Multidomain Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention (NCT05141578) | Clinical Trial Compass
CompletedNot Applicable
Multidomain Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention
Canada120 participantsStarted 2021-11-15
Plain-language summary
The overarching aim is to develop and deploy a multidomain intervention delivered on a mobile application to help middle-aged to older adults reduce their risk for dementia by improving a set of modifiable lifestyle risk factors associated with cognitive decline/dementia. This registration concerns the Pilot Feasibility study which examines different aspects of feasibility in a small-scale randomized pilot study, before implementing an efficacy study on a larger sample. A secondary objective is to determine whether the program can result in a larger improvement on risk factors (measured with Behavioural Risk outcomes) compared to a control intervention. It is expected that persons enrolled in the Luci program show larger change in Behavioural Risk outcomes than those enrolled in the comparator condition.
Who can participate
Age range
50 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Proficient or native speakers in French;
* Computer literate defined as being able to read mails and browse the Internet, and having access to a computer, smartphone or tablet with an Internet connection;
* Committed not to participate in another program related to any of the three intervention domains for the duration of the trial;
* At least one of the following:
* Low cognitive engagement in cognitively stimulating activities, defined as a score ≤ 22 on the adapted Cognitive Activity Questionnaire;
* Low level of physical activity defined as less than 150 minutes/week) of moderate to vigorous physical activity measured using the Godin-Shephard Leisure Time Physical Activity Questionnaire, and no medical contraindication to physical activity based on the Physical Readiness Questionnaire for Everyone (PAR-Q+);
* Low adherence to the Mediterranean-type diet defined as a score of ≤ 8 on the adapted Canadian Mediterranean Diet Scale, and no severe food allergy or intolerance or history of eating disorder.
Exclusion Criteria:
* Presence of a cognitive impairment as measured by the Cogstate Brief BatteryTM.
* General anesthesia within the last 6 months;
* Participation in any previous validation studies related to the program;
* Participation, currently or within the last 6 months, in a program where they received any of the three interventions;
* Unable to commit participation over the period of the study.
* Participants in the precontemplation st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.