The AUstralian multidomain Approach to Reduce dementia Risk by prOtecting brain health With lifestyle intervention study (AU-ARROW)

MULTIDOMAIN LIFESTYLE (ML) INTERVENTION: There are 4 intervention domains, to be introduced sequentially at group meetings over the first 4 months: the physical activity domain in weeks 1-4, diet education in weeks 5-8, cognitive training in weeks 8-12, and health education & medical monitoring in weeks 13-16. Once participants have received education concerning an intervention domain, they are asked to adopt lifestyle changes advised for that domain for the remainder of the 24-month study. The physical activity will require time commitment of at least 3 hours/week, brain training 2 hours/week, dietary intervention may involve longer meal preparation time, as well as time to record food intake (15-20 minutes daily, for 1 week/month) in a diet app. Health monitoring will require a maximum of one hour/week. The 42 ML group meetings over the 24 months will last 60-90 minutes each. There are also 27 telehealth dietary counselling calls over the 24 months (15-20 minutes/call). Please note that computer access, home internet and mobile phone usage are inclusion criteria for enrolment. INDIVIDUAL ML INTERVENTIONS: Physical activity intervention: 30-minute aerobic exercise for 4 days/week at 70-80% heart rate reserve and at 6-8 rate of perceived exertion (RPE), 20-minutes of resistance training for 2 days/week at 4-6 RPE, and 15-minutes of stretching exercises for 2 days/week at 2-3 RPE, to be carried out at study-designated gyms. Personalised regimes will be provided following physical assessments by accredited exercise physiologists. Exercise regimes will be updated 6 times over the 24 months, as participant fitness improves. Exercise regimes can be carried out by participants in the gyms at a time of their choosing, and participants will also be encouraged to engage in exercise physiologist-approved group classes. Such classes will be run by qualified staff, typically in groups of 10-20/class. The study-associated gyms will have exercise physiology and first aid qualified staff on site at all times, to ensure correct equipment use, and to encourage adherence. All participants will be provided with Fitbits, to be worn all waking hours, preferably also at night, for the full 24 months. Gym program example: Resistance training: 2 times/week: Upright Bike 5 minutes, level 1-2; Seated leg press, 2 sets, 8-12 repeats (reps), 30 kg; Lat Pulldown, 2 sets, 8-12 reps, 10 kg; Seated row, 2 sets, 8-12 reps, 10 kg; Seated bench press, 2 sets, 8-12 reps, 10 kg; Seated shoulder press, 2 sets, 8-12 reps, 5 kg. Cardio training: 4 times/week: Upright bike 5 minutes, speed 1-2, 45% of maximum heart rate (max HR); Upright bike - 10 minutes, speed 3, 65% of max HR; Treadmill, 10 minutes, 6 km/mild incline, 65% max HR; Elliptical trainer, 10 minutes, speed 3, 65% max HR; Cool down, - upright bike 5 minutes, speed 2, 45% max HR. Balance and Flexibility: 2 times/week: Single leg stance 30 seconds (sec), 3 x each leg; Tandem stance, 30 sec, 2 each way; Calf stretch, 30 sec, 1 each leg; Seated hamstring stretch, 30 sec, 1 each side; Seated gluteal stretch, 30 sec, 1 each side; Seated quadriceps stretch, 30 sec, 1 each side; Seated spine twist, 30 sec, 1 each side; Chest stretch, 30 sec, once; Upper back stretch, 30 sec, once; Triceps stretch, 30 sec, 1 each arm. Diet Education: Dietary counselling via group education and individual synchronous telehealth, by the study’s accredited dietitians, to support adopting the MIND diet (Mediterranean-DASH intervention for neurodegenerative delay). Dietary advice will be presented in the context of the NHMRC Australian Dietary Guidelines. Following weeks 5-8 diet education sessions, participants will receive monthly telehealth dietary counselling up to month 24, complimented by use of the Easy Diet Diary app. Cognitive training: Participants will be asked to complete 30-minute sessions of online BrainHQ computerised cognitive training (CCT), 4 times/week, on a home computer or laptop. Trial staff with BrainHQ intervention trial experience will explain use of the program at the initial CCT meetings; and at later CCT-related monthly group meetings, will provide support for increased cognitive and social engagement, and address training and adherence problems. Medical Monitoring component: Participants will receive Australian medical guideline-based health education to promote self-management of cardiometabolic risk factors through regular blood pathology tests, weight monitoring, blood pressure measurement, and healthy lifestyle goal-setting. Medical Monitoring group meetings will be facilitated by study dietitians, exercise physiologists or other trained study staff. INITIAL 16 WEEKLY GROUP MEETINGS: These will all be presented using PowerPoint slides. Group discussion will be encouraged. Groups of approximately 15 participants will be determined at the start of the intervention, and participants will remain in these groups for the 24 months. Each intervention domain will be introduced by specialists for that domain, as mentioned above. ALL group meetings for ML participants will last a maximum of 90 minutes. Weeks 1-4: Physical activity In these first 4 group meetings, participants will be introduced to a variety of physical training activities by study exercise physiologists (aerobic, resistance, balance and stretching exercises), and they will be educated on the links between regular physical activity and cardiac health, associated reduction in type 2 diabetes and hypertension, and improved balance. They will be given strategies to promote adherence. Individualised exercise regimes will be explained, as well as how to determine rate of perceived exertion. During these 4 weeks, ML participants will start their gym membership, and they will have equipment use explained by study exercise physiologists and exercise physiology students, during a group visit to the gym. Weeks 5-8: Diet education In these 4 meetings, an accredited dietitian will provide nutrition education and teach nutrition literacy skills, to increase the capability, opportunity and motivation of participants to adopt the MIND diet and change their dietary behaviours. Use of the Easy Diet Diary app will be explained. The dietitians will explain MIND diet components, foods to increase intake of and those to limit; NHMRC Australian Dietary Guidelines, healthy serving sizes, recipes, meal timing, snack ideas, and nutrition information label reading. Weeks 9-12: Cognitive training At these 4 group meetings, the online BrainHQ CCT program will be explained to participants, who will then be asked to complete 30-minute BrainHQ CCT exercises for 4 days/week at home on a computer or laptop, through month 24. The importance of cognitive and social activity will be explained, and appropriate activities suggested. Meetings will include material to help participants relate CCT activities to real life challenges, and will be facilitated by trial staff with BrainHQ intervention experience. Weeks 13-16: General health education and medical monitoring These group meetings will be facilitated by a study dietitian, exercise physiologist, or other trained trial staff member. The meetings will include education focused on cardiovascular and metabolic health, and will include information concerning the links between cardiovascular disease, diabetes type II, hypertension, as well as metabolic and lipid dysregulation and the increased risk of cognitive decline. It will be emphasized that the risk of such conditions can be reduced with regular exercise and diets such as the MIND diet. Participants will be encouraged to have their blood pressure, blood glucose and lipid levels monitored regularly, to facilitate timely treatment and clinical advice for any emerging health conditions. MONTHLY MEETINGS FROM MONTHS 5 TO 24: Following the first 16 weeks, there will be monthly facilitated group meetings, with 5 meetings dedicated to each of the four domains above. Topics (domains) will rotate every month, and meetings will be conducted by study exercise physiologists, dietitians, research officers, or other trained study staff. The meetings may involve PowerPoint presentations, and will reinforce each intervention’s purpose, discuss problems, and will encourage adherence. Blood pressure will be measured by a trained research assistant at each meeting. CLINICAL CONSULTATIONS: Clinician consultations occur every 6 months (in person at 0, 12 & 24 months, and via “Telehealth” at 6 & 18 months), to discuss 6-monthly blood test results (fasting glucose, lipids, Haemoglobin A1c), vital signs, medication changes and adverse events. The clinician will also provide Australian guideline-based medical advice to support the adoption of a healthier lifestyle. In-person consultations will last 30-45 minutes; Telehealth consultations will last 20-30 minutes. ADHERENCE CRITERIA: Participants may be withdrawn from the study if unable to attend one or more of the 6-monthly reviews, if their adherence to the exercise regimen or the CCT drops below 70% for over a month (without good reason, such as unexpected injury, or holiday). Adherence reviews will occur on a 4-6 weekly basis. Physical activity monitoring will be through gym attendance data, downloadable Fitbit data (for example, heart rate and daily steps), also the 3-monthly logs of all activities in the Physical and Mental Activities survey, and the 1-week/month physical activity log. Participant BrainHQ log-in times will be monitored to check program adherence. The 3-monthly MIND diet surveys, the 6-monthly Cancer Council of Victoria food frequency questionnaire, and the diet diary app will provide data on participant dietary changes; however, no minimum adherence level has been set for the diet intervention. Monthly group meetings and dietitian Telehealth, BrainHQ support, gym staff support, exercise physiologists’ reviews and 6-monthly clinician advice will all encourage intervention adherence.