Lifestyle Intervention in the Memory Clinics of General and Academic Hospitals Trial

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.).

• 15-Word Verbal Learning Test [Time frame: 1 year]
• Digit Symbol Substitution Test (DSST) [Time frame: 1 year]
• Wechsler Adult Intelligent Scale (WAIS) digit span [Time frame: 1 year]
• Trail Making Test [Time frame: 1 year]
• Semantic Fluency Test [Time frame: 1 year]
• EuroQol-5D-5L [Time frame: 1 year]
• ICEpop CAPability measure for Older people (ICECAP-O) [Time frame: 1 year]
• Health locus of Control Scale [Time frame: 1 year]
• General Self-Efficacy scale [Time frame: 1 year]
• Pearlin Mastery Scale [Time frame: 1 year]
• Cholesterol [Time frame: 1 year]
• Hemoglobin A1c [Time frame: 1 year]