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The effect of a 6-month personalised lifestyle medicine on the change in the progression of Type 2 Diabetes

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000494437
Enrollment
100
Registered
2025-05-21
Start date
2025-07-01
Completion date
2025-10-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this project is to investigate the effect of a 6-month personalised lifestyle protocol that incorporates recommendations from the Shae platform (nutrition, exercise, sleep, mindset, relationships, environment) and group coaching (to support adherence) on the change in markers of diabetes and pre-diabetes. It is hypothesised that those individuals following personalised lifestyle medicine guidance will experience a meaningful improvement in blood glucose control and markers associated with Type 2 Diabetes risk. Participants will be randomised into two arms: (Group 1) Immediate intervention; (Group 2) Wait-list control. Those in the wait-list control will be monitored for 6 months without intervention while they recieve standard care under the supervision of their personal health care provider.

Interventions

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 deliver

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.

Sponsors

Griffith University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
35 Years to 65 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026