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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02329015
Enrollment
112
Registered
2014-12-31
Start date
2014-09-30
Completion date
2015-08-31
Last updated
2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior

Keywords

stress, alternative, complementary, self-regulation

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.

Interventions

BEHAVIORALYoga-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).

BEHAVIORALPhysical Education Class

Standard physical education

Sponsors

Long Island University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
Yes

Inclusion criteria

* • Male or female students attending NYC schools

Exclusion criteria

* Lack of permission to attend physical education class

Design outcomes

Primary

MeasureTime frameDescription
Academic Performance: Grade Point Averages1 yearGPA 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

MeasureTime frameDescription
Response to Stress Questionnaire (RSQ)1 yearA 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 Scale1 yearA 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

MeasureTime frameDescription
Self Report Questionnaire (Child and Adolescent Mindfulness Measure)1 yearA 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 Function1 yearAn 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 FunctionOne yearTeacher 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Health and Wellness Program
Behavioral intervention 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).
48
Physical Education Class
Behavioral intervention Physical Education Class: Standard physical education
64
Total112

Baseline characteristics

CharacteristicTotalHealth and Wellness ProgramPhysical Education Class
Age, Continuous15.3 years
STANDARD_DEVIATION 0.97
15.2 years
STANDARD_DEVIATION 0.94
15.4 years
STANDARD_DEVIATION 0.98
Cardiovascular Fitness (Pacer Test: Fitnessgram)50.8 Number of 20 meter laps completed
STANDARD_DEVIATION 15.63
48 Number of 20 meter laps completed
STANDARD_DEVIATION 13.3
52.9 Number of 20 meter laps completed
STANDARD_DEVIATION 17.3
Grade Point Average Previous Academic Year84.34 per cent
STANDARD_DEVIATION 7.81
85.62 per cent
STANDARD_DEVIATION 7.9
83.38 per cent
STANDARD_DEVIATION 7.68
Height in inches56.4 inches
STANDARD_DEVIATION 5.23
54.9 inches
STANDARD_DEVIATION 5.7
57.5 inches
STANDARD_DEVIATION 4.9
Lunch Status
Free lunch
71 participants31 participants40 participants
Lunch Status
Full Price Lunch
15 participants7 participants8 participants
Lunch Status
Reduced Lunch
17 participants6 participants11 participants
Race/Ethnicity, Customized
Asian
12 participants7 participants5 participants
Race/Ethnicity, Customized
Black
29 participants12 participants17 participants
Race/Ethnicity, Customized
Hispanic
59 participants21 participants38 participants
Race/Ethnicity, Customized
White
12 participants8 participants4 participants
Region of Enrollment
United States
112 participants48 participants64 participants
Sex: Female, Male
Female
54 Participants29 Participants25 Participants
Sex: Female, Male
Male
58 Participants19 Participants39 Participants
Weight128.64 pounds
STANDARD_DEVIATION 23.9
129.5 pounds
STANDARD_DEVIATION 26.6
128.0 pounds
STANDARD_DEVIATION 21.9

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 480 / 64
serious
Total, serious adverse events
0 / 480 / 64

Outcome results

Primary

Academic Performance: Grade Point Averages

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.

Time frame: 1 year

Population: Intent to treat analysis. Data from all participants was available at baseline and at end of study.

ArmMeasureValue (MEAN)Dispersion
Health and Wellness ProgramAcademic Performance: Grade Point Averages85.71 per centStandard Deviation 8.44
Physical Education ClassAcademic Performance: Grade Point Averages83.45 per centStandard Deviation 8.79
Comparison: Model 1: An intent to treat analyses was performed determining effect of group assignment on academic performance while controlling for previous year GPA.p-value: 0.5495% CI: [-1.25, 2.41]Regression, Logistic
Comparison: Model 2: As active participation between groups was significantly different a second intent to treat analysis was performed which added to Model 1 (controlling for previous year GPA) by controlling for active participation.p-value: 0.0895% CI: [-0.21, 3.55]Regression, Linear
Comparison: Model 3: Per Protocol Analysis: it was hypothesized that any benefit of yoga education would only accrue if the student was assigned to yoga classes and actively participated in the class. A third Model was fit with an interaction term for class assignment and class participation.p-value: 0.00995% CI: [0.69, 4.71]Regression, Linear
Secondary

Response to Stress Questionnaire (RSQ)

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.

Time frame: 1 year

Population: Missing data: 2 from experimental group, none from control group

ArmMeasureGroupValue (MEAN)Dispersion
Health and Wellness ProgramResponse to Stress Questionnaire (RSQ)Involuntary Engagement0.84 units on a scaleStandard Deviation 0.76
Health and Wellness ProgramResponse to Stress Questionnaire (RSQ)Voluntary Engagement1.37 units on a scaleStandard Deviation 0.61
Physical Education ClassResponse to Stress Questionnaire (RSQ)Involuntary Engagement0.67 units on a scaleStandard Deviation 0.64
Physical Education ClassResponse to Stress Questionnaire (RSQ)Voluntary Engagement1.27 units on a scaleStandard Deviation 0.61
Comparison: Analysis of the Voluntary subscale of the Response to Stress Questionnairep-value: 0.301Regression, Linear
Secondary

Warwick Edinburgh Mental Well Being Scale

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.

Time frame: 1 year

Population: 9 subjects missing from experimental group and 11 subjects missing from comparison group

ArmMeasureValue (MEAN)Dispersion
Health and Wellness ProgramWarwick Edinburgh Mental Well Being Scale48.90 units on a scaleStandard Deviation 13.44
Physical Education ClassWarwick Edinburgh Mental Well Being Scale49.51 units on a scaleStandard Deviation 12.04
Other Pre-specified

Self Report Questionnaire (Child and Adolescent Mindfulness Measure)

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.

Time frame: 1 year

Population: 9 subjects missing from experimental group and 11 subjects missing from comparison group

ArmMeasureValue (MEAN)Dispersion
Health and Wellness ProgramSelf Report Questionnaire (Child and Adolescent Mindfulness Measure)25.59 units on a scaleStandard Deviation 8.72
Physical Education ClassSelf Report Questionnaire (Child and Adolescent Mindfulness Measure)26.38 units on a scaleStandard Deviation 8.45
Other Pre-specified

Student Self-Report Behavior Rating Inventory of Executive Function

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.

Time frame: 1 year

Population: 9 subjects missing from experimental group and 9 subjects missing from comparison group

ArmMeasureValue (MEAN)Dispersion
Health and Wellness ProgramStudent Self-Report Behavior Rating Inventory of Executive Function52.49 units on a scaleStandard Deviation 13.84
Physical Education ClassStudent Self-Report Behavior Rating Inventory of Executive Function46.84 units on a scaleStandard Deviation 11.93
Other Pre-specified

Teacher Report Behavior Rating Inventory of Executive Function

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.

Time frame: One year

Population: 3 subjects missing from experimental group and 5 subjects missing from comparison group

ArmMeasureValue (MEAN)Dispersion
Health and Wellness ProgramTeacher Report Behavior Rating Inventory of Executive Function64.51 units on a scaleStandard Deviation 20.4
Physical Education ClassTeacher Report Behavior Rating Inventory of Executive Function59.39 units on a scaleStandard Deviation 16.61

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026