Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000494437p
Ethics application status
Submitted, not yet approved
Date submitted
15/04/2025
Date registered
21/05/2025
Date last updated
21/05/2025
Date data sharing statement initially provided
21/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a 6-month personalised lifestyle medicine on the change in the progression of Type 2 Diabetes
Scientific title
The effect of a 6-month personalised lifestyle medicine on the change in the progression of Type 2 Diabetes in participants aged 35 to 65
Secondary ID [1] 313701 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes and Pre-diabetes 336291 0
Condition category
Condition code
Metabolic and Endocrine 332829 332829 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves the participants following the recommendations from the Shae platform and Shae app for a period of 6 months. There will be 3 distinct phases of the intervention:
Phase 1: Baseline to 6 weeks: Virtual and live group information sessions to inform and promote adherence - 45 to 60 min sessions will occur weekly for 6 weeks - delivered by an Accredited Exercise Physiologist, Accredited Practising Dietitian, or Accredited mental health social worker. The information delivered will cover familiarisation with the Shae app, goal
setting, nutrition, movement, sleep, mindfulness and environmental considerations for health in the context of Type 2 Diabetes and it’s prevention
- Recordings will be made available to those who missed it, with follow up to support them in watching the replay at their earliest convenience. Attendance and view rates will be tracked
Phase 2: 7 and 12 weeks, small group coaching by group forum support only, continue behaviours from baseline to 6 weeks - small group coaching will occur 3 times, once every 2 weeks.
Phase 3: 12 to 24 weeks: Group forum support only online. No formal compulsory group sessions in Phase 3
- Access to closed page facebook community will allow participants to encourage each other. The professionals will supervise and respond to any discussions. Weekly reminders will also be placed there. All online resources will be available to support participants.

The ph360 platform, app and diabetes health protocol:
The ph360 type 2 diabetes health protocol and Shae application collate relevant information from the participant to generate specific lifestyle recommendations including:
FOOD - Specific foods, meal & fluid timing and food preparation suggestions based on their current health state and goals
FITNESS - Specific types of strength, cardiovascular and flexibility exercises
PLACE - The physical environment, climate, temperature and other factors related to environmental exposure
LIFESTYLE - Provides guidance around the neural tendencies of an individual, and how they can be optimised through awareness and alteration of the social, professional and physical environment.
The app also features an area to track food intake, measurements and resources for further learning.

After onboarding, participants will gain access to the ‘Metabolic Health Dashboard’.
This features the following:
An overview display of completion rates for food diaries, weekly and daily lifestyle guides that provide an overview of optimal lifestyle behaviours, and general supportive resources for the 6 week challenge.

The Shae application and metabolic health protocol will be made available to all active participants in the intervention phase. They will be supported in initial onboarding with a 30 min individual session and 60 min onboarding webinar that takes place 1 week before the 6 week protocol start point.

The group coaching sessions will be conducted by allied health professionals specialising in exercise physiology, nutrition and dietetics, naturopathy and behavioural change (with a focus on acceptance and commitment therapy). The sessions will run for approximately 30 min and will cover information on the application and how it supports 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.

Shae diabetes 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. 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.

The SHAE app is a phone-based app that links the information that is found in the platform, and also provides notifications to the user to prompt their awareness for relevant behaviours throughout the day based on their profile. For example, the information in the Shae platform indicates the full structure and timing of food and hydration strategies, i.e. it may recommend lunch between 11 am and 1 pm. The app houses this information, and will also send a notification to the user at 10:30 am reminding them that lunch is approaching and suggest a number of suitable options from the recipe list. This will be replicated for preferred exercise and stretching times, optimal sleep times, and suggestions around lifestyle factors. The user can turn these notifications on or off depending on their preferences.
The Shae diabetes health protocol is a feature within the Shae platform and Shae app technology that the participant will activate once their platform is live.
Intervention code [1] 330297 0
Prevention
Intervention code [2] 330298 0
Lifestyle
Comparator / control treatment
Control Group will be called Wait-list group. These participants will be instucted to perform
all baseline measures within the appropriate time-frame. Following this, the participants will then be instructed to continue their current lifestyle as normal, i.e. follow standard care as outlined by their medical professional. They will have access to Shae platform for 1 year free of charge after 6 months of standard care.
Control group
Placebo

Outcomes
Primary outcome [1] 340355 0
Blood test results pre and post intervention including: HbA1c Fasting insulin Fasting glucose Total cholesterol HDL-Cholesterol LDL-Cholesterol Hs-C-Reactive Protein Fasting Triglycerides
Timepoint [1] 340355 0
Baseline (within 2 weeks of the intervention starting). Follow up - 6, 12 and 26 weeks post intervention commencement.
Primary outcome [2] 340356 0
Blood pressure Waist circumference and other anthropometric measurements.
Timepoint [2] 340356 0
Baseline (within 2 weeks of the intervention starting). Follow up - 6, 12 and 26 weeks post intervention commencement.
Secondary outcome [1] 443813 0
Anxiety Stress levels
Timepoint [1] 443813 0
Baseline and 26 weeks post intervention commencement
Secondary outcome [2] 443814 0
Physical activity
Timepoint [2] 443814 0
Baseline and 26 weeks post intervention commencement
Secondary outcome [3] 447174 0
Food intake diary
Timepoint [3] 447174 0
Food diary weekly for the first 6 weeks and fortnightly for 7-12 weeks post intervention commencement
Secondary outcome [4] 447579 0
Sleep Pattern
Timepoint [4] 447579 0
Baseline and 26 weeks post intervention commencement

Eligibility
Key inclusion criteria
The participants will be :
1. Aged 35 to 65 yrs of age
2. Have a previous diagnosis of diabetes or pre-diabetes and are not currently taking insulin
3. A positive diagnosis of pre-diabetes is determined by at least one of the following conditions being met following an oral glucose tolerance test:
-Impaired fasting glucose: Fasting glucose is >6.1 to 7mmol/L
-Impaired glucose tolerance: Glucose is 7.8 to 11mmo/L 2 hours after the test
-Return a risk score of more than 15 on the AUS-DIAB test
OR
-Previous diagnosis of Type 2 Diabetes by a medical practitioner in the last 24 months
4. Have a mobile phone with SMS capability.
5. Have internet access.
6. Be an Australian Resident.
7. Be fluent in English.
8. Be willing to be randomised into any of the three groups which includes contact through email and may include regular SMS communication or involvement in weekly videoconferencing.
9. Permit anonymous data to be used for research.
10. Provide informed consent.
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently experiencing heart failure, or has a previous diagnosis of heart failure
2. Pregnant, breastfeeding or planning pregnancy in the next 12-18 weeks
3. Currently taking warfarin
4. Any other contraindications identified by the individuals medical practitioner

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Some participants will be randomly selected through computer randomisation to be allocated to waitlisted group. They will be instructed to perform all baseline testing and measures within approprriate timeframe and then will continue with their normal life style and usual standard care before providing samples at the end of week 26.
Participants will be allocated a unique identification code. The web-based platform that captures data is protected to Health Insurance Privacy and Portability Act (HIPPA)
standards. The research team will access de-identified data only and individual participants will not be identified or reported on.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The minimum number of participants required was determined by a priori power analysis based off previous research (Oude, etal. 2015) and using G-Power version 3.1.9.6 (Faul etal. 2007). As the primary outcome is exploring the association between guideline adherence and patients’ health outcomes, the following parameters were set for a hierarchical linear regression controlling for patient characteristics (age, sex, SES, and years since diagnosis), using a moderate effect size of 0.15, power set to 0.95 and an adjusted alpha of 0.0083 to allow for multiple comparisons of the health outcomes. Therefore, for the current study an estimated sample size of 80 is required. An additional 20% has been added to the initial estimate to allow for missing data.
Quantitative data will be analysed using the SPSS Statistics Software (version 29).
Cummulative data between intervention (group 1) and wait-list (Group 2) will be compared to evaluate the impact of PHA personalised intervention. The associations will be evaluated using hierarchical linear and logistic regression models depending on each health outcome. From the regression models we will derive beta scores (for continuous outcomes) or odds ratios (for binary outcomes) and 95% confidence intervals. Significance will be evaluated at p<.05.
The method of analysis will be decided based on number of data points and survey results. Most probably multivariate analysis of Variance (MANOVA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318167 0
Other
Name [1] 318167 0
In kind funding of technology and staffing will be provided by Shae Group
Country [1] 318167 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 320548 0
Commercial sector/Industry
Name [1] 320548 0
Precision Health Alliance
Address [1] 320548 0
Country [1] 320548 0
Australia
Other collaborator category [1] 283477 0
Individual
Name [1] 283477 0
Prof Roselyn Rose'Meyer - Griffith University
Address [1] 283477 0
Country [1] 283477 0
Australia
Other collaborator category [2] 283478 0
Individual
Name [2] 283478 0
Dr Avinash Kundur - Griffith University
Address [2] 283478 0
Country [2] 283478 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316814 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 316814 0
Ethics committee country [1] 316814 0
Australia
Date submitted for ethics approval [1] 316814 0
11/04/2025
Approval date [1] 316814 0
Ethics approval number [1] 316814 0

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

Contacts
Principal investigator
Name 139090 0
Prof Indu Singh
Address 139090 0
School of Pharmacy & Medical Sciences, G05_2.33 Gold Coast Campus, Parklands Drive, Griffith University, QLD, 4215
Country 139090 0
Australia
Phone 139090 0
+61 410445247
Fax 139090 0
Email 139090 0
[email protected]
Contact person for public queries
Name 139091 0
Cameron McDonald
Address 139091 0
Precision Health Alliance, Greater Brisbane Area, 4000 QLD
Country 139091 0
Australia
Phone 139091 0
+61 411380566
Fax 139091 0
Email 139091 0
[email protected]
Contact person for scientific queries
Name 139092 0
Prathibha Jose
Address 139092 0
Carrara Family Practice, 2 Alzino Place, Carrara, QLD 4211
Country 139092 0
Australia
Phone 139092 0
+61 411734289
Fax 139092 0
Email 139092 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This trial will be evaluating efficacy of a tool (App) in improving adherance to diabetes management plan including lifestyle changes so individual participants details are not necessary to reach final outcome.



What supporting documents are/will be available?




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.