Houston Independent School District (HISD) Yoga Evaluation

NCT02606591 | Terminated

• 1 other identifier: PA15-0677
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Health and Wellness

Keywords

Electroencephalograph; EEG; Hair sample; Cognitive tests; Cortisol analysis; Brain activity; Stress hormones

Outcome Measures

Primary Outcomes (2)

• Feasibility of Collecting Electroencephalograms (EEGs; for Brain Activity Analysis in Elementary-Aged Children Participating in a Health and Wellness Program

  Trial feasible if 50% of students who are enrolled complete the EEG's.

  9 months

• Feasibility of Collecting Hair Samples (for Cortisol Analysis) in Elementary-Aged Children Participating in a Health and Wellness Program

  Trial feasible if 50% of students who are enrolled submit hair samples.

  9 months

Secondary Outcomes (1)

• Changes in EEG During Each State (Eyes Open, Eyes Closed, and During Cognitive Testing)

  At baseline and at 9 months

Study Arms (1)

Electroencephalograph (EEG) + Testing

EXPERIMENTAL

Participants complete an electroencephalograph (EEG) cognitive tests, and provide a hair sample shortly after entering the study and again near the end of the school year. Hair sample tested to measure a stress hormone called cortisol.

Procedure: Electroencephalograph; Behavioral: Cognitive Tests; Other: Hair Sample

Interventions

Electroencephalograph PROCEDURE

EEG performed at beginning and end of school year.

Also known as: EEG

Electroencephalograph (EEG) + Testing

Cognitive Tests BEHAVIORAL

During the EEG, participant asked to wear headphones and do some simple tests on the computer that measure their abilities to see, hear, and understand information.

Electroencephalograph (EEG) + Testing

Hair Sample OTHER

Participants provide a sample of hair at baseline (near the beginning of school), and follow-up (near the end of school). Sample tested to measure cortisol levels.

Electroencephalograph (EEG) + Testing

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Lorenzo Cohen, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 17, 2015
• Study Start: March 31, 2016
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (1)