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.).