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

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ClinicalTrials.gov Identifier: NCT02329015
Recruitment Status : Completed
First Posted : December 31, 2014
Results First Posted : November 4, 2016
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Marshall Hagins, Long Island University

Tracking Information
First Submitted Date  ICMJE December 29, 2014
First Posted Date  ICMJE December 31, 2014
Results First Submitted Date  ICMJE April 25, 2016
Results First Posted Date  ICMJE November 4, 2016
Last Update Posted Date November 4, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 30, 2014)
Self-report questionnaire (Response to Stress Questionnaire) [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2014)
  • Academic Performance: Grade Point Averages for each semester [ Time Frame: 1 year ]
    Grade Point Averages for each semester
  • Self-report questionnaire (Warwick Edinburgh Mental Well being Scale) [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures
 (submitted: September 17, 2016)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: December 30, 2014)
  • Self Report Questionnaire (Child and Adolescent Mindfulness Measure) [ Time Frame: 1 year ]
  • Self-Report questionnaire of executive function [ Time Frame: 1 year ]
 
Descriptive Information
Brief Title  ICMJE Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools
Official Title  ICMJE Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Adolescent Behavior
Intervention  ICMJE
  • 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).
  • Behavioral: Physical Education Class
    Standard physical education
Study Arms  ICMJE
  • Experimental: Health and Wellness program
    Behavioral intervention
    Intervention: Behavioral: Yoga-informed Health and Wellness Program
  • Active Comparator: Physical Education Class
    Behavioral intervention
    Intervention: Behavioral: Physical Education Class
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2016)
112
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2014)
100
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • • Male or female students attending NYC schools

Exclusion Criteria:

  • Lack of permission to attend physical education class
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02329015
Other Study ID Numbers  ICMJE SONIMA001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marshall Hagins, Long Island University
Study Sponsor  ICMJE Long Island University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marshall Hagins, PhD Long Island University
PRS Account Long Island University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP