FINGER-NL: Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: high-intensity group The high intensity group receives a personalized, supervised intervention consisting of group meetings and individual sessions. |
Behavioral: 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.
|
| No Intervention: low-intensity group The low-intensity arm receives online access to general lifestyle-related health information. |
Outcome Measures
Primary Outcome Measures
- 2-year change from baseline in global cognitive composite score [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 Outcome Measures
- 15-Word Verbal Learning Test delayed recall [2 years (measured at baseline, follow-up 1 and follow-up 2)]
discrete number; score: 0-15 (higher score means a better outcome)
- Digit Symbol Substitution Test 90 seconds [2 years (measured at baseline, follow-up 1 and follow-up 2)]
discrete number; 0-90 (higher score means a better outcome)
- Wechsler Adult Intelligence Scale (WAIS) digit span backwards [2 years (measured at baseline, follow-up 1 and follow-up 2)]
discrete number; 0-14 (higher score means a better outcome)
- Semantic fluency [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.
- Instrumental activities of daily living using the Amsterdam Instrumental Activity of Daily Living Questionnaire (A-IADL-Q) [2 years (measured at baseline, follow-up 1 and follow-up 2)]
Total scores range approximately 20-70, higher scores indicate better IADL functioning
- 5 level EuroQol-5D (EQ-5D-5L) [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
- LIfestyle for BRAin health (LIBRA) [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)
- grip strength test [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
- SQUASH questionnaire [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).
- LASA Sedentary Behavior Questionnaire [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.
- Pittsburgh Fatigability Scale [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.
- SARC-F Sarcopenia Questionnaire [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).
- Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) [2 years (measured at baseline, follow-up 1 and follow-up 2)]
Total scale ranges from 24 - 120, higher scores indicate more mindfulness
- Perceived Stress Scale [2 years (measured at baseline, follow-up 1 and follow-up 2)]
Total score, scale 0 - 40, higher scores indicate more perceived stress
- MetaMemory in Adulthood (MIA) [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.
- Blood pressure [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.
- Cholesterol [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)
- Blood glucose [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.
- Waist circumference [2 years (measured at baseline, follow-up 1 and follow-up 2)]
measured in cm
- Hip circumference [2 years (measured at baseline, follow-up 1 and follow-up 2)]
measured in cm
- Height [2 years (measured at baseline, follow-up 1 and follow-up 2)]
measured in cm
- Weight [2 years (measured at baseline, follow-up 1 and follow-up 2)]
measured in kg
- Hill-Bone Medication Adherence Scale [2 years (measured at baseline, follow-up 1 and follow-up 2)]
scores range from 9-26, with lower scores indicating better medication adherence
- MIND-adjusted Eetscore-FFQ [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.
- Nutritional intake [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
- Pittsburg Sleep Quality Index [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
- Insomnia severity index [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
- Lubben Social Network Scale [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)
- De Jong Gierveldt Loneliness Scale [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)
- Aβ42/40 ratio [2 years (measured at baseline and follow-up 2)]
amyloid-β (1-42)/(1-40) (pg/mL)
- p-tau [2 years (measured at baseline and follow-up 2)]
phosphorylated tau (pg/mL)
- NfL [2 years (measured at baseline and follow-up 2)]
neurofilament light chain (pg/mL)
- GFAP [2 years (measured at baseline and follow-up 2)]
glial fibrillary acidic protein (pg/mL)
- BDNF [2 years (measured at baseline and follow-up 2)]
brain-derived neurotrophic factor (pg/mL)
Other Outcome Measures
- MOCA [baseline]
Montreal Cognitive Assessment, minimum score 0, maximum score 30, with higher scores indicating better cognitive performance
- Motivation to Change Lifestyle and Health Behavior for Dementia Risk Reduction scale [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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
60-79 years of age at pre-screening;
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Adequate fluency in Dutch to understand the informed consent and complete questionnaires;
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Providing informed consent to all study procedures;
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Internet access at home;
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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:
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Diagnosis of dementia or mild cognitive impairment at baseline (self-reported);
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Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score<23);
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alzheimer Center Amsterdam | Amsterdam | Netherlands | ||
| 2 | University Medical Center Groningen | Groningen | Netherlands | ||
| 3 | Maastricht University | Maastricht | Netherlands | ||
| 4 | Radboud University | Nijmegen | Netherlands | ||
| 5 | Wageningen Unversity and Research | Wageningen | Netherlands |
Sponsors and Collaborators
- Alzheimercentrum Amsterdam
- Maastricht University
- Radboud University Medical Center
- Wageningen University and Research
- University Medical Center Groningen
- Danone Nutricia Research
Investigators
- Principal Investigator: Wiesje M van der Flier, Prof, Alzheimer Center Amsterdam
- Principal Investigator: Sebastian Köhler, Ass Prof, Maastricht University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021.0220
- NL77242.029.21