None listed
Conditions
Brief summary
The purpose of this project is to investigate the effect of a 6-month personalised lifestyle protocol that incorporates recommendations from the ph360/Shae platform and phone app (nutrition, exercise, sleep, mindset, relationships, environment) and group coaching on the change in markers of diabetes and pre-diabetes. It is hypothesised that the personalised intervention using Shae will result in greater overall improvement in markers relating to Type 2 Diabetes. If the results are confirmatory, this study will contribute to an evidence-based rationale for personalising lifestyle medicine interventions for the care of type 2 diabetes.
Interventions
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
Sponsors
Study design
Eligibility
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
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