Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention

NCT04616794 | Completed

• 1 other identifier: LUCI-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Risk Behavior; Cognitive Decline

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)

Secondary Outcomes (11)

• Change from Baseline in Luci Cognitive Engagement Score at study end

  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

  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

  Baseline (within 1 week before the first coaching session) and study end (within 1 week after the last coaching session)

• Goal Attainment

  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

  Study end (within 1 week after the last coaching session)

Study Arms (4)

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)

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)

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).

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.

Behavioral: Multimodal group

Interventions

Cognitive Engagement Group BEHAVIORAL

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.

Cognitive Engagement Group

Physical Activity Group BEHAVIORAL

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.

Physical Activity Group

Diet Group BEHAVIORAL

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.

Diet Group

Multimodal group BEHAVIORAL

Participants assigned to this group will select which domain they wish to tackle first. Interventions are as described for the single-domain interventions.

Multi-modal Group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• LuciLab: lead
• Sojecci II Ltd: collaborator
• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: collaborator

Study Sites (1)

Sylvie Belleville

Montreal, Quebec, H3W 1W5, Canada

Location

MeSH Terms

Conditions

Risk-Taking; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sylvie Belleville, PhD

  Centre de recherche de l'Institut Universitaire de gériatrie de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: November 5, 2020
• Study Start: October 13, 2020
• Primary Completion: December 24, 2020
• Study Completion: January 15, 2021
• Last Updated: November 2, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)