NCT05565170

Brief 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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
4 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 26, 2022

Last Update Submit

September 23, 2024

Conditions

Cognitive ImpairmentCognitive DeclineDementia

Keywords

PreventionRisk reductionBrain healthLifestyle interventionDigital interventioneHealthTelemedicine

Outcome Measures

Primary Outcomes (3)

  • Feasibility: retention rate

    Percentage of participants completing the 24-month trial period in each study arm. Higher percentage indicates a better outcome.

    24 months

  • Feasibility: adherence to the structured multimodal lifestyle intervention

    Attendance at scheduled intervention sessions (percentage), usage of / engagement with the digital devices (LETHE App, Fitbit smartwatch). Possible values range from a minimum of 0, with higher values indicating better adherence and more active engagement.

    Continuously measured during 24 months

  • Change in dementia risk scores (LIBRA and CAIDE), units on a scale

    Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) risk score and Change in the LIfestyle for BRAin health (LIBRA) score are validated tools to estimate late-life dementia risk based on a combination of non-modifiable and modifiable risk factors (CAIDE) or modifiable factors only (LIBRA). Total score ranges from 0 to 15 (CAIDE) and from -5.9 to +12.7 (LIBRA). Higher scores indicate higher risk.

    Baseline, 12 months, 24 months

Secondary Outcomes (6)

  • Change in healthy lifestyle, unit on a scale

    Baseline, 12 months, 24 months

  • Change in cognition: composite z-score based on an extended Neuropsychological Test Battery (NTB), unit on a scale

    Baseline, 12 months, 24 months

  • Change in stress-related symptoms (Perceived Stress Scale, PSS-14), unit on a scale

    Baseline, 12 months, 24 months

  • Change in sleep problems (Insomnia Severity Index, ISI), unit on a scale

    Baseline, 12 months, 24 months

  • Change in health-related quality of life (RAND-36), unit on a scale

    Baseline, 12 months, 24 months

  • +1 more secondary outcomes

Other Outcomes (30)

  • Exploratory: Change in physical activity - self-reported, unit on a scale

    Baseline, 12 months, 24 months

  • Exploratory: Change in physical activity - objective, based on Fitbit smartwatch

    Continuously for 24 months

  • Exploratory: Change in dietary intake, unit on a scale

    Baseline, 12 months, 24 months

  • +27 more other outcomes

Study Arms (2)

Structured ICT-assisted multimodal lifestyle intervention

ACTIVE COMPARATOR

Participants assigned to this study arm follow an intensive structured, digitally supported multimodal lifestyle intervention programme (combination of individual and group-based in-person consultations/sessions and digital activities in the LETHE mobile phone App). Intervention duration is 2 years.

Behavioral: Structured ICT-assisted multimodal lifestyle intervention

Self-guided multimodal lifestyle intervention

SHAM COMPARATOR

Participants assigned to this study arm receive regular health advice in connection with the study visits (and through a simplified version of the LETHE mobile phone App), and are recommended and encouraged to independently implement healthy lifestyle changes that are suitable and fit in with their daily routine. Intervention duration is 2 years.

Behavioral: Self-guided multimodal lifestyle intervention

Interventions

Structured ICT-assisted multimodal lifestyle interventionBEHAVIORAL

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.

Structured ICT-assisted multimodal lifestyle intervention
Self-guided multimodal lifestyle interventionBEHAVIORAL

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.

Self-guided multimodal lifestyle intervention

Eligibility Criteria

Age60 Years - 77 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60-77 years
  • Cardiovascular Risk Factors, Aging and Incidence of Dementia (CAIDE) Risk Score ≥ 6 points
  • Cognitive performance at the mean level or slightly lower than expected for age, assessed with Mini-Mental State Examination (MMSE) and the Consortium to Establish a registry for Alzheimer's Disease (CERAD) verbal learning test (word list learning/recall)
  • Proficiency in the local language (German, Italian, Finnish or Swedish)
  • Ability and willingness to use an Android smartphone, access to and ability to use the internet (digital readiness)
  • Existing compatible smartphone (Android) or willingness to use a new Android smartphone provided from the study

You may not qualify if:

  • Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician)
  • Current or past use of medications for Alzheimer's disease or related diseases (e.g., cholinesterase inhibitors, memantine)
  • Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical judgement
  • Other significant neurologic disease, including but not limited to Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities
  • Any condition affecting safe engagement in the intervention, e.g., malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within 1 year previously
  • Severe loss of vision, hearing, or communicative ability; conditions preventing cooperation as judged by the study physician
  • Concomitant participation in an interventional trial (unless this will not interfere with the LETHE trial based on study staff's judgement)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Medical University of Vienna

Vienna, Austria

Location

Finnish Institute for Health and Welfare

Helsinki, Finland

Location

University of Perugia

Perugia, Italy

Location

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (1)

  • Rosenberg A, Untersteiner H, Guazzarini AG, Bodenler M, Bruinsma J, Buchgraber-Schnalzer B, Colombo M, Crutzen R, Diaz A, Fotiadis DI, Hilberger H, Huber S, Kaartinen N, Kassiotis T, Kivipelto M, Lehtisalo J, Loukas VS, Lotjonen J, Pirani M, Thunborg C, Hanke S, Mangialasche F, Mecocci P, Stogmann E, Ngandu T; on behaf of the LETHE Consortium. A digitally supported multimodal lifestyle program to promote brain health among older adults (the LETHE randomized controlled feasibility trial): study design, progress, and first results. Alzheimers Res Ther. 2024 Nov 21;16(1):252. doi: 10.1186/s13195-024-01615-4.

    PMID: 39574193DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionDementiaRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • Tiia Ngandu, MD PhD

    Finnish Institute for Health and Welfare

    PRINCIPAL INVESTIGATOR

  • Elisabeth Stögmann, MD PhD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

  • Francesca Mangialasche, MD PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

  • Patrizia Mecocci, MD PhD

    University Of Perugia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will not be actively told to what group they have been assigned (intervention or control). Outcome assessors will be blinded to the group allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomised 1:1 to two parallel arms: * structured ICT-assisted multimodal lifestyle intervention (intervention group) * self-guided multimodal lifestyle intervention (control group)
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 4, 2022

Study Start

January 30, 2023

Primary Completion

January 31, 2025

Study Completion

March 31, 2025

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

The LETHE consortium is open to requests from external researchers for data collected in this study. Applicants will be asked to submit a study protocol, including the research question, planned analysis, and data required. Data controllers will evaluate this plan (i.e., relevance of the research question, suitability of data, quality of proposed analyses, planned/ongoing LETHE analyses, and other matters) on a case-by-case basis and provide the data or reject the request. Shared data will encompass the data dictionary and de-identified data only. Any analysis will be conducted in collaboration with the LETHE Group. Access is subject to the LETHE legal framework. An access agreement will be prepared and signed by relevant parties.

Time Frame
Applications for data will be considered after the trial results have been published and data will be made available according to the terms of the access agreement.
Access Criteria
As described above in the Plan Description.

Locations

SE(1)IT(1)AU(1)FI(1)