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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02329015
Other study ID # SONIMA001
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received December 29, 2014
Last updated December 30, 2014
Start date September 2014
Est. completion date August 2016

Study information

Verified date December 2014
Source Long Island University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the academic and psycho-social benefits of a yoga-informed health and wellness program to a standard physical education program for middle and high school students within New York City schools.


Description:

Approximately 100 students at a public New York City High School will be randomized at the level of class into either the experimental (yoga-informed health and wellness program) or control arm (physical education class). Students will receive two classes per week of approximately 45 minutes throughout the academic year. Data will be collected in September 2014 and February and May of 2015.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 14 Years to 19 Years
Eligibility Inclusion Criteria:

- • Male or female students attending NYC schools

Exclusion Criteria:

- Lack of permission to attend physical education class

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Yoga-informed Health and Wellness Program
The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June).
Physical Education Class
Standard physical education

Locations

Country Name City State
United States Eastside Community High School New York New York

Sponsors (1)

Lead Sponsor Collaborator
Long Island University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Self Report Questionnaire (Child and Adolescent Mindfulness Measure) 1 year No
Other Self-Report questionnaire of executive function 1 year No
Primary Self-report questionnaire (Response to Stress Questionnaire) 1 year No
Secondary Academic Performance: Grade Point Averages for each semester Grade Point Averages for each semester 1 year No
Secondary Self-report questionnaire (Warwick Edinburgh Mental Well being Scale) 1 year No
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