NCT02329015

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 4, 2016

Completed
Last Updated

November 4, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

December 29, 2014

Results QC Date

April 25, 2016

Last Update Submit

September 17, 2016

Conditions

Keywords

stressalternativecomplementaryself-regulation

Outcome Measures

Primary Outcomes (1)

  • Academic Performance: Grade Point Averages

    GPA was calculated as the numeric average of course scores of all courses taken by the student weighted by credit load of each course using a standard process within NYC public schools.

    1 year

Secondary Outcomes (2)

  • Response to Stress Questionnaire (RSQ)

    1 year

  • Warwick Edinburgh Mental Well Being Scale

    1 year

Other Outcomes (3)

  • Self Report Questionnaire (Child and Adolescent Mindfulness Measure)

    1 year

  • Student Self-Report Behavior Rating Inventory of Executive Function

    1 year

  • Teacher Report Behavior Rating Inventory of Executive Function

    One year

Study Arms (2)

Health and Wellness program

EXPERIMENTAL

Behavioral intervention

Behavioral: Yoga-informed Health and Wellness Program

Physical Education Class

ACTIVE COMPARATOR

Behavioral intervention

Behavioral: Physical Education Class

Interventions

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).

Health and Wellness program

Standard physical education

Physical Education Class

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male or female students attending NYC schools

You may not qualify if:

  • Lack of permission to attend physical education class

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastside Community High School

New York, New York, 10009, United States

Location

MeSH Terms

Conditions

Adolescent BehaviorSelf-Control

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

This study had several limitations including the lack of blinding of tester and an excessive reliance on self-report. Analysis limited by an inability to test effects due to clustering. Novelty, Pygmalion, or motivational effect cannot be ruled out.

Results Point of Contact

Title
Marshall Hagins PhD, PT
Organization
Long Island University

Study Officials

  • Marshall Hagins, PhD

    Long Island University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 29, 2014

First Posted

December 31, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 4, 2016

Results First Posted

November 4, 2016

Record last verified: 2016-09

Locations