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Multidomain Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention

Primary Purpose

Risk Behavior, Cognitive Decline

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Luci Coach Assisted Intervention

About this trial

This is an interventional prevention trial for Risk Behavior focused on measuring Primary Prevention, Aging, Cognition

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Lucilab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Luci Intervention

Wait-list Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Enrollment Ratio

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

Recruitment Rate

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

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.

Retention rate

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

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.

Secondary Outcome Measures

Change from baseline in Cognitive Engagement

Cognitive engagement is measured using the Cognitive Activity Questionnaire. Participants are asked to indicate the frequency in which they engage in 10 cognitive leisure activities. Scores range from 0 to 70. A higher score represents a higher cognitive engagement level.

Change from baseline in Physical Activity

Physical activity will be measured using the modified Godin-Shephard Leisure Time Physical Activity Questionnaire. An overall physical activity score is computed in Metabolic equivalent tasks (MET)-minutes/week, as well as a moderate-to-vigorous physical activity score. A higher MET value represents a higher physical activity level.

Change from baseline in Sitting Time

Sitting time will be investigated using a single question from the International Physical Activity Questionnaire. Participants will be asked the following question "During the last 7 days, how much time in total did you usually spend sitting on a week day?" (Number of hours and minutes, Don't know). A lower value represents a lower sitting time.

Change from baseline in Mediterranean Diet Adherence

Adherence to the Mediterranean Diet is measured with an adaptation of the Canadian Mediterranean Diet Scale. The scale consists of 13 questions on food consumption frequency and intake habits. Scores range from 0 to 13, where a higher score represents a higher adherence level.

Change from baseline in Luci Cognitive Engagement Score

Six questions are added to the Cognitive Activity Questionnaire to include activities not covered in the original questionnaire. All 16 items will be used to calculate the Luci Cognitive Engagement score. Scores range from 0 to 112. A higher score represents a higher cognitive engagement level.

Change from baseline in Luci Physical Activity Score

For 15 physical activity types, three questions will assess frequency, duration and intensity of activity on a typical week over the past 30 days. Responses will be used to calculate the Luci Physical Activity score as well as 3 subscores related to aerobic exercise, muscular resistance, and flexibility training, respectively. The total score and subscores are in Metabolic equivalent tasks (MET)-minutes/week. A higher score represents a higher physical activity level.

Change from baseline in Luci Medi Diet Adherence Score

Five questions are added to the Canadian Mediterranean Diet Scale to include food groups and food intake habits not covered in the original questionnaire. From the whole questionnaire, we selected 14 items that are most relevant for the intervention and grouped them into 12 categories to calculate the Luci Medi Diet adherence score. Scores range from 0 to 36, where a higher score represents a higher adherence level.

Goal Attainment (Luci Coach Assisted Intervention condition only)

Goal attainment will be self-rated by participants in the Luci Intervention group. For each goal, an indicator of perceived goal attainment will be established as well as an indicator of their perceived effort towards goal attainment. These will be reported using a 3-item categorical scale.

Perceived Progress

Perceived Progress domain specific will be rated on a 10-point Likert-scale.

Change from baseline in Readiness to Change (Luci Coach Assisted Intervention condition only)

Readiness to change will be determined using a 5-item categorical question.

Action Taken

Action taken will be measured using a 3-item question (Yes, No, Don't know).

Change from baseline in Expectation (Luci Coach Assisted Intervention condition only)

For each selected domain, participants' expectations will be assessed using a 7-point Likert scale.

Overall User Experience (Luci Coach Assisted Intervention condition only)

Different sets of measures will assess user experience. They will evaluate quality and usability of the platform, and participants' satisfaction and continuance usage intention of the program. Feedback about the overall user experience with the platform will be collected using a semi-structured interview conducted by phone.

Platform Usage

Continuous measures of different parameters linked to platform usage during the study period will be recorded and analyzed, including pattern of use (e.g., time of day), frequency (e.g., number of platform access), duration of use (e.g., duration of the coach sessions) and the functionalities used (e.g., content viewed).

Change from baseline in Cognitive Performance

Cognitive performance will be assessed using the Cogstate Brief Battery. Scores range from 0 to 200, where a score ≤ 90 will indicates a cognitive impairment.

Change from baseline in Current memory concerns

Memory concerns will be evaluated using 2 Yes/No questions.

Change from baseline in Perceived Stress

Perceived stress will be investigated using a 5-item categorical question, where a higher score indicates a higher stress level.

Change from baseline in Sleep Quality

Sleep quality will be assessed using a 4-point Likert scale, where a higher score indicates worse sleep quality.

Change from baseline in Depression

Depression will be assessed using a single Yes/No question.

Change from baseline in Quality of Life

Quality of life will be measured with the SF-12. Scores range from 0 to 100, where a higher score represents higher levels of quality of life.

Change from baseline in Dementia Literacy

Dementia literacy will be assessed using 20 questions. These will be answered using 5-point categorical scales.

Full Information

NCT ID

NCT05141578

First Posted

November 19, 2021

Last Updated

October 31, 2022

Sponsor

LuciLab

Collaborators

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Sojecci II Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05141578

Brief Title

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

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

November 15, 2021 (Actual)

Primary Completion Date

June 16, 2022 (Actual)

Study Completion Date

June 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LuciLab

Collaborators

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Sojecci II Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Risk Behavior, Cognitive Decline

Keywords

Primary Prevention, Aging, Cognition

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Luci Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Wait-list Control

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Luci Coach Assisted Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Enrollment Ratio

Description

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

Time Frame

At baseline post-enrollment

Title

Recruitment Rate

Description

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

Time Frame

At baseline post-randomization

Title

Acceptability of randomization

Description

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

Time Frame

Week 24

Title

Retention rate

Description

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

Time Frame

Week 24

Title

Program adherence

Description

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.

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Change from baseline in Cognitive Engagement

Description

Time Frame

At baseline, week 12, week 24

Title

Change from baseline in Physical Activity

Description

Time Frame

At baseline, week 12, week 24

Title

Change from baseline in Sitting Time

Description

Time Frame

At baseline, week 12, week 24

Title

Change from baseline in Mediterranean Diet Adherence

Description

Time Frame

At baseline, week 12, week 24

Title

Change from baseline in Luci Cognitive Engagement Score

Description

Time Frame

At baseline, week 12, week 24

Title

Change from baseline in Luci Physical Activity Score

Description

Time Frame

At baseline, week 12, week 24

Title

Change from baseline in Luci Medi Diet Adherence Score

Description

Time Frame

At baseline, week 12, week 24

Title

Goal Attainment (Luci Coach Assisted Intervention condition only)

Description

Time Frame

On a weekly basis from week 1 to 12, and every 2 weeks from week 13 to 24

Title

Perceived Progress

Description

Perceived Progress domain specific will be rated on a 10-point Likert-scale.

Time Frame

Week 12, week 24

Title

Change from baseline in Readiness to Change (Luci Coach Assisted Intervention condition only)

Description

Readiness to change will be determined using a 5-item categorical question.

Time Frame

At baseline, week 24

Title

Action Taken

Description

Action taken will be measured using a 3-item question (Yes, No, Don't know).

Time Frame

At baseline, week 24

Title

Change from baseline in Expectation (Luci Coach Assisted Intervention condition only)

Description

For each selected domain, participants' expectations will be assessed using a 7-point Likert scale.

Time Frame

At baseline, week 24

Title

Overall User Experience (Luci Coach Assisted Intervention condition only)

Description

Time Frame

Week 24

Title

Platform Usage

Description

Time Frame

Continuously from baseline until week 24

Title

Change from baseline in Cognitive Performance

Description

Cognitive performance will be assessed using the Cogstate Brief Battery. Scores range from 0 to 200, where a score ≤ 90 will indicates a cognitive impairment.

Time Frame

At baseline, week 24

Title

Change from baseline in Current memory concerns

Description

Memory concerns will be evaluated using 2 Yes/No questions.

Time Frame

At baseline, week 24

Title

Change from baseline in Perceived Stress

Description

Perceived stress will be investigated using a 5-item categorical question, where a higher score indicates a higher stress level.

Time Frame

At baseline, week 24

Title

Change from baseline in Sleep Quality

Description

Sleep quality will be assessed using a 4-point Likert scale, where a higher score indicates worse sleep quality.

Time Frame

At baseline, week 24

Title

Change from baseline in Depression

Description

Depression will be assessed using a single Yes/No question.

Time Frame

At baseline, week 24

Title

Change from baseline in Quality of Life

Description

Quality of life will be measured with the SF-12. Scores range from 0 to 100, where a higher score represents higher levels of quality of life.

Time Frame

At baseline, week 24

Title

Change from baseline in Dementia Literacy

Description

Dementia literacy will be assessed using 20 questions. These will be answered using 5-point categorical scales.

Time Frame

At baseline, week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sylvie Belleville, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lucilab

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H32T 1A8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Multidomain Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention

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