Efficacy of a Multidomain Intervention on Lifestyle Risk Factors for Dementia Prevention
NCT ID: NCT06748625
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
370 participants
INTERVENTIONAL
2025-02-28
2026-07-31
Brief Summary
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Detailed Description
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The project deployment follows the Obesity-Related Behavioural Intervention Trials (ORBIT) model. A proof-of-concept study (NCT04616794) was conducted followed by a feasibility study (NCT05141578). All targets (recruitment, enrolment, retention, acceptability, and adherence) were met, which suggests that the protocol is feasible and acceptable and supports moving forward to the efficacy trial.
This study is a 2-arm, randomized, single-blind, parallel-group study aiming to assess the immediate post-intervention (24-weeks) effects of the Luci intervention and their 52-week maintenance, compared to a Waitlist condition in at-risk middle-aged to older individuals. Assessments will be done at Screening (T0), Baseline (T1), week 12 (T2), week 24 (T3), and week 52 (T4).
The primary objective of this study is to determine whether the Luci intervention can result in a greater number of people reducing their behavioural risks when compared to the Waitlist condition. It is hypothesised that the proportion of people with a significant risk reduction will be higher in the Luci condition than in the Waitlist condition.
Individuals assigned to the Intervention group have weekly (weeks 1-12) or bi-monthly (weeks 13-24) sessions with their coach. Coaching sessions last 30 or 60 minutes and are conducted by video call and/or through a chat system.
Throughout the coaching sessions, participants are assisted in creating personalised behavioural SMART (specific, measurable, attainable, relevant and time bound) goals. Coaches also provide motivational support as well as tools to help participants maintain their behaviour changes.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Luci intervention
Participants enrolled in this group will receive the Luci intervention for a 24-week period.
Luci Coach-Assisted Intervention
The Luci intervention is a personalized behaviour change program delivered via an interactive web platform with the online support of a coach. It targets 3 lifestyle domains: physical activity, healthy diet and cognitive engagement. Participants will be encouraged to adopt a healthy lifestyle, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and by assisting participants outlining SMART goals to progressively adopt and maintain a healthier lifestyle. Coaching sessions will be held on a weekly basis from week 1 to 12, and every 2 weeks from week 13 to 24.
Wait-list Control
Participants in the waiting-list control group will not receive any intervention during the study. They will be invited to participate in the program at the end of the trial.
No interventions assigned to this group
Interventions
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Luci Coach-Assisted Intervention
The Luci intervention is a personalized behaviour change program delivered via an interactive web platform with the online support of a coach. It targets 3 lifestyle domains: physical activity, healthy diet and cognitive engagement. Participants will be encouraged to adopt a healthy lifestyle, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and by assisting participants outlining SMART goals to progressively adopt and maintain a healthier lifestyle. Coaching sessions will be held on a weekly basis from week 1 to 12, and every 2 weeks from week 13 to 24.
Eligibility Criteria
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Inclusion Criteria
* Proficient or native speakers in French or English;
* Computer literate defined as being able to read mails and browse the Internet, and having access to a computer or tablet with an Internet connection;
* Eligible in at least one of the 3 intervention domains, where eligibility is defined as follows:
* 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 dietary restriction, severe allergy or intolerance or history of eating disorder.
Exclusion Criteria
* General anesthesia within the last 6 months;
* Previous participation in the Luci program or in any validation studies related to the program;
* Current participation in another study;
* Unable to commit participation over the period of the study;
* Being in the precontemplation stage of change;
* High level of perceived stress;
* Having received a diagnosis of :
* Dementia or neurodegenerative disease (AD and other dementias);
* Past or present neurological disorder (multiple sclerosis, brain tumour, epilepsy, stroke, traumatic brain injury);
* Severe psychiatric disorder (schizophrenia, major depression, bipolar disorder);
* Diabetes or hypertension without medical monitoring;
* Alcoholism or drug addiction;
* Any other condition expected to limit participation (e.g., low visual acuity).
50 Years
75 Years
ALL
Yes
Sponsors
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Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
OTHER
Sojecci II Ltd
UNKNOWN
LuciLab
INDUSTRY
Responsible Party
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Locations
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Lucilab
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Sylvie Belleville
Role: primary
Isabelle Lussier
Role: backup
Other Identifiers
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LUCI-03
Identifier Type: -
Identifier Source: org_study_id