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 Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Condition: Adolescent Behavior
• Interventions: Behavioral: Yoga-informed Health and Wellness Program; Behavioral: Physical Education Class
• Enrollment: 112

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Health and Wellness Program	Physical Education Class
Arm/Group Description	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).	Behavioral intervention Physical Education Class: Standard physical education
Period Title: Overall Study
Started	48	64
Completed	48	64
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Health and Wellness Program	Physical Education Class	Total
Arm/Group Description		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).	Behavioral intervention Physical Education Class: Standard physical education	Total of all reporting groups
Overall Number of Baseline Participants		48	64	112
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	48 participants	64 participants	112 participants
		15.2 (.94)	15.4 (.98)	15.3 (.97)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	48 participants	64 participants	112 participants
	Female	29 60.4%	25 39.1%	54 48.2%
	Male	19 39.6%	39 60.9%	58 51.8%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	48 participants	64 participants	112 participants
Asian		7	5	12
Black		12	17	29
Hispanic		21	38	59
White		8	4	12
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	48 participants	64 participants	112 participants
		48	64	112
Grade Point Average Previous Academic Year [1]; Mean (Standard Deviation); Unit of measure: Per cent
	Number Analyzed	48 participants	64 participants	112 participants
		85.62 (7.9)	83.38 (7.68)	84.34 (7.81)
		[1] Measure Description: 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
Height in inches; Mean (Standard Deviation); Unit of measure: Inches
	Number Analyzed	48 participants	64 participants	112 participants
		54.9 (5.7)	57.5 (4.9)	56.4 (5.23)
Weight; Mean (Standard Deviation); Unit of measure: Pounds
	Number Analyzed	48 participants	64 participants	112 participants
		129.5 (26.6)	128.0 (21.9)	128.64 (23.9)
Lunch Status [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	48 participants	64 participants	112 participants
Free lunch		31	40	71
Reduced Lunch		6	11	17
Full Price Lunch		7	8	15
		[1] Measure Description: Data was not available for some participants relative to lunch status, therefore totals for each group do not equal baseline values
Cardiovascular Fitness (Pacer Test: Fitnessgram) [1]; Mean (Standard Deviation); Unit of measure: Number of 20 meter laps completed
	Number Analyzed	48 participants	64 participants	112 participants
		48 (13.3)	52.9 (17.3)	50.8 (15.63)
		[1] Measure Description: The Pacer test is a test of aerobic fitness wherein participants are required to run back and forth on a level surface 20 meters in length. The allowed time to successfully complete each 20 meter run is gradually increased via an audible timer. The score represents the final number of runs successfully completed within the allowed time. Values range from 1-106 with higher values representing greater levels of aerobic fitness.

Outcome Measures

1. Primary Outcome

Title	Academic Performance: Grade Point Averages
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Health and Wellness Program	Physical Education Class
Arm/Group Description:	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).	Behavioral intervention Physical Education Class: Standard physical education
Overall Number of Participants Analyzed	48	64
Mean (Standard Deviation); Unit of Measure: per cent
	85.71 (8.44)	83.45 (8.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Health and Wellness Program, Physical Education Class
	Comments	Model 1: An intent to treat analyses was performed determining effect of group assignment on academic performance while controlling for previous year GPA.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.54
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 95%; -1.25 to 2.41
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Health and Wellness Program, Physical Education Class
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.08
	Comments	[Not Specified]
	Method	Regression, Linear
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.67
	Confidence Interval	(2-Sided) 95%; -0.21 to 3.55
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Health and Wellness Program, Physical Education Class
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.009
	Comments	[Not Specified]
	Method	Regression, Linear
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	2.70
	Confidence Interval	(2-Sided) 95%; 0.69 to 4.71
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Response to Stress Questionnaire (RSQ)
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Health and Wellness Program	Physical Education Class
Arm/Group Description:	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).	Behavioral intervention Physical Education Class: Standard physical education
Overall Number of Participants Analyzed	46	64
Mean (Standard Deviation); Unit of Measure: units on a scale
Involuntary Engagement	0.84 (0.76)	0.67 (0.64)
Voluntary Engagement	1.37 (0.61)	1.27 (0.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Health and Wellness Program, Physical Education Class
	Comments	Analysis of the Voluntary subscale of the Response to Stress Questionnaire
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.301
	Comments	[Not Specified]
	Method	Regression, Linear
	Comments	[Not Specified]

3. Secondary Outcome

Title	Warwick Edinburgh Mental Well Being Scale
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Health and Wellness Program	Physical Education Class
Arm/Group Description:	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).	Behavioral intervention Physical Education Class: Standard physical education
Overall Number of Participants Analyzed	39	53
Mean (Standard Deviation); Unit of Measure: units on a scale
	48.90 (13.44)	49.51 (12.04)

4. Other Pre-specified Outcome

Title	Self Report Questionnaire (Child and Adolescent Mindfulness Measure)
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Health and Wellness Program	Physical Education Class
Arm/Group Description:	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).	Behavioral intervention Physical Education Class: Standard physical education
Overall Number of Participants Analyzed	39	53
Mean (Standard Deviation); Unit of Measure: units on a scale
	25.59 (8.72)	26.38 (8.45)

5. Other Pre-specified Outcome

Title	Student Self-Report Behavior Rating Inventory of Executive Function
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Health and Wellness Program	Physical Education Class
Arm/Group Description:	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).	Behavioral intervention Physical Education Class: Standard physical education
Overall Number of Participants Analyzed	39	55
Mean (Standard Deviation); Unit of Measure: units on a scale
	52.49 (13.84)	46.84 (11.93)

6. Other Pre-specified Outcome

Title	Teacher Report Behavior Rating Inventory of Executive Function
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Health and Wellness Program	Physical Education Class
Arm/Group Description:	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).	Behavioral intervention Physical Education Class: Standard physical education
Overall Number of Participants Analyzed	45	59
Mean (Standard Deviation); Unit of Measure: units on a scale
	64.51 (20.40)	59.39 (16.61)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	Teachers were instructed to report to the PI any incident in which a student was injured during the intervention. Minor injuries not requiring a visit to the nurses station were not reported.
Arm/Group Title	Health and Wellness Program	Physical Education Class
Arm/Group Description	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).	Behavioral intervention Physical Education Class: Standard physical education
All-Cause Mortality
	Health and Wellness Program	Physical Education Class
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Health and Wellness Program	Physical Education Class
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/48 (0.00%)	0/64 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Health and Wellness Program	Physical Education Class
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/48 (0.00%)	0/64 (0.00%)

Limitations and Caveats

This study had several limitations including the lack of blinding of tester and an excessive reliance on self-report. Analysis limited by an inability to test effects due to clustering. Novelty, Pygmalion, or motivational effect cannot be ruled out.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Marshall Hagins PhD, PT
• Organization: Long Island University
• Phone: 3478048512
• EMail: mhagins@liu.edu

• Responsible Party: Marshall Hagins, Long Island University
• ClinicalTrials.gov Identifier: NCT02329015
• Other Study ID Numbers: SONIMA001
• First Submitted: December 29, 2014
• First Posted: December 31, 2014
• Results First Submitted: April 25, 2016
• Results First Posted: November 4, 2016
• Last Update Posted: November 4, 2016