Risk BehaviorNCT04616794
Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention
A study testing Cognitive Engagement Group, Physical Activity Group and Diet Group 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 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?
- Cognitive Engagement Group, Physical Activity Group and Diet Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- 13 Oct 2020to 15 Jan 2021
- 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;
- 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 ≤ 15 on the CAQ
- Low level of physical activity defined as less than 600 MET-min/week (~150 minutes/week) of MVPA measured using the IPAQ-SF
- Low adherence to the Mediterranean-type diet defined as a score of ≤ 8 on the adapted Canadian MDS
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;
- Past or present neurological disorder;
- Severe psychiatric disorder;
- Uncontrolled cardiovascular or metabolic diseases;
- Alcoholism or drug addiction;
- Any other conditions expected to limit participation.
- Domain-Specific exclusion criteria
- Participants will be excluded from the physical activity intervention, but not the trial, if they have a medical contraindication to physical activity based on the Physical Activity Readiness Questionnaire
- Individuals with dietary restrictions due to medical reasons, allergies or severe intolerance or an history of eating disorders will be excluded from participation in the healthy diet intervention.
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 Proof-of-concept Study
The overarching aim is to develop and deploy a multidomain intervention delivered on a mobile application to help older adults reduce their risk for dementia by improving a set of modifiable lifestyle risk factors associated with cognitive decline/dementia. The targeted domains are physical activity, diet, and cognitively stimulating activity. This registration concerns the Proof-of-concept study which will examine if individual parts of the intervention program achieve a clinically significant degree of change in the targeted behavioral risk outcomes. It is expected that following the program, at least 50% of participants will show evidence of a clinically significant degree of change in the behavioral risk outcome targeted by the intervention, when compared to baseline.
Read the detailed description
There are encouraging indications from observational and prospective studies that late life multidomain lifestyle interventions can reduce the risk of cognitive decline and dementia, as well as improve cognition. However, these studies raise major issues related to scalability and adherence which can be addressed by relying on technology. These studies mainly used intensive and costly face-to-face interventions that are not easily implemented on a large scale. Furthermore, there are challenges with the adherence to all the components of a multi-domain lifestyle program.
Technology-delivered interventions have the potential to overcome some of the limitations of traditional face-to-face interventions. They confer numerous advantages including scalability of use in a real-world setting while limiting geographical constraints and other logistical challenges such as clinic attendance requirements. Such delivery modes also offer user convenience (e.g., undertaken at home and flexible schedule) and reduced costs associated with large-scale deployment of studies and programs.
In addition to the inclusion of technology, the success of health promotion interventions may also be improved by integrating models of lifestyle habit patterns and behaviour change determinants. The coach-based intervention will integrate behavioural change techniques based on the Behaviour Change Wheel developed by Michie. The coach intervention approach will also be guided by the Transtheoretical model of behaviour change principles proposed by Prochaska and DiClemente, and Motivational Interviewing techniques described by Rollnick and Miller.
The Proof-of-Concept study is a 10-week pre-post within-subject parallel group treatment-only study. There will be three single-domain groups (diet; physical activity or cognitive engagement), and one multidomain group. Participants will receive up to 9 weekly coach-assisted counselling sessions. The goal is to recruit up to 55 participants with at least one of the target risk factors : unhealthy diet, low level of cognitively stimulating activity or physical activity). Participants with a single risk factor will be invited to the single-domain condition for which they have a risk. Participants with multiple risk factors will be invited to the multidomain condition. The risk level for each domain will be examined before and after the intervention to assess whether the intervention has induced a clinically significant change.
- Conditions
- Risk Behavior, Cognitive Decline
- Being tested
- Cognitive Engagement Group, Physical Activity Group, Diet Group, Multimodal group
- 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.
Cognitive Engagement GroupBehavioural
Participants in this group will be encouraged to lead a cognitively stimulating lifestyle, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and suggestions about the different options to increase cognitively stimulating activities and by assisting participants outlining goals to progressively adopt a more cognitively active lifestyle.
Physical Activity GroupBehavioural
Participants in this group will be encouraged to lead a physically active lifestyle, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and suggestions about the different options to increase physical activities and by assisting participants outlining goals to progressively adopt a more physically active lifestyle.
Diet GroupBehavioural
Participants in this group will be encouraged to adopt a healthy diet, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and suggestions about the different options to change their diet and by assisting participants outlining goals to progressively adopt a Mediterranean-like diet.
Multimodal groupBehavioural
Participants assigned to this group will select which domain they wish to tackle first. Interventions are as described for the single-domain interventions.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Engagement Group | Experimental | Participants eligible to enter this group must show low cognitive engagement in cognitively stimulating activities, defined as a score < 22 on the Cognitive Activity Questionnaire (CAQ) Receives: Behavioral: Cognitive Engagement Group |
| Physical Activity Group | Experimental | Participants eligible to enter this group must have a low level of physical activity defined as less than 600 MET-min/week (~150 minutes/week) of moderate to vigorous physical activity (MVPA), measured using the International Physical Activity Questionnaire - short form (IPAQ-SF) Receives: Behavioral: Physical Activity Group |
| Diet Group | Experimental | Participants eligible to enter this group must have a low adherence to the Mediterranean-type diet defined as a score of ≤ 8 on the adapted Canadian Mediterranean Diet Scale (MDS). Receives: Behavioral: Diet Group |
| Multi-modal Group | Experimental | Participants eligible to enter this group must be eligible for at least two of the three single-arm conditions. Receives: Behavioral: Multimodal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Cognitive Engagement at study end
Cognitive engagement is measured using the Cognitive Activity Questionnaire (CAQ). 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: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Change from Baseline in Mediterranean Diet Adherence at study end
Adherence to the Mediterranean Diet is measured with an adaptation of the Canadian Mediterranean Diet Scale (MDS). 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: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Change from Baseline in Physical Activity at study end
Physical activity level is measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF consists of 7 items to assess Moderate to vigorous physical activity (MVPA) as well as walking and sitting time in the last 7 days. An overall total physical activity score is computed in Metabolic equivalent tasks (MET)-minutes/week, where a higher MET value represents a higher level of physical activity.
Measured: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Secondary outcomes (10)
Change from Baseline in Luci Cognitive Engagement Score at study end
Six questions are added to the Cognitive Activity Questionnaire to include stimulating cognitive activities not covered in the original questionnaire. From the whole questionnaire, a total score is computed ranging from 0 to 112, where a higher score represents a higher cognitive engagement level.
Measured: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Change from Baseline in Luci Mediterranean Diet Adherence Score at study end
Eight questions are added to the Canadian Mediterranean Diet questionnaire to include food groups and food intake habits not covered in the original questionnaire. From the whole questionnaire, a total score is computed ranging from 0 to 36, where a higher score represents a higher adherence level.
Measured: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Change from Baseline in Luci Physical Activity Score at study end
Three questions assess frequency and intensity of specific physical activities related to aerobic, resistance and flexibility training over the past 7 days. Three subscores and a total score ranging from 0-30 are computed, where higher scores represent higher physical activity levels.
Measured: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Goal Attainment
For each goal, level of attainment and perceived effort towards goal attainment are rated weekly using a 10-point Likert-like scale, where 10 represents "completed" and "maximal effort", respectively.
Measured: Weekly (within 1 week after the first coaching session) up to study end (within 1 week after the last coaching session)
Perceived Progress in adopting lifestyle changes
Perceived Progress in adopting lifestyle changes will be investigated with a single question, "To what extent do you think you changed your (domain specified) lifestyle since the beginning of the program?", using a 10-point Likert-like scale, where 10 represents a major change.
Measured: Study end (within 1 week after the last coaching session)
Change from Baseline in Readiness to change at study end
Readiness to change will be determined using a 6-item questionnaire at Baseline and a 3-item questionnaire at study end.
Measured: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Satisfaction with the Program
Satisfaction with the program is assessed using a 34-item questionnaire. This questionnaire includes questions derived from the end-user version of the Mobile App Rating Scale (uMARS), from the Satisfaction and Continuance Usage Intention Questionnaire, from the the Client Evaluation of Motivational Interviewing (CEMI), from the Behaviour Change Counselling Index (BECCI) as well as study-specific questions. Scores range from 0-5, where a higher score represents a higher satisfaction.
Measured: Study end (within 1 week after the last coaching session)
Program Usability
The usability of the program is assessed using the System Usability Scale (SUS). The SUS is a 10-item questionnaire. Scores range from 0-5, where a higher score represents a higher usability.
Measured: Study end (± 1 week after the last coaching session)
Overall User Experience
Feedback about the overall user experience with the platform will be collected using a semi-structured interview conducted by phone.
Measured: Study end (within 1 week after the last coaching session)
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: Baseline (within 1 week before the first coaching session) to study end (within 1 week after the last coaching session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start13 Oct 2020
- Primary completion24 Dec 2020
- Study completion15 Jan 2021
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The Luci intervention is a personalized lifestyle behaviour change program delivered via an interactive mobile platform with the online support of a coach. The system will allow participants to communicate with their coach through video calls and a messaging/chat system. The coaching sessions will focus on providing personalized support to help participants improve their eating habits, cognitive engagement and/or physical activity. The coach will offer assistance, feedback, information where appropriate, and motivational support throughout the trial. The Proof-of-Concept study is a 10-week pre-post within-subject parallel group treatment-only study. There will be three single-domain groups, and one multidomain group. Participants will receive coach-assisted counselling for up to 9 weeks.
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT04616794
- Sponsor's protocol ID
- LUCI-01
- Status last verified
- Feb 2021
- First submitted
- 13 Oct 2020
- Last updated
- 24 Aug 2026
- 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 24 Aug 2026. 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 Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT04616794
- Acronym / sponsor ID
- LUCI-01
- Conditions
- Risk Behavior, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 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
- 13 Oct 2020 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 5 Nov 2020 (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 older adults reduce their risk for dementia by improving a set of modifiable lifestyle risk factors associated with cognitive decline/dementia. The targeted domains are physical activity, diet, and cognitively stimulating activity. This registration concerns the Proof-of-concept study which will examine if individual parts of the intervention program achieve a clinically significant degree of change in the targeted behavioral risk outcomes. It is expected that following the program, at least 50% of participants will show evidence of a clinically significant degree of change in the behavioral risk outcome targeted by the intervention, when compared to baseline.
Detailed description
There are encouraging indications from observational and prospective studies that late life multidomain lifestyle interventions can reduce the risk of cognitive decline and dementia, as well as improve cognition. However, these studies raise major issues related to scalability and adherence which can be addressed by relying on technology. These studies mainly used intensive and costly face-to-face interventions that are not easily implemented on a large scale. Furthermore, there are challenges with the adherence to all the components of a multi-domain lifestyle program.
Technology-delivered interventions have the potential to overcome some of the limitations of traditional face-to-face interventions. They confer numerous advantages including scalability of use in a real-world setting while limiting geographical constraints and other logistical challenges such as clinic attendance requirements. Such delivery modes also offer user convenience (e.g., undertaken at home and flexible schedule) and reduced costs associated with large-scale deployment of studies and programs.
In addition to the inclusion of technology, the success of health promotion interventions may also be improved by integrating models of lifestyle habit patterns and behaviour change determinants. The coach-based intervention will integrate behavioural change techniques based on the Behaviour Change Wheel developed by Michie. The coach intervention approach will also be guided by the Transtheoretical model of behaviour change principles proposed by Prochaska and DiClemente, and Motivational Interviewing techniques described by Rollnick and Miller.
The Proof-of-Concept study is a 10-week pre-post within-subject parallel group treatment-only study. There will be three single-domain groups (diet; physical activity or cognitive engagement), and one multidomain group. Participants will receive up to 9 weekly coach-assisted counselling sessions. The goal is to recruit up to 55 participants with at least one of the target risk factors : unhealthy diet, low level of cognitively stimulating activity or physical activity). Participants with a single risk factor will be invited to the single-domain condition for which they have a risk. Participants with multiple risk factors will be invited to the multidomain condition. The risk level for each domain will be examined before and after the intervention to assess whether the intervention has induced a clinically significant change.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The Luci intervention is a personalized lifestyle behaviour change program delivered via an interactive mobile platform with the online support of a coach. The system will allow participants to communicate with their coach through video calls and a messaging/chat system. The coaching sessions will focus on providing personalized support to help participants improve their eating habits, cognitive engagement and/or physical activity. The coach will offer assistance, feedback, information where appropriate, and motivational support throughout the trial. The Proof-of-Concept study is a 10-week pre-post within-subject parallel group treatment-only study. There will be three single-domain groups, and one multidomain group. Participants will receive coach-assisted counselling for up to 9 weeks.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Engagement Group | Experimental | Behavioral: Cognitive Engagement GroupParticipants eligible to enter this group must show low cognitive engagement in cognitively stimulating activities, defined as a score < 22 on the Cognitive Activity Questionnaire (CAQ) |
| Physical Activity Group | Experimental | Behavioral: Physical Activity GroupParticipants eligible to enter this group must have a low level of physical activity defined as less than 600 MET-min/week (~150 minutes/week) of moderate to vigorous physical activity (MVPA), measured using the International Physical Activity Questionnaire - short form (IPAQ-SF) |
| Diet Group | Experimental | Behavioral: Diet GroupParticipants eligible to enter this group must have a low adherence to the Mediterranean-type diet defined as a score of ≤ 8 on the adapted Canadian Mediterranean Diet Scale (MDS). |
| Multi-modal Group | Experimental | Behavioral: Multimodal groupParticipants eligible to enter this group must be eligible for at least two of the three single-arm conditions. |
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;
- 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 (17 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 |
|---|---|---|
| Cognitive Engagement GroupParticipants in this group will be encouraged to lead a cognitively stimulating lifestyle, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and suggestions about the different options to increase cognitively stimulating activities and by assisting participants outlining goals to progressively adopt a more cognitively active lifestyle. | Behavioural | Cognitive Engagement Group |
| Physical Activity GroupParticipants in this group will be encouraged to lead a physically active lifestyle, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and suggestions about the different options to increase physical activities and by assisting participants outlining goals to progressively adopt a more physically active lifestyle. | Behavioural | Physical Activity Group |
| Diet GroupParticipants in this group will be encouraged to adopt a healthy diet, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and suggestions about the different options to change their diet and by assisting participants outlining goals to progressively adopt a Mediterranean-like diet. | Behavioural | Diet Group |
| Multimodal groupParticipants assigned to this group will select which domain they wish to tackle first. Interventions are as described for the single-domain interventions. | Behavioural | Multi-modal Group |
Primary outcome
Change from Baseline in Cognitive Engagement at study end
Time frame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Cognitive engagement is measured using the Cognitive Activity Questionnaire (CAQ). 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 Mediterranean Diet Adherence at study end
Time frame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Adherence to the Mediterranean Diet is measured with an adaptation of the Canadian Mediterranean Diet Scale (MDS). 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 Physical Activity at study end
Time frame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Physical activity level is measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF consists of 7 items to assess Moderate to vigorous physical activity (MVPA) as well as walking and sitting time in the last 7 days. An overall total physical activity score is computed in Metabolic equivalent tasks (MET)-minutes/week, where a higher MET value represents a higher level of physical activity.
10 secondary outcomes
Change from Baseline in Luci Cognitive Engagement Score at study end
Time frame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Change from Baseline in Luci Mediterranean Diet Adherence Score at study end
Time frame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Change from Baseline in Luci Physical Activity Score at study end
Time frame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Goal Attainment
Time frame: Weekly (within 1 week after the first coaching session) up to study end (within 1 week after the last coaching session)
Perceived Progress in adopting lifestyle changes
Time frame: Study end (within 1 week after the last coaching session)
Change from Baseline in Readiness to change at study end
Time frame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Satisfaction with the Program
Time frame: Study end (within 1 week after the last coaching session)
Program Usability
Time frame: Study end (± 1 week after the last coaching session)
Overall User Experience
Time frame: Study end (within 1 week after the last coaching session)
Platform usage
Time frame: Baseline (within 1 week before the first coaching session) to study end (within 1 week after the last coaching session)
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 24 Aug 2026.
- 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 Cognitive Engagement Group, Physical Activity Group and Diet Group 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 17 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 24 Aug 2026. 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?
Change from Baseline in Cognitive Engagement at study end (time frame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)). The study lists 3 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 24 Aug 2026.