Clinical trial NCT06070025: Impact of Pre-Military Life Experiences/Exposures on Active-Duty Service Members' Psychological Health
Official title: Impact of Pre-Military Life Experiences/Exposures on Active-Duty Service Members' Psychological Health and Adjustment Over a Marine Battalion Deployment Cycle
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Traumatic Brain Injury
Keywords: brain health
traumatic brain injury
marines
wearables
physiological sensors
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy service members of the 1st Marine Division 1st Battalion out of Camp Pendleton, CA

Brief summary: The goal of this observational study is to learn about the impact of historic and current Traumatic Brain Injuries on a Marine Battalion. Its main objectives are:

* Establish individual mental and physical performance profile and brain health baseline in Infantry Marines
* Develop predictive models to identify early signs of mental and/or physical degradation that can help predict "red-line" behavioral events and degradation in brain health.
* Gather insights that will lead to developing personalized, evidence-based interventions to restore mental and physical performance.
* Increase warfighter self-knowledge and personal awareness to monitor and maximize performance.

Participants will wear wear smart watches and analyte sensors to track their real time physiological and sleep measures and complete subjective and psychological measures in a custom research app.

Detailed description: To prevent brain health degradation, it is necessary to understand the factors that contribute to brain insult and injury. The investigators aim to understand and identify pre-exposure risk, reversible and irreversible injury, and the impact of stressors. The investigators will research the real-time interaction between exposure and injury biomarkers and identify how the interaction affects long-term health and measures such as time to recovery.

The project will work with a newly formed Infantry Marine Battalion on Camp Pendleton. This group of Service Members will have many that are beginning their military careers, and thus will bring in only the components of brain health and emotional trauma they have accumulated during their civilian lives to this point.

Participants will be provided with a customized research mobile application that will obtain baseline information related to their military history and experience, and then continuously track activity, physiologic parameters, sleep, cognition and emotional state. Detailed dietary consumption and metabolic data, if indicated, will be tracked and displayed. The data will be collected continuously

During the study, participants will be provided with their data in real-time and this will be displayed along with their schedule and tasks. During and upon completion of the study investigators will provide a detailed summary and analysis of their health and human performance metrics, including insights on how diet and activity impacts their metabolic control or other biomarkers and how all of these factors impact sleep, cognition and behavioral state. The investigators will collaborate with the participants to identify the most useful data displays and information that will best help them achieve optimized physical, mental and cognitive training and recovery and gain understanding of how metabolic control or other biomarkers impact these metrics.

These insights will be used to develop insight dashboards on the holistic health metrics mentioned above, and help provide optimization insights. We will work with participants to create additional app content specific for them that relates to optimal diet and mental and physical training and recovery.

Eligibility criteria: Inclusion Criteria:

* Members of the 1st Marine Division 1st Battalion

Exclusion Criteria:

* None

Primary outcomes:
measure: Explanation of Outcomes
timeFrame: 18 months
measure: Establish individual mental and physical performance profile and brain health baseline in Infantry Marines.
timeFrame: 1 month
measure: Develop predictive models
timeFrame: 18 months
measure: Increase warfighter self-knowledge and personal awareness
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Camp Pendleton
state: California
Study officials:
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