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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,210
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.
Alzheimer Center Amsterdam
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Maastricht University
Maastricht, Netherlands
Radboud University
Nijmegen, Netherlands
Wageningen Unversity and Research
Wageningen, Netherlands
2-year change from baseline in global cognitive composite score
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)).
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
15-Word Verbal Learning Test delayed recall
discrete number; score: 0-15 (higher score means a better outcome)
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Digit Symbol Substitution Test 90 seconds
discrete number; 0-90 (higher score means a better outcome)
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Wechsler Adult Intelligence Scale (WAIS) digit span backwards
discrete number; 0-14 (higher score means a better outcome)
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Semantic fluency
word count in one minute; minimum 0, no maximum, higher score means a better outcome.
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Instrumental activities of daily living using the Amsterdam Instrumental Activity of Daily Living Questionnaire (A-IADL-Q)
Total scores range approximately 20-70, higher scores indicate better IADL functioning
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
5 level EuroQol-5D (EQ-5D-5L)
Quality of life, score 0-100, higher scores indicate better quality of life
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
LIfestyle for BRAin health (LIBRA)
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)
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
grip strength test
Scores between 0 to 90 kg can be measured on the Jamar Hand dynamometer, with higher scores indicating better grip strength
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
SQUASH questionnaire
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).
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
LASA Sedentary Behavior Questionnaire
Average hours and minutes of sedentary behavior a day, range from 0 to 24 hours. Higher scores (more hours) means a more sedentary behavior.
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Pittsburgh Fatigability Scale
Total physical and mental fatigability scores range from 0-50, with higher scores indicating higher fatigability.
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
SARC-F Sarcopenia Questionnaire
sarcopenia, scores range from 0 to 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst).
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
Total scale ranges from 24 - 120, higher scores indicate more mindfulness
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Perceived Stress Scale
Total score, scale 0 - 40, higher scores indicate more perceived stress
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
MetaMemory in Adulthood (MIA)
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.
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Blood pressure
scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Cholesterol
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)
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Blood glucose
HbA1C, scores range from approximately 30-100 mmol/mol, with higher scores indicate higher blood glucose levels.
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Waist circumference
measured in cm
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Hip circumference
measured in cm
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Height
measured in cm
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Weight
measured in kg
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Hill-Bone Medication Adherence Scale
scores range from 9-26, with lower scores indicating better medication adherence
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
MIND-adjusted Eetscore-FFQ
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.
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Nutritional intake
Change in nutritional intake measured by an online 3-day food diary (assessed by Traqq application), qualitative assessment
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Pittsburg Sleep Quality Index
Total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Insomnia severity index
The score ranges from 0 (minimum score) to 28 (maximum score), with lower scores indicating a better outcome
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Lubben Social Network Scale
The score ranges from 0 (minimum score) to 30 (maximum score), with higher scores meaning a better outcome (higher level of perceived social support)
Time frame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
De Jong Gierveldt Loneliness Scale
The score ranges from 0 (minimum score) to 6 (maximum score), with higher scores representing a worse outcome (higher loneliness scores)
Time frame: 2 years (measured at baseline and follow-up 2)
Aβ42/40 ratio
amyloid-β (1-42)/(1-40) (pg/mL)
Time frame: 2 years (measured at baseline and follow-up 2)
p-tau
phosphorylated tau (pg/mL)
Time frame: 2 years (measured at baseline and follow-up 2)
NfL
neurofilament light chain (pg/mL)
Time frame: 2 years (measured at baseline and follow-up 2)
GFAP
glial fibrillary acidic protein (pg/mL)
Time frame: 2 years (measured at baseline and follow-up 2)
BDNF
brain-derived neurotrophic factor (pg/mL)
Time frame: 2 years (measured at baseline and follow-up 2)
Actigraph (Groningen site only)
physical activity, sedentary behavior and sleep-wake activity
Time frame: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)
Physical Activity Record questionnaire (Groningen site only)
physical activity, sedentary behavior and sleep-wake activity
Time frame: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)
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