Kimel Family Centre for Brain Health and Wellness

NCT06933667 | Recruiting

• 1 other identifier: #23-26
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Participants (n=450; aged 50+; without a diagnosis of dementia; sufficiently fluent in English to complete the assessments and engage in programming) receive a comprehensive dementia risk assessment, including nonmodifiable and modifiable risk factors, from which they receive a Personalized Dementia Risk Report and Program Strategy, indicating their health conditions increasing and their risk level in five modifiable risk domains: physical activity, brain- healthy eating, cognitive engagement, social connections, and mental wellbeing. Equipped with this information, participants enroll in programs within the Centre to address their risk factors. Changes to their dementia risk, cognition, and Personalized Program Strategy are communicated through re-assessments of risk factors every six months (risk and cognition) and every year (comprehensive assessment).

Conditions

Prevention; Dementia

Keywords

personalized dementia prevention; lifestyle factors

Outcome Measures

Primary Outcomes (14)

• Physical Activity

  Hours of moderate-to-vigorous physical activity a week, as determined by the CHAMPS (0 - 168, with higher scores indicating greater activity).

  Every six months over two years.

• Cognition

  We expect cognition to be maintained or improved, as assessed by Cogniciti's Brain Health Assessment, to the extent that participants adhere to their Personalized Program Strategy.

  We expect to see this at the two year mark.

• Brain-Healthy Eating

  Brain-healthy eating as assessed by the Brain Health Food Guide derived Eating Pattern Self-Assessment (range 0 - 15, with higher scores indicating greater adherence to the Brain Health Food Guide).

  Every six months over two years.

• Cognitive Engagement

  Amount of engagement in higher-order cognitively engaging activities, as assessed by the Higher Cognition subscale of the Florida Cognitive Activities Scale (range 0-40, with higher scores indicated greater engagement).

  Every six months over two years.

• Social Connections

  Degree of loneliness as assessed by the UCLA Loneliness Scale (Version 3; range = 0-80, where higher scores indicate greater loneliness).

  Every six months over two years.

• Mental Wellbeing

  A composite of depression, anxiety, and (dis)stress from the Depression, Anxiety, and Stress Scale-21 (DASS-21), as well as perceived stress from the Perceived Stress Scale (with each subscale converted to a percentage of maximum and summed; range: 0 - 400).

  Every six months over two years.

• Diastolic Blood Pressure

  Diastolic Blood Pressure, which lower numbers indicated better blood pressure.

  Every year over two years.

• Systolic Blood Pressure

  Systolic Blood Pressure, where lower numbers indicate better blood pressure

  Every year over two years.

• Percent body fat

  Percent body fat as determined by dual-energy X-ray absorptiometry (DXA), where lower numbers indicate less body fat.

  Every year over two years.

• Low density lipoprotein

  Low density lipoprotein, assessed via blood draw, where lower numbers indicate less cholesterol.

  Every year over two years.

• C-reactive protein

  C-reactive protein, assessed via blood draw, where lower numbers indicate less inflammation.

  Every year over two years.

• Interleukin-6

  Interleukin-6, assessed via blood draw, where lower numbers indicate less inflammation.

  Every year over two years.

• HbA1c

  Hemoglobin A1C (HbA1c), measured through blood draw, where lower numbers indicate less blood sugar.

  Every year over two years.

• Cognition

  Cognition, assessed as an age- and sex-adjusted percentile on the Brain Health Assessment (an online cognitive assessment of episodic memory, working memory, and executive functioning).

  Every six months over two years.

Study Arms (5)

Physical Activity

ACTIVE COMPARATOR

Participants are encouraged to work up to the Canadian Guidelines of 150 minutes a week of moderate to vigorous activity and to focus on balance and stretching.

Behavioral: Physical Activity

Brain-healthy Eating

ACTIVE COMPARATOR

Participants are recommended to take five required courses about the CCNA Brain Health Food Guide, then take additional courses of their choice.

Behavioral: Brain-healthy Eating

Cognitive Engagement

ACTIVE COMPARATOR

Participants are encouraged to participate in at least one hour of cognitively engaging programs.

Behavioral: Cognitive Engagement

Social Connections

ACTIVE COMPARATOR

All programs, regardless of type, encourage social connections, through ice-breakers, peer mentoring, and time to chat before and after classes.

Behavioral: Social Connections

Mental Wellbeing

ACTIVE COMPARATOR

Participants are encouraged to participate in at least one hour of programming focused on mental wellbeing (e.g., meditation, relaxation).

Behavioral: Mental Wellbeing

Interventions

Physical Activity BEHAVIORAL

Participants can chose (with input from a kinesiologist as required) from courses of varying intensity in our gym, warm water pool, or classrooms.

Physical Activity

Brain-healthy Eating BEHAVIORAL

Participants take five foundational courses: Brain-healthy eating, Healthy protein choices, Colour your diet: Maximize the benefits of fruits and vegetables; Interpreting nutrition facts labels; and Salt and sugar: How much is too much? They are also encouraged to take additional nutrition programs.

Brain-healthy Eating

Cognitive Engagement BEHAVIORAL

Participants can sign up for any lecture, discussion group, book club, creative arts program, etc. linked to the Cognitive Engagement risk factor.

Cognitive Engagement

Social Connections BEHAVIORAL

Social Connections are baked into all other programming. Our instructors are trained in how to foster connections among participants, through peer coaching, ice-breakers, etc., and are asked to leave some time at the beginning and end of programs for participants to chat. We also hold special social events such as game nights.

Social Connections

Mental Wellbeing BEHAVIORAL

Participants are encouraged to enroll in one a week of relevant programming (e.g., meditation, relaxation).

Mental Wellbeing

Eligibility Criteria

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

You may qualify if:

• Aged 50 years or older
• Sufficiently fluent in English to complete the assessments and participate in programming.

You may not qualify if:

• Diagnosis of dementia.

Sponsors & Collaborators

• Baycrest: lead

Study Sites (1)

Baycrest

Toronto, Ontario, M6A 2E1, Canada

RECRUITING

Related Publications (1)

• Anderson ND, D'Amico D, Rotenberg S, Addis DR, Gillen J, Moore D, Furlano JA, Tan B, Binns M, Santarossa M, Chertkow H. Validation of a Community-Based Approach Toward Personalized Dementia Risk Reduction: The Kimel Family Centre for Brain Health and Wellness. J Prev Alzheimers Dis. 2024;11(5):1455-1466. doi: 10.14283/jpad.2024.98.

  PMID: 39350393 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Dementia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nicole D. Anderson, PhD, CPsych

  Baycrest

  PRINCIPAL INVESTIGATOR

• Howard Chertkow, MD

  Baycrest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole D. Anderson, PhD, CPsych

CONTACT

416-785-2500; nanderson@research.baycrest.org

Study Design

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

Model Details: Participants are encouraged to sign up for programs that address their specific cluster of modifiable dementia risk factors in five domains: physical activity, brain-healthy eating, cognitive engagement, social connections, and mental wellbeing.

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 18, 2025
• Study Start: March 26, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The study protocol has been published (http://dx.doi.org/10.14283/jpad.2024.98); the only exception is that due to funding, we are not currently including the episodic future simulation aspect of that report. That also describes our statistical analysis plan. The analytic code will be posted on OSF with the primary paper(s).
• Access Criteria: When it is on OSF, anyone can access it.

Locations

CA (1)