- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02329015
Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools
September 17, 2016 updated by: Marshall Hagins, Long Island University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10009
- Eastside Community High School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- • Male or female students attending NYC schools
Exclusion Criteria:
- Lack of permission to attend physical education class
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health and Wellness program
Behavioral intervention
|
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).
|
|
Active Comparator: Physical Education Class
Behavioral intervention
|
Standard physical education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Academic Performance: Grade Point Averages
Time Frame: 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response to Stress Questionnaire (RSQ)
Time Frame: 1 year
|
A 57-item self-report questionnaire that was used as a measure of emotional regulation We examined two of the five constructs (24 of the 57 items) within the RSQ as these were most directly theoretically relevant to expected changes due to yoga practice: voluntary engagement and involuntary engagement.
Higher values represent higher levels of negative stress responses.
Values for the voluntary engagement subscale represent the mean value across 9 questions on the survey and values for the involuntary subscale represent the mean value across 15 questions on the survey.
Values for each item range from 0-3, trherefore the total mean values reported as outcomes range from 0-3.
|
1 year
|
|
Warwick Edinburgh Mental Well Being Scale
Time Frame: 1 year
|
A 14 item self-report measure assessing subjective well-being (1-5 scale).
Higher values represent more positive mental well being.
The summary measure is a sum of the 14 questions (not a mean).
Summary values therefore range from 14-70.
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self Report Questionnaire (Child and Adolescent Mindfulness Measure)
Time Frame: 1 year
|
A 10 item self-report measure assessing mindfulness skills (Scale 1-4).
Items are reverse scored and summed (not mean).
Higher scores mean more positive mindfulness skills.
Min and maximum scores are 0-40.
|
1 year
|
|
Student Self-Report Behavior Rating Inventory of Executive Function
Time Frame: 1 year
|
An 80 item self-report questionnaire assessing executive function and self regulation.
The BRIEF-SR measures 8 non-overlapping clinical scales that measure different aspects of executive functioning with the Inhibit, Shift, Emotional control and Monitor subscales combining to create a Behavioral Regulation Index (BRI) and the Working Memory, Plan/Organize, Organization of Materials and Task Completion combining to create a Meta Cognition Index.
These two indices combine to create a Global Executive Composite (GEC).
Only the GEC was used within this study for analysis.
Raw scores were converted to T scores (using gender and age for population norms) wherein a score of 50 represents the mean and a difference of 10 from the mean indicates a difference of one standard deviation.
|
1 year
|
|
Teacher Report Behavior Rating Inventory of Executive Function
Time Frame: One year
|
Teacher reported 87 item questionnaire on students executive function and self regulation.
The BRIEF for teachers measures 8 non-overlapping theoretically and empirically derived clinical scales that measure different aspects of executive functioning with the Inhibit, Shift, Emotional control and Monitor subscales combining to create a Behavioral Regulation Index (BRI) and the Working Memory, Plan/Organize, Organization of Materials and Task Completion combining to create a Meta Cognition Index.
These two indices combine to create a Global Executive Composite (GEC).
Only the GEC was used within this study for analysis Raw scores were converted to T scores (using gender and age for population norms) wherein a score of 50 represents the mean and a difference of 10 from the mean indicates a difference of one standard deviation.
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marshall Hagins, PhD, Long Island University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
December 29, 2014
First Submitted That Met QC Criteria
December 30, 2014
First Posted (Estimate)
December 31, 2014
Study Record Updates
Last Update Posted (Estimate)
November 4, 2016
Last Update Submitted That Met QC Criteria
September 17, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SONIMA001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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