The BrainHealth Project
ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-110
SponsorThe University of Texas at Dallas
About this trial
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/
Eligibility criteria
This trial accepts healthy volunteersQualifiers
English-speaking
Access to an internet connect and device
Able to read information and hear sounds
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
BrainHealth App-Based Program
BehavioralParticipants 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.
Treatment groups
100,000 Participants
are divided into 1 treatment groupGroup A: BrainHealth Intervention ProtocolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
BrainHealth Index (BHI)
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.
Time frame
Every 6 months until end of studySecondary outcomes
1
Neural and Physiological Markers of Brain Health
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.
Time frame
baseline, 6 months, then annually until study end2
Engagement in Intervention
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.
Time frame
From enrollment through study completionOther outcomes
1
Exploratory Participant-Reported and Task-Based Measures
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.
Time frame
Collected at varying intervals throughout participation2
Exploratory Wearable Device Metrics
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.
Time frame
Collected continuously and/or at varying intervals throughout participationSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas at Dallas
Lead sponsor
University of Iowa
Collaborator
University of California, Santa Barbara
Collaborator
University of Kansas Medical Center
Collaborator
Northeastern University
Collaborator
Georgia State University
Collaborator
University of Southern California
Collaborator
NeuroScouting
Collaborator
Source ClinicalTrials.gov