Clinical trial NCT06832761: Lifestyle Intervention in the Memory Clinics of General and Academic Hospitals Trial
Official title: Secondary Prevention of Dementia in Memory Clinics: Implementation and (Cost-)Effectiveness of an Integrated Lifestyle Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lifestyle Intervention
Lifestyle Risk Reduction
Cognitive Decline
Dementia
Keywords: Lifestyle intervention
Risk reduction
Dementia
Memory clinic
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: InHolland University of Applied Sciences
First posted: 2025-02-18
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A receives a personalised lifestyle intervention. Group B will receive general information on lifestyle in relation to dementia risk reduction.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.).

Eligibility criteria: Inclusion Criteria:

* ≥50 years of age at pre-screening;
* Having a diagnosis of SCD or MCI;
* Presence of ≥ 2 modifiable risk factors for dementia.

Exclusion Criteria:

* Having a diagnosis of dementia;
* Insufficient understanding of the Dutch language;
* 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), other conditions preventing co-operation as judged by the local study nurse or consulted physician at the local study site;
* Participation in any other research intervention trial at time of pre-screening and throughout the study period.

Primary outcomes:
measure: Lifestyle for BRAin Health (LIBRA) score 2
timeFrame: 1 year
Secondary outcomes:
measure: 15-Word Verbal Learning Test
timeFrame: 1 year
measure: Digit Symbol Substitution Test (DSST)
timeFrame: 1 year
measure: Wechsler Adult Intelligent Scale (WAIS) digit span
timeFrame: 1 year
measure: Trail Making Test
timeFrame: 1 year
measure: Semantic Fluency Test
timeFrame: 1 year
measure: EuroQol-5D-5L
timeFrame: 1 year
measure: ICEpop CAPability measure for Older people (ICECAP-O)
timeFrame: 1 year
measure: Health locus of Control Scale
timeFrame: 1 year
measure: General Self-Efficacy scale
timeFrame: 1 year
measure: Pearlin Mastery Scale
timeFrame: 1 year
measure: Cholesterol
timeFrame: 1 year
measure: Hemoglobin A1c
timeFrame: 1 year
measure: Estimated glomerular filtration rate (eGFR)
timeFrame: 1 year
measure: Body mass Index (BMI)
timeFrame: 1 year
measure: Blood pressure
timeFrame: 1 year
measure: Medical history
timeFrame: 1 year
measure: Amsterdam-Instrumental Activities Daily Living (ADL) Questionnaire
timeFrame: 1 year
measure: Mediterranean Diet Adherence Screener (MEDAS)
timeFrame: 1 year
measure: Investigation into Cancer and Nutrition (EPIC) physical activity questionnaire
timeFrame: 1 year
measure: Cognitive and Leisure Activities Scale
timeFrame: 1 year
measure: Perceived Stress Scale
timeFrame: 1 year
measure: Patient Health Questionnaire (PHQ)-9
timeFrame: 1 year
measure: Groningen Sleep Quality Scale (GSKS)
timeFrame: 1 year
measure: 6-item Lubben social network Scale
timeFrame: 1 year
measure: De Jong Gierveld 6-item Scale
timeFrame: 1 year
measure: Knowledge on dementia risk questionnaire
timeFrame: 1 year
measure: Smoking
timeFrame: 1 year
measure: Alcohol intake
timeFrame: 1 year
measure: Medical Consumption Questionnaire (iMCQ)
timeFrame: 1 year
measure: Productivity Costs Questionnaire (iPCQ)
timeFrame: 1 year
measure: Adherence
timeFrame: 1 year
Other outcomes:
measure: Biomarkers
timeFrame: 1 year
Locations:
city: Amsterdam
country: Netherlands
facility: Alzheimer Center Amsterdam
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Sebastian Köhler, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deckers K, Zwan MD, Soons LM, Waterink L, Beers S, van Houdt S, Stiensma B, Kwant JZ, Wimmers SCPM, Heutz RAM, Claassen JAHR, Oosterman JM, de Heus RAA, van de Rest O, Vermeiren Y, Voshaar RCO, Smidt N, Broersen LM, Sikkes SAM, Aarts E; MOCIA consortium; FINGER-NL consortium; Kohler S, van der Flier WM. A multidomain lifestyle intervention to maintain optimal cognitive functioning in Dutch older adults-study design and baseline characteristics of the FINGER-NL randomized controlled trial. Alzheimers Res Ther. 2024 Jun 13;16(1):126. doi: 10.1186/s13195-024-01495-8.
citation: Rosenau C, Kohler S, Soons LM, Anstey KJ, Brayne C, Brodaty H, Engedal K, Farina FR, Ganguli M, Livingston G, Lyketsos CG, Mangialasche F, Middleton LE, Rikkert MGMO, Peters R, Sachdev PS, Scarmeas N, Salbaek G, van Boxtel MPJ, Deckers K. Umbrella review and Delphi study on modifiable factors for dementia risk reduction. Alzheimers Dement. 2024 Mar;20(3):2223-2239. doi: 10.1002/alz.13577. Epub 2023 Dec 30.