Clinical trial NCT02606591: Houston Independent School District (HISD) Yoga Evaluation
Official title: Houston Independent School District (HISD) Yoga and Wellness Program Evaluation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Health and Wellness
Keywords: Electroencephalograph
EEG
Hair sample
Cognitive tests
Cortisol analysis
Brain activity
Stress hormones
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 5
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Fourth and Fifth graders in Houston Independent School District (HISD) schools that are participating in the Sonima Foundation's Health and Wellness Program
2. Participant on USD study protocol.

Exclusion Criteria: 1)

1. Participants who are taking any antipsychotic medications
2. Participants with active central nervous system (CNS) disease or encephalopathy
3. Participants who have ever been diagnosed with bipolar disorder or schizophrenia
4. Participants who have a history of head injury or who have a known seizure activity.

Primary outcomes:
measure: Feasibility of Collecting Electroencephalograms (EEGs; for Brain Activity Analysis in Elementary-Aged Children Participating in a Health and Wellness Program
timeFrame: 9 months
measure: Feasibility of Collecting Hair Samples (for Cortisol Analysis) in Elementary-Aged Children Participating in a Health and Wellness Program
timeFrame: 9 months
Secondary outcomes:
measure: Changes in EEG During Each State (Eyes Open, Eyes Closed, and During Cognitive Testing)
timeFrame: At baseline and at 9 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorenzo Cohen, PHD
role: PRINCIPAL_INVESTIGATOR
References: