A Mediterranean Diet and Walking Intervention to Reduce Cognitive Decline and Dementia Risk in Independently Living Older Australians: The MedWalk Randomized Controlled Trial Experimental Protocol, Including COVID-19 Related Modifications and Baseline Characteristics
Creators: name: Pipingas, Andrew
name: Murphy, Karen J
name: Davis, Courtney R
name: Itsiopoulos, Catherine
name: Kingsley, Michael
name: Scholey, Andrew
name: Macpherson, Helen
name: Segal, Leonie
name: Breckon, Jeff
name: Minihane, Anne-Marie
name: Meyer, Denny
name: Ogden, Edward
name: Dyer, Kathryn A
name: Eversteyn, Emily
name: Hardman, Roy J
name: Poorun, Kaylass
name: Justice, Keri
name: Hana, Maher
name: Buckley, Jonathan D
name: White, David
name: Davison, Kade
name: Clark, Jessie S
name: Bracci, Ella L
name: Kennedy, Greg
name: team, MedWalk collaborative
Publisher: name: La Trobe
Year: 2023
Subjects: classificationCode: 520106
subject: Psychology of ageing
classificationCode: 3210
subject: Nutrition and dietetics
classificationCode: 3209
subject: Neurosciences
subject: FOS: Clinical medicine
classificationCode: 5202
subject: Biological psychology
classificationCode: 3202
subject: Clinical sciences

description: BACKGROUND: Several clinical trials have examined diet and physical activity lifestyle changes as mitigation strategies for risk factors linked to cognitive decline and dementias such as Alzheimer's disease. However, the ability to modify these behaviors longer term, to impact cognitive health has remained elusive. OBJECTIVE: The MedWalk trial's primary aim is to investigate whether longer-term adherence to a Mediterranean-style diet and regular walking, delivered through motivational interviewing and cognitive-behavioral therapy (MI-CBT), can reduce age-associated cognitive decline and other dementia risk factors in older, independently living individuals without cognitive impairment. METHODS: MedWalk, a one-year cluster-randomized controlled trial across two Australian states, recruited 60-90-year-old people from independent living retirement villages and the wider community. Participants were assigned to either the MedWalk intervention or a control group (maintaining their usual diet and physical activity). The primary outcome is 12-month change in visual memory and learning assessed from errors on the Paired Associates Learning Task of the Cambridge Neuropsychological Test Automated Battery. Secondary outcomes include cognition, mood, cardiovascular function, biomarkers related to nutrient status and cognitive decline, MI-CBT effectiveness, Mediterranean diet adherence, physical activity, quality of life, cost-effectiveness, and health economic evaluation.Progress and Discussion:Although COVID-19 impacts over two years necessitated a reduced timeline and sample size, MedWalk retains sufficient power to address its aims and hypotheses. Baseline testing has been completed with 157 participants, who will be followed over 12 months. If successful, MedWalk will inform interventions that could substantially reduce dementia incidence and ameliorate cognitive decline in the community. TRIAL REGISTRATION: Registered on the Australia New Zealand Clinical Trials Registry ANZCTR 12620000978965 (https://www.anzctr.org.au).