Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention
Condition: Risk Behavior; Cognitive Decline
MeSH terms: Dementia; Cognitive Dysfunction
Study type: Interventional

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. 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.
    

Intervention name(s): Cognitive Engagement Group; Physical Activity Group; Diet Group; Multimodal group
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Prevention