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

Cognitive Decline Clinical Trial

— FINGER-NL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05256199
• Other study ID #: 2021.0220
• Secondary ID: NL77242.029.21
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: January 2024
• Source: Alzheimercentrum Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1210
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Life Style
• Risk Reduction

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Alzheimer Center Amsterdam	Amsterdam
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Maastricht University	Maastricht
Netherlands	Radboud University	Nijmegen
Netherlands	Wageningen Unversity and Research	Wageningen

Sponsors (6)

Lead Sponsor	Collaborator
Alzheimercentrum Amsterdam	Danone Nutricia Research, Maastricht University, Radboud University Medical Center, University Medical Center Groningen, Wageningen University and Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MOCA	Montreal Cognitive Assessment, minimum score 0, maximum score 30, with higher scores indicating better cognitive performance	baseline
Other	Motivation to Change Lifestyle and Health Behavior for Dementia Risk Reduction scale	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Waist circumference	measured in cm	2 years (measured at baseline, follow-up 1 and follow-up 2)
Secondary	Hip circumference	measured in cm	2 years (measured at baseline, follow-up 1 and follow-up 2)
Secondary	Height	measured in cm	2 years (measured at baseline, follow-up 1 and follow-up 2)
Secondary	Weight	measured in kg	2 years (measured at baseline, follow-up 1 and follow-up 2)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Aß42/40 ratio	amyloid-ß (1-42)/(1-40) (pg/mL)	2 years (measured at baseline and follow-up 2)
Secondary	p-tau	phosphorylated tau (pg/mL)	2 years (measured at baseline and follow-up 2)
Secondary	NfL	neurofilament light chain (pg/mL)	2 years (measured at baseline and follow-up 2)
Secondary	GFAP	glial fibrillary acidic protein (pg/mL)	2 years (measured at baseline and follow-up 2)
Secondary	BDNF	brain-derived neurotrophic factor (pg/mL)	2 years (measured at baseline and follow-up 2)
Secondary	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)
Secondary	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)