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

Study Overview
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Brief Summary
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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).

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

Conditions
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Cognitive Decline, Life Style, Risk Reduction

Intervention / Treatment
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* Behavioral: Multidomain lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high-intensity group<br>The high intensity group receives a personalized, supervised intervention consisting of group meetings and individual sessions. | Behavioral: Multidomain lifestyle intervention<br>* 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.<br>|
| No Intervention: low-intensity group<br>The low-intensity arm receives online access to general lifestyle-related health information. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)). | 2 years (measured at baseline, follow-up 1 and follow-up 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15-Word Verbal Learning Test delayed recall | discrete number; score: 0-15 (higher score means a better outcome) | 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) | 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) | 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. | 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 | 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 | 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) | 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 | 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). | 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. | 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. | 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). | 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 | 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 | 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. | 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. | 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) | 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. | 2 years (measured at baseline, follow-up 1 and follow-up 2) | 
| Waist circumference | measured in cm | 2 years (measured at baseline, follow-up 1 and follow-up 2) | 
| Hip circumference | measured in cm | 2 years (measured at baseline, follow-up 1 and follow-up 2) | 
| Height | measured in cm | 2 years (measured at baseline, follow-up 1 and follow-up 2) | 
| Weight | measured in kg | 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 | 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. | 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 | 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 | 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 | 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) | 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) | 2 years (measured at baseline and follow-up 2) | 
| Aβ42/40 ratio | amyloid-β (1-42)/(1-40) (pg/mL) | 2 years (measured at baseline and follow-up 2) | 
| p-tau | phosphorylated tau (pg/mL) | 2 years (measured at baseline and follow-up 2) | 
| NfL | neurofilament light chain (pg/mL) | 2 years (measured at baseline and follow-up 2) | 
| GFAP | glial fibrillary acidic protein (pg/mL) | 2 years (measured at baseline and follow-up 2) | 
| BDNF | brain-derived neurotrophic factor (pg/mL) | 2 years (measured at baseline and follow-up 2) |