TY - JOUR
T1 - A Mediterranean Diet and Walking Intervention to Reduce Cognitive Decline and Dementia Risk in Independently Living Older Australians
T2 - The MedWalk Randomized Controlled Trial Experimental Protocol, Including COVID-19 Related Modifications and Baseline Characteristics
AU - Pipingas, Andrew
AU - Murphy, Karen J.
AU - Davis, Courtney R.
AU - Itsiopoulos, Catherine
AU - Kingsley, Michael
AU - Scholey, Andrew
AU - MacPherson, Helen
AU - Segal, Leonie
AU - Breckon, Jeff
AU - Minihane, Anne Marie
AU - Meyer, Denny
AU - Ogden, Edward
AU - Dyer, Kathryn A.
AU - Eversteyn, Emily
AU - Hardman, Roy J.
AU - Poorun, Kaylass
AU - Justice, Keri
AU - Hana, Maher
AU - Buckley, Jonathan D.
AU - White, David
AU - Davison, Kade
AU - Clark, Jessie S.
AU - Bracci, Ella L.
AU - Kennedy, Greg
AU - MedWalk collaboration team
PY - 2023/10
Y1 - 2023/10
N2 - 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).
AB - 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).
KW - Alzheimer's disease
KW - cardiovascular
KW - cluster-randomized clinical trial
KW - cognition
KW - cognitive behavioral therapy
KW - dementia
KW - exercise
KW - Mediterranean diet
KW - mood
KW - motivational interviewing
KW - physical activity
UR - http://www.scopus.com/inward/record.url?scp=85175405864&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/NHMRC/1171300
U2 - 10.3233/JAD-230641
DO - 10.3233/JAD-230641
M3 - Article
C2 - 37781806
AN - SCOPUS:85175405864
SN - 1387-2877
VL - 96
SP - 409
EP - 427
JO - Journal of Alzheimer's Disease
JF - Journal of Alzheimer's Disease
IS - 1
ER -
