Lifestyle Intervention in the memory clinics of General and academic Hospitals Trial (LIGHT) is a multi-center, randomized, controlled, lifestyle intervention trial among 300 older adults (≥50 years) with subjective cognitive decline (SCD) and mild cognitive impairment (MCI) at risk of dementia. Participants are randomized in a 1:1 ratio to Group A (tailored lifestyle intervention) or Group B (general health advice) for a duration of 12 months. The lifestyle intervention comprises three parts 1) Lifestyle coaching, 2) a voucher program, and 3) online self-management. Group B will receive general health advice.
Rationale: Dementia prevention through lifestyle has much potential but is not implemented in routine care. Patients referred to memory clinics, such as people with mild cognitive impairment (MCI) and subjective cognitive disorder (SCD), are at high risk for dementia and tend to have a worse health and lifestyle profile. While they might greatly benefit from lifestyle changes, there is no offer to help them make those changes. Objective: The primary objectives are to examine both the (cost-)effectiveness of an innovative 1-year lifestyle intervention on lifestyle change measured by the validated Lifestyle for Brain Health Score (LIBRA) in older adults with SCD or MCI; and to identify possibilities, barriers, and facilitators for sustainable implementation of the lifestyle intervention. Study design: Multicenter, randomized controlled trial comparing a lifestyle intervention with care as usual and general health advice. Study population: 300 older adults (≥50 years) with SCD and MCI at risk of dementia. Intervention: Participants are randomly allocated on a 1:1 ratio to participate either in Group A (tailored lifestyle intervention) or Group B (general health advice) for a duration of 12 months. The lifestyle intervention comprises three parts 1) Lifestyle coaching, 2) a voucher program, and 3) online self-management. Group B will receive general health advice. Main study parameters/endpoints: The primary outcome will be change in participants' dementia risk profile as measured by the LIBRA score between baseline and 12 months. Secondary outcomes include cognitive functions (episodic memory, executive functions, information processing speed and attention). Other secondary outcomes include measures of body mass index (height and weight), office systolic and diastolic blood pressure, and lab measures including cholesterol levels (total, HDL, LDL, triglycerides), HbA1c levels, creatinine-based eGFR levels. Smoking, alcohol intake and current relevant medical conditions (coronary heart disease, kidney disease, type 2 diabetes, depression, hearing loss, sleep disorders) will be assessed through self-report. Additional questionnaires include health-related quality of life and capabilities, instrumental activities of daily living, health locus of control, self-efficacy, mastery, healthy diet, physical activity, cognitive stimulation, stress, and depressive symptoms, sleep quality, social support and feelings of loneliness, and lastly knowledge on dementia risk and protective factors. For cost-effectiveness, questionnaires on resource utilization, medical consumption, and productivity costs are administered. Additional measures include change in diagnosis (if applicable), demographics (age, sex, educational level, socioeconomic position (household income), paid/voluntary work hours, ethnicity, marital status, living situation), medication use, hearing loss. For process evaluation, questionnaires and interviews are administered on implementation, mechanisms of impact and contact (e.g., appointments with lifestyle coach, use of the breinzorg.nl self-management tool, use of the voucher program, experiences and usefulness, etc.).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
300
The lifestyle intervention in Group A comprises three parts (1) three individual consultations with a trained lifestyle coach, (2) a voucher program to encourage brain healthy activities, and (3) access to an online self-management tool for dementia risk reduction (www.breinzorg.nl).
Alzheimer Center Amsterdam
Amsterdam, Netherlands
RECRUITINGMaastricht University
Maastricht, Netherlands
RECRUITINGLifestyle for BRAin Health (LIBRA) score 2
1-year change in the Lifestyle for BRAin Health (LIBRA) score 2. This is a weighted score of fifteen lifestyle-related risk factors that are proven to be associated with increased dementia risk. Higher score means a greater risk for dementia. Scored from -6.1 to 25.8 (absolute weight).
Time frame: 1 year
15-Word Verbal Learning Test
Measure of immediate and delayed memory. Wordlist is presented five times in a row and asked to be recalled immediately and after 15 minutes. Discrete number; score: 0-15 (higher score means a better outcome)
Time frame: 1 year
Digit Symbol Substitution Test (DSST)
Measure of attention/processing speed, number of correctly matched symbols to digits within 90 seconds. Discrete number; 0-90 (higher score means a better outcome).
Time frame: 1 year
Wechsler Adult Intelligent Scale (WAIS) digit span
Measure of working memory. Scored as the maximum number of digits repeated correctly. Discrete number; 0-14 (higher score means a better outcome).
Time frame: 1 year
Trail Making Test
Measure of attention and executive function. Task A and B. Time taken to complete the test; minimum 0, no maximum, lower score means a better outcome.
Time frame: 1 year
Semantic Fluency Test
Measure of language fluency. Semantic fluency test with category animals at baseline and professions at follow-up. Word count in one minute; minimum 0, no maximum, higher score means a better outcome.
Time frame: 1 year
EuroQol-5D-5L
Quality of life, score 0-100, higher scores indicate better quality of life
Time frame: 1 year
ICEpop CAPability measure for Older people (ICECAP-O)
Capabilities, score 0-1, higher scores indicate greater capabilities.
Time frame: 1 year
Health locus of Control Scale
3 subscales, where each subscale ranges from 6 (minimum score) to 36 (maximum score). Higher scores indicate higher health locus of control.
Time frame: 1 year
General Self-Efficacy scale
Total score ranges from 10 (minimum score) to 40 (maximum score), with higher scores representing higher self-efficacy.
Time frame: 1 year
Pearlin Mastery Scale
Total score ranges from 7 (minimum score) to 28 (maximum score), where higher scores indicate greater levels of mastery.
Time frame: 1 year
Cholesterol
Total, HDL, LDL and triglycerides in plasma (mmol/L).
Time frame: 1 year
Hemoglobin A1c
Hemoglobin A1C (HbA1c) measured in plasma (%), indicates plasma glucose as a measure for diabetes status
Time frame: 1 year
Estimated glomerular filtration rate (eGFR)
Creatinine-based (as measured in plasma) estimated glomerular filtration rate (eGFR) (healthy level: higher than 60) indicating kidney function.
Time frame: 1 year
Body mass Index (BMI)
As calculated from weight (kg) and height (m), weight / height \^2
Time frame: 1 year
Blood pressure
Scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher measures indicating higher blood pressure.
Time frame: 1 year
Medical history
History of diabetes, coronary heart disease, kidney disease, hypertension, dyslipidemia, depression, hearing loss, poor vision, sleep disorders (asked in interview)
Time frame: 1 year
Amsterdam-Instrumental Activities Daily Living (ADL) Questionnaire
Total scores range approximately 20-70, higher scores indicate better ADL functioning.
Time frame: 1 year
Mediterranean Diet Adherence Screener (MEDAS)
Total score ranges from 0 (minimum score) to 14 (maximum score), with higher scores indicating higher adherence to Mediterranean diet.
Time frame: 1 year
Investigation into Cancer and Nutrition (EPIC) physical activity questionnaire
Physical activity, uses Cambridge Physical Activity Index to categorize into 4 levels based on occupational and leisure-time activities.
Time frame: 1 year
Cognitive and Leisure Activities Scale
The score ranges from 0 (minimum score) to 45 (maximum score), with higher scores representing higher cognitive and leisure activities.
Time frame: 1 year
Perceived Stress Scale
Total score, scale 0 - 40, higher scores indicate more perceived stress.
Time frame: 1 year
Patient Health Questionnaire (PHQ)-9
Total score ranges from 0 (minimum score) to 27 (maximum score), with higher scores representing a worse outcome (more depressive symptoms).
Time frame: 1 year
Groningen Sleep Quality Scale (GSKS)
The score ranges from 0 (minimum score) to 14 (maximum score), with higher scores representing a worse outcome (worse sleep quality)
Time frame: 1 year
6-item 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)
Time frame: 1 year
De Jong Gierveld 6-item Scale
The score ranges from 0 (minimum score) to 6 (maximum score), with higher scores representing a worse outcome (higher loneliness scores).
Time frame: 1 year
Knowledge on dementia risk questionnaire
Measure awareness on risk and protective factors, higher score indicates better knowledge (0-25).
Time frame: 1 year
Smoking
Duration (current/history) and quantity
Time frame: 1 year
Alcohol intake
Measured in duration (current/history) and quantity
Time frame: 1 year
Medical Consumption Questionnaire (iMCQ)
Medical consumption, selection of specific questions on care use such as GP visits and dietician. Used to calculate overall costs of medical care to define the cost-effectiveness of the intervention. Lower costs is a better score.
Time frame: 1 year
Productivity Costs Questionnaire (iPCQ)
Measures productivity costs, used to calculate cost-effectiveness of the intervention. Higher productivity and lower costs is a better score.
Time frame: 1 year
Adherence
Appointments missed, personal goals reached in coaching sessions (number), vouchers used (number), usage log of breinzorg.nl self-management tool (time active, modules completed). Together, they will be used in a model to calculate cost-effectiveness of the intervention based on the adherence.
Time frame: 1 year
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