search
Back to results

Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline (FINGER-NL)

Primary Purpose

Cognitive Decline, Life Style, Risk Reduction

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Multidomain lifestyle intervention
Sponsored by
Alzheimercentrum Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline

Eligibility Criteria

60 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Alzheimer Center AmsterdamRecruiting
  • University Medical Center Groningen
  • Maastricht UniversityRecruiting
  • Radboud UniversityRecruiting
  • Wageningen Unversity and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

high-intensity group

low-intensity group

Arm Description

The high intensity group receives a personalized, supervised intervention consisting of group meetings and individual sessions.

The low-intensity arm receives online access to general lifestyle-related health information.

Outcomes

Primary Outcome Measures

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)).

Secondary Outcome Measures

15-Word Verbal Learning Test delayed recall
discrete number; score: 0-15 (higher score means a better outcome)
Digit Symbol Substitution Test 90 seconds
discrete number; 0-90 (higher score means a better outcome)
Wechsler Adult Intelligence Scale (WAIS) digit span backwards
discrete number; 0-14 (higher score means a better outcome)
Semantic fluency
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)
Total scores range approximately 20-70, higher scores indicate better IADL functioning
5 level EuroQol-5D (EQ-5D-5L)
Quality of life, score 0-100, higher scores indicate better quality of life
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)
grip strength test
Scores between 0 to 90 kg can be measured on the Jamar Hand dynamometer, with higher scores indicating better grip strength
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).
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.
Pittsburgh Fatigability Scale
Total physical and mental fatigability scores range from 0-50, with higher scores indicating higher fatigability.
SARC-F Sarcopenia Questionnaire
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)
Total scale ranges from 24 - 120, higher scores indicate more mindfulness
Perceived Stress Scale
Total score, scale 0 - 40, higher scores indicate more perceived stress
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.
Blood pressure
scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.
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)
Blood glucose
HbA1C, scores range from approximately 30-100 mmol/mol, with higher scores indicate higher blood glucose levels.
Waist circumference
measured in cm
Hip circumference
measured in cm
Height
measured in cm
Weight
measured in kg
Hill-Bone Medication Adherence Scale
scores range from 9-26, with lower scores indicating better medication adherence
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.
Nutritional intake
Change in nutritional intake measured by an online 3-day food diary (assessed by Traqq application), qualitative assessment
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
Insomnia severity index
The score ranges from 0 (minimum score) to 28 (maximum score), with lower scores indicating a better outcome
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)
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)
Aβ42/40 ratio
amyloid-β (1-42)/(1-40) (pg/mL)
p-tau
phosphorylated tau (pg/mL)
NfL
neurofilament light chain (pg/mL)
GFAP
glial fibrillary acidic protein (pg/mL)
BDNF
brain-derived neurotrophic factor (pg/mL)

Full Information

First Posted
January 11, 2022
Last Updated
July 20, 2022
Sponsor
Alzheimercentrum Amsterdam
Collaborators
Maastricht University, Radboud University Medical Center, Wageningen University and Research, University Medical Center Groningen, Danone Nutricia Research
search

1. Study Identification

Unique Protocol Identification Number
NCT05256199
Brief Title
Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline
Acronym
FINGER-NL
Official Title
Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alzheimercentrum Amsterdam
Collaborators
Maastricht University, Radboud University Medical Center, Wageningen University and Research, University Medical Center Groningen, Danone Nutricia Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Life Style, Risk Reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high-intensity group
Arm Type
Experimental
Arm Description
The high intensity group receives a personalized, supervised intervention consisting of group meetings and individual sessions.
Arm Title
low-intensity group
Arm Type
No Intervention
Arm Description
The low-intensity arm receives online access to general lifestyle-related health information.
Intervention Type
Behavioral
Intervention Name(s)
Multidomain lifestyle intervention
Intervention Description
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 Outcome Measure Information:
Title
2-year change from baseline in global cognitive composite score
Description
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)
Secondary Outcome Measure Information:
Title
15-Word Verbal Learning Test delayed recall
Description
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)
Title
Digit Symbol Substitution Test 90 seconds
Description
discrete number; 0-90 (higher score means a better outcome)
Time Frame
2 years (measured at baseline, follow-up 1 and follow-up 2)
Title
Wechsler Adult Intelligence Scale (WAIS) digit span backwards
Description
discrete number; 0-14 (higher score means a better outcome)
Time Frame
2 years (measured at baseline, follow-up 1 and follow-up 2)
Title
Semantic fluency
Description
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)
Title
Instrumental activities of daily living using the Amsterdam Instrumental Activity of Daily Living Questionnaire (A-IADL-Q)
Description
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)
Title
5 level EuroQol-5D (EQ-5D-5L)
Description
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)
Title
LIfestyle for BRAin health (LIBRA)
Description
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)
Title
grip strength test
Description
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)
Title
SQUASH questionnaire
Description
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)
Title
LASA Sedentary Behavior Questionnaire
Description
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)
Title
Pittsburgh Fatigability Scale
Description
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)
Title
SARC-F Sarcopenia Questionnaire
Description
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)
Title
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
Description
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)
Title
Perceived Stress Scale
Description
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)
Title
MetaMemory in Adulthood (MIA)
Description
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)
Title
Blood pressure
Description
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)
Title
Cholesterol
Description
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)
Title
Blood glucose
Description
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)
Title
Waist circumference
Description
measured in cm
Time Frame
2 years (measured at baseline, follow-up 1 and follow-up 2)
Title
Hip circumference
Description
measured in cm
Time Frame
2 years (measured at baseline, follow-up 1 and follow-up 2)
Title
Height
Description
measured in cm
Time Frame
2 years (measured at baseline, follow-up 1 and follow-up 2)
Title
Weight
Description
measured in kg
Time Frame
2 years (measured at baseline, follow-up 1 and follow-up 2)
Title
Hill-Bone Medication Adherence Scale
Description
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)
Title
MIND-adjusted Eetscore-FFQ
Description
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)
Title
Nutritional intake
Description
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)
Title
Pittsburg Sleep Quality Index
Description
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)
Title
Insomnia severity index
Description
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)
Title
Lubben Social Network Scale
Description
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)
Title
De Jong Gierveldt Loneliness Scale
Description
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)
Title
Aβ42/40 ratio
Description
amyloid-β (1-42)/(1-40) (pg/mL)
Time Frame
2 years (measured at baseline and follow-up 2)
Title
p-tau
Description
phosphorylated tau (pg/mL)
Time Frame
2 years (measured at baseline and follow-up 2)
Title
NfL
Description
neurofilament light chain (pg/mL)
Time Frame
2 years (measured at baseline and follow-up 2)
Title
GFAP
Description
glial fibrillary acidic protein (pg/mL)
Time Frame
2 years (measured at baseline and follow-up 2)
Title
BDNF
Description
brain-derived neurotrophic factor (pg/mL)
Time Frame
2 years (measured at baseline and follow-up 2)
Other Pre-specified Outcome Measures:
Title
MOCA
Description
Montreal Cognitive Assessment, minimum score 0, maximum score 30, with higher scores indicating better cognitive performance
Time Frame
baseline
Title
Motivation to Change Lifestyle and Health Behavior for Dementia Risk Reduction scale
Description
scores range from 27-135, with higher scores indicating greater motivation to change
Time Frame
2 years (measured at baseline, follow-up 1 and follow-up 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wiesje M. van der Flier, Prof
Phone
+31(0)20-4440816
Email
wm.vdflier@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Marissa D. Zwan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wiesje M van der Flier, Prof
Organizational Affiliation
Alzheimer Center Amsterdam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sebastian Köhler, Ass Prof
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alzheimer Center Amsterdam
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WM van der Flier
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nynke Smidt
Facility Name
Maastricht University
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Köhler
Facility Name
Radboud University
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jurgen Claassen
Facility Name
Wageningen Unversity and Research
City
Wageningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ondine van de Rest

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs