The BrainHealth Project

June 18, 2026 updated by: Sandra Chapman, PhD, The University of Texas at Dallas

The BrainHealth Project, a Longitudinal Study in Generally Healthy Adults

The BrainHealth Project is a longitudinal study designed to identify factors associated with brain health and cognitive performance across the lifespan. Participants complete online assessments approximately twice per year to measure changes in cognitive, behavioral, and lifestyle-related domains.

Between assessments, participants have access to digital training modules, educational resources, and optional coaching sessions. A subset of participants may be invited to participate in additional components, including neuroimaging.

For an overview of the study and link TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/

Study Overview

Status

Recruiting

Conditions

Detailed Description

Description of Study:

The BrainHealth Project is a longitudinal study designed to examine factors associated with brain health, including both maintenance and changes in cognitive function across the lifespan. Additionally, researchers aim to identify more personalized practices for promoting brain health.

The study design is informed by prior longitudinal research, namely the Framingham study, demonstrating the value of large-scale, repeated assessments in identifying modifiable factors associated with health outcomes. The goal of this study is to characterize determinants of brain health and support future research on prevention and intervention strategies.

Participants complete online assessments approximately twice per year to measure changes in cognitive performance and related domains over time. Between assessment time points, participants may engage in digital training modules, educational resources, and optional coaching sessions.

Assessments:

BrainHealth Index (~70 min) - An online battery of cognitive measures and questionnaires. The Clarity section looks at complex thinking capacities such as reasoning, flexibility and strategy. In this section, you will be asked to complete different cognitive tasks. The questionnaires measure other aspects of life that relate to brain health, such as emotional well-being, quality of life, happiness, social support systems, and sleep. In this section, you will rate these aspects of your own life. Participants will also complete a 5 minute assessment with BrainHQ to measure processing speed.

The small group of participants who are invited to complete the brain imaging portion of the study will undergo annual brain imaging and will also complete brain gauge (in-person computer assessment). We will offer participants additional sub-studies, and they will have the opportunity to participate or not.

Additional and Exploratory Assessments:

Participants may be invited to complete additional optional surveys or behavioral tasks administered online to further characterize brain health and related behavioral, lifestyle, and biological domains. These additional assessments are exploratory in nature and are not designated as primary or secondary outcome measures.

Online Trainings, habits, and resources:

Trainings can be accessed through the online dashboard and include videos, exercises, and application opportunities. Trainings include strategies to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize Training will also include strategies for stress management and healthy sleep routines, as well as other brain health education and resources. Most trainings are no more than 10 minutes a day.

Online Coaching:

Online coaching sessions will be offered to participants. Participants can elect to take advantage of this offer to the extent they chose.

For an overview of the study and LINK TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/

Study Type

Interventional

Enrollment (Estimated)

100000

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 Contact Backup

Study Locations

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

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • English-speaking
  • Access to an internet connect and device
  • Able to read information and hear sounds

Exclusion Criteria:

  • Diagnosed neurodegenerative disease
  • History of stroke, concussion, or brain injury that currently hinders you from functioning at your prior level
  • Diagnosed with Autism Spectrum Disorder and not functioning independently

For an overview of the study and LINK TO REGISTER please go to -- https://brainhealth.utdallas.edu/programs/the-brainhealth-project/

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BrainHealth Intervention Protocol

Participants will engage in a BrainHealth app-based program tailored for this study. The program includes ongoing microlearning modules focused on supporting brain health through evidence-informed approaches, such as thinking strategies, cognitive exercises, lifestyle practices, stress management techniques, and other brain-healthy behaviors.

Participants can access educational resources on the broad topic of brain health and can utilize tools to support habit formation. Participants can complete (optional) coaching calls designed to support goal setting, accountability, and application of concepts learned through the program.

Participants will engage in a BrainHealth app-based program tailored for this study. The program includes ongoing microlearning modules focused on supporting brain health through evidence-informed approaches, such as thinking strategies, cognitive exercises, lifestyle practices, stress management techniques, and other brain-healthy behaviors.

Participants can access educational resources on the broad topic of brain health and can utilize tools to support habit formation. Participants can complete (optional) coaching calls designed to support goal setting, accountability, and application of concepts learned through the program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BrainHealth Index (BHI)
Time Frame: Every 6 months until end of study
Longitudinal change in overall brain health as measured by the BrainHealth Index (BHI), a multidimensional assessment that integrates cognitive performance, social-emotional functioning, well-being, purpose, and lifestyle-related factors. Analyses will evaluate changes in BHI scores (composite and factors) over time. Higher scores indicate better brain health.
Every 6 months until end of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neural and Physiological Markers of Brain Health
Time Frame: baseline, 6 months, then annually until study end

For the subset of participants completing in-person study visits, we will measure longitudinal change in neural and physiological markers of brain health, including neuroimaging-derived measures (e.g., cerebral blood flow, functional connectivity, and diffusion metrics) and physiological indicators (e.g., heart rate variability, sleep patterns, and physical activity measured through wearable devices). Relationships between these markers and BrainHealth Index scores will be evaluated over time.

This outcome includes multiple measures with differing scales and interpretations; therefore, the meaning of higher or lower values depends on the specific marker being evaluated.

baseline, 6 months, then annually until study end
Engagement in Intervention
Time Frame: From enrollment through study completion
Participant engagement with study intervention will be measured through training completion, coaching participation, and overall app utilization. Higher values generally indicate greater engagement with the intervention. Associations between engagement metrics and longitudinal changes in brain health outcomes will be evaluated throughout the study.
From enrollment through study completion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Participant-Reported and Task-Based Measures
Time Frame: Collected at varying intervals throughout participation

Participants may complete optional exploratory surveys and tasks assessing demographic, behavioral, lifestyle, health, cognitive, psychosocial, and life-experience factors that may be associated with brain health outcomes. Specific measures may be added or modified during the study to address emerging research questions.

This outcome includes multiple measures with differing scales and interpretations; therefore, the meaning of higher or lower values depends on the specific measure being evaluated.

Collected at varying intervals throughout participation
Exploratory Wearable Device Metrics
Time Frame: Collected continuously and/or at varying intervals throughout participation

Participants may optionally link personal wearable or fitness devices to the BrainHealth app. Shared data may include measures such as physical activity, sleep, heart rate, heart rate variability, and other health-related metrics available through connected devices. Relationships between wearable device metrics and brain health outcomes, including BrainHealth Index scores, will be evaluated over time.

This outcome includes multiple measures with differing scales and interpretations; therefore, the meaning of higher or lower values depends on the specific metric being evaluated.

Collected continuously and/or at varying intervals throughout participation

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2020

Primary Completion (Estimated)

August 1, 2038

Study Completion (Estimated)

August 1, 2038

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 23-745

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Subscribe