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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Health and Wellness Program Physical Education Class
Hide 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
Arm/Group Title Health and Wellness Program Physical Education Class Total
Hide 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
Hide 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.
1.Primary Outcome
Title Academic Performance: Grade Point Averages
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data: 2 from experimental group, none from control group
Arm/Group Title Health and Wellness Program Physical Education Class
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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   --/--   --/-- 
Hide 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%) 
Hide 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%) 
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.
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
Layout table for Results Point of Contact information
Name/Title: Marshall Hagins PhD, PT
Organization: Long Island University
Phone: 3478048512
EMail: mhagins@liu.edu
Layout table for additonal information
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