Back to resultsThe Effects of a Multidomain Lifestyle Intervention on Brain Functioning and Its Relation With Immunometabolic Markers in Ageing (HELI)
Primary Purpose
Life Style, Risk Reduction, Cognitive Decline
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Multidomain lifestyle intervention
Sponsored by
About this trial
This is an interventional prevention trial for Life Style
Eligibility Criteria
Inclusion Criteria: Written informed consent; Age between 60-75 years (at pre-screening); Fluency in Dutch (speaking, reading and writing); Lives near study centres in Nijmegen and Wageningen (max. 50 kilometers of travelling, to ensure study centre visits are possible without excessive travel burden); Presence of ≥2 self-reported risk factors for cognitive decline (BMI of 30 or higher, physical inactivity according to World Health Organization guidelines, hypertension [not using hypertensive drugs counts as an additional risk factor], hypercholesterolemia, diabetes type-II, non-symptomatic cardiovascular disease). Exclusion Criteria: Concurrent participation in other intervention trials; Technologically illiterate (complete incompetence in working with computers, apps, online questionnaires, etc.); No internet access from home; Clinical diagnosis of ≥1 of the following: vascular event (CVA), neurological pathology (e.g. mild cognitive impairment, dementia, multiple sclerosis, Parkinson's, epilepsy), current malignant disease(s) (with or without current treatment), current psychiatric disorder(s) (e.g. depression, psychosis, bipolar episodes), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), revascularisation surgery in the last 12 months at pre-screening, inflammatory bowel disease (characterised with diarrhoea), visual impairment (e.g. blindness), hearing or communicative impairment; Unable to undergo MRI (e.g. metal objects in upper body, past brain surgery, active implants, claustrophobic); Cognitive impairment as determined by the Telephone Interview for Cognitive Status (TICS-M1), performed during pre-screening before inclusion.
Sites / Locations
- Donders Centre for Cognitive NeuroimagingRecruiting
- Wageningen University & 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 supervised multidomain lifestyle intervention consisting of weekly group meetings. During the weekly group meetings, information and exercises are provided, and participants are able to exchange experiences and advice with other group members.
The low-intensity group only receives access to general lifestyle-related health information through biweekly leaflets, which are provided through e-mail.
Outcomes
Primary Outcome Measures
Change in brain activity during working memory
Blood-oxygen level dependent activity during N-back (2-back) fMRI task
Change in working memory performance
Task accuracy during N-back (2-back) fMRI task
Change in cerebral perfusion levels
Cerebral perfusion measured using arterial spin labelling (ASL)
Change in inflammatory profile in blood plasma
Blood plasma analysis to measure hs-CRP, IL-6 and TNF-α concentrations
Change in microbiota profile
16S rRNA based profile of gut microbiota in faeces
Secondary Outcome Measures
Change in Body mass index
Measured in kg/m^2
Change in Waist circumference
Measured in cm
Change in Hip circumference
Measured in cm
Change in Blood pressure
Measured by blood pressure monitor. Scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.
Change in Abdominal fat distribution (neuroimaging)
Visceral adipose tissue(VAT)/subcutaneous adipose tissue (SAT) ratio measured by abdominal T1-weighted MRI scan
Change in Brain structure volume profile (neuroimaging)
Brain structure volumes (grey matter, white matter, brain vesicles), measured by MP2RAGE structural sequence
Change in Brain myo-inositol levels (neuroimaging)
Brain myo-inositol levels reflecting local neuroinflammation in dorsolateral prefrontal cortex and hippocampus, measured by magnetic resonance spectroscopy (MRS)
Intracranial iron deposition (neuroimaging)
Local aggregation of iron deposition within the brain, measured by quantitative susceptibility mapping (QSM)
Change in Neuropsychological test battery scoring
Z-scoring of cognitive assessments targeting cognitive domains predominantly affected by cognitive ageing: executive function (incl. working memory), episodic memory and processing speed
Change in Trail Making Test A (TMT-A) Numbers : trial time (cognitive assessment)
Discrete number; score 0 - no maximum (seconds to assessment completion). Lower score indicates a better outcome
Change in Trail Making Test A (TMT-A) Numbers: errors (cognitive assessment)
Discrete number; score 0 - no maximum (amount of errors). Lower score indicates a better outcome
Change in Trail Making Test B (TMT-B) Numbers and Letters : trial time (cognitive assessment)
Discrete number; score 0 - no maximum (seconds to assessment completion). Lower score indicates a better outcome
Change in Trail Making Test B (TMT-B) Numbers and Letters: errors (cognitive assessment)
Discrete number; score 0 - no maximum (amount of errors). Lower score indicates a better outcome
Change in Verbal Fluency Test (VFT) (cognitive assessment)
Word count in one minute; score 0 - no maximum. Higher score indicates a better outcome
Change in Rey Auditory Verbal Learning Test (RAVLT): learning trials (cognitive assessment)
Discrete number; score 0 - 15 (amount of words remembered during learning trial 1 to 5). Higher score indicates a better score
Change in Rey Auditory Verbal Learning Test (RAVLT): delayed recall (cognitive assessment)
Discrete number; score 0 - 15 (amount of words remembered during delayed recall). Higher score indicates a better score
Change in Digit Symbol Substitution Test (DSST) (cognitive assessment)
Discrete number; score 0 - 90 (amount of symbols correctly substituted). Higher score indicates better outcome
Change in Wechsler Adult Intelligence Scale (WAIS) digit span (cognitive assessment)
Discrete number; score 0 - 90 (amount of digit spans correctly repeated). Higher score indicates better outcome
Change in Five Facet Mindfulness Questionnaire (questionnaire)
Self-assessment of mindfulness; score 24 - 120. Higher score indicate more mindfulness
Change in Sedentary Behaviour Questionnaire (questionnaire)
Average hours and minutes of sedentary behavior a day; score 0 - 24 hours. Higher score (more hours) indicates more sedentary behavior
Change in Eetscore food questionnaire (questionnaire)
Dutch Healthy Diet Index 2015; score 0 - 160. Higher score indicates a better outcome
Change in Perceived Stress Scale (questionnaire)
Stress perception; score 0 - 40. Higher score indicate more perceived stress
Change in Pittsburgh Sleep Quality Index (PSQI) (questionnaire)
Sleep quality; score 0 - 21. Higher score (referred to as global or total score) indicates worse sleep quality
Change in SQUASH (questionnaire)
Physical activity. 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)
Change in Cognitive Failures Questionnaire (questionnaire)
Subjective cognitive functioning; score 0 - 100. A higher score indicates more subjective cognitive failure
Change in Memory Self-Efficacy MIA (questionnaire)
Self-evaluation and confidence of memory. 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 (score 23 - 115, higher score indicates better memory self-efficacy) and Part 2B: Locus (score 7 - 35, higher scores indicate better perceived personal control over remembering abilities)
Change in total amount of bacteria, fungi and specific bacterial strains (faeces)
Total amount of bacteria, fungi and specific bacterial strains are quantified using digital droplet PCR in faecal samples
Change in individual short-chain fatty acids (SCFAs) profile (faeces)
GC-MS and LC-MS measurements to assess profile of individual SCFAs in faecal samples (acetic acid, formic acid, propionic acid, isobutyric acid, butyric acid, isovaleric acid, valeric acid, 4-methyl valeric acid, hexanoic acid, heptanoic acid)
Change in microbiome-derived bioactive compounds (faeces)
Amount of microbiome-derived bioactive compounds is measured by untargeted LC-MS microbiota-derived metabolite analysis in faecal samples
Change in intestinal inflammation profile (faeces)
Assay-based profile of intestinal inflammation measured in faecal samples
Change in Gut transit time
Gut transit time measured by blue muffin consumption and appearance in faeces
Change in metabolic profile (blood)
Assay-based profile of (energy) metabolism measured in plasma samples
Change in inflammation profile (blood)
Assay-based profile of systemic inflammation measured in plasma samples
Change in intestinal integrity profile (blood)
Assay-based profile of intestinal integrity measured in plasma samples
Change in brain health profile (blood)
Assay-based profile of brain health measured in plasma samples
Change in white blood cell count (blood)
White blood cell count measured via finger prick analysis
Change in small intestinal bacterial overgrowth (SIBO) (breath)
Measurement of total exhaled hydrogen gas after glucose consumption in breath samples
Full Information
NCT ID
NCT05777863
First Posted
September 27, 2022
Last Updated
March 29, 2023
Sponsor
Donders Centre for Cognitive Neuroimaging
Collaborators
Wageningen University and Research
1. Study Identification
Unique Protocol Identification Number
NCT05777863
Brief Title
The Effects of a Multidomain Lifestyle Intervention on Brain Functioning and Its Relation With Immunometabolic Markers in Ageing
Acronym
HELI
Official Title
The Effects of a Multidomain Lifestyle Intervention on Brain Functioning and Its Relation With Immunometabolic Markers in Ageing: the HELI Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Donders Centre for Cognitive Neuroimaging
Collaborators
Wageningen University and 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
HELI is a multicenter, randomised controlled trial in two Dutch research centres (Donders Centre for Cognitive Neuroimaging, Nijmegen, and the department of Human Nutrition & Health at Wageningen University) among 104 older adults aged 60-75 years who are at risk for cognitive decline with an intervention duration of 26 weeks (roughly 6 months). Participants are randomized in a 1:1 ratio to a multidomain lifestyle intervention characterized by group-sessions and guidance (high-intensity intervention group) versus online access to general lifestyle-related health information in the form of biweekly leaflets (low-intensity intervention group).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Life Style, Risk Reduction, Cognitive Decline, Aging
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multidomain lifestyle intervention. Participants are randomized in a 1:1 ratio to a multidomain lifestyle intervention characterized by group-sessions and supervision (high-intensity intervention group) versus access to general lifestyle-related health information in the form of biweekly leaflets which are provided through e-mail (low-intensity intervention group).
Masking
Outcomes Assessor
Masking Description
Participants come for baseline outcome measurement visits in Nijmegen and Wageningen prior to randomization. The follow-up measurements are carried out by researchers, investigators and research-assistants who are not guiding the intervention groups, have no contact with included participants after randomization, and are not involved in the randomization process.
Participants are aware of their group allocation, as it is clear to participants multiple groups are formed which differ in the way the intervention material is provided.
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-intensity group
Arm Type
Experimental
Arm Description
The high-intensity group receives a supervised multidomain lifestyle intervention consisting of weekly group meetings. During the weekly group meetings, information and exercises are provided, and participants are able to exchange experiences and advice with other group members.
Arm Title
Low-intensity group
Arm Type
No Intervention
Arm Description
The low-intensity group only receives access to general lifestyle-related health information through biweekly leaflets, which are provided through e-mail.
Intervention Type
Behavioral
Intervention Name(s)
Multidomain lifestyle intervention
Intervention Description
A multidomain lifestyle intervention including the following lifestyle domains: (1) diet, (2) physical activity, (3) sleep, (4) stress/mindfulness, and (5) cognitive training.
Primary Outcome Measure Information:
Title
Change in brain activity during working memory
Description
Blood-oxygen level dependent activity during N-back (2-back) fMRI task
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in working memory performance
Description
Task accuracy during N-back (2-back) fMRI task
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in cerebral perfusion levels
Description
Cerebral perfusion measured using arterial spin labelling (ASL)
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in inflammatory profile in blood plasma
Description
Blood plasma analysis to measure hs-CRP, IL-6 and TNF-α concentrations
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in microbiota profile
Description
16S rRNA based profile of gut microbiota in faeces
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Secondary Outcome Measure Information:
Title
Change in Body mass index
Description
Measured in kg/m^2
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Waist circumference
Description
Measured in cm
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Hip circumference
Description
Measured in cm
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Blood pressure
Description
Measured by blood pressure monitor. Scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Abdominal fat distribution (neuroimaging)
Description
Visceral adipose tissue(VAT)/subcutaneous adipose tissue (SAT) ratio measured by abdominal T1-weighted MRI scan
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Brain structure volume profile (neuroimaging)
Description
Brain structure volumes (grey matter, white matter, brain vesicles), measured by MP2RAGE structural sequence
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Brain myo-inositol levels (neuroimaging)
Description
Brain myo-inositol levels reflecting local neuroinflammation in dorsolateral prefrontal cortex and hippocampus, measured by magnetic resonance spectroscopy (MRS)
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Intracranial iron deposition (neuroimaging)
Description
Local aggregation of iron deposition within the brain, measured by quantitative susceptibility mapping (QSM)
Time Frame
Baseline (T0)
Title
Change in Neuropsychological test battery scoring
Description
Z-scoring of cognitive assessments targeting cognitive domains predominantly affected by cognitive ageing: executive function (incl. working memory), episodic memory and processing speed
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Trail Making Test A (TMT-A) Numbers : trial time (cognitive assessment)
Description
Discrete number; score 0 - no maximum (seconds to assessment completion). Lower score indicates a better outcome
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Trail Making Test A (TMT-A) Numbers: errors (cognitive assessment)
Description
Discrete number; score 0 - no maximum (amount of errors). Lower score indicates a better outcome
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Trail Making Test B (TMT-B) Numbers and Letters : trial time (cognitive assessment)
Description
Discrete number; score 0 - no maximum (seconds to assessment completion). Lower score indicates a better outcome
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Trail Making Test B (TMT-B) Numbers and Letters: errors (cognitive assessment)
Description
Discrete number; score 0 - no maximum (amount of errors). Lower score indicates a better outcome
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Verbal Fluency Test (VFT) (cognitive assessment)
Description
Word count in one minute; score 0 - no maximum. Higher score indicates a better outcome
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Rey Auditory Verbal Learning Test (RAVLT): learning trials (cognitive assessment)
Description
Discrete number; score 0 - 15 (amount of words remembered during learning trial 1 to 5). Higher score indicates a better score
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Rey Auditory Verbal Learning Test (RAVLT): delayed recall (cognitive assessment)
Description
Discrete number; score 0 - 15 (amount of words remembered during delayed recall). Higher score indicates a better score
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Digit Symbol Substitution Test (DSST) (cognitive assessment)
Description
Discrete number; score 0 - 90 (amount of symbols correctly substituted). Higher score indicates better outcome
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Wechsler Adult Intelligence Scale (WAIS) digit span (cognitive assessment)
Description
Discrete number; score 0 - 90 (amount of digit spans correctly repeated). Higher score indicates better outcome
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Five Facet Mindfulness Questionnaire (questionnaire)
Description
Self-assessment of mindfulness; score 24 - 120. Higher score indicate more mindfulness
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Sedentary Behaviour Questionnaire (questionnaire)
Description
Average hours and minutes of sedentary behavior a day; score 0 - 24 hours. Higher score (more hours) indicates more sedentary behavior
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Eetscore food questionnaire (questionnaire)
Description
Dutch Healthy Diet Index 2015; score 0 - 160. Higher score indicates a better outcome
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Perceived Stress Scale (questionnaire)
Description
Stress perception; score 0 - 40. Higher score indicate more perceived stress
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Pittsburgh Sleep Quality Index (PSQI) (questionnaire)
Description
Sleep quality; score 0 - 21. Higher score (referred to as global or total score) indicates worse sleep quality
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in SQUASH (questionnaire)
Description
Physical activity. 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
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Cognitive Failures Questionnaire (questionnaire)
Description
Subjective cognitive functioning; score 0 - 100. A higher score indicates more subjective cognitive failure
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Memory Self-Efficacy MIA (questionnaire)
Description
Self-evaluation and confidence of memory. 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 (score 23 - 115, higher score indicates better memory self-efficacy) and Part 2B: Locus (score 7 - 35, higher scores indicate better perceived personal control over remembering abilities)
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in total amount of bacteria, fungi and specific bacterial strains (faeces)
Description
Total amount of bacteria, fungi and specific bacterial strains are quantified using digital droplet PCR in faecal samples
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in individual short-chain fatty acids (SCFAs) profile (faeces)
Description
GC-MS and LC-MS measurements to assess profile of individual SCFAs in faecal samples (acetic acid, formic acid, propionic acid, isobutyric acid, butyric acid, isovaleric acid, valeric acid, 4-methyl valeric acid, hexanoic acid, heptanoic acid)
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in microbiome-derived bioactive compounds (faeces)
Description
Amount of microbiome-derived bioactive compounds is measured by untargeted LC-MS microbiota-derived metabolite analysis in faecal samples
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in intestinal inflammation profile (faeces)
Description
Assay-based profile of intestinal inflammation measured in faecal samples
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Gut transit time
Description
Gut transit time measured by blue muffin consumption and appearance in faeces
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in metabolic profile (blood)
Description
Assay-based profile of (energy) metabolism measured in plasma samples
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in inflammation profile (blood)
Description
Assay-based profile of systemic inflammation measured in plasma samples
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in intestinal integrity profile (blood)
Description
Assay-based profile of intestinal integrity measured in plasma samples
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in brain health profile (blood)
Description
Assay-based profile of brain health measured in plasma samples
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in white blood cell count (blood)
Description
White blood cell count measured via finger prick analysis
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in small intestinal bacterial overgrowth (SIBO) (breath)
Description
Measurement of total exhaled hydrogen gas after glucose consumption in breath samples
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Other Pre-specified Outcome Measures:
Title
Montreal Cognitive Assessment (MOCA) (cognitive assessment)
Description
Discrete number; score 0 - 30. Higher score indicates better cognitive performance (≥26 indicates normal cognitive functioning)
Time Frame
Baseline (T0)
Title
Baseline Demographics and medical history (questionnaire)
Description
Demographic information, medical history and medication use - qualitative assessment
Time Frame
Baseline (T0)
Title
Change in 4DKL (questionnaire)
Description
(Psychosocial) complaints in daily life; separate scores for distress (>10 moderate, >20 severe), depression (>2 moderate, >5 severe), anxiety (>3 moderate, >9 severe) and somatisation (>10 moderate, >20 severe)
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in EQ-5D-5L (questionnaire)
Description
Quality of life; score 0 - 100. Higher score indicate better quality of life
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in LIBRA (questionnaire)
Description
Modifiable dementia risk using lifestyle for brain health; score -5.9 - +12.7. Higher score indicates a worse outcome (higher dementia risk)
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Lubben Social Network Scale (questionnaire)
Description
Social contact and perceived social support; score 0 - 30. Higher score indicates a better outcome (higher level of perceived social support)
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in SARC-F Sarcopenia questionnaire (questionnaire)
Description
Sarcopenia; score 0 - 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst)
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Cognitive Emotions Regulation Questionnaire (questionnaire)
Description
Cognitive coping strategies. Answers are scored on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The scoring takes the average of all the scores in each subscale of cognitive reappraisal and expressive suppression
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Hospital Anxiety and Depression Scale (questionnaire)
Description
Anxiety and depression; separate scores for anxiety (0 - 21) and depression (0 - 21). For each domain, a score >8 indicates psychiatric condition of anxiety or depression
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Starkstein Apathy Scale (questionnaire)
Description
Screen and measure apathetic symptoms. A higher total score (range 0-42) indicates more severe apathy, with a score greater than 14 or greater is indicative of clinical apathy
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in COVID status (questionnaire)
Description
Vaccination status, COVID history - qualitative assessment
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Gastrointestinal symptoms questionnaire (questionnaire)
Description
Gastrointestinal symptoms, qualitative assessment
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
Title
Change in Bristol stool chart (questionnaire)
Description
Classification of faeces type, qualitative assessment
Time Frame
Change between Baseline (T0) and Follow-up after 6 months (T1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent;
Age between 60-75 years (at pre-screening);
Fluency in Dutch (speaking, reading and writing);
Lives near study centres in Nijmegen and Wageningen (max. 50 kilometers of travelling, to ensure study centre visits are possible without excessive travel burden);
Presence of ≥2 self-reported risk factors for cognitive decline (BMI of 30 or higher, physical inactivity according to World Health Organization guidelines, hypertension [not using hypertensive drugs counts as an additional risk factor], hypercholesterolemia, diabetes type-II, non-symptomatic cardiovascular disease).
Exclusion Criteria:
Concurrent participation in other intervention trials;
Technologically illiterate (complete incompetence in working with computers, apps, online questionnaires, etc.);
No internet access from home;
Clinical diagnosis of ≥1 of the following: vascular event (CVA), neurological pathology (e.g. mild cognitive impairment, dementia, multiple sclerosis, Parkinson's, epilepsy), current malignant disease(s) (with or without current treatment), current psychiatric disorder(s) (e.g. depression, psychosis, bipolar episodes), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), revascularisation surgery in the last 12 months at pre-screening, inflammatory bowel disease (characterised with diarrhoea), visual impairment (e.g. blindness), hearing or communicative impairment;
Unable to undergo MRI (e.g. metal objects in upper body, past brain surgery, active implants, claustrophobic);
Cognitive impairment as determined by the Telephone Interview for Cognitive Status (TICS-M1), performed during pre-screening before inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Aarts, PhD
Phone
+31(0)631132617
Email
esther.aarts@donders.ru.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Mark R. van Loenen, MSc
Phone
+31243668388
Email
mark.vanloenen@donders.ru.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Aarts, PhD
Organizational Affiliation
Donders Centre for Cognitive Neuroimaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Donders Centre for Cognitive Neuroimaging
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Aarts, PhD
Phone
+31(0)631132617
Email
esther.aarts@donders.ru.nl
First Name & Middle Initial & Last Name & Degree
Mark R. van Loenen, MSc
Phone
+31243668388
Email
mark.vanloenen@donders.ru.nl
First Name & Middle Initial & Last Name & Degree
Esther Aarts, PhD
Facility Name
Wageningen University & Research
City
Wageningen
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilma T. Steegenga, PhD
Phone
+31317485181
Email
wilma.steegenga@wur.nl
First Name & Middle Initial & Last Name & Degree
Mara P. van Trijp, PhD
Phone
+31317484067
Email
mara.vantrijp@wur.nl
First Name & Middle Initial & Last Name & Degree
Wilma T. Steegenga, PhD
12. IPD Sharing Statement
Learn more about this trial
The Effects of a Multidomain Lifestyle Intervention on Brain Functioning and Its Relation With Immunometabolic Markers in Ageing
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