Clinical trial NCT06748625: Efficacy of a Multidomain Intervention on Lifestyle Risk Factors for Dementia Prevention
Official title: Tailored, Multidomain, and Coach-assisted Digital Program for the Adoption and Maintenance of a Healthy Lifestyle in Middle-aged and Older Adults with Modifiable Risk Factors for Dementia: an Efficacy Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Risk Behavior
Cognitive Decline
Keywords: Primary Prevention
Aging
Cognition
Lead sponsor: LuciLab
Sponsor class: INDUSTRY
Collaborators: name: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
name: Sojecci II Ltd
First posted: 2024-12-27
Enrollment: 370
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Alzheimer's Disease (AD) and other Dementias have far-reaching consequences on the lives of sufferers and their loved ones, not to mention the impact on the healthcare system. Several studies have identified protective lifestyle habits that might help reduce the risk of cognitive decline: cognitive engagement, physical activity, and a healthy diet. Our aim is to determine the efficacy of the Luci program, an online, coach-assisted, multidomain, behavioural intervention designed to help middle-aged to older adults reduce their risk of dementia by improving their lifestyle habits. In this study, we hope to demonstrate that participating in the Luci program helps to improve lifestyle habits and that the program could therefore become an effective health promotion tool.

Detailed description: Multidomain lifestyle interventions supported by technology might help dementia prevention by reducing the risk associated with lifestyle behaviours. The goal of Luci is to help middle-aged to older adults improve modifiable lifestyle risk factors (diet, physical activity and cognitive engagement) associated with cognitive decline. The intervention is a theory-based, tailored, multidomain, coach-assisted program offered through an interactive online platform promoting healthy lifestyle behaviour changes and their maintenance.

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.

Eligibility criteria: Inclusion Criteria :

* Aged between 50 and 75;
* 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 :

* Presence of a cognitive impairment as measured by the Creyos Dementia Assessment;
* 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).

Primary outcomes:
measure: Lifestyle Risk Reduction criterion
timeFrame: Change from Screening to Week 24
measure: Cognitive Engagement
timeFrame: Screening, Week 12, Week 24, Week 52
measure: Physical Activity
timeFrame: Screening, Week 12, Week 24, Week 52
measure: Mediterranean Diet Adherence
timeFrame: Screening, Week 12, Week 24, Week 52
Secondary outcomes:
measure: Quality of Life
timeFrame: Baseline, Week 24, Week 52
measure: Cognitive Performance
timeFrame: Screening, Week 24, Week 52
Other outcomes:
measure: Multifactorial index of dementia risk
timeFrame: Baseline, Week 24, Week 52
measure: Perceived Stress
timeFrame: Screening, Week 24, Week 52
measure: Sleep Quality
timeFrame: Baseline, Week 24, Week 52
measure: Anxiety Symptoms
timeFrame: Baseline, Week 24, Week 52
measure: Curent Memory Concerns
timeFrame: Baseline, Week 24, Week 52
measure: Readiness to Change
timeFrame: Baseline, Week 12, Week 24, Week 52
measure: Self-efficacy
timeFrame: Baseline, Week 12, Week 24, Week 52
measure: Motivations
timeFrame: Baseline, Week 12, Week 24, Week 52
measure: Dementia Literacy
timeFrame: Baseline, Week 12, Week 24, Week 52
measure: Perceived Progress
timeFrame: Week 12, Week 24, Week 52
measure: Luci Cognitive Engagement Score
timeFrame: Baseline, Week 12, Week 24, Week 52
measure: Luci Physical Activity Score
timeFrame: Baseline, Week 12, Week 24, Week 52
measure: Luci Medi Diet Adherence Score
timeFrame: Baseline, Week 12, Week 24, Week 52
measure: Health Service Utilisation
timeFrame: Baseline, Week 24, Week 52
measure: Retention Rate
timeFrame: Week 24, Week 52
measure: Program Adherence
timeFrame: Week 24
measure: Platform Usage
timeFrame: Week 24
measure: User Experience
timeFrame: Week 24
measure: Usability
timeFrame: Week 24
measure: Goal Attainment
timeFrame: Weekly up to Week 12, then bi-weekly up to Week 24
Locations:
city: Montreal
country: Canada
facility: Lucilab
state: Quebec
Study officials:
References: