Risk BehaviorNCT05141578
Multidomain Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention
A study testing Luci Coach Assisted Intervention in people with Risk Behavior and Cognitive Decline, run by LuciLab at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Behavior, Cognitive Decline
- What is being tested?
- Luci Coach Assisted Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2021to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Luci Coach Assisted Intervention
- Keywords
- Primary Prevention, Aging, Cognition
- Medical subject headings
- Risk-Taking, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luci Coach Assisted InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Luci Intervention | Experimental | Participants enrolled in this group will receive the Luci intervention for a 24-week period. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Ratio
Screening-to-enrollment ratio will be calculated as the number of enrolled participants over the number of screened participants.
Measured: At baseline post-enrollment
Recruitment Rate
Recruitment rate will be calculated as the number of participants randomized per month over the recruitment period
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 24
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, week 24
Action Taken
Action taken will be measured using a 3-item question (Yes, No, Don't know).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At baseline, week 24
Change from baseline in Current memory concerns
Memory concerns will be evaluated using 2 Yes/No questions.
Measured: 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.
Measured: 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.
Measured: At baseline, week 24
Change from baseline in Depression
Depression will be assessed using a single Yes/No question.
Measured: 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.
Measured: 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.
Measured: At baseline, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start15 Nov 2021
- Primary completion16 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- LuciLab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Sojecci II Ltd
- Responsible party
- Sponsor
- Investigators
- Sylvie Belleville, PhD, Principal investigator, Centre de recherche de l'Institut Universitaire de gériatrie de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141578
- Sponsor's protocol ID
- LUCI-02
- Status last verified
- Dec 2021
- First submitted
- 19 Nov 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05141578
- Acronym / sponsor ID
- LUCI-02
- Conditions
- Risk Behavior, Cognitive Decline
- Keywords
- Primary Prevention, Aging, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- LuciLabIndustry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Sojecci II Ltd
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Luci Intervention | Experimental | Behavioral: Luci Coach Assisted InterventionParticipants enrolled in this group will receive the Luci intervention for a 24-week period. |
| 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Luci Coach Assisted InterventionThe 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. | Behavioural | Luci Intervention |
Primary outcome
Enrollment Ratio
Time frame: At baseline post-enrollment
Screening-to-enrollment ratio will be calculated as the number of enrolled participants over the number of screened participants.
Recruitment Rate
Time frame: At baseline post-randomization
Recruitment rate will be calculated as the number of participants randomized per month over the recruitment period
Acceptability of randomization
Time frame: Week 24
Acceptability of randomization will be assessed by comparing the post-randomization dropout rate in the control group relative to the intervention group.
Retention rate
Time frame: Week 24
Retention rate will be calculated as the proportion of randomized participants completing at least one of the measures at study end.
Program adherence
Time frame: Week 24
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.
21 secondary outcomes
Change from baseline in Cognitive Engagement
Time frame: At baseline, week 12, week 24
Change from baseline in Physical Activity
Time frame: At baseline, week 12, week 24
Change from baseline in Sitting Time
Time frame: At baseline, week 12, week 24
Change from baseline in Mediterranean Diet Adherence
Time frame: At baseline, week 12, week 24
Change from baseline in Luci Cognitive Engagement Score
Time frame: At baseline, week 12, week 24
Change from baseline in Luci Physical Activity Score
Time frame: At baseline, week 12, week 24
Change from baseline in Luci Medi Diet Adherence Score
Time frame: At baseline, week 12, week 24
Goal Attainment (Luci Coach Assisted Intervention condition only)
Time frame: On a weekly basis from week 1 to 12, and every 2 weeks from week 13 to 24
Perceived Progress
Time frame: Week 12, week 24
Change from baseline in Readiness to Change (Luci Coach Assisted Intervention condition only)
Time frame: At baseline, week 24
Action Taken
Time frame: At baseline, week 24
Change from baseline in Expectation (Luci Coach Assisted Intervention condition only)
Time frame: At baseline, week 24
Overall User Experience (Luci Coach Assisted Intervention condition only)
Time frame: Week 24
Platform Usage
Time frame: Continuously from baseline until week 24
Change from baseline in Cognitive Performance
Time frame: At baseline, week 24
Change from baseline in Current memory concerns
Time frame: At baseline, week 24
Change from baseline in Perceived Stress
Time frame: At baseline, week 24
Change from baseline in Sleep Quality
Time frame: At baseline, week 24
Change from baseline in Depression
Time frame: At baseline, week 24
Change from baseline in Quality of Life
Time frame: At baseline, week 24
Change from baseline in Dementia Literacy
Time frame: At baseline, week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Belleville, PhD principal investigator
Centre de recherche de l'Institut Universitaire de gériatrie de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luci Coach Assisted Intervention in people with Risk Behavior and Cognitive Decline, run by LuciLab at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Ratio (time frame: At baseline post-enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.