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| ID | Type | Description | Link |
|---|---|---|---|
| NL77242.029.21 | Other Identifier | Centrale Commissie Mensgebonden Onderzoek (CCMO) |
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| Name | Class |
|---|---|
| Maastricht University | OTHER |
| Radboud University Medical Center | OTHER |
| Wageningen University and Research | OTHER |
| University Medical Center Groningen |
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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). After the intervention period, participants are invited for a 24 month extension of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high-intensity group | Experimental | The high intensity group receives a personalized, supervised intervention consisting of group meetings and individual sessions. |
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| low-intensity group | No Intervention | The low-intensity arm receives online access to general lifestyle-related health information. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MOCA | Montreal Cognitive Assessment, minimum score 0, maximum score 30, with higher scores indicating better cognitive performance | baseline |
| Motivation to Change Lifestyle and Health Behavior for Dementia Risk Reduction scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marissa D. Zwan, Dr. | Alzheimer Center Amsterdam | Principal Investigator |
| Sebastian Köhler, Prof. | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alzheimer Center Amsterdam | Amsterdam | 1671 EA | Netherlands | |||
| University Medical Center Groningen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38872204 | Derived | Deckers K, Zwan MD, Soons LM, Waterink L, Beers S, van Houdt S, Stiensma B, Kwant JZ, Wimmers SCPM, Heutz RAM, Claassen JAHR, Oosterman JM, de Heus RAA, van de Rest O, Vermeiren Y, Voshaar RCO, Smidt N, Broersen LM, Sikkes SAM, Aarts E; MOCIA consortium; FINGER-NL consortium; Kohler S, van der Flier WM. A multidomain lifestyle intervention to maintain optimal cognitive functioning in Dutch older adults-study design and baseline characteristics of the FINGER-NL randomized controlled trial. Alzheimers Res Ther. 2024 Jun 13;16(1):126. doi: 10.1186/s13195-024-01495-8. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| OTHER |
| Danone Nutricia Research | INDUSTRY |
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|
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) |
| Actigraph (Groningen site only) | physical activity, sedentary behavior and sleep-wake activity | 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 | 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2) |
scores range from 27-135, with higher scores indicating greater motivation to change
| 2 years (measured at baseline, follow-up 1 and follow-up 2) |
| Groningen |
| Netherlands |
| Maastricht University | Maastricht | Netherlands |
| Radboud University | Nijmegen | Netherlands |
| Wageningen Unversity and Research | Wageningen | Netherlands |