Maintain Your Brain (MYB): a 3-year study of a personalised online program to prevent cognitive decline and incident dementia amongst community dwelling 55-77 year olds.

The MYB intervention comprises up to 4, 10-wk modules delivered quarterly in the first 12 months of the trial, with periodic boosters for modules where appropriate (up to 3 yrs follow-up). The modules are Physical Activity, Nutrition, Peace of Mind and Brain Training. Eligibility for each module is determined by baseline assessments and includes health conditions, physical activity, diet and mental activity. All modules are fully online and accessed through the MYB eHealth platform. Physical Activity: Participants will receive personalised goals and feedback, and exercise information, to change behaviour. All goals, feedback and materials (videos, factsheets) are arranged around 3 exercise modalities: aerobic exercise, resistance training and balance training. The basic PA prescription aims to increase aerobic and resistance training to levels with a demonstrated positive impact on cognition and other health outcomes. Where feasible, progression to higher exercise intensities will be encouraged as this is also linked to improved cognition. Daily balance training exercises will also be incorporated. A behavioural change program is integrated by providing personalised goals, feedback, and encouraging activity logging. Procedure. The long-term goal for participants is 300 min/wk of moderate activity, 3 days/wk of vigorous resistance training and balance training every day. Over the initial 10wk module, activity levels (self-report) will be used to generate a personalised visual display of progress as well as a combination of short-term goals and feedback. Progression to the long-term goal will be achieved by first encouraging exercise at low frequencies/intensities for those not currently exercising, with the goal volume being reached over the first month. Once achieved, focus will then be on increasing intensity. Weekly logging will be encouraged, as well as use of an action plan both of which will be used to measure adherence. During follow-up, booster sessions will be added once a month (up to 3yrs), with activity logging (and therefore updated goals/feedback) also reduced. The PA module is designed to be self-administered, with participants able to engage with materials (such as factsheets and videos) in their own time and as often as they like. Materials are developed by qualified exercise physiologists and can be added, removed or updated. The module will be supported by “module trainers” (qualified exercise physiologists) who will respond to participant questions or module issues. Tailoring. The PA module can be adjusted based on risk of falls to ensure strength and balance are improved prior to engaging in aerobic activity. During annual assessments, participants could be reallocated to the main PA module if appropriate. Participants may also have their module adjusted during the study if any reported health events make continuing in the module unsafe. Nutrition. An overall Mediterranean-based MYB Healthy Brain diet will be offered that incorporates elements of the DASH Diet and Australian Healthy Eating guidelines, while emphasising unique parts of the Mediterranean diet. The rationale for this is based on relevance to risks for cognitive decline, and at this time it is the dietary pattern most strongly associated with cognitive benefits in clinical trials. Procedure. Personalised dietary messages and feedback are used to encourage adoption of a Mediterranean-based diet. All messages, feedback and materials (videos, recipes, etc) are arranged around 10 food groups (discretionary, animal protein, olive oil, nuts, vegetables, fruit, legumes, wholegrains, fish/seafood and water) within the Mediterranean Diet to provide smaller manageable targets for change. The Nutrition portal provides a personalised visual display of progress towards the ideal Mediterranean Diet based on weekly food logs. The combination of dietary messages and feedback will target the most poorly scored and crucial changes first, while ensuring participants only receive a manageable number of changes (max 4). If a participant does not make any changes for 2 wks, messages move onto other food groups and cycle back to unchanged groups if time is available. If a participant reaches a completed pyramid, maintenance will be encouraged. During the initial 10-wks, participants are encouraged to log their diet adherence weekly, with dietary messages and feedback updating based on this. They are also encouraged to fill out an action plan for achieving each suggested change. During follow-up, booster sessions will be monthly, with food logging (and goals/feedback) also only monthly. The module is self-administered with participants able to engage with materials in their own time and as often as they like. All content, designed by qualified dietitians, can be added, removed or updated. The module will be supported by “module trainers” (qualified dietitians) who will respond to participant questions or module issues. Tailoring. There are two planned modifications to the Nutrition module based on alcohol consumption and being underweight. If participants report a high rate of alcohol consumption, messages related to alcohol will be prioritised. If participants report low body weight they will receive modified advice. Allocation to these modified streams or to the main Nutrition module can also happen during follow-up (i.e. booster period). Besides these planned streams, participants could be removed from the module should medical events be reported that makes it unsafe for them to continue. Peace of Mind. Participants who are currently depressed and/or anxious; and/or have ever been diagnosed/treated for depression and/or anxiety will have access to the “Mixed Depression & Anxiety” course. This course has been developed by the Clinical Research Unit for Anxiety and Depression (CRUfAD) at UNSW/St Vincent’s Hospital. During the module, participants will be able to contact CRUfAD staff with clinical and technical questions. CRUfAD staff and participants are also provided with information about changes in psychological distress. Procedure. The course is self-paced and includes 6 lessons delivered over 10 wks. Lessons are completed independently and include: 1)Psychoeducation about anxiety & depression, identifying symptoms, the fight or flight response, controlled breathing, and physical activity/exercise; 2) Cognitive therapy components: education about the cognitive model, cognitive distortions, and introduction to thought monitoring; activity planning; 3) Thought challenging/cognitive restructuring; challenging positive & negative meta-cognitive beliefs about repetitive thinking; shifting attention, hunt for positives; 4) Education about avoidance and safety behaviours; graded exposure and structured problem solving; 5) Advanced graded exposure (imaginal exposure, interoceptive exposure); troubleshooting difficulties with graded exposure; 6) Relapse prevention. Adherence is measured by number of completed lessons (downloaded homework). Brain Training. Participants with an at-risk cognitive profile will be eligible for this module. Participants will complete a fully online, automated personalised cognitive training program that is vertically and horizontally adaptive called “Brain Training System (BTS)”. That is, the training regime is defined on participant’s baseline cognitive profile and continues to evolve in response to within-training task performance. Individual cognitive exercises are run as Flash files as provided by our commercial partner (Synaptikon, trading as NeuroNation, Germany); more than 30 are available at the outset and will be supplemented during the trial. BTS has otherwise been originally designed, including the approach to exercise selection, streaming, feedback, coaching and social support. Procedure. A participant’s cognitive profile is generated based on baseline cognitive tests. Profiles rank performance across cognitive domains (verbal executive, speed, verbal memory, visual executive, visual memory, visual attention). Initial exercise selection and streaming order will reflect this profile, preferentially targeting areas of weakness in the middle of the session. Exercise selection and streaming will be recalculated during training based on degree of improvement on exercises at the domain-level. Exercises will be presented in 3 sessions/wk, translating to 30 sessions over 10 wks. Each session will last 45 mins and comprise 17 exercises. If participants miss sessions, they will remain available until completed. During follow-up, exercises will be offered once a month (up to 3-yrs). Cognitive training materials for each session will also be provided and can be accessed as many times as the participant wishes. After completing the first 5 sessions, participants will receive a feedback performance graph that summarises their cognitive performance on each cognitive domain trained thus far. This performance graph will also indicate the range of scores for the top 25% highest performers in the module based on previous week’s sessions. Participants’ individual performance will be updated after completing each session and the top 25% range will be updated weekly. To maximise adherence and motivation, BTS will deploy several socialisation and gaming strategies. This includes access to an online Trainer (researcher), prioritised for participants ‘red-flagged’ as struggling with engagement or performance. Video chat will be preferred for these interactions, but participants will also be able to contact module trainers via MYB’s online interface. Participants can also nominate friends or family members who will be advised via email when the participant reaches certain adherence milestones, with the aim of providing social support and encouragement and establishing a community of practice. The Brain Training module is therefore designed to be automatically adaptive to a participant’s baseline score and progress during training.