Actively Recruiting
Secondary Prevention of Dementia in Memory Clinics: Implementation and (Cost-)Effectiveness of an Integrated Lifestyle Intervention
Led by Maastricht University Medical Center · Updated on 2025-02-18
300
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
A
Amsterdam UMC, location VUmc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying older adults aged 50 years and above who have subjective cognitive decline (SCD) or mild cognitive impairment (MCI) and are at risk for dementia. This multi-center randomized controlled trial called LIGHT aims to evaluate the impact and cost-effectiveness of a one-year lifestyle intervention on lifestyle changes and dementia risk reduction compared with general health advice. The study focuses on improving factors related to brain health and identifying how to best implement sustainable lifestyle changes in memory clinic patients. Participants are randomly assigned to one of two groups for 12 months. Group A receives a personalized lifestyle intervention that includes three individual coaching sessions with a trained lifestyle coach, a voucher program to promote brain-healthy activities, and access to an online self-management tool for dementia risk reduction. Group B receives general health advice and regular healthcare, including an informational folder about lifestyle and dementia risk reduction. Throughout the study, participants undergo various assessments including cognitive tests, measurements of body mass index, blood pressure, cholesterol, and blood sugar levels. Questionnaires cover lifestyle habits, health status, quality of life, physical activity, stress, sleep quality, social support, and knowledge of dementia risk factors. Researchers also collect data on healthcare use and costs. The primary outcome is the change in dementia risk profile measured by the Lifestyle for Brain Health (LIBRA) score after one year. Additional evaluations include interviews and questionnaires about the intervention's implementation and participant experiences.
CONDITIONS
Brief Title
Lifestyle Intervention in the Memory Clinics of General and Academic Hospitals Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 50 years of age or older at pre-screening
- Diagnosed with subjective cognitive decline (SCD) or mild cognitive impairment (MCI)
- Presence of two or more modifiable risk factors for dementia
You will not qualify if you...
- Diagnosis of dementia
- Insufficient understanding of the Dutch language
- Conditions preventing safe and continuous participation, such as current malignant diseases under treatment or major psychiatric disorders (e.g., major depression, psychosis, bipolar disorder)
- Participation in any other research intervention trial at pre-screening or during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either a personalized lifestyle intervention including coaching, a voucher program, and online self-management tools, or general health advice over the course of one year.
Multiple visits during the 12 months for coaching and assessments
Duration - Assessments throughout and at the end of the 12-month period
Participants complete assessments on lifestyle, cognitive function, physical health, and quality of life to evaluate the effectiveness of the intervention.
Visits coincide with treatment period assessments
Trial Site Locations
Total: 2 locations
1
Alzheimer Center Amsterdam
Amsterdam, Netherlands
Actively Recruiting
2
Maastricht University
Maastricht, Netherlands
Actively Recruiting
Research Team
N
Niels Janssen, PhD
V
Veerle van Gils, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2