Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06832761

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alzheimer Center Amsterdam, Amsterdam, Netherlands

Loading trial locations.

About this study

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.).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personalized lifestyle intervention

Behavioral

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).

Primary outcomes

  1. Lifestyle for BRAin Health (LIBRA) score 2

    Time frame: 1 year

    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).

Secondary outcomes

  1. 15-Word Verbal Learning Test

    Time frame: 1 year

    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)

  2. Digit Symbol Substitution Test (DSST)

    Time frame: 1 year

    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).

  3. Wechsler Adult Intelligent Scale (WAIS) digit span

    Time frame: 1 year

    Measure of working memory. Scored as the maximum number of digits repeated correctly. Discrete number; 0-14 (higher score means a better outcome).

  4. Trail Making Test

    Time frame: 1 year

    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.

  5. Semantic Fluency Test

    Time frame: 1 year

    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.

  6. EuroQol-5D-5L

    Time frame: 1 year

    Quality of life, score 0-100, higher scores indicate better quality of life

  7. ICEpop CAPability measure for Older people (ICECAP-O)

    Time frame: 1 year

    Capabilities, score 0-1, higher scores indicate greater capabilities.

  8. Health locus of Control Scale

    Time frame: 1 year

    3 subscales, where each subscale ranges from 6 (minimum score) to 36 (maximum score). Higher scores indicate higher health locus of control.

  9. General Self-Efficacy scale

    Time frame: 1 year

    Total score ranges from 10 (minimum score) to 40 (maximum score), with higher scores representing higher self-efficacy.

  10. Pearlin Mastery Scale

    Time frame: 1 year

    Total score ranges from 7 (minimum score) to 28 (maximum score), where higher scores indicate greater levels of mastery.

  11. Cholesterol

    Time frame: 1 year

    Total, HDL, LDL and triglycerides in plasma (mmol/L).

  12. Hemoglobin A1c

    Time frame: 1 year

    Hemoglobin A1C (HbA1c) measured in plasma (%), indicates plasma glucose as a measure for diabetes status

  13. Estimated glomerular filtration rate (eGFR)

    Time frame: 1 year

    Creatinine-based (as measured in plasma) estimated glomerular filtration rate (eGFR) (healthy level: higher than 60) indicating kidney function.

  14. Body mass Index (BMI)

    Time frame: 1 year

    As calculated from weight (kg) and height (m), weight / height ^2

  15. Blood pressure

    Time frame: 1 year

    Scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher measures indicating higher blood pressure.

  16. Medical history

    Time frame: 1 year

    History of diabetes, coronary heart disease, kidney disease, hypertension, dyslipidemia, depression, hearing loss, poor vision, sleep disorders (asked in interview)

  17. Amsterdam-Instrumental Activities Daily Living (ADL) Questionnaire

    Time frame: 1 year

    Total scores range approximately 20-70, higher scores indicate better ADL functioning.

  18. Mediterranean Diet Adherence Screener (MEDAS)

    Time frame: 1 year

    Total score ranges from 0 (minimum score) to 14 (maximum score), with higher scores indicating higher adherence to Mediterranean diet.

  19. Investigation into Cancer and Nutrition (EPIC) physical activity questionnaire

    Time frame: 1 year

    Physical activity, uses Cambridge Physical Activity Index to categorize into 4 levels based on occupational and leisure-time activities.

  20. Cognitive and Leisure Activities Scale

    Time frame: 1 year

    The score ranges from 0 (minimum score) to 45 (maximum score), with higher scores representing higher cognitive and leisure activities.

  21. Perceived Stress Scale

    Time frame: 1 year

    Total score, scale 0 - 40, higher scores indicate more perceived stress.

  22. Patient Health Questionnaire (PHQ)-9

    Time frame: 1 year

    Total score ranges from 0 (minimum score) to 27 (maximum score), with higher scores representing a worse outcome (more depressive symptoms).

  23. Groningen Sleep Quality Scale (GSKS)

    Time frame: 1 year

    The score ranges from 0 (minimum score) to 14 (maximum score), with higher scores representing a worse outcome (worse sleep quality)

  24. 6-item Lubben social network Scale

    Time frame: 1 year

    The score ranges from 0 (minimum score) to 30 (maximum score), with higher scores meaning a better outcome (higher level of perceived social support)

  25. De Jong Gierveld 6-item Scale

    Time frame: 1 year

    The score ranges from 0 (minimum score) to 6 (maximum score), with higher scores representing a worse outcome (higher loneliness scores).

  26. Knowledge on dementia risk questionnaire

    Time frame: 1 year

    Measure awareness on risk and protective factors, higher score indicates better knowledge (0-25).

  27. Smoking

    Time frame: 1 year

    Duration (current/history) and quantity

  28. Alcohol intake

    Time frame: 1 year

    Measured in duration (current/history) and quantity

  29. Medical Consumption Questionnaire (iMCQ)

    Time frame: 1 year

    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.

  30. Productivity Costs Questionnaire (iPCQ)

    Time frame: 1 year

    Measures productivity costs, used to calculate cost-effectiveness of the intervention. Higher productivity and lower costs is a better score.

  31. Adherence

    Time frame: 1 year

    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.

Other outcomes

  1. Biomarkers

    Time frame: 1 year

    Plasma samples will be stored to later assess biomarkers. For example amyloid, p-tau, NFL, GFAP, BDNF.

Study contacts

Contact information is provided by the study sponsor or research team.

Niels Janssen, PhD

CONTACT

[email protected]

+316 14348188

Veerle van Gils, PhD

CONTACT

[email protected]

+316 14348188

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Amsterdam UMC, location VUmc
  • InHolland University of Applied Sciences

Registry information

Official study title

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

Acronym: LIGHT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.