To investigate the effectiveness of a personalized multi-domain lifestyle intervention compared to online access to general lifestyle-related health information on cognitive performance in older adults at risk of cognitive decline. Cognitive…
ID
Source
Brief title
Condition
- Other condition
- Lifestyle issues
Synonym
Health condition
risicofactoren voor verminderd cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
2-year change from baseline in global cognitive composite score derived from
subtest scores from the Neuropsychological Test Battery (NTB) that includes
15-Word Verbal Learning Test delayed recall, DDST 90 seconds, WAIS digit span
backwards, and semantic fluency.
Secondary outcome
Secondary endpoints
2-year change from baseline in:
a) individual cognitive test performances, representing memory (15-Word Verbal
Learning Test delayed recall), processing speed (Digit Symbol Substitution Test
90 seconds) and attention and executive functioning (WAIS digit span backwards,
semantic fluency);
b) Instrumental activities of daily living using the Amsterdam Instrumental
Activity of Daily Living Questionnaire (A-IADL-Q);
c) Quality of life using the 5-level EuroQol-5D (EQ-5D-5L);
d) Modifiable dementia risk using LIfestyle for BRAin health (LIBRA);
e) Intervention specific outcomes:
• Physical activity: grip strength, physical activity (SQUASH questionnaire),
sedentary behavior (LASA Sedentary Behavior Questionnaire) and sarcopenia
(SARC-F Sarcopenia Questionnaire. For participants at UMCG only: a physical
activity diary (Physical Activity Record)
• Cognitive training: cognitive function (semantic fluency test), metamemory
(Metamemory in Adulthood Questionnaire);
• Cardiovascular: blood pressure, cholesterol (total, HDL, LDL +
triglycerides), blood glucose (HbA1C), medication adherence (Hill-Bone
Medication Adherence Scale);
• Dietary counselling: nutritional intake (Traqq app), adherence to Dutch
dietary guidelines (Dutch healthy diet index);
• Sleep counselling: sleep behavior (7 day sleep diary), insomnia (Insomnia
severity index);
• Stress management: mindfulness (Five Facet Mindfulness Questionnaire),
perception of stress (Perceived Stress Scale);
• Social activities: perceived social support (Lubben Social Network Scale),
emotional and social loneliness (De Jong Gierveld Loneliness Scale).
f) Blood-based biomarkers for Alzheimer*s disease (Aβ42/40, p-tau), axonal
damage (NfL), astrocytes activity/injury or stress (GFAP) and brain plasticity
(BDNF).
Background summary
Findings from previous observational studies have linked several vascular and
lifestyle-related risk factors with increased risk of late-life cognitive
impairment. Up till 40% of dementia cases worldwide is estimated to be
attributable to twelve modifiable factors (including e.g. midlife hypertension,
midlife obesity, physical inactivity, and low social contact), providing
prevention opportunities (1, 2). Randomised controlled trials are needed to
confirm whether intervention strategies targeting modifiable risk factors
indeed help to maintain cognitive functioning (3, 4). Intervention studies
targeting lifestyle factors to prevent cognitive decline and dementia have
yielded mainly negative results, although some positive effects on cognition
have been reported for dietary intervention, physical activity and cognitive
training (5-12).
Successful prevention of cardiovascular disease and type 2 diabetes have
emphasized the importance of a multidomain lifestyle approach, as different
aspects of lifestyle and vascular risk are thought to exert their influence in
synergy (13, 14). FINGER was the first intervention study to evaluate a
multi-modal lifestyle intervention to prevent cognitive decline (15). FINGER
simultaneously targeted four lifestyle domains (physical activity, cognitive
training, dietary counselling and cardiovascular risk management) and showed a
positive effect on the cognitive composite primary outcome measure (NTB),
particularly on executive functioning and processing speed. Other multi-domain
intervention studies showed a beneficial effect on cognition in specific
subgroups that were at highest risk (16, 17), illustrating that for lifestyle
interventions to be successful, participants should be selected for *prevention
potential* - i.e. there should be room for improvement in modifiable risk
factors.
Inspired by the positive results in FINGER, World-Wide FINGERS (WW-FINGERS,
wwfingers.com) is a global effort to replicate the original findings around the
globe, while simultaneously optimizing the intervention under local
circumstances. Additional lifestyle domains which may benefit cognition are
sleep, mindfulness and social activities. Sleep problems increase with ageing
and may be associated with cognitive decline in older people (18).
Internet-delivered cognitive behavioral strategies are promising to improve
sleep efficiency and decrease insomnia (19). Second, cultivation of mindfulness
has been shown to be beneficial in stress management, coping with daily events,
and promotes mental resilience. Recent studies have shown that long-term
mindfulness meditation practice can help maintain brain health, by beneficially
influencing inflammatory processes or vascular damage (20-23). Last, social
participation can help maintain cognitive health as a result of cognitive
stimulation, stress buffering or enhancement of healthy behavior (24). In the
context of a lifestyle intervention, the latter is of particular interest,
since participants can help each other adhere to the lifestyle changes.
In addition, recent developments have shown promise of medical food,
specifically designed to promote synapse growth and prevent cognitive decline
(25, 26). Souvenaid is a medical food which has been shown to prevent cognitive
decline in mild cognitive impairment (27, 28). It is conceivable that daily
consumption of Souvenaid could help maintain cognitive function in elderly at
risk of cognitive decline as well.
The COVID19 pandemic has boosted the application of online delivery of
interventions. Online applications have great potential for promoting
interaction with and between participants. A former review has shown that
web-based lifestyle programs can positively influence brain health outcomes and
have the potential to help maintain brain health (29). Particularly in the
Netherlands, where internet access is remarkably high, also among elderly (30).
Taking the original FINGER study as a starting point, and embedded in the
WW-Finger network, FINGER-NL is designed as a multidomain lifestyle
intervention targeting eight lifestyle aspects to improve cognitive
functioning, with a hybrid approach including both online and on site
intervention sessions.
Study objective
To investigate the effectiveness of a personalized multi-domain lifestyle
intervention compared to online access to general lifestyle-related health
information on cognitive performance in older adults at risk of cognitive
decline.
Cognitive performance is measured as the global cognitive composite score
derived from subtest scores from the Neuropsychological Test Battery (NTB).
Study design
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 2 year (open-label) extension of follow-up to maintain and
promote positive and sustainable lifestyle changes.
Intervention
The FINGER-NL multidomain lifestyle intervention comprises eight domains,
namely 1) physical activity, 2) cognitive training, 3) cardiovascular risk
factor management, 4) dietary counselling, 5) Souvenaid, 6) sleep counselling,
7) stress management, and 8) social activities. The eight domains are
integrated in a hybrid (both online and at study site) fashion. The online
dashboard (see 6.2) is a central feature of the intervention, which provides
access to the online aspects of the intervention.
Participants are randomized in a 1:1 ratio to either the high-intensity group
or the low-intensity group for a duration of 24 months. The high-intensity
group receives a structured and personalized intervention consisting of group
meetings and individual sessions (see 6.3). The low-intensity group gets online
access to general lifestyle-related health information (see 6.4).
Study burden and risks
The high-intensity intervention group receives a personalized, hybrid
intervention including online group meetings, group meetings at the study site,
personal lifestyle coach sessions, individual online sessions and free access
to Souvenaid®. Former studies have shown that Souvenaid® is safe and well
tolerated. The high-intensity intervention takes on average 3 hours per week
for 24 months. The high-intensity group is supervised by an educated lifestyle
coach to oversee and if necessary mitigate putative risks associated with the
intervention. The low-intensity group gets online access to general
lifestyle-related health information which takes on average ~30 minutes per
month for 24 months.
In addition to the intervention activities, both groups visit the study site 3
times (at baseline, follow-up 1 (12 months after start intervention) and
follow-up 2 (24 months after start intervention)) for outcome assessments
including neuropsychological testing, clinical measures, blood sampling and
questionnaires (duration ~3 hours). Study participation might be beneficial, as
it can improve (brain) health. Drawing blood samples might cause mild pain and
sometimes a bruise.
*
De Boelelaan 1117
AMSTERDAM 1081 HZ
NL
De Boelelaan 1117
AMSTERDAM 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
- 60-79 years of age at pre-screening;
- Adequate fluency in Dutch to understand the informed consent and complete
(online) questionnaires ;
- Providing informed consent to all study procedures;
- Internet access at home
- >=3 (self-reported) risk factors (must contain at least 2 modifiable risk
factors and 1 non-modifiable risk factor):
Modifiable risk factors:
- Physical inactivity (1)
- Unhealthy diet (1)
- Low mental/cognitive activity (1)
- High blood pressure (1)
- High cholesterol (1)
- High body mass index (BMI) (2)
Non-modifiable risk factors:
- First-degree family history of dementia
- Subjective cognitive decline/memory complaints
(1) Measured using LIBRA questionnaire;
(2) Defined as >=25 kg/m2 for 60-69 years old, and >=28 kg/m2 for >=70 years old,
based on self-reported height and weight.
Exclusion criteria
1. Diagnosis of dementia or mild cognitive impairment at baseline
(self-reported);
2. Significant cognitive impairment assessed using a validated
telephone-administered cognitive battery (TICSm score<23).
3. 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;
4. Coincident participation in any other intervention trial at time of
pre-screening.
5. Coincident participation of spouse/partner in the FINGER-NL trial.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77242.029.21 |
| Other | volgt |