Clinical trial NCT05141578: Multidomain Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention
Official title: Tailored, Multidomain, and Coach-assisted Interactive Mobile Application for the Adoption and Maintenance of a Healthy Lifestyle in Middle-aged and Older Adults With Modifiable Risk Factors for Dementia: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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: 2021-12-02
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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).

Primary outcomes:
measure: Enrollment Ratio
timeFrame: At baseline post-enrollment
measure: Recruitment Rate
timeFrame: At baseline post-randomization
measure: Acceptability of randomization
timeFrame: Week 24
measure: Retention rate
timeFrame: Week 24
measure: Program adherence
timeFrame: Week 24
Secondary outcomes:
measure: Change from baseline in Cognitive Engagement
timeFrame: At baseline, week 12, week 24
measure: Change from baseline in Physical Activity
timeFrame: At baseline, week 12, week 24
measure: Change from baseline in Sitting Time
timeFrame: At baseline, week 12, week 24
measure: Change from baseline in Mediterranean Diet Adherence
timeFrame: At baseline, week 12, week 24
measure: Change from baseline in Luci Cognitive Engagement Score
timeFrame: At baseline, week 12, week 24
measure: Change from baseline in Luci Physical Activity Score
timeFrame: At baseline, week 12, week 24
measure: Change from baseline in Luci Medi Diet Adherence Score
timeFrame: At baseline, week 12, week 24
measure: Goal Attainment (Luci Coach Assisted Intervention condition only)
timeFrame: On a weekly basis from week 1 to 12, and every 2 weeks from week 13 to 24
measure: Perceived Progress
timeFrame: Week 12, week 24
measure: Change from baseline in Readiness to Change (Luci Coach Assisted Intervention condition only)
timeFrame: At baseline, week 24
measure: Action Taken
timeFrame: At baseline, week 24
measure: Change from baseline in Expectation (Luci Coach Assisted Intervention condition only)
timeFrame: At baseline, week 24
measure: Overall User Experience (Luci Coach Assisted Intervention condition only)
timeFrame: Week 24
measure: Platform Usage
timeFrame: Continuously from baseline until week 24
measure: Change from baseline in Cognitive Performance
timeFrame: At baseline, week 24
measure: Change from baseline in Current memory concerns
timeFrame: At baseline, week 24
measure: Change from baseline in Perceived Stress
timeFrame: At baseline, week 24
measure: Change from baseline in Sleep Quality
timeFrame: At baseline, week 24
measure: Change from baseline in Depression
timeFrame: At baseline, week 24
measure: Change from baseline in Quality of Life
timeFrame: At baseline, week 24
measure: Change from baseline in Dementia Literacy
timeFrame: At baseline, week 24
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Lucilab
state: Quebec
Study officials:
affiliation: Centre de recherche de l'Institut Universitaire de gériatrie de Montréal
name: Sylvie Belleville, PhD
role: PRINCIPAL_INVESTIGATOR
References: