Health and Wellness Clinical Trial
Official title:
Houston Independent School District (HISD) Yoga and Wellness Program Evaluation
The goal of this research study is to learn about how brain activity, cognitive tests (tests of participant's brain function), and stress hormones are related to taking part in a health and wellness program in elementary-aged students.
If participant agrees to take part in this study, they will complete an electroencephalograph
(EEG -- a test that measures the electrical activity of the brain), cognitive tests, and
provide a hair sample shortly after they enter the study and again near the end of the school
year.
The testing will take place in a room at participant's school chosen by the teachers. A
member of the study staff will walk participant from their classroom and be with them the
whole time the testing is taking place and then take them back to their classroom. If the
testing is done before or after school, participant will stay with the member of study staff
until their parent or guardian comes to pick them up.
During the EEG, researchers will place 19 electrodes on participant's head and 1 or 2
electrodes on each earlobe. Gel will be used to help attach the electrodes. The electrodes
will measure and record participant's brain wave activity, similar to the way a doctor
listens to their heart beat from the surface of their skin. During the EEG, participant will
be also asked to wear headphones and do some simple tests on the computer that measure their
abilities to see, hear, and understand information. The EEG will take up to 5 minutes to set
up and then 25 minutes for testing.
Participant will also provide a sample of hair, about 75 strands which is like the thickness
of a pencil. The hair will tested to measure a stress hormone called cortisol. The hair will
be destroyed after study testing.
Data obtained from the hair samples and EEG will be analyzed alongside the data participant
is providing our collaborators at the University of San Diego and the Houston Independent
School District.
The EEG that is collected for this study is for research purposes only. It is not the same as
a "clinical EEG" that is used in medical diagnosis. The EEG that the study staff will collect
looks at how the brain functions. It is not designed to look for medical conditions, the way
that an MRI or CAT scan would be used. However, if a possible medical condition is suspected,
participant will be told to follow up with their medical provider.
Length of Participation:
Participation on this study will be over after participant provides a hair sample, complete
the EEG, and complete the cognitive tests the second time near the end of the school year.
This is an investigational study.
Up to 200 participants will be enrolled in this study. All will take part through MD Anderson
at their schools.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03431051 -
The Impact of Workplace Food and Beverage Choices on Health and Wellness
|
N/A |