Trauma and Cardiometabolic Health in an American Indian Community
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorMontana State University
About this trial
Volunteers for the study are asked to participate in two laboratory sessions. In the first laboratory session, volunteers are asked to provide a blood sample which will be used to measure factors related to health. Participants also complete questionnaires related to demographic and health-related information and undergo evaluations of their body composition. In the second laboratory visit, participants are asked to have cardiovascular, neuroendocrine, and inflammatory activity measured during a brief period of rest and during a short challenging psychological task. Participants will also complete questionnaires. The study is designed to examine the associations between experiences such as trauma and resiliency with changes in bodily systems during a challenge and current health.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18-40 years
Identifying as American Indian
Living on or near Blackfeet reservation
Disqualifiers
Uncontrolled hypertension
Trial design
Design model
Single group
Treatments tested in this trial
Acute psychological stress task (Paced Auditory Serial Addition Task)
BehavioralVolunteers will complete a 4-minute Paced Auditory Serial Addition Task which is a standardized laboratory challenge that is widely used to monitor cardiovascular, neuroendocrine, and inflammatory responses in the laboratory.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Paced Auditory Serial Addition TaskExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in systolic blood pressure activity from baseline to task
The mean systolic blood pressure (mmHg) will be subtracted from the mean of the task period.
Time frame
10 minute resting baseline mean will be subtracted from the 4 minute task period for each value2
Changes in diastolic blood pressure activity from baseline to task
The mean diastolic blood pressure (mmHg) will be subtracted from the mean of the task period.
Time frame
10 minute resting baseline mean will be subtracted from the 4 minute task period for each value3
Changes in heart rate activity from baseline to task
The mean heart rate (bpm) will be subtracted from the mean of the task period.
Time frame
10 minute resting baseline mean will be subtracted from the 4 minute task period for each value4
Change in cortisol from baseline to task
Salivary samples will be taken to measure cortisol (nmol/L) the mean from the peak stress period will be subtracted from the baseline
Time frame
Baseline will be subtracted from the peak (15 minutes after task onset, 35 minute task onset)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Montana State University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Baylor University
Collaborator
Blackfeet Community College
Collaborator
Source ClinicalTrials.gov