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NCT Number: NCT04869111

The BrainHealth Project

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/

Recruiting

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Key information

Conditions

Healthy

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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/

Who can participate

Healthy volunteers accepted: Yes

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

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/

Treatment and study plan

BrainHealth App-Based Program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erin C, MS

CONTACT

[email protected]

9728833208

Margaret Chaplin, MA

CONTACT

[email protected]

(972) 883-3347

Sponsors and collaborators

Lead sponsor

The University of Texas at Dallas

Other

Collaborators

  • Georgia State University
  • NeuroScouting
  • Northeastern University
  • University of California, Santa Barbara
  • University of Iowa
  • University of Kansas Medical Center
  • University of Southern California

Registry information

Official study title

The BrainHealth Project, a Longitudinal Study in Generally Healthy Adults

Important dates

Study start
2020
Primary completion
2038
Study completion
2038
First posted
May 3, 2021
Registry last updated
Jun 23, 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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