NCT07364019

Brief Summary

This study will recruit participants at risk for dementia to participate in an online educational program called Brain Health PRO (BHPro). The BHPro intervention is designed to address modifiable risk factors for dementia through a 6-month, fully online, educational program conveying the best available evidence for lifestyle changes that can mitigate dementia risk, and foster engagement toward one's own brain health. Achieving lifestyle changes in a diverse Canadian population through online education would be a major achievement in dementia prevention in Canada, with widespread personal and socioeconomic benefits. Eligible participants will be randomly assigned to either start Brain Health PRO immediately or in 6 months (delayed-start control group). All participants will have the opportunity to have access to BHPro for 6 months during the course of the study and will have open access to all content for 12 months following the initial 6-month intervention. Participation will last from 18-24 months depending on group assignment.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Oct 2028

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Dementia PreventionSubjective Cognitive ImpairmentMild Cognitive ImpairmentCognitive ChangeLifestyle InterventionDementia Education

Keywords

dementia educationat risk for dementialifestyle interventiondementia reductiondementia risk factordementia preventioncognitive impairmentAlzheimer risk

Outcome Measures

Primary Outcomes (1)

  • Change in modifiable risk factors as measured by a 7-item composite dementia risk factor score after 6 months.

    The primary outcome is the change in a composite modifiable risk score comprised of the following 7 lifestyle risk questionnaires: Physical Activity, Nutrition, Sleep, Cognitive Engagement, Social and Psychological Health, Vascular Heatlh, and Vision and Hearing (each questionnaire is individually described under the secondary outcomes). Scores for each risk factor will be standardized (z-score transformation using cohort-wide mean and standard deviation at baseline). When necessary, scores will be multiplied by -1 so that positive scores reflect lower risk (e.g., greater engagement in physical activity). The participant-level mean risk score will be calculated which reflects the average z-score for the participant across the modifiable risk factors.

    Change from baseline to month 6

Secondary Outcomes (10)

  • Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Physical Activity

    Change from baseline to month 6

  • Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Nutrition

    Change from baseline to month 6

  • Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Sleep

    Change from baseline to month 6

  • Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Cognitive Engagement

    Change from baseline to month 6

  • Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Social and Psychological Health

    Change from baseline to month 6

  • +5 more secondary outcomes

Study Arms (2)

Immediate BHPro Intervention Group

EXPERIMENTAL

Participants in this group will start Brain Health PRO immediately at baseline

Other: Brain Health PRO

Delayed Start BHPro

OTHER

Participants in this group will start Brain Health PRO in 6 months (delayed)

Other: Brain Health PRO

Interventions

Brain Health PROOTHER

Immediate start of 6-month Brain Health PRO Intervention

Also known as: BHPro
Immediate BHPro Intervention Group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completion and documentation of the electronic Informed Consent Process (from the participant)
  • Sufficient proficiency in English or French to undergo online assessments and participate in an online educational program.
  • Technical ability to participate in an online educational program and remote assessments (i.e., regularly have access to a computer or tablet with an internet connection; have access to a desktop or laptop computer with an internet connection at least once every 6 months; ability to send and receive emails; ability to complete online assessments)
  • Sufficient vision to participate in an online educational program and complete online cognitive testing
  • Ages 50-80
  • Classified as being at increased risk of dementia based on at least one of the following:
  • First-degree family history of dementia
  • Education level at or below high school (grade 12 or less)
  • Self-Reported: Hypertension, Hypercholesterolemia, Body Mass Index \> 30 kg/m2 (derived from NIH Metric BMI Calculator), or Physical Inactivity (active is defined as engaging in a minimum of 20- 30 min of physical activity causing sweating and breathlessness, at least 2 times a week)

You may not qualify if:

  • Individuals who have a clinical diagnosis of Dementia (based on self-report)
  • Individuals who are currently participating in or have participated in a past study involving BHPro

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Colubmia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Pennny Slack, MSc

CONTACT

604-822-6379penny.slack@ubc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: This is a randomized delayed-start control trial examining the effects of the 6-month BHPro Intervention on modifiable lifestyle risk factors in older adults at risk for dementia. Participants will be randomized to either immediately receive the BHPro intervention or to the control group (6 month delayed start).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2028

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Locations

CA(1)