Clinical trial NCT05256199: Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline
Official title: Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Decline
Life Style
Risk Reduction
Lead sponsor: Alzheimercentrum Amsterdam
Sponsor class: OTHER
Collaborators: name: Maastricht University
name: Radboud University Medical Center
name: Wageningen University and Research
name: University Medical Center Groningen
name: Danone Nutricia Research
First posted: 2022-02-25
Enrollment: 1210
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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). After the intervention period, participants are invited for a 24 month extension of follow-up.


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.

Primary outcomes:
measure: 2-year change from baseline in global cognitive composite score
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Secondary outcomes:
measure: 15-Word Verbal Learning Test delayed recall
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Digit Symbol Substitution Test 90 seconds
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Wechsler Adult Intelligence Scale (WAIS) digit span backwards
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Semantic fluency
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Instrumental activities of daily living using the Amsterdam Instrumental Activity of Daily Living Questionnaire (A-IADL-Q)
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: 5 level EuroQol-5D (EQ-5D-5L)
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: LIfestyle for BRAin health (LIBRA)
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: grip strength test
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: SQUASH questionnaire
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: LASA Sedentary Behavior Questionnaire
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Pittsburgh Fatigability Scale
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: SARC-F Sarcopenia Questionnaire
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Perceived Stress Scale
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: MetaMemory in Adulthood (MIA)
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Blood pressure
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Cholesterol
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Blood glucose
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Waist circumference
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Hip circumference
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Height
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Weight
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Hill-Bone Medication Adherence Scale
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: MIND-adjusted Eetscore-FFQ
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Nutritional intake
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Pittsburg Sleep Quality Index
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Insomnia severity index
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: Lubben Social Network Scale
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
measure: De Jong Gierveldt Loneliness Scale
timeFrame: 2 years (measured at baseline and follow-up 2)
measure: Aβ42/40 ratio
timeFrame: 2 years (measured at baseline and follow-up 2)
measure: p-tau
timeFrame: 2 years (measured at baseline and follow-up 2)
measure: NfL
timeFrame: 2 years (measured at baseline and follow-up 2)
measure: GFAP
timeFrame: 2 years (measured at baseline and follow-up 2)
measure: BDNF
timeFrame: 2 years (measured at baseline and follow-up 2)
measure: Actigraph (Groningen site only)
timeFrame: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)
measure: Physical Activity Record questionnaire (Groningen site only)
timeFrame: 2 year (measured for 1 week at baseline, follow-up 1 and follow-up 2)
Other outcomes:
measure: MOCA
timeFrame: baseline
measure: Motivation to Change Lifestyle and Health Behavior for Dementia Risk Reduction scale
timeFrame: 2 years (measured at baseline, follow-up 1 and follow-up 2)
Locations:
city: Amsterdam
country: Netherlands
facility: Alzheimer Center Amsterdam
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: Maastricht University
city: Nijmegen
country: Netherlands
facility: Radboud University
city: Wageningen
country: Netherlands
facility: Wageningen Unversity and Research
Study officials:
affiliation: Alzheimer Center Amsterdam
name: Wiesje M van der Flier, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Sebastian Köhler, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References: