Multidomain Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention

NCT ID: NCT05141578

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2022-06-21

Brief 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.

Detailed Description

Multidomain lifestyle interventions show promising results in reducing the risk of cognitive decline and dementia.

In this study, we pilot the feasibility of a coach-based digital multidomain risk-reduction program to improve cognitive engagement, physical activity, and healthy eating in older adults at risk of dementia. This trial is the second step in the clinical validation process of the Luci program (see NCT04616794). In this 24-week study, participants are randomly assigned to the Luci Intervention group or to the Waiting-list Control group (i.e., participants receive the program after the end of the trial). Assessments will be done at study entry (T1), week 12 (T2), and week 24 (T3).

Conditions

Risk Behavior; Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Luci Intervention

Participants enrolled in this group will receive the Luci intervention for a 24-week period.

Group Type: EXPERIMENTAL

Luci Coach Assisted Intervention

Intervention Type: BEHAVIORAL

The Luci intervention is a personalized behaviour change program delivered via an interactive mobile platform with the online support of a coach. It targets 3 lifestyle domains: physical activity, healthy diet and cognitive engagement.

Participants in this group 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 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 to the program at the end of the trial.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Luci Coach Assisted Intervention

The Luci intervention is a personalized behaviour change program delivered via an interactive mobile platform with the online support of a coach. It targets 3 lifestyle domains: physical activity, healthy diet and cognitive engagement.

Participants in this group 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 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 stage of change.
• Participants with a 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);
• Uncontrolled cardiovascular or metabolic diseases;
• Alcoholism or drug addiction;
• Any other conditions expected to limit participation (e.g., visual acuity).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

OTHER

Sponsor Role: collaborator

Sojecci II Ltd

UNKNOWN

Sponsor Role: collaborator

LuciLab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Belleville, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche de l'Institut Universitaire de gériatrie de Montréal

Locations

Lucilab

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

LUCI-02

Identifier Type: -

Identifier Source: org_study_id