None listed
Conditions
Brief summary
The Gro-AUS study is a cluster-randomised controlled trial designed to evaluate the effectiveness of the Gro-AUS app, an AI-enhanced digital health intervention for managing Type 2 diabetes. The app provides personalised support, education, and behaviour change strategies to aid self-management. The primary hypothesis is that participants using the Gro-AUS app will experience a statistically significant reduction in HbA1c levels compared to those receiving standard care. The study plans to recruit 240 participants from various GP practices within the Western Sydney Local Health District. This research aims to enhance the understanding of digital health interventions in chronic disease management and inform clinical practice.
Interventions
The Gro-AUS intervention is an AI-enhanced mobile application designed to support self-management among individuals with Type 2 diabetes (T2D). It provides structured education, behavior change tools, and health management services aimed at improving glycaemic control, cardiovascular risk factors, and achieving diabetes remission. The app offers tailored recommendations for diet, physical activity, and mental well-being based on individual health goals, ethnicity, and lifestyle factors. Participants in the study, recruited from GP practices in Western Sydney, will have access to Gro-AUS for 12 months. The app’s usage will be monitored, and follow-up assessments will be conducted at 3, 6, and 9 months post-recruitment. The app enables users to track their health, receive personalised feedback, and engage with the content in multiple languages. The study aims to evaluate the effectiveness of this digital health intervention compared to standard care. The Gro Health app is designed to support users in managing their health through a comprehensive, structured approach. It covers a wide range of topics including nutrition, physical activity, sleep, mental wellbeing, stress management, mindfulness, and chronic disease management, such as diabetes, obesity, and hypertension. The app also integrates behavioural change techniques, which help users develop lasting, positive health behaviours. To engage users, the app offers a variety of educational content, such as interactive tools for food tracking, meal planning, and exercise logging. It also includes evidence-based reading materials, guided meditations, mindfulness exercises, and video clips demonstrating different exercises. Personalised feedback driven by AI ensures that each user receives tailored support to meet their specific health goals. The resources within the app, which have been developed in collaboration with leading clinicians, were not created specifically for this study. However, they are well-established and cover key areas of health, including sleep, activity, and nutrition. These resources are adaptable, allowing the app to cater to individual users’ needs and preferences, making it an excellent tool for the research. For daily engagement, participants can use the app for around 15-30 minutes each day or 1-2 hours a week, depending on their schedules and goals. The app is flexible, meaning users can choose whether to engage in quick check-ins or dive deeper into health topics when they have more time. Beyond the educational content, the app includes a variety of tools that help users make positive changes to their behaviour. These include personalised goal-setting using AI, interactive activities, and a daily wellness score that offers insights into their progress. The app also features smart food tracking, including a food diary, barcode scanner, and AI-powered plate recognition. Additionally, it helps with exercise tracking, offers guided workouts for all fitness levels, provides tools for better sleep, and includes techniques for managing stress. Users can also take part in a peer-to-peer community for motivation, attend live drop-in sessions with health experts, and receive one-on-one guidance from certified coaches. In this study, participants will use the app in a natural way, without being told how often or for how long they need to engage. This approach will allow the study to assess how people naturally interact with the app and whether it helps them make lasting changes to their health behaviours. Although there are no specific usage requirements, participants may be asked to complete occasional surveys or assessments to track their progress. The Gro Health app also offers personalised health management services, which help users manage their weight, control blood glucose levels, and improve their mental health and wellbeing. Services include one-on-one coaching with nutritionists and psychotherapists, a clinical dashboard that allows for remote tracking of user progress, and optional integration with wearable devices for more detailed health data. Live drop-in sessions with health experts are also available, along with a peer-to-peer community for additional support. Recommendations within the app are highly personalised, taking into account factors like self-selected health goals, ethnicity, gender, dietary preferences, activity levels, and other unique aspects of each individual. These recommendations may include personalised diet plans, physical activity goals, and stress management techniques, all tailored to help users meet their health objectives. Participants will be able to access the app by downloading it from the Apple App Store or Google Play Store. They will receive a code from the researchers to unlock the app for free, and assistance will be provided to help them download and navigate its features. To measure adherence to the intervention, the study will track app usage data, including completed sessions and activities. Participants’ progress will be monitored through the daily wellness scores and their progress towards their personalised goals. This will help assess how well the app engages participants and whether it helps them achieve their health goals.
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion Criteria: 1- Adults diagnosed with Type 2 diabetes attending GP practices within the Western Sydney Local Health District (WSLHD). 2- Ownership of a smartphone compatible with the Gro-AUS app. 3- Able to speak or read one of the languages supported by the Gro-AUS app (English, Hindi, Chinese, Arabic). 4- HbA1c level greater than 7.5% within 6 months. 5- Diagnosis of Type 2 diabetes within the past 10 years.
Exclusion criteria
Exclusion Criteria: 1- Individuals with diabetes types other than Type 2 (e.g. Type 1 or gestational diabetes). Current pregnancy or breastfeeding. 2- History of severe mental health conditions, particularly eating disorders. 3- No access to a smartphone capable of running the Gro-AUS app. 4- Severe kidney disease (Chronic Kidney Disease stage 2, eGFR <30). 5- Previous bariatric surgery. 6- Genetic metabolic disorders such as porphyria, carnitine deficiency, or fatty acid oxidation defects (e.g. CPT I/II deficiency, multiple acyl-CoA dehydrogenase deficiencies). 7- Severe complications or comorbidities that may affect the participant’s ability to follow the study protocol.