Efficacy of health promotion interventions in adults with lifestyle and health risk factors for dementia

This project compares three different interventions: a risk reduction intervention called Body Brain Life-GP (BBL-GP) that is designed to reduce risk of cognitive decline; a Lifestyle Modification Program (LMP) that is designed to enhance general wellbeing and improve lifestyle to reduce risk of chronic disease, once a week making a total of six sessions; and an Active Control condition involving emails containing information about healthy lifestyle. BBL-GP is an intervention package that builds on two published interventions developed by our team: the BBL intervention (Trial ID:ACTRN12612000147886) and the Fitness for the Ageing Brain (FABs; Trial ID: ACTRN 12609000755235). For BBL-GP we revised our previously published interventions to include newly available health self-monitoring technology, we adapted our modules after extensive consumer evaluation, and included a more intensive physical activity program designed for a younger age-group. This revised program (Body Brain Life-Fit) was piloted with the general public (Trial ID: ACTRN12615000822583). The sample for the current project is adults in Primary Care who meet criteria to participate in the GP Practice's Lifestyle Management Program. These are the types of adults who a GP would refer to a dementia risk reduction trial in 'real life' and we are aiming to evaluate our intervention in a naturalistic context. Primary care is the appropriate setting for the implementation of this program because it is where adults with high risk of developing dementia are identified. Participants in the BBL-GP group will be required to complete 8 modules (dementia literacy, risk factors, physical activity, nutrition, health, cognitive activity, social activity and mood) delivered online, and receive an individually tailored one hour face to face physical activity session and where indicated an individually tailored one hour face to face nutrition intervention. They will complete one module per week, each taking approximately 30-40 minutes. Participants will receive an email reminding them of the next module (during the first 8 weeks of the trial). Participants who are late competing modules will receive up to 3 reminder emails. The first eight weeks will be spent completing the 8 modules and the following four weeks will be spent revising the materials in the modules. The session duration and frequency of the physical activity (PA) program will vary between participants based on individual tailoring. An exercise physiologist/physiotherapist will design an individual program for the participant, deliver this in a face-to-face workshop and monitor the physical activity program via the returned diaries and telephone monitoring. For those not doing any regular PA at baseline, the target will be 150 minutes/week moderate intensity PA, for those doing less than 100 minutes/week, an additional 100 minutes/week will be prescribed and for those meeting the target, an additional 50 minutes/week will be prescribed. A diary in the format of a calendar returned monthly for 24 weeks, will be used to record PA and rating of perceived exertion. The dietary intervention will be provided to those individuals who have experienced significant weight gain in the last 6 months or indicate an unhealthy dietary pattern at the baseline assessment. A one hour face to face intervention will involve individually tailored dietary advice, formal dietary prescription, and a dietitian tailored plan. Participants will complete an online diary to record their dietary intake. Participants in the BBL group will be asked to continue being active and having a healthy dietary pattern after the completion of the intervention but they will be monitored through phone calls at week 4, 12 and 20. In addition, they will receive a general booster session at 12 months with a phone call and a mailed out booklet. Participants in the LMP group will receive group sessions on basic nutrition, meal planning, physical activity, health conditions, motivation and goals, medications, and sleep. This program will be provided by various health professionals (dietitian, exercise physiologist, nurse practitioner, psychologist, pharmacist and sleep physician) for a duration of 6 weeks. Each session will last for 2 hours. The course is currently run by the practice for their patients to assist them to improve their lifestyle and management of chronic disease and so it is a real-life comparison condition. This trial will be conducted to evaluate the efficacy of health promotion interventions (BBL-GP and LMP) compared with the Active Control. There will be 240 participants (80 in BBL-GP, 80 in LMP and 80 in the Actvie Control group) followed for 62 weeks from baseline. There will be 4 follow-up assessments (immediately after the completion of the intervention or at 13 weeks for the Active Control, and at 18, 36 and 62 weeks after commencement of the intervention).