NCT05167045

Brief Summary

Prior studies have shown that programs that focus on promoting brain health and managing lifestyle risks (such as poor diet, obesity, physical inactivity, sleep issues, loneliness) may help in preventing or lowering the risk of dementia. To address this, investigators have developed the CAN-THUMBS UP program to conduct studies that target lifestyle risk and focus on dementia prevention. An online Brain Health Support Program (BHSP) has been developed. The BHSP is an educational program designed to teach about dementia. Before the full BHSP is offered to a large group, we are conducting an initial pilot study to help assess the usability of the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

November 1, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

January 16, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

November 1, 2021

Last Update Submit

January 15, 2026

Conditions

DementiaMild Cognitive ImpairmentSubjective Cognitive ImpairmentPre-dementiaDementia Prevention

Outcome Measures

Primary Outcomes (5)

  • Functionality of the BHSP

    Functionality of the web-based components of the BHSP measured in the pilot and qualitative focus group(s) questions

    Nov 2021-Mar 2022

  • User acceptance of the BHSP

    User adherence and engagement using the online program during the pilot including dates and times of use, duration of use and completion of program assessments

    Nov 2021-Mar 2022

  • Usability of the BHSP

    User satisfaction and evaluation of usability and acceptability of BHSP measured during the pilot and focus group(s)

    Nov 2021-Mar 2022

  • To assess participant satisfaction with the organization, presentation and personalization of the BHSP content

    Qualitative evaluation of participant responses during the focus group discussion

    Nov 2021-Mar 2022

  • To evaluate the feasibility of remote data collection

    User data, feedback and adherence to remote measures, such as: Screening evaluation by tele/video-conference, Neuropsychological Test Battery, Burst cognitive testing with the MyCogHealth app, online version of the Cogstate Brief Battery, Assessments of lifestyle risk factors (sleep, diet, mood, cognition, physical activity, vascular health, social and psychological health, vision and hearing), Actigraphy and EEG wearables as measures of total daily physical activity and sleep fragmentation, and Saliva sample collection for genomics testing (Polygenic Hazard Score)

    Nov 2021-Mar 2022

Study Arms (1)

No Dementia

Behavioral: Brain Health PRO

Interventions

Brain Health PROBEHAVIORAL

The BHSP is an educational program designed to teach about dementia. It aims to provide best available evidence for lifestyle changes that can help lower dementia risk, and to provide specific recommendations for positive lifestyle changes (e.g., physical exercises to try at home, healthy recipes). The program was developed as a collaborative effort by Canadian investigators who have expertise in the different areas of dementia prevention, along with input from older-adult citizen advisors.

Also known as: Brain Health Support Program
No Dementia

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will recruit it's cohort from various locations around Canada.

You may qualify if:

  • Meets criteria for No Dementia and one of the following (according to CCNA criteria):
  • Cognitively Intact (CI) Cognitively Intact plus Subjective Cognitive Impairment (CI + SCI) Mild Cognitive Impairment (MCI)
  • AND Classified as being at increased risk of dementia based on at least one of the following: First-degree family history of dementia
  • Self-Reported or documented current and/or history at midlife (45-60) on any of the following risk factors:
  • Hypertension (documented Systolic Blood Pressure \> 140 mm Hg; OR physician diagnosis of hypertension; OR treatment for hypertension; OR other approaches to treatment (e.g. diet, exercise))
  • Hypercholesterolemia (documented total cholesterol \> 6.5 mmol/L; OR physician diagnosis of hypercholesterolemia; OR treatment for hypercholesterolemia; OR other approaches to treatment (e.g. diet, exercise))
  • Body Mass Index \> 30 kg/m2 (derived from NIH Metric BMI Calculator)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

University of New Brunswick

Fredericton, New Brunswick, E3B 5A3, Canada

Location

Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location

Related Publications (2)

  • Philip G, Fiocco AJ, Belleville S, Chertkow H, Feldman HH, Montero-Odasso M, Nygaard HB, Savundranayagam MY; Canadian Consortium on Neurodegeneration in Aging (CCNA), CAN-THUMBS UP Study Group. Exploring the usability and perceived benefits of Brain Health PRO: An online educational program for healthy brain aging. Digit Health. 2025 Nov 19;11:20552076251395585. doi: 10.1177/20552076251395585. eCollection 2025 Jan-Dec.

    PMID: 41278371RESULT

  • Belleville S, Anderson ND, Bherer L, Camicioli R, Carrier J, Chan S, Cuesta M, Dang-Vu TT, Dwosh E, Fiocco AJ, Ferland G, Gilbert B, Harris E, Itzhak I, Jarrett P, Kadri MA, Laurin D, Liu-Ambrose T, McGibbon CA, Middleton L, Miller L, Nygaard HB, Montero-Odasso M, Murphy K, Phillips N, Pichora-Fuller MK, Robillard JM, Smith EE, Speechley M, Trigui A, Wittich W, Chertkow H, Feldman HH; CTU expert group for the Canadian Consortium on Neurodegeneration in Aging (CCNA), CAN-THUMBS UP Study Group. Brain health PRO/Sante cerveau PRO: The development of a web-based program for dementia literacy and risk factor reduction. J Prev Alzheimers Dis. 2025 Jun;12(6):100134. doi: 10.1016/j.tjpad.2025.100134. Epub 2025 Mar 15.

    PMID: 40090784RESULT

MeSH Terms

Conditions

DementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Director, Canadian Consortium on Neurodegeneration in Aging

Study Record Dates

First Submitted

November 1, 2021

First Posted

December 22, 2021

Study Start

November 15, 2021

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

January 16, 2026

Record last verified: 2025-12

Locations

CA(3)