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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Long Island University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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