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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Adolescent Behavior	Behavioral: Yoga-informed Health and Wellness Program; Behavioral: Physical Education Class	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools
• Study Start Date: September 2014
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Health and Wellness program; Behavioral 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).
Active Comparator: Physical Education Class; Behavioral intervention	Behavioral: Physical Education Class; Standard physical education

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Other Outcome Measures:

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 19 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• • Male or female students attending NYC schools

Exclusion Criteria:

• Lack of permission to attend physical education class

Contacts and Locations

Locations

United States, New York

Eastside Community High School

New York, New York, United States, 10009

Sponsors and Collaborators

Long Island University

Investigators

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

More Information

• Responsible Party: Marshall Hagins, Professor, Long Island University
• ClinicalTrials.gov Identifier: NCT02329015
• Other Study ID Numbers: SONIMA001
• First Posted: December 31, 2014
• Results First Posted: November 4, 2016
• Last Update Posted: November 4, 2016
• Last Verified: September 2016

Keywords provided by Marshall Hagins, Long Island University:

stress; alternative; complementary; self-regulation