm after the 1st intervention recruitment window has closed.

The active intervention consists of intensive support for 6 weeks, moderate support for another 6 weeks and socially supported (facebook group) observational follow up from weeks 13-24. The 2 weeks before the start of the 12 week active interventions will be used as an orientation to the program, with weeks 1 to 12 will be used for active behaviour change, education and support.

The first 6 weeks includes both online individual contact and online group based coaching sessions designed to support the knowledge and adherence to their specific recommendations within the ph360 platform and Shae application.

From the initial onboarding to the 12 week time-point, individuals will receive 10 x 30min webinars aimed at the following: The 2 weeks leading into the program start - supporting set up of the profile, baseline testing and familiarisation with the study resources. Weeks 1 to 6 of the intervention will contain weekly 30min webinars which will discuss how to best apply insights from the application around exercise, nutrition, sleep, social relationships, mindfulness, stress and work habits

All interaction with participants will be delivered online, with no face to face interaction at all for the research team and the participants. Involved in this contact is:
- Group coaching session/webinar engagement/attendance - 1/wk
- Group forum interaction - Requested for 1-2 posts per week to update their progress for the group
- Individual email/text (preferred contact method) to support completion of individual milestones - these will be performed weekly for the first 6 weeks and then fortnightly for 7-12 weeks
App usage is expected to be 10-15min per day with a slow reduction over time as individuals become more familiar with the outputs
They will be requested to visit the learning management system at least twice per week to ensure they have completed the relevant data collection
Intervention code [1] 323371 0
Lifestyle
Intervention code [2] 323372 0
Treatment: Other
Intervention code [3] 323373 0
Behaviour
Comparator / control treatment
Those individuals assigned to the wait-list control will be instructed to perform all baseline measures within the same time-frame as the intervention group.
They will have the following testing completed during their wait-list period during onboarding, week 6, 12 and 24:
- Blood tests and clinical measures (anthropometrics)
- Re-measure their phenotype within their Shae app
- Track exercise, food intake and perceived stress
Participants will be exposed to 1 x 30min onboarding webinar to ensure they understand the timings of the study and their expectations as participants.
Following this, the participants will then be instructed to continue their current lifestyle as normal. I.e. They will be advised to follow the recommendations they have already received through their medical practitioner and/or health professionals.
The wait-list control group will be offered the active intervention after the 24 weeks
Control group
Active

Outcomes
Primary outcome [1] 331075 0
Change in blood HbA1c through standard clinical testing
Timepoint [1] 331075 0
12 weeks after Day 1 of intervention period, i.e. the day following the end of the 2 week onboarding process)
24 weeks after the start of the intervention period i.e. the day following the end of the 2 week onboarding process
Primary outcome [2] 331076 0
Fasting glucose from whole blood sample communicated via their medical professional
Timepoint [2] 331076 0
6 weeks after the start of the intervention period, i.e. the day following the end of the 2 week onboarding process
12 weeks after Day 1 of intervention period, i.e. the day following the end of the 2 week onboarding process
24 weeks after the start of the intervention period i.e. the day following the end of the 2 week onboarding process
Primary outcome [3] 331077 0
Fasting insulin from whole blood sample communicated via their medical professional
Timepoint [3] 331077 0
6 weeks after the start of the intervention period, i.e. the day following the end of the 2 week onboarding process
12 weeks after Day 1 of intervention period, i.e. the day following the end of the 2 week onboarding process
24 weeks after the start of the intervention period i.e. the day following the end of the 2 week onboarding process
Secondary outcome [1] 408650 0
Total cholesterol from whole blood sample communicated via their medical professional
Timepoint [1] 408650 0
6 weeks after the start of the intervention period, i.e. the day following the end of the 2 week onboarding process
12 weeks after Day 1 of intervention period, i.e. the day following the end of the 2 week onboarding process
24 weeks after the start of the intervention period i.e. the day following the end of the 2 week onboarding process
Secondary outcome [2] 409120 0
HDL-Cholesterol from whole blood sample communicated via their medical professional
Timepoint [2] 409120 0
6 weeks after the start of the intervention period, i.e. the day following the end of the 2 week onboarding process
12 weeks after Day 1 of intervention period, i.e. the day following the end of the 2 week onboarding process
24 weeks after the start of the intervention period i.e. the day following the end of the 2 week onboarding process
Secondary outcome [3] 409121 0
LDL-Cholesterol from whole blood sample communicated via their medical professional
Timepoint [3] 409121 0
6 weeks after the start of the intervention period, i.e. the day following the end of the 2 week onboarding process
12 weeks after Day 1 of intervention period, i.e. the day following the end of the 2 week onboarding process
24 weeks after the start of the intervention period i.e. the day following the end of the 2 week onboarding process
Secondary outcome [4] 409122 0
Fasting Triglycerides from whole blood sample communicated via their medical professional
Timepoint [4] 409122 0
6 weeks after the start of the intervention period, i.e. the day following the end of the 2 week onboarding process
12 weeks after Day 1 of intervention period, i.e. the day following the end of the 2 week onboarding process
24 weeks after the start of the intervention period i.e. the day following the end of the 2 week onboarding process
Secondary outcome [5] 409123 0
Homocysteine from whole blood sample communicated via their medical professional
Timepoint [5] 409123 0
6 weeks after the start of the intervention period, i.e. the day following the end of the 2 week onboarding process
12 weeks after Day 1 of intervention period, i.e. the day following the end of the 2 week onboarding process
24 weeks after the start of the intervention period i.e. the day following the end of the 2 week onboarding process
Secondary outcome [6] 409124 0
Serum Plasminogen from whole blood sample communicated via their medical professional
Timepoint [6] 409124 0
6 weeks after the start of the intervention period, i.e. the day following the end of the 2 week onboarding process
12 weeks after Day 1 of intervention period, i.e. the day following the end of the 2 week onboarding process
24 weeks after the start of the intervention period i.e. the day following the end of the 2 week onboarding process
Secondary outcome [7] 409127 0
Blood Vitamin D from whole blood sample communicated via their medical professional
Timepoint [7] 409127 0
6 weeks after the start of the intervention period, i.e. the day following the end of the 2 week onboarding process
12 weeks after Day 1 of intervention period, i.e. the day following the end of the 2 week onboarding process
24 weeks after the start of the intervention period i.e. the day following the end of the 2 week onboarding process
Secondary outcome [8] 409329 0
Blood pressure measured by sphygmomanometer by trained nurse/medical professional after 5min of seated rest
Timepoint [8] 409329 0
6 weeks after the start of the intervention period, i.e. the day following the end of the 2 week onboarding process
12 weeks after Day 1 of intervention period, i.e. the day following the end of the 2 week onboarding process
24 weeks after the start of the intervention period i.e. the day following the end of the 2 week onboarding process

Eligibility
Key inclusion criteria
Individuals aged 35 to 65yrs who have been determined to meet the following criteria:
They have a:
A diagnosis of type 2 diabetes within the last 24 months and are not currently taking insulin
Classification of pre-diabetes by a medical practitioner
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently experiencing heart failure, or has a previous diagnosis of heart failure
Pregnant, breastfeeding or planning pregnancy in the next 12-18 weeks
Once deemed eligible for the study, unwilling to wait up to 11 weeks to enter the program
Currently taking warfarin or another anti-coagulant
Any other contraindications identified by the individuals medical practitioner

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)
allocation involved contacting the holder of the allocation schedule who was at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation through computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Wait list control
I.e. the first randomisation will allocate for immediate start or wait list group. The wait-list group will continue with standard care while the active group will receive the intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data will be analysed using the SPSS Statistics Software (version 25).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/05/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/12/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24728 0
New Zealand
State/province [1] 24728 0

Funding & Sponsors
Funding source category [1] 311243 0
Commercial sector/Industry
Name [1] 311243 0
Precision Health Alliance
Country [1] 311243 0
Australia
Primary sponsor type
University
Name
Avondale University
Address
582 Freemans Drive
Cooranbong NSW 2265
Country
Australia
Secondary sponsor category [1] 312601 0
Individual
Name [1] 312601 0
Dr Cameron McDonald
Address [1] 312601 0
Precision Health Alliance
413/52 Crosby Rd, Albion, QLD, 4010
Country [1] 312601 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310756 0
Avondale Human Research Ethics Committee
Ethics committee address [1] 310756 0
Ethics committee country [1] 310756 0
Australia
Date submitted for ethics approval [1] 310756 0
01/01/2021
Approval date [1] 310756 0
24/03/2021
Ethics approval number [1] 310756 0
ETH.2021.002

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

Contacts
Principal investigator
Name 118758 0
Dr Cameron McDonald
Address 118758 0
Precision Health Alliance
413/52 Crosby Rd, Albion, QLD 4010
Country 118758 0
Australia
Phone 118758 0
+61411380566
Fax 118758 0
Email 118758 0
[email protected]
Contact person for public queries
Name 118759 0
Darren Morton
Address 118759 0
Avondale University
582 Freemans Drive
Cooranbong NSW 2265
Country 118759 0
Australia
Phone 118759 0
+61412287138
Fax 118759 0
Email 118759 0
[email protected]
Contact person for scientific queries
Name 118760 0
Cameron McDonald
Address 118760 0
Precision Health Alliance
413/52 Crosby Rd, Albion, QLD 4010
Country 118760 0
Australia
Phone 118760 0
+61411380566
Fax 118760 0
Email 118760 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Current decision of the research team


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.