Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults

Summary

Previous research has shown that a healthy lifestyle, including a balanced diet, physical and social activity, and management of vascular risk factors can support both cardiovascular and brain health. In a landmark Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), a multimodal lifestyle programme had clear benefits on older adults' cognition, functioning, and quality of life. The LETHE study utilises novel technologies and digital tools to deliver an optimised and more personalised FINGER-type multimodal lifestyle intervention.

A total of 160 digitally skilled older adults (age 60-77) with risk factors for dementia but without substantial cognitive impairment will be recruited in Austria, Finland, Italy, and Sweden. Participants will be randomly assigned in a 1:1 ratio to the structured ICT-assisted multimodal lifestyle program (intervention group) or a self-guided lifestyle program (control group). Duration of the study and the intervention is 24 months. The multimodal lifestyle program covers the following domains: physical activity, nutrition, cognitive activity, vascular risk management, social interaction, sleep, and relaxation. The structured intervention program follows a hybrid model where regular in-person, individual and group-based intervention activities led by professionals are supported with activities in the LETHE mobile phone application. The self-guided (control) group receives relevant health advice and is recommended and encouraged to independently implement healthy lifestyle changes that are suitable and fit in with their daily routine. Control group will have access to a simplified version of the LETHE app without any structured, scheduled activities or personalized content.

The primary objective of the LETHE trial is to test the feasibility of a digitally supported multimodal lifestyle program (i.e., retention rate, adherence to intervention), and assess change in dementia risk based on validated risk scores (CAIDE, LIBRA). Other objectives include testing the intervention effects on lifestyle and risk factors, cognition, function, health-related quality of life, health literacy, physical functioning, and dementia-related biomarkers. To this aim, a range of personal, lifestyle, and health-related data will be collected both actively and passively with the help of digital devices. Attitudes towards digital tools and experiences of trial participation will also be explored.

Conditions

• Cognitive Impairment
• Cognitive Decline
• Dementia

Interventions

BEHAVIORAL

Structured ICT-assisted multimodal lifestyle intervention

The structured lifestyle intervention programme, partly tailored and personalised to individual needs, covers the following domains: physical activity, nutrition, cognitive activity, cardiovascular risk management, social interaction, sleep, and relaxation / stress management. The programme includes regular scheduled in-person sessions (group-based + individual) which are supported with independent digital activities in the LETHE App. The App has features such as e.g., a cognitive training programme, on-demand exercise videos, calendar to schedule activities, advice and educational material, group chat, and possibility to set and monitor goals and self-monitor risk factors such as e.g., blood pressure.

BEHAVIORAL

Self-guided multimodal lifestyle intervention

Participants are advised to build their own healthy lifestyle programme based on standard healthy lifestyle advice that they will receive at individual consultations with the study physician/nurse as part of the study visits and through the simplified version of the LETHE app. The control group app does not include any structured / scheduled activities or personalised content.

Sponsors & Collaborators

• Medical University of Vienna

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• University Of Perugia

  collaborator OTHER

• FH Joanneum Gesellschaft mbH

  collaborator INDUSTRY

• Foundation for Research and Technology - Hellas (FORTH)

  collaborator UNKNOWN

• Infotrend Innovations Co Ltd

  collaborator UNKNOWN

• Innovation To Grow

  collaborator UNKNOWN

• Kaasa solution GmbH

  collaborator UNKNOWN

• Lisbon Council

  collaborator UNKNOWN

• Maastricht University

  collaborator OTHER

• Combinostics Oy

  collaborator UNKNOWN

• Alzheimer Europe

  collaborator OTHER

• Extra Red s.r.l.

  collaborator UNKNOWN

• Stichting EGI

  collaborator UNKNOWN

• Finnish Institute for Health and Welfare

  lead OTHER_GOV

Principal Investigators

• Tiia Ngandu, MD PhD · Finnish Institute for Health and Welfare

• Elisabeth Stögmann, MD PhD · Medical University of Vienna

• Francesca Mangialasche, MD PhD · Karolinska Institutet

• Patrizia Mecocci, MD PhD · University Of Perugia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

77 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-30

Primary Completion

2025-01-31

Completion

2025-03-31

Countries

• Austria
• Finland
• Italy
• Sweden

Study Locations