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Completed

NCT Number: NCT05167045

A Pilot Study for the Brain Health Support Program

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Prevention Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Pre-dementia Subjective Cognitive Impairment

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Treatment and study plan

Brain Health PRO

Behavioral

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.

Other names: Brain Health Support Program

Primary outcomes

  1. Functionality of the BHSP

    Time frame: Nov 2021-Mar 2022

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

  2. User acceptance of the BHSP

    Time frame: Nov 2021-Mar 2022

    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

  3. Usability of the BHSP

    Time frame: Nov 2021-Mar 2022

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

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

    Time frame: Nov 2021-Mar 2022

    Qualitative evaluation of participant responses during the focus group discussion

  5. To evaluate the feasibility of remote data collection

    Time frame: Nov 2021-Mar 2022

    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)

Sponsors and collaborators

Lead sponsor

Baycrest

Other

Registry information

Official study title

A Pilot Study for the Brain Health Support Program (BHSP) Intervention of the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia

Acronym: CTU BHSP-P

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 22, 2021
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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