An interventional study of Cognitive Engagement Group and Physical Activity Group in Risk Behavior and Cognitive Decline, sponsored by LuciLab. Completed at 1 site in Canada. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by LuciLab · Not applicable, Interventional, and Prevention
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.
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.
136 studies on the registry are indexed under Risk-Taking; 18 are open to participants now.
This study's enrollment of 41 is below the median of 255 across 117 interventional studies indexed under Risk-Taking.
Browse Risk-Taking studies →LuciLab is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least one of the following:
Exclusion Criteria
Having received a diagnosis of:
Domain-Specific exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Behavioral: Cognitive Engagement Group
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)
Behavioral: Physical Activity Group
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).
Behavioral: Diet Group
Participants eligible to enter this group must be eligible for at least two of the three single-arm conditions.
Behavioral: Multimodal group
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.
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.
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.
Participants assigned to this group will select which domain they wish to tackle first. Interventions are as described for the single-domain interventions.
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.
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 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.
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 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.
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 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.
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
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.
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
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.
Time frame: 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.
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
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (within 1 week before the first coaching session) to study end (within 1 week after the last coaching session)
Plan to share: No
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