Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline
Information about the intervention that will be tested in the study
Name of the intervention
Multidomain lifestyle intervention comprising 7 lifestyle modules (physical exercise, cognitive training, management of metabolic and vascular risk factors, nutritional counseling, sleep counselling, stress management, and social activities) and nutritional product Souvenaid®.
Administration
Personalised, supervised and hybrid (both online and at study site) intervention consisting of group meetings and individual sessions both online and at the study site.
Is the intervention already on the market for another medical condition?
No
Will all participants receive the same intervention?
Participants will be selected at random to either receive one of the following options:
- Multidomain lifestyle intervention (hybrid structured interventional high-intensity group)
- Online access to general lifestyle-related health information (self-guided low-intensity group).
Information about participating in the study
What are the researchers trying to find out?
The purpose of this study is to investigate the efficacy of an optimised personalised 2-year multi-domain lifestyle intervention on cognitive performance in older adults at risk of cognitive decline.
How long will the study last?
24 months
What your involvement will entail?
- During the study, participants will be asked to complete tests and questionnaires to evaluate executive function, memory, cognition, activities of daily living and behaviour
- To complete some laboratory and biological tests (i.e. blood test, blood pressure, nutritional intake).
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be 60 to 79 years old
- Be fluent in Dutch to understand the informed consent and complete questionnaires
- Provide informed consent to all study procedures
- Have internet access at home
- Have self-reported risk factors for cognitive decline.
Who cannot participate in the study?
People cannot take part in the study if they have:
- Diagnosis of dementia or mild cognitive impairment
- Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score<23)
- A disease or condition that may interfere with the safety, tolerability and/or study assessments (e.g., major depression, schizophrenia, bipolar disorder, multiple sclerosis, stroke, heart disease)
- Participation in any other intervention trial.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Where and when will the study be conducted?
European country involved in the trial
Netherlands - The participants will be primarily recruited from the online participant recruitment platform Dutch Brain Research Registry. FINGER-NL is part of the overarching national ‘Maintaining Optimal Cognitive function In Ageing (MOCIA)’ project, funded by NWO.
Estimated start date of recruitment
February 2022
Information for your doctor
Clinicaltrials.gov identifier
NCT05256199
Study contact information
Wiesje M. van der Flier wm.vdflier@amsterdamumc.nl
Sebastian Köhler s.koehler@maastrichtuniversity.nl
Link to full text
https://clinicaltrials.gov/ct2/show/NCT05256199
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on February 2023.
This document has been reviewed by the institution running this trial.
