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

• 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: Long Island University
• Information provided by (Responsible Party): Marshall Hagins, Long Island University

Tracking Information

• First Submitted Date: December 29, 2014
• First Posted Date: December 31, 2014
• Results First Submitted Date: April 25, 2016
• Results First Posted Date: November 4, 2016
• Last Update Posted Date: November 4, 2016
• Study Start Date: September 2014
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: December 30, 2014): Self-report questionnaire (Response to Stress Questionnaire) [ Time Frame: 1 year ]

Current Secondary Outcome Measures (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 (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: Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Condition: 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).
• Behavioral: Physical Education Class
  Standard physical education

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 17, 2016): 112
• Original Estimated Enrollment (submitted: December 30, 2014): 100
• Actual Study Completion Date: August 2015
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• • Male or female students attending NYC schools

Exclusion Criteria:

• Lack of permission to attend physical education class

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02329015
• Other Study ID Numbers: SONIMA001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Marshall Hagins, Long Island University
• Study Sponsor: Long Island University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Marshall Hagins, PhD; Long Island University

• PRS Account: Long Island University
• Verification Date: September 2016