The Brain Health PRO Online Risk Factor Reduction Study to Prevent Dementia (BHPROOF)

May 14, 2026 updated by: Haakon Nygaard, University of British Columbia

The Brain Health PRO Online Risk Factor Reduction Study for The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Recruiting
        • University of British Colubmia
        • Principal Investigator:
          • Haakon Nygaard, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate BHPro Intervention Group
Participants in this group will start Brain Health PRO immediately at baseline
Other: Brain Health PRO
Immediate start of 6-month Brain Health PRO Intervention
Other Names:
  • BHPro
Other: Brain Health PRO
Delayed start of 6-month Brain Health PRO
Other Names:
  • BHPro
Other: Delayed Start BHPro
Participants in this group will start Brain Health PRO in 6 months (delayed)
Other: Brain Health PRO
Immediate start of 6-month Brain Health PRO Intervention
Other Names:
  • BHPro
Other: Brain Health PRO
Delayed start of 6-month Brain Health PRO
Other Names:
  • BHPro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in modifiable risk factors as measured by a 7-item composite dementia risk factor score after 6 months.
Time Frame: Change from baseline to month 6
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 Health, 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires after 6 months: Physical Activity
Time Frame: Change from baseline to month 6
The International Physical Activity Questionnaire-Short Form is a brief 7-item self-report measure that captures types of and intensity of physical activity and sitting time. The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between 0-9, with a higher score indicating more 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
Time Frame: Change from baseline to month 6
Shorter 11-item version of the Eating Pattern Self-Assessment Questionnaire developed by CCNA Team 5. The total score is calculated by calculating the accrued number of points assigned per question. The total score ranges between 0 and 22, with a higher score indicating more healthy eating habits.
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
Time Frame: Change from baseline to month 6
Brief 10-item questionnaire developed by BHPro sleep module content leads that assesses sleep duration, sleep patterns, and difficulties and daytime fatigue over the past 3 months. The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between 1 and 20, with a higher score indicating healthier 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
Time Frame: Change from baseline to month 6
A 6-item questionnaire assessing types and duration of cognitively engaging activities. The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between 0 and 36, with a higher score indicating more cognitively stimulating activities.
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
Time Frame: Change from baseline to month 6
An 8-item questionnaire comprising 1 item on loneliness, 1 item on ageism, 1 item on subjective age, 1 item on essentialist beliefs of aging and 4 items on depression, anxiety, stress, and social support from STOP-D. The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between -1 and 50, with a higher score indicating poorer social and psychological health.
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: Vascular Health
Time Frame: Change from baseline to month 6
12-item self-report questionnaire developed by the BHPro Vascular Health team based on the American Heart Association's Life's Simple Seven checklist of the main risk factors for heart disease and stroke. The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between -4 and 8, with a higher score indicating better vascular health.
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: Vision and Hearing
Time Frame: Change from baseline to month 6
10-item questionnaire developed by BHSP Vision and Hearing Module content leads that assesses perceived visual and auditory ability and actions taken to address potential vision/hearing difficulties. The total score is calculated by summing the accrued number of points assigned per question. If a user selects "Yes" for example, they receive 2 points for that question. The total score ranges between 0 and 20 points, with a higher score indicating poorer vision and hearing.
Change from baseline to month 6
Change in self-efficacy as measured by the General Self-Efficacy Scale after 6 months.
Time Frame: Change from baseline to month 6
Change in self-efficacy following participation in the study, as measured by the General Self-Efficacy Scale (GSE). The GSE measures perceived competence in dealing with a range of stressful or challenging situations. This self-report questionnaire contains 10-items, each rated on a 4-point scale (not true at all, hardly true, moderately true, exactly true). The total score is the sum of the scores for the 10 items, which is quantitative and ranges from 10-40, with a higher score indicating more self-efficacy.
Change from baseline to month 6
Change in dementia literacy as measured by the Alzheimer's Disease Knowledge Scale after 6 months.
Time Frame: Change from baseline to month 6.
Change in dementia literacy following participation in the study, as measured by the Alzheimer's Disease Knowledge Scale (ADKS). The ADKS is designed to assess knowledge about Alzheimer's Disease (AD) among laypeople, patients, caregivers, and professionals. This self-report questionnaire contains 30 true/false items. The total score is the sum of the scores from the 30 items, which is quantitative and ranges from 0-30, with a higher score indicating better knowledge about AD.
Change from baseline to month 6.
Change in cognition as measured by the Cogniciti Brain Health Assessment after 6 months.
Time Frame: Change from baseline to month 6
The Cogniciti Brain Health Assessment (BHA) is a self-administered validated computerized cognitive assessment comprised of four tests (Spatial Working Memory, Stroop Interference, Face-Name Association, and Number-Letter Alternation). The overall Cogniciti Brain Health Assessment score ranges from 0-100 with a higher score indicating better cognition.
Change from baseline to month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)
Baycrest
Alzheimer Society of Canada
The Canadian Consortium on Neurodegeneration in Aging (CCNA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H25-03523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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