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Dutch multidomain lifestyle intervention in older adults at risk of cognitive decline

Dutch multidomain lifestyle intervention in older adults at risk of cognitive decline - FINGER-NL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52236
Enrollment
1206
Registered
2021-04-01
Start date
2022-02-09
Completion date
Unknown
Last updated
2025-11-10

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

Conditions

cognitive functioning brain health

Interventions

The FINGER-NL multidomain lifestyle intervention comprises eight domains, namely 1) physical activity, 2) cognitive training, 3) cardiovascular risk factor management, 4) dietary counselling, 5) Sou

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 60-79 years of age at pre-screening; - Adequate fluency in Dutch to understand the informed consent and complete (online) questionnaires ; - Providing informed consent to all study procedures; - Internet access at home - >=3 (self-reported) risk factors (must contain at least 2 modifiable risk factors and 1 non-modifiable risk factor): Modifiable risk factors: - Physical inactivity (1) - Unhealthy diet (1) - Low mental/cognitive activity (1) - High blood pressure (1) - High cholesterol (1) - High body mass index (BMI) (2) Non-modifiable risk factors: - First-degree family history of dementia - Subjective cognitive decline/memory complaints (1) Measured using LIBRA questionnaire; (2) Defined as >=25 kg/m2 for 60-69 years old, and >=28 kg/m2 for >=70 years old, based on self-reported height and weight.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of dementia or mild cognitive impairment at baseline (self-reported); 2. Significant cognitive impairment assessed using a validated telephone-administered cognitive battery (TICSm score

Design outcomes

Primary

MeasureTime frame
2-year change from baseline in global cognitive composite score derived from subtest scores from the Neuropsychological Test Battery (NTB) that includes 15-Word Verbal Learning Test delayed recall, DDST 90 seconds, WAIS digit span backwards, and semantic fluency.

Secondary

MeasureTime frame
Secondary endpoints 2-year change from baseline in: a) individual cognitive test performances, representing memory (15-Word Verbal Learning Test delayed recall), processing speed (Digit Symbol Substitution Test 90 seconds) and attention and executive functioning (WAIS digit span backwards, semantic fluency); b) Instrumental activities of daily living using the Amsterdam Instrumental Activity of Daily Living Questionnaire (A-IADL-Q); c) Quality of life using the 5-level EuroQol-5D (EQ-5D-5L); d) Modifiable dementia risk using LIfestyle for BRAin health (LIBRA); e) Intervention specific outcomes: • Physical activity: grip strength, physical activity (SQUASH questionnaire), sedentary behavior (LASA Sedentary Behavior Questionnaire) and sarcopenia (SARC-F Sarcopenia Questionnaire. For participants at UMCG only: a physical activity diary (Physical Activity Record) • Cognitive training: cognitive function (semantic fluency test), metamemory (Metamemory in Adulthood Questionnaire); • Cardiovascular: blood pressure, cholesterol (total, HDL, LDL + triglycerides), blood glucose (HbA1C), medication adherence (Hill-Bone Medication Adherence Scale); • Dietary counselling: nutritional intake (Traqq app), adherence to Dutch dietary guidelines (Dutch healthy diet index); • Sleep counselling: sleep behavior (7 day sleep diary), insomnia (Insomnia severity index); • Stress management: mindfulness (Five Facet Mindfulness Questionnaire), perception of stress (Perceived Stress Scale); • Social activities: perceived social support (Lubben Social Network Scale), emotional and social loneliness (De Jong Gierveld Loneliness Scale). f) Blood-based biomarkers for Alzheimer*s disease (Aβ42/40, p-tau), axonal damage (NfL), astrocytes activity/injury or stress (GFAP) and brain plasticity (BDNF).

Countries

Netherlands

Contacts

Public ContactM.D. Zwan

Amsterdam UMC

fingernl@amsterdamumc.nl0204448523

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)