Multidomain Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention

NCT05141578 | Completed

• 1 other identifier: LUCI-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Risk Behavior; Cognitive Decline

Keywords

Primary Prevention; Aging; Cognition

Outcome Measures

Primary Outcomes (5)

• Enrollment Ratio

  Screening-to-enrollment ratio will be calculated as the number of enrolled participants over the number of screened participants.

  At baseline post-enrollment

• Recruitment Rate

  Recruitment rate will be calculated as the number of participants randomized per month over the recruitment period

  At baseline post-randomization

• Acceptability of randomization

  Acceptability of randomization will be assessed by comparing the post-randomization dropout rate in the control group relative to the intervention group.

  Week 24

• Retention rate

  Retention rate will be calculated as the proportion of randomized participants completing at least one of the measures at study end.

  Week 24

• Program adherence

  Program adherence will be calculated as the number of participants from the Luci condition who attend at least 66% of the prescribed coaching sessions over the 24-week intervention period.

  Week 24

Secondary Outcomes (21)

• Change from baseline in Cognitive Engagement

  At baseline, week 12, week 24

• Change from baseline in Physical Activity

  At baseline, week 12, week 24

• Change from baseline in Sitting Time

  At baseline, week 12, week 24

• Change from baseline in Mediterranean Diet Adherence

  At baseline, week 12, week 24

• Change from baseline in Luci Cognitive Engagement Score

  At baseline, week 12, week 24

Study Arms (2)

Luci Intervention

EXPERIMENTAL

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

Behavioral: Luci Coach Assisted Intervention

Wait-list Control

NO INTERVENTION

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.

Interventions

Luci Coach Assisted Intervention 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.

Luci Intervention

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• LuciLab: lead
• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: collaborator
• Sojecci II Ltd: collaborator

Study Sites (1)

Lucilab

Montreal, Quebec, H32T 1A8, Canada

Location

MeSH Terms

Conditions

Risk-Taking; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sylvie Belleville, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: November 15, 2021
• Primary Completion: June 16, 2022
• Study Completion: June 21, 2022
• Last Updated: November 2, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)