Clinical trial NCT04616794: Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Behavior
Cognitive Decline
Lead sponsor: LuciLab
Sponsor class: INDUSTRY
Collaborators: name: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
name: Sojecci II Ltd
First posted: 2020-11-05
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

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;
  * 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.

Primary outcomes:
measure: Change from Baseline in Cognitive Engagement at study end
timeFrame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
measure: Change from Baseline in Mediterranean Diet Adherence at study end
timeFrame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
measure: Change from Baseline in Physical Activity at study end
timeFrame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
Secondary outcomes:
measure: Change from Baseline in Luci Cognitive Engagement Score at study end
timeFrame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
measure: Change from Baseline in Luci Mediterranean Diet Adherence Score at study end
timeFrame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
measure: Change from Baseline in Luci Physical Activity Score at study end
timeFrame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
measure: Goal Attainment
timeFrame: Weekly (within 1 week after the first coaching session) up to study end (within 1 week after the last coaching session)
measure: Perceived Progress in adopting lifestyle changes
timeFrame: Study end (within 1 week after the last coaching session)
measure: Change from Baseline in Readiness to change at study end
timeFrame: Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)
measure: Program Quality
timeFrame: Study end (within 1 week after the last coaching session)
measure: Program Usability
timeFrame: Study end (± 1 week after the last coaching session)
measure: Satisfaction and Continuance Usage Intention
timeFrame: Study end (within 1 week after the last coaching session)
measure: Overall User Experience
timeFrame: Study end (within 1 week after the last coaching session)
measure: Platform usage
timeFrame: Baseline (within 1 week before the first coaching session) to study end (within 1 week after the last coaching session)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Sylvie Belleville
state: Quebec
Study officials:
affiliation: Centre de recherche de l'Institut Universitaire de gériatrie de Montréal
name: Sylvie Belleville, PhD
role: PRINCIPAL_INVESTIGATOR
References: