Trial Outcomes & Findings for Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools (NCT NCT02329015)
NCT ID: NCT02329015
Last Updated: 2016-11-04
Results Overview
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.
COMPLETED
PHASE1
112 participants
1 year
2016-11-04
Participant Flow
Participant milestones
| Measure |
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).
|
Physical Education Class
Behavioral intervention
Physical Education Class: Standard physical education
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
64
|
|
Overall Study
COMPLETED
|
48
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools
Baseline characteristics by cohort
| Measure |
Health and Wellness Program
n=48 Participants
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).
|
Physical Education Class
n=64 Participants
Behavioral intervention
Physical Education Class: Standard physical education
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.2 years
STANDARD_DEVIATION .94 • n=5 Participants
|
15.4 years
STANDARD_DEVIATION .98 • n=7 Participants
|
15.3 years
STANDARD_DEVIATION .97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 participants
n=5 Participants
|
17 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
21 participants
n=5 Participants
|
38 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
64 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Grade Point Average Previous Academic Year
|
85.62 per cent
STANDARD_DEVIATION 7.9 • n=5 Participants
|
83.38 per cent
STANDARD_DEVIATION 7.68 • n=7 Participants
|
84.34 per cent
STANDARD_DEVIATION 7.81 • n=5 Participants
|
|
Height in inches
|
54.9 inches
STANDARD_DEVIATION 5.7 • n=5 Participants
|
57.5 inches
STANDARD_DEVIATION 4.9 • n=7 Participants
|
56.4 inches
STANDARD_DEVIATION 5.23 • n=5 Participants
|
|
Weight
|
129.5 pounds
STANDARD_DEVIATION 26.6 • n=5 Participants
|
128.0 pounds
STANDARD_DEVIATION 21.9 • n=7 Participants
|
128.64 pounds
STANDARD_DEVIATION 23.9 • n=5 Participants
|
|
Lunch Status
Free lunch
|
31 participants
n=5 Participants
|
40 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Lunch Status
Reduced Lunch
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Lunch Status
Full Price Lunch
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Cardiovascular Fitness (Pacer Test: Fitnessgram)
|
48 Number of 20 meter laps completed
STANDARD_DEVIATION 13.3 • n=5 Participants
|
52.9 Number of 20 meter laps completed
STANDARD_DEVIATION 17.3 • n=7 Participants
|
50.8 Number of 20 meter laps completed
STANDARD_DEVIATION 15.63 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Intent to treat analysis. Data from all participants was available at baseline and at end of study.
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.
Outcome measures
| Measure |
Health and Wellness Program
n=48 Participants
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).
|
Physical Education Class
n=64 Participants
Behavioral intervention
Physical Education Class: Standard physical education
|
|---|---|---|
|
Academic Performance: Grade Point Averages
|
85.71 per cent
Standard Deviation 8.44
|
83.45 per cent
Standard Deviation 8.79
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Missing data: 2 from experimental group, none from control group
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.
Outcome measures
| Measure |
Health and Wellness Program
n=46 Participants
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).
|
Physical Education Class
n=64 Participants
Behavioral intervention
Physical Education Class: Standard physical education
|
|---|---|---|
|
Response to Stress Questionnaire (RSQ)
Involuntary Engagement
|
0.84 units on a scale
Standard Deviation 0.76
|
0.67 units on a scale
Standard Deviation 0.64
|
|
Response to Stress Questionnaire (RSQ)
Voluntary Engagement
|
1.37 units on a scale
Standard Deviation 0.61
|
1.27 units on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 9 subjects missing from experimental group and 11 subjects missing from comparison group
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.
Outcome measures
| Measure |
Health and Wellness Program
n=39 Participants
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).
|
Physical Education Class
n=53 Participants
Behavioral intervention
Physical Education Class: Standard physical education
|
|---|---|---|
|
Warwick Edinburgh Mental Well Being Scale
|
48.90 units on a scale
Standard Deviation 13.44
|
49.51 units on a scale
Standard Deviation 12.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: 9 subjects missing from experimental group and 11 subjects missing from comparison group
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.
Outcome measures
| Measure |
Health and Wellness Program
n=39 Participants
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).
|
Physical Education Class
n=53 Participants
Behavioral intervention
Physical Education Class: Standard physical education
|
|---|---|---|
|
Self Report Questionnaire (Child and Adolescent Mindfulness Measure)
|
25.59 units on a scale
Standard Deviation 8.72
|
26.38 units on a scale
Standard Deviation 8.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: 9 subjects missing from experimental group and 9 subjects missing from comparison group
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.
Outcome measures
| Measure |
Health and Wellness Program
n=39 Participants
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).
|
Physical Education Class
n=55 Participants
Behavioral intervention
Physical Education Class: Standard physical education
|
|---|---|---|
|
Student Self-Report Behavior Rating Inventory of Executive Function
|
52.49 units on a scale
Standard Deviation 13.84
|
46.84 units on a scale
Standard Deviation 11.93
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One yearPopulation: 3 subjects missing from experimental group and 5 subjects missing from comparison group
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.
Outcome measures
| Measure |
Health and Wellness Program
n=45 Participants
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).
|
Physical Education Class
n=59 Participants
Behavioral intervention
Physical Education Class: Standard physical education
|
|---|---|---|
|
Teacher Report Behavior Rating Inventory of Executive Function
|
64.51 units on a scale
Standard Deviation 20.40
|
59.39 units on a scale
Standard Deviation 16.61
|
Adverse Events
Health and Wellness Program
Physical Education Class
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place