Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2027-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

FINGER-NL is a multi-center, randomized, controlled, multidomain lifestyle intervention trial among 1,206 older adults at risk for cognitive decline with a duration of 24 months. Participants are randomized in a 1:1 ratio to a personalized multi-domain lifestyle intervention (high-intensity intervention group) versus online access to general lifestyle-related health information (low-intensity intervention group). After the intervention period, participants are invited for a 24 month extension of follow-up.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

STRONGER 60+: Assessing the Clinical Effectiveness and Delivery of an Adapted FINGER Model for Brain Health in Primary Care

NCT07117916

Older Adults at High Risk for MCI Older Adults With Mild to Moderate Level of Dementia

NOT_YET_RECRUITING NA

Evaluating an In-home Multicomponent Program to Manage Concerns About Falling in Frail Community Dwelling Older People

NCT01358032

Concerns About Falling Aged

COMPLETED NA

A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China

NCT05886114

Cognitive Impairment Alzheimer Disease Vascular Cognitive Impairment +7 more

RECRUITING NA

Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability

NCT01041989

Cognitive Impairment Dementia

ACTIVE_NOT_RECRUITING NA

Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention

NCT04616794

Risk Behavior Cognitive Decline

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cognitive Decline Life Style Risk Reduction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

high-intensity group

The high intensity group receives a personalized, supervised intervention consisting of group meetings and individual sessions.

Group Type EXPERIMENTAL

Multidomain lifestyle intervention

Intervention Type BEHAVIORAL

A multidomain lifestyle intervention, including (1) physical activity, (2) cognitive training, (3) cardiovascular risk factor management (Cardiovascular), (4) dietary counselling, (5) Souvenaid, (6) sleep counselling, (7) stress management, and (8) social activities.

low-intensity group

The low-intensity arm receives online access to general lifestyle-related health information.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multidomain lifestyle intervention

A multidomain lifestyle intervention, including (1) physical activity, (2) cognitive training, (3) cardiovascular risk factor management (Cardiovascular), (4) dietary counselling, (5) Souvenaid, (6) sleep counselling, (7) stress management, and (8) social activities.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 60-79 years of age at pre-screening;
* Adequate fluency in Dutch to understand the informed consent and complete questionnaires;
* Providing informed consent to all study procedures;
* Internet access at home;
* Presence of ≥3 self-reported risk factors for cognitive decline (must contain at least 2 modifiable risk factors and 1 non-modifiable riskfactor).

Exclusion Criteria

* Diagnosis of dementia or mild cognitive impairment at baseline (self-reported);
* Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score\<23);
* Conditions affecting safe and continuous engagement in the intervention (e.g. under treatment for current malignant diseases, major psychiatric disorders (e.g. major depression, psychosis, bipolar disorder), neurological disorders (e.g. Parkinson's disease, multiple sclerosis), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), re-vascularization within three months, severe loss of vision, hearing or communicative ability, severe mobility impairment, other conditions preventing co-operation) as judged by the local study nurse or consulted physician at the local study site;
* Coincident participation in any other intervention trial at time of pre-screening.
* Coincident participation of spouse in FINGER-NL trial.

Minimum Eligible Age

60 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes