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Investigating the effect of diet and exercise lifestyle interventions on cognitive performance and dementia risk in older people.

Investigating the effect of Mediterranean diet and exercise on cognitive performance and dementia risk in independently living older Australians: the MedWalk randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000978965
Acronym
MedWalk
Enrollment
161
Registered
2020-09-30
Start date
2021-04-07
Completion date
2022-10-13
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study aims to determine if a combination of following a Mediterranean style of diet and walking-based exercise, slows the decline in brain function (cognition) that is commonly associated with older age. A study we recently conducted is the only clinical trial to investigate the effect of a combined Mediterranean diet and exercise lifestyle intervention on cognition in older people. This small (pilot) study showed improved memory and thinking in a sub-group of older participants adhering to a combination of Mediterranean diet and daily walking for 6 months. We are now extending the pilot trial, into a 2-year, definitive clinical trial involving over 364 participants, across 28 sites in Victoria and South Australia. Translating this knowledge into a lifestyle program for behaviour change for the prevention of dementia could be physically, socially and economically significant. This study will investigate the effects of diet and exercise on memory, attention and other mental functions. We will also investigate: mood, stress, fitness and wellbeing. While memory and other brain functions have been shown to normally decline over the lifespan, poorer diet and lack of exercise has been linked with a faster decline in brain functions. This research is aimed at investigating the effectiveness of a combined Mediterranean diet and walking intervention (MedWalk), on cognitive decline in an older population, living independently without cognitive impairment. The study will examine participants’ memory and attention, heart and artery health, mood and wellbeing, and biological markers in blood and faeces following a 24-month lifestyle intervention.

Interventions

This will be a 1-year trial will consist of 180 participants, aged 60 to 90, who will be recruited from at least 28 facility sites through agreements with Independent Living providers or other community groups in Vic and SA via advertisements and information sessions held at these sites. Residents in these communities live independently, undertaking all of their own activities of daily living (such as cooking, shopping and cleaning). Participants will be randomised to one of two conditions: Gro

This will be a 1-year trial will consist of 180 participants, aged 60 to 90, who will be recruited from at least 28 facility sites through agreements with Independent Living providers or other community groups in Vic and SA via advertisements and information sessions held at these sites. Residents in these communities live independently, undertaking all of their own activities of daily living (such as cooking, shopping and cleaning). Participants will be randomised to one of two conditions: Group 1: MedWalk Intervention - Diet and exercise change intervention Group 2 : Control - No requirement to change diet or exercise / social engagement 1. MedWalk Intervention: The intervention combines dietary modification with a supervised progressive walking program and is underpinned by established psychosocial behavioural change techniques (embedded within dietary modification and walking program). Participants will be supported by a study dietitian for the first year in a tapering visit regime. During these visits MI-CBT, as outlined below, will be employed by the dietitian. The ‘intense support’ phase will last 8 weeks, in which each participant will have fortnightly, face-to-face, 60-minute consultations with a dietitian. Further the dietitian will be available to answer questions via email and phone during this time. These visits will occur 2 weeks, 4 weeks, 6 weeks and 8 weeks after the baseline session. The ‘continued support’ phase will follow the first 8 weeks and consist of monthly visits for 4 months and then quarterly visits until the end of year 1. These visits will be similar to the fortnightly visits, whereby MI-CBT will be used to provide support and empower participants to continue the intervention. These visits are expected to take up to 60 minutes. During the continued support phase, the dietitian will be available via email and phone to answer questions during business hours. The monthly visits will occur at weeks 12, 16, 20 and 26 (6 months). Quarterly visits will occur at week 39 and week 52 (12 months). Walking exercise intervention will take place in parallel with the dietary intervention. Supervised group walking sessions, involving all participants at a site, will take place weekly for the first 6 months, and then reduce to monthly sessions for the following 6 months. Supervised walking sessions will be ceased after 1 year. 1.1 MedWalk - Mediterranean dietary component: The dietary intervention is based on the PREDIMED dietary guidelines, modified for Australian use investigators. Abundant use of EVOO for cooking and dressing vegetables and salad; 2 or more daily serves of both vegetables and fresh fruits and dried fruit as snacks; 3 or more weekly servings of the following: legumes; fish and seafood (at least 1 serving of oily fish); nuts or seeds; daily consumption of Greek yoghurt, low-fat cheese (feta, ricotta, hard cheese) and milk; ad libitum consumption of wholegrains; select white meats over red and processed meat; cook 2 or more times a week with tomato, garlic and onion; eliminate or limit the consumption of sweetened soft drinks; for alcohol consumers, choose red wine and consume no more than 2 standard drinks per day. The assistant dietitian will provide detailed instructions on following a MedDiet together with meal planning and recipes and utilise MI-CBT to assist with dietary behaviour change and manage ambivalence toward change. This level of education and support initially, is vital to allow participants to fully comprehend the dietary pattern and how it differs from the Australian diet. As extra-virgin olive oil (EVOO) is an essential component of the MedDiet, Cobram Estate will donate EVOO for MedWalk. Adherence to the dietary component of this study will be evaluated using attendance by attendance at dietician information session, the MEDAS dietary screening tool. 1.2 MedWalk - Walking component The assistant exercise scientist will prescribe an individualised, structured, progressive home-based walking program together with a handout and stretching routine. Participants will be asked to walk for at least 30 min on 5-days per week (150 min in total, consistent with the current national physical activity guidelines); working up from 10-30 min sessions performed 2-3 days per week. Each session will include a 5-minute warm-up and cool-down period of walking slowly. The objective is to increase fitness as measured by distance covered during the 6-minute walk test. Consistent with the American College of Sports Medicine guidelines, training intensity will commence at a low-moderate intensity (a rating of 2-3 on the Modified Borg Category-Ratio Scale (Borg CR10)) and will be progressively increased. Walking groups will be organised at each IL facility, and will consist of all the participants (13) at that facility. The weekly trainer-led group sessions provide the opportunity for each participant’s walking program to be progressed to maintain desired intensity. Training intensity will be modified through a reduction in rest intervals, increasing walking speed and number of steps per walk, or per week, and/or through the prescription of hill walking or interval walk training. All participants in the MedWalk intervention group will be provided with a wrist-worn activity tracker for motivational purposes. Adherence to the walking exercise component will be assessed via attendance at group walking sessions and the International Physical Activity Questionnaire modified for the elderly (IPAQ-E). Additionally, change in free-living ambulatory physical activity and sedentary behaviour will be assessed via accelerometry. 1.3 MedWalk – Behaviour change counselling using Motivational Interviewing – Cognitive Behavioural Therapy (MI-CBT) MI uses a combination of relational and technical micro-skills (e.g., open questions, affirmations and reflective listening) to explore and action plan around an individual’s barriers to change. MI is an effective approach to promote physical activity (PA) and diet change. CBT includes action-orientated treatments (e.g. behavioural counselling, goal-orientated therapy, cognitive behaviour therapy) to build maintenance skills. Our team has recently demonstrated that integrated MI-CBT can increase physical activity in older insufficiently active secondary care patients. The intervention will be underpinned with a theoretical framework (self-determination theory; SDT) which identifies progression by clients towards autonomous (self-directed) behaviours. This will be evaluated at each stage of the intervention delivery and receipt. The MI component will be delivered by research assistants trained in MI by one of the MI trained chief investigators or a member of the MI Network of Trainers (MINT) to a level of proficiency according to the Motivational Interviewing Treatment Integrity guidelines. To achieve change in diet and exercise behaviour, staff will use open questions, affirmations, reflective listening skills to build social support; identify change barriers and goals; develop flexible goal setting; action planning; managing relapse; building maintenance strategies and processes for self-monitoring. This will be conducted by trained researchers, and done in a non-judgemental, collaborative and compassionate manner guided by the participant. The format of the intervention will be a 12-session psycho-educational approach underpinned by the four processes (engaging, focusing, evoking, planning) and relational (spirit) and technical (Open ended questions, Affirmations, Reflective listening and Summarising; OARS) components of MI. The approach develops autonomy, evoking their perceived resources and abilities, and developing collaboration. Specific applications for the use of MI in PA and diet modification will form the basis of the training and subsequent MI delivery as well as adaptations required for the use of MI in individual and group settings. Along with the CB aspects, the intervention includes relapse prevention to support long-term behaviour change and contingency management. The relapse prevention components include, a) identifying high risk situations for relapse, b) flexible rather than rigid PA and diet change goals, and c) strategies for dealing with setbacks. Each session will be clearly manualised for content and style of delivery and will include psycho-educational, emotional and applied skills for managing barriers. Sessions will also explore the participants’ attitudes, motives and values toward PA and diet and how behaviours can be congruent to these three components. The proposed programme will be based on successful MI interventions to promote PA to adolescent populations and the 12 aspects of the intervention will be: 1) Getting to know each other: ice breaker and team activities (focussed around activity and healthy nutrition), 2) psycho-education: the background to PA and diet, group activities and knowledge exchange (elicit-provide-elicit; MI-based strategy), 3) Exploring attitudes and values toward change (PA and diet), 4) Understanding motives and reasons for PA and health nutrition, 5) Getting to know your options: How to take responsibility for your health in your environment, 6) Identifying and managing your barriers to change, 7) Identifying and managing risks of setbacks in yourself and others, 8) Identifying and managing flexible approaches to being more active and eating well, 9) Developing cognitive skills: recognising thoughts and emotions, 10) Developing cognitive skills: helpful thoughts and emotions, 11) Developing cognitive skills: Staying on track, 12) Where next and action planning MI-CBT will not be delivered as separate sessions, but will be incorporated into the dietitian visits and exercise sessions.

Sponsors

Swinburne University of Technology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

• Live in independent living supported accommodation • Fluent in written and spoken English • Able to walk independently and free from major physical conditions that would prevent regular walking • Willing to provide blood and stool samples throughout the testing phases • Willing to participate in all scheduled assessments • Willing to participate in regular engagement sessions

Exclusion criteria

• Have been diagnosed with dementia (e.g. Alzheimer’s disease) or other forms of cognitive impairment. • Have a history of stroke or any other conditions that affect your brain function • Participate (on average) in more than 150 min of moderate-to-vigorous leisure time physical activity per week AND already eat a mostly Mediterranean style diet • Have a diagnosed allergy or intolerance of food groups (e.g. olive oil/nuts/seafood) that would prevent you from eating a Mediterranean style diet

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026