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NCT Number: NCT05256199

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cognitive Decline Behavior Cognition Disorders Cognitive Dysfunction Life Style Mental Disorders Neurocognitive Disorders Risk Reduction Risk Reduction Behavior

Age range

60 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alzheimer Center Amsterdam, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multidomain lifestyle intervention

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.

Primary outcomes

  1. 2-year change from baseline in global cognitive composite score

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Global cognitive composite score derived from subtest scores from the Neuropsychological Test Battery (NTB) that includes 15-Word Verbal Learning Test delayed recall (discrete number; 0-15 (higher score means a better outcome)), Digit Symbol Substitution Test 90 seconds (discrete number; 0-90 (higher score means a better outcome)), WAIS digit span backwards (discrete number; 0-14 (higher score means a better outcome)), and semantic fluency (discrete number; 0-no maximum, higher score means a better outcome)).

Secondary outcomes

  1. 15-Word Verbal Learning Test delayed recall

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    discrete number; score: 0-15 (higher score means a better outcome)

  2. Digit Symbol Substitution Test 90 seconds

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    discrete number; 0-90 (higher score means a better outcome)

  3. Wechsler Adult Intelligence Scale (WAIS) digit span backwards

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    discrete number; 0-14 (higher score means a better outcome)

  4. Semantic fluency

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    word count in one minute; minimum 0, no maximum, higher score means a better outcome.

  5. Instrumental activities of daily living using the Amsterdam Instrumental Activity of Daily Living Questionnaire (A-IADL-Q)

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Total scores range approximately 20-70, higher scores indicate better IADL functioning

  6. 5 level EuroQol-5D (EQ-5D-5L)

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Quality of life, score 0-100, higher scores indicate better quality of life

  7. LIfestyle for BRAin health (LIBRA)

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Modifiable dementia risk using lifestyle for brain health; The score ranges from -5.9 (minimum score) to +12.7 (maximum score), with higher scores meaning a worse outcome (higher dementia risk)

  8. grip strength test

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Scores between 0 to 90 kg can be measured on the Jamar Hand dynamometer, with higher scores indicating better grip strength

  9. SQUASH questionnaire

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    METs derived from the Ainsworth's compendium of physical activity will be used to classify physical activity intensity (<1.5METs- sedentary, 1.6-2.9 METs- light, 3.0-5.9METs- moderate, >6.0- vigorous physical activity).

  10. LASA Sedentary Behavior Questionnaire

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Average hours and minutes of sedentary behavior a day, range from 0 to 24 hours. Higher scores (more hours) means a more sedentary behavior.

  11. Pittsburgh Fatigability Scale

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Total physical and mental fatigability scores range from 0-50, with higher scores indicating higher fatigability.

  12. SARC-F Sarcopenia Questionnaire

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    sarcopenia, scores range from 0 to 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst).

  13. Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Total scale ranges from 24 - 120, higher scores indicate more mindfulness

  14. Perceived Stress Scale

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Total score, scale 0 - 40, higher scores indicate more perceived stress

  15. MetaMemory in Adulthood (MIA)

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Sum of Part 1 + Part 2A and B. Part 1: Strategy (scores 10 - 50, higher scores indicate more use of strategies), Part 2A: Subjective memory functioning, scores ranges from 23 - 115, with higher scores indicate better memory self-efficacy and 2B: Locus, scores ranges from 7 - 35, higher scores indicate better perceived personal control over remembering abilities.

  16. Blood pressure

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.

  17. Cholesterol

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    total (healthy level: 125 to 200mg/dL), HDL (healthy level = 40mg/dL or higher), LDL (healthy level = Less than 100mg/dL) + triglycerides (healthy level = less than 150-199 mg/dL)

  18. Blood glucose

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    HbA1C, scores range from approximately 30-100 mmol/mol, with higher scores indicate higher blood glucose levels.

  19. Waist circumference

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    measured in cm

  20. Hip circumference

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    measured in cm

  21. Height

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    measured in cm

  22. Weight

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    measured in kg

  23. Hill-Bone Medication Adherence Scale

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    scores range from 9-26, with lower scores indicating better medication adherence

  24. MIND-adjusted Eetscore-FFQ

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Dutch Healthy Diet Index 2015 score (range 0-160 points, higher scores mean better outcome) and MIND score (range 0-15 points, higher scores mean better outcome), assessed by a short Food Frequency Questionnaire.

  25. Nutritional intake

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Change in nutritional intake measured by an online 3-day food diary (assessed by Traqq application), qualitative assessment

  26. Pittsburg Sleep Quality Index

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    Total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality

  27. Insomnia severity index

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    The score ranges from 0 (minimum score) to 28 (maximum score), with lower scores indicating a better outcome

  28. Lubben Social Network Scale

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    The score ranges from 0 (minimum score) to 30 (maximum score), with higher scores meaning a better outcome (higher level of perceived social support)

  29. De Jong Gierveldt Loneliness Scale

    Time frame: 2 years (measured at baseline and follow-up 2)

    The score ranges from 0 (minimum score) to 6 (maximum score), with higher scores representing a worse outcome (higher loneliness scores)

  30. Aβ42/40 ratio

    Time frame: 2 years (measured at baseline and follow-up 2)

    amyloid-β (1-42)/(1-40) (pg/mL)

  31. p-tau

    Time frame: 2 years (measured at baseline and follow-up 2)

    phosphorylated tau (pg/mL)

  32. NfL

    Time frame: 2 years (measured at baseline and follow-up 2)

    neurofilament light chain (pg/mL)

  33. GFAP

    Time frame: 2 years (measured at baseline and follow-up 2)

    glial fibrillary acidic protein (pg/mL)

  34. BDNF

    Time frame: 2 years (measured at baseline and follow-up 2)

    brain-derived neurotrophic factor (pg/mL)

  35. Actigraph (Groningen site only)

    Time frame: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)

    physical activity, sedentary behavior and sleep-wake activity

  36. Physical Activity Record questionnaire (Groningen site only)

    Time frame: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)

    physical activity, sedentary behavior and sleep-wake activity

Other outcomes

  1. MOCA

    Time frame: baseline

    Montreal Cognitive Assessment, minimum score 0, maximum score 30, with higher scores indicating better cognitive performance

  2. Motivation to Change Lifestyle and Health Behavior for Dementia Risk Reduction scale

    Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)

    scores range from 27-135, with higher scores indicating greater motivation to change

Sponsors and collaborators

Lead sponsor

Alzheimercentrum Amsterdam

Other

Collaborators

  • Danone Nutricia Research
  • Maastricht University
  • Radboud University Medical Center
  • University Medical Center Groningen
  • Wageningen University and Research

Registry information

Acronym: FINGER-NL

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Feb 25, 2022
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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