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Completed

NCT Number: NCT02329015

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

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.

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Key information

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eastside Community High School

New York, 10009, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Male or female students attending NYC schools

Exclusion criteria

  • Lack of permission to attend physical education class

Treatment and study plan

Yoga-informed Health and Wellness Program

Behavioral

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).

Physical Education Class

Behavioral

Standard physical education

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Long Island University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 31, 2014
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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