Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools

Adolescent Behavior Clinical Trial

Official title:

Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02329015
• Other study ID #: SONIMA001
• 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

• Adolescent Behavior

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