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

Secondary Prevention of Dementia in Memory Clinics: Implementation and (cost-)effectiveness of an Integrated Lifestyle Intervention

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Cognitive Decline; Lifestyle Intervention; Lifestyle Risk Reduction
• Intervention / Treatment: Behavioral: Personalized lifestyle intervention

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.).

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niels Janssen, PhD; Phone Number: +316 14348188; Email: n.janssen@maastrichtuniversity.nl
• Study Contact Backup: Name: Veerle van Gils, PhD; Phone Number: +316 14348188; Email: v.vangils@maastrichtuniversity.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Alzheimer Center Amsterdam
    • Contact: Lisa Waterink, PhD; Email: l.waterink@amsterdamumc.nl
    • Contact: Wiesje M van der Flier, Professor
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht University
    • Contact: Veerle Van Gils, PhD; Phone Number: +316-14348188; Email: v.vangils@maastrichtuniversity.nl
    • Contact: Sebastian Köhler, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle intervention (Group A); Group A receives a personalized lifestyle intervention.	Behavioral: Personalized lifestyle intervention; 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).
No Intervention: Regular healthcare (Group B); Group B receives regular health care and a folder with general information on lifestyle and dementia risk reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lifestyle 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).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	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).	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.	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.	1 year
EuroQol-5D-5L	Quality of life, score 0-100, higher scores indicate better quality of life	1 year
ICEpop CAPability measure for Older people (ICECAP-O)	Capabilities, score 0-1, higher scores indicate greater capabilities.	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.	1 year
General Self-Efficacy scale	Total score ranges from 10 (minimum score) to 40 (maximum score), with higher scores representing higher self-efficacy.	1 year
Pearlin Mastery Scale	Total score ranges from 7 (minimum score) to 28 (maximum score), where higher scores indicate greater levels of mastery.	1 year
Cholesterol	Total, HDL, LDL and triglycerides in plasma (mmol/L).	1 year
Hemoglobin A1c	Hemoglobin A1C (HbA1c) measured in plasma (%), indicates plasma glucose as a measure for diabetes status	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.	1 year
Body mass Index (BMI)	As calculated from weight (kg) and height (m), weight / height ^2	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.	1 year
Medical history	History of diabetes, coronary heart disease, kidney disease, hypertension, dyslipidemia, depression, hearing loss, poor vision, sleep disorders (asked in interview)	1 year
Amsterdam-Instrumental Activities Daily Living (ADL) Questionnaire	Total scores range approximately 20-70, higher scores indicate better ADL functioning.	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.	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.	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.	1 year
Perceived Stress Scale	Total score, scale 0 - 40, higher scores indicate more perceived stress.	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).	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)	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)	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).	1 year
Knowledge on dementia risk questionnaire	Measure awareness on risk and protective factors, higher score indicates better knowledge (0-25).	1 year
Smoking	Duration (current/history) and quantity	1 year
Alcohol intake	Measured in duration (current/history) and quantity	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.	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.	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.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers	Plasma samples will be stored to later assess biomarkers. For example amyloid, p-tau, NFL, GFAP, BDNF.	1 year

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Amsterdam UMC, location VUmc; InHolland University of Applied Sciences
• Investigators: Principal Investigator: Sebastian Köhler, Professor, Maastricht University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• ZonMw description
• Alzheimer Center Limburg description

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Dementia; Lifestyle intervention; Risk reduction; Memory clinic
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Dementia
• Other Study ID Numbers: NL86513.068.24; 10930012310012 (Other Grant/Funding Number: ZonMw)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No