Brain enhancement study (BES): A multi-modal lifestyle-based intervention for individuals with amnestic mild cognitive impairment

METHODS - THE PERSONALISED INTERVENTION (how ‘Targets’ will be met) In all face-to-face sessions, at least one Research Team member with CPR/First-aid certification will be present. The Intervention is designed to educate participants and facilitate behavioural change to promote progression towards Biochemical & Physiological Targets. The ultimate objective of the Intervention is to foster behaviours that: a. Do not stimulate neurodegenerative, inflammatory, or oxidative processes, or redox imbalance, b. Stimulate biochemical pathways known to reduce inflammatory or oxidative processes, promote repair, neurogenesis and general brain health and c. Stimulate positive neuroplastic change. To help participants successful make and sustain changes in their behaviour the Intervention will a) educate participants’ and their companion about the impact of lifestyle on brain health b) demonstrate how healthy lifestyle practices can be implemented and c) assist with implementation of the healthy behaviours within the participants’ home. To achieve these objectives the Intervention is divided into three key phases (Figure 2): - Phase 1, Preparation - Phase 2, Intensive Workshop and - Phase 3, Home Implementation Figure 2. Intervention Group Schedule 12.1 Phase 1 - Preparation The purpose of Phase 1- Preparation, is to physiologically and psychologically acclimatise both participants and their companion to the Intervention Guidelines that will be initiated during the Phase 2 - Intensive. To achieve this, 14 days prior to commencement of the Intensive Phase, the participant and their study companion will be asked to a) reduce their intake of meat, coffee and alcohol, b) increase their fibre intake through consumption of more fruit and vegetables and c) cease consumption of non-prescribed supplements. If not already engaging in regular physical activity, participants will be asked to commence light levels of activity as appropriate for their health (e.g. walking). 12.2 Phase 2 – Intensive Workshop To complete the Intensive Workshop Schedule, participants and their companion will visit Avondale University, another appropriate location (e.g. office space or clinical rooms), or have research staff visit their home, for 5 ½ consecutive days. In line with the expert approved Intervention Guidelines, through both education and demonstration, the Intensive is designed to motivate participants and their companion towards adopting healthy behaviours in four key areas: 1. Nutrition 2. Physical activity 3. Optimised biorhythms (sleep/rest/time of meals) 4. Cognitive training (Computerised Cognitive Remediation Therapy) This is achieved through: - Educational lectures series (5x ~1 hr lectures) (Section 12.2.1), - Modelling of meals ) - Supplement provision (Memorease + Omega 3) - Cooking tutorials (x1) , - Exercise classes (x5) , - Computerised cognitive remediation therapy sessions (x5) . Please Note: During the Intensive Phase participants and their companion will be provided with the Intervention Group Participant Materials . 12.2.1 Lectures Participants and their companions will be asked to view a series of educational lectures explaining the theoretical link between brain health and positive modifications made in the four key areas listed above. The goal of the lecture series is to empower the participant/companion through knowledge, enhancing their ability to make healthy lifestyle choices and mobilise the necessary resources to do so. The viewing of nine, approximately one-hour lectures will commence on the first day of the Intensive period and run into Phase 3 – Home Implementation (Part A). The lecture series will cover the following topics: 1. Welcome/Introduction, Our Amazing Brain, MCI, Study Overview – Intensive day 1 2. CCRT; Your Brains Gym – Intensive day 2 3. Nutrition Part 1 – Intensive day 3 4. Nutrition Part 2 – Intensive day 4 5. Supplements: What is there Place? – Intensive day 5 6. What’s Next? – Intensive day 5.5 7. The Importance of Keeping Active – Home Implementation, week 5 8. The Importance of a Good Night’s Rest – Home Implementation, week 7 9. The Importance of Maintaining Good Mental Health – Home Implementation, week 9 12.2.2 Modelling of Meals In line with the Intervention Guidelines. an evidence based, dietician approved, brain healthy diet, will be modelled through the provision of ALL meals to both participants and their companions during the Intensive Phase. Meals will be supplied by an external caterer who's business complies with all relevant NSW food industry legislations as outlined by the NSW Food Authority. Allergies will be check for and accommodated. 12.2.3 Supplement Provision Participants will be asked to consume 17 g per day of a novel supplement, Memorease, and two capsules per day of Blackmores Omega Triple, Super Strength Fish Oil. The Memorease choc supplement (developed for this study) is comprised of only Food Standards Australia and New Zealand (FSANZ), or Therapeutic Goods Australia (TGA) permissible ingredients, in permitted concentrations. Supplementation will commence during the Intensive and continue for the remainder of the study. Participants will be asked to consume two 8.5 g serves of Memorease per day after meals. Please refer to the Investigational Brochure for supplement details as well as Section 14 (Risks, Discomfort & Inconvenience), Section 16 (Adverse Event & Safety Monitoring), and Section 21 (Premature Closure of Study) of this document. Consuming 2 capsules of Blackmores Omega Triple, Super Strength Fish Oil is the equivalent of 1080 mg Eicosapentaenoic acid (EPA) and, 720 mg Docosahexaenoic acid (DHA). 12.2.4 Cooking tutorials To facilitate the voluntary adoption of healthy dietary practices, participants and their companion will actively participate in one Cooking Tutorial during the Intensive. This will be supplemented with an additional three Cooking Tutorials during Phase 3, Home Implementation. In these tutorials participants and their companion will learn how to prepare simple, whole food, plant-based meals from easily obtainable ingredients. One breakfast, main meal, light meal and dessert, that meet the Nutritional Guidelines, will be demonstrated by the Intervention Facilitator also termed Study Coach in participant/companion documentation). 12.2.5 Exercise Class During the Intensive Phase participants will take part in five, one-hour group physical activity sessions. These sessions will be run by a First-Aid/CPR qualified, personal trainer (PT) with the assistance of the Dementia Care Physiotherapist and Intervention Facilitator (if necessary). Alternative exercises will be recommended as required to accommodate each participant’s individual physical capability. During the Intensive Phase, physical activity sessions will be held on the grounds of Avondale University, either in the gym or at another suitable venue. Alternatively, sessions may be held at a commercial gym or park as appropriate. 12.2.6 Computerised Cognitive Remediation Therapy (CCRT) During the Intensive, participants will begin a 24 week course of computer based Cognitive Remediation Therapy (CCRT) (i.e. brain training) using the BrainHQ platform developed by Posit Science. Utilising this platform the participant will work through a series of exercises designed to improve overall brain health and recover behavioural competencies. This will take about 60 hours to complete, played out in daily 30-minute sessions, 5 days per week for 24 weeks. The CCRT course will be initiated during the Intensive Phase under the guidance of the Associate Investigator who has received training in CCRT facilitation. Participants will continue their CCRT through Phase 3: Home Implementation. For further information about the exercises included and CCRT implementation. 12.3 Phase 3 – Home Implementation - Facilitated behaviour change 12.3.1 Home Implementation Part (A) (4 weeks) During Home Implementation Part (A), the Intervention Facilitator will visit each participant and their companions 1-3 times per week. The number of weekly visits will be stipulated by the participant/companion and vary depending on individual needs. During this time the Intervention Facilitator will help participants and their companions implement within the home, ALL the changes in behaviour initiated during Phase 2: Intensive. This will be in accord with the Intervention Guidelines and any personalised recommendations made within. In partnership with the participant/companion, the Intervention Facilitator may assist in; - Nutrition; removal/replacement of unhealthy food, locating healthy food items in store, assistance with food label reading, demonstrations of cooking techniques, adaption of recipes to suit personal tastes and study Nutritional Guidelines, - Physical Activity; answer basic questions regarding personalised Exercise Plan, - CCRT training; answer technical questions. The Intervention Facilitator will also run three cooking tutorials as described in Section 12.2.4. During this period the Intervention Facilitator and the Chief and/or Associate Investigator will have weekly meetings to discuss how each participant is progressing and any issues/concerns/complex questions raised. This will occur in consultation with the Clinical Supervisor or PT/Physiotherapist or Dietician as appropriate. The Intervention Facilitator or, if more appropriate, the Chief or Associate Investigator, will then relay the solution/outcome to the participant and companion. 12.3.1.1 Exercise Plan During Home Implementation Part (A) participants will also begin their personalised Exercise Plan. The goal of the Exercise Plan is to facilitate participant’s progress towards the quantity of physical activity outlined in the Physical Activity Guidelines. The Exercise Plan will be developed by the PT, based on the participant’s performance in the Seniors Fitness Test administered at Assessment 1 and group exercise classes run during the Intensive. This will occur in consultation with the study Physiotherapist as required. The personalised Exercise Plan initiated at this time will be followed for six weeks (i.e. Home Implementation Part (A) plus 2 weeks of Home Implementation Part (B)). Importantly it is recognised that each participant will start with different baseline levels of strength and aerobic fitness and have varying levels of physical aptitude. Thus, it is expected that the rate at which participant’s progress towards the level of physical activity outlined in the Intervention Guidelines will vary. 12.3.1.2 Group Physical Activity Sessions With the primary purpose of increasing social connection and motivation, but also helping to facilitate safe exercise, participants will also commence weekly group physical activity sessions during this phase. These will be run for the duration of the study by the PT on the grounds of Avondale University or at another suitable community venue. Alternatively sessions may be held at a commercial gym or park as appropriate. 12.3.2 Home Implementation Part (B) (19 weeks) During Home Implementation Part (B), in person visits by the Intervention Facilitator will be replaced by weekly phones calls and/or online meetings. (~15-30 min) The purpose of these calls/meetings is to monitor participant compliance and provide motivation and support as required. The Intervention Facilitator and the Chief or Associate Investigator will have fortnightly meetings to discuss both how the participant is progressing and any issues/concerns/complex questions raised. This will occur in consultation with the study Clinical Supervisor or PT/Physiotherapist or Dietician as appropriate. The Intervention Facilitator or, if more appropriate, the Chief or Associate Investigator, will then relay the solution/outcome to the participant. 12.3.2.1 Exercise Plan Updates After participants have completed their first 6 week personalised Exercise Plan, the participant and their companion, together with the PT or physiotherapist, and the Chief or Associate Investigator will discuss the positives and negatives of the completed plan as well as any gains in physical fitness or areas of physical concern. Based on this, the PT/physiotherapist will develop a second 6 week Exercise Plan for the participant to follow. A third and final Exercise Plan will then be developed as described above and followed for the remainder of Phase 3 – Home Implementation (i.e. until study completion). Importantly, if concerns are raised by the participant/companion at any stage, the Exercise Plan may be adjusted by the PT/physiotherapist through the course of the study. 12.3.2.2 Group Physical Activity Sessions Group physical activity sessions will continue during this phase as described in Section 12.3.1.2 above. 12.4 How the Intervention is Personalised The Chief Investigator or Chief and Associate Investigator, will thoroughly review the outcome of all participant assessments. Based on the Biochemical & Physiological Target results, and considering the auxiliary information derived from the Secondary Assessments and Markers, personalised recommendations within the Intervention Guidelines will be formulated such that the likelihood of meeting each Target is increased. This process will occur at the end of the 12 week assessment period in consultation with the study Clinical Supervisor, Dietician and PT/physiotherapist as appropriate. The assessment results and personalised recommendations will then be used to populate the main body of an Assessment Report a copy of which will be provided to the participant’s primary healthcare physician(s). Participants and their companion will meet with the Chief Investigator or Chief and Associate Investigator, either online or in person, to discuss each Assessment Report and any personalised recommendations made within. This may take up to 1 hour. During this time the participant and their companion will be encouraged to ask questions, either about the current Assessment Report specifically or the Intervention and their progress in general. Following this, the Intervention Facilitator will assist the participant and companion in implementing the personalised recommendations in the home. Please note a log of participant attendance will be maintained for daily activities in the 5.5 day intensive and for the weekly exercise classes scheduled over the 24 weeks of the trial. All unused supplements will be requested to be returned to the researchers at the end of each 2 weeks, when the new supplements will be distributed.