Study Design of FINGER‐NL: a Multidomain Lifestyle Intervention in Dutch Older Adults to Maintain Optimal Cognitive Functioning

Abstract

AbstractBackgroundEvidence on the effectiveness of multidomain lifestyle interventions to prevent cognitive decline in non‐demented older individuals is mixed. The multidomain FINGER study1 found small positive effects on cognition among older people at risk for dementia. As part of the World‐Wide FINGERS initiative to replicate and build on these results, FINGER‐NL aims to investigate the effectiveness of a 2‐year high versus low intensive multidomain lifestyle intervention on cognitive functioning in Dutch older at‐risk individuals.MethodFINGER‐NL is a Dutch multi‐center, randomized, controlled, multidomain lifestyle intervention trial aiming to include 1,206 adults at risk for cognitive decline. Adults aged 60‐80 years with at least 3 modifiable dementia risk factors (based on ‘LIfestyle for BRAin Health’ (LIBRA))2 and either a family history of dementia or self‐reported cognitive decline are eligible for inclusion. Participants are randomized (1:1 ratio) to either a high (HI‐group) or low‐intensity (LI‐group) intervention group. The multi‐domain intervention comprises a combination of 7 lifestyle components (physical exercise, cognitive training, cardiovascular risk management, nutritional counseling (with a specific focus on the MIND diet), sleep counseling, stress management, social activities) and 1 nutritional product (Souvenaid, 125ml). The HI‐group receives a personalized, supervised and hybrid intervention consisting of group meetings and individual sessions guided by a lifestyle coach. The LI‐group receives online lifestyle‐related health education. Primary outcome is 2‐year change from baseline on the cognitive composite score covering processing speed, executive function and memory. Secondary outcomes including changes in specific cognitive domains, instrumental activities of daily living, LIBRA score, and lifestyle component specific outcomes. For recruitment, we use the Dutch Brain Research Registry.3 ResultParticipant recruitment started in January 2022. So far, 2405 people were interested, 1711 individuals have been screened for eligibility, 949 underwent baseline testing and 880 participants (73% of target sample) have been randomized and started with the intervention. The intervention is well‐accepted based on drop‐out rate (0.5%) and use of the online intervention portal. We expect to finalize randomization in Q2 of 2023 and complete the two‐year trial in 2025.ConclusionResults so far show that FINGER‐NL is well on track, the intervention is well‐accepted and the trial will reach its inclusion target.