Multidomain Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Risk Behavior, Cognitive Decline

Intervention / Treatment
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* Behavioral: Luci Coach Assisted Intervention


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luci Intervention<br>Participants enrolled in this group will receive the Luci intervention for a 24-week period. | Behavioral: Luci Coach Assisted Intervention<br>* 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.<br>|
| No Intervention: Wait-list Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At baseline, week 12, week 24 | 
| 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. | At baseline, week 12, week 24 | 
| 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. | At baseline, week 12, week 24 | 
| 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. | At baseline, week 12, week 24 | 
| 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. | At baseline, week 12, week 24 | 
| 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. | At baseline, week 12, week 24 | 
| 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. | At baseline, week 12, week 24 | 
| 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. | On a weekly basis from week 1 to 12, and every 2 weeks from week 13 to 24 | 
| Perceived Progress | Perceived Progress domain specific will be rated on a 10-point Likert-scale. | Week 12, week 24 | 
| 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. | At baseline, week 24 | 
| Action Taken | Action taken will be measured using a 3-item question (Yes, No, Don't know). | At baseline, week 24 | 
| 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. | At baseline, week 24 | 
| 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. | Week 24 | 
| 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). | Continuously from baseline until week 24 | 
| 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. | At baseline, week 24 | 
| Change from baseline in Current memory concerns | Memory concerns will be evaluated using 2 Yes/No questions. | At baseline, week 24 | 
| 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. | At baseline, week 24 | 
| 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. | At baseline, week 24 | 
| Change from baseline in Depression | Depression will be assessed using a single Yes/No question. | At baseline, week 24 | 
| 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. | At baseline, week 24 | 
| Change from baseline in Dementia Literacy | Dementia literacy will be assessed using 20 questions. These will be answered using 5-point categorical scales. | At baseline, week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Prevention, Aging, Cognition