Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools (NCT02329015), a randomized phase 1 study. The primary outcome is Academic Performance: Grade Point Averages.

2. Clinical Question

The study’s stated purpose was to compare academic and psychosocial benefits of the yoga-informed program with those of standard physical education. The primary endpoint addresses the academic part of that question. The registry also identifies the Response to Stress Questionnaire and the Warwick Edinburgh Mental Well Being Scale among the secondary outcomes, so the broader evaluation included self-reported or scale-based measures as well as GPA. The detailed posted secondary results include the Warwick Edinburgh scale.

The clinical question is a comparison between two school-based programs, not a comparison with no program. Both arms are behavioral interventions, and the registry record does not describe a medication or a usual-care-only group. The trial is listed as randomized, single-masked, and parallel. The identity of the person or people masked is not reported in the registry record.

The outcome information can describe the observed group averages and the uncertainty around a recalculated comparison. It cannot, on its own, establish that any observed difference was caused by the program. Interpretation also depends on the sponsor’s reported analyses, how outcomes and analyses were selected, and details of implementation and missing data that are not reported in the registry record.

3. Trial Design

The registry record describes a randomized, single-masked, parallel-group trial of a yoga-informed Health and Wellness Program and a physical education class. It lists the study as Phase 1 and completed, with enrollment of 112. The study began in 2014-09, and primary completion was recorded as 2015-08. The setting was New York City schools, and the stated population was middle and high school students.

Students were assigned to one of the two behavioral program arms. The registry record does not report the randomization method, how allocation was concealed, or who was masked. It also does not describe the exact curriculum, class frequency, duration of sessions, instructor training, adherence, or how consistently either program was delivered. Those details matter for understanding what the assigned interventions involved in practice, but they are not reported in the registry record.

The primary outcome was GPA, measured at the one-year timeframe. Its description says course scores were averaged numerically, with each course weighted by credit load, using a standard process within New York City public schools. The outcome population is described as intent to treat, and the record states that data from all participants were available at baseline and at the end of the study. The posted arm summaries show 48 participants for the Health and Wellness Program and 64 for physical education.

The registry lists six outcome measures and four analyses. It names the Response to Stress Questionnaire and Warwick Edinburgh Mental Well Being Scale among secondary outcomes; a detailed set of descriptive results is posted for the Warwick Edinburgh scale. The record does not explain how the listed analyses correspond to the outcomes, which measures were considered primary beyond the GPA designation, or how the analyses were selected.

Random assignment is intended to make the groups comparable on average at the start of a study, but it does not guarantee balance in every characteristic in a particular trial. Baseline characteristics, allocation procedures, masking details, and intervention adherence are not included in the registry record from the registry record. The design therefore supports a randomized comparison, while the extent to which potential sources of bias were controlled cannot be fully assessed from the recorded details.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Intent to treat analysis. Data from all participants was available at baseline and at end of study.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Academic Performance: Grade Point Averages, measured over 1 year.

The primary endpoint is academic performance, measured as grade point average at the one-year timeframe. The registry describes GPA as the numeric average of course scores for all courses taken by a student, weighted by each course’s credit load. It says this was calculated using a standard process within New York City public schools. The endpoint is reported as a mean with standard deviation, and its unit is listed as per cent.

GPA is used as an indicator of academic performance because it condenses students’ course scores into a single measure that can be compared across the assigned groups. Weighting courses by credit load means that a course’s contribution to the average reflects its credit load, as described in the registry record. The measure is relevant to the study’s stated academic question, although it does not represent every dimension of learning or school experience.

The group summaries report a mean GPA of 85.71 for the Health and Wellness Program arm and 83.45 for the physical education arm. The corresponding standard deviations are 8.44 and 8.79. These summaries describe the posted observations; they do not, by themselves, establish a causal effect or show how the program operated in schools.

The registry says the primary outcome analysis followed an intent-to-treat approach and that data were available for all participants at baseline and at study end. Further details about the exact statistical model for the sponsor’s GPA analysis, adjustment variables, and handling of any other forms of missingness are not reported in the registry record.

7. Results Posted in the Registry

• Physical Education Class: mean 83.45 versus 85.71 on control; difference -2.26 (95% CI -5.48 to 0.96), standardized effect d = -0.26; z-test p = 0.168.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Warwick Edinburgh Mental Well Being Scale

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Physical Education Class: mean 49.51 versus 48.90 on control; difference 0.61 (95% CI -4.71 to 5.93), standardized effect d = 0.05; z-test p = 0.822.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Physical Education Class and the control. The interval gives the range of effects that remain compatible with the data.

The registry record names the Response to Stress Questionnaire and the Warwick Edinburgh Mental Well Being Scale among the secondary outcomes. The detailed posted secondary results include the Warwick Edinburgh scale, while the broader record indicates that six outcome measures and four analyses were recorded. The information available does not map every measure to every analysis, so the full pattern across all recorded outcomes cannot be reconstructed from these details alone.

Overall, the secondary evidence should be read as additional descriptive and inferential context rather than as a replacement for the primary academic-performance question. A mental well-being scale addresses a related but distinct domain from GPA. Agreement or disagreement between domains would not by itself establish why either result occurred, and a secondary outcome cannot settle the discrepancy between the sponsor analysis and the unadjusted GPA recalculation.

Secondary results generally carry less confirmatory weight when many outcomes or analyses may have been considered and the multiplicity strategy is unclear. If several statistical tests are performed, the chance of finding at least one apparently notable result can increase. General explanation: multiplicity procedures are methods for controlling or accounting for that issue; the registry record does not report whether such a procedure was used. Results from secondary outcomes are therefore best treated as exploratory unless a prespecified hierarchy or adjustment is documented.

The record identifies multiple outcome measures and analyses but does not report the prespecified analysis hierarchy, which results were emphasized, or how missing observations were handled for every secondary measure. These uncertainties make it difficult to judge the weight that should be assigned to any isolated secondary finding. They also limit claims about consistency across psychosocial and academic domains.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Response to Stress Questionnaire (RSQ)
• Warwick Edinburgh Mental Well Being Scale

9. Statistical Interpretation

10. Statistical Methods Explained

Several statistical ideas help interpret these results. The distinctions below are general explanations, followed by how they apply to the information recorded for this trial.

What does a group mean describe?

For a continuous measure such as GPA, a mean is the arithmetic average within a group. The posted means describe the average GPA in each arm at the recorded endpoint. A mean gives a compact summary, but it does not show the range of individual scores, the shape of the distribution, or whether all participants had similar experiences. The standard deviation describes how dispersed individual observations are around the group mean. It is not the same as the uncertainty around the mean or the uncertainty around a comparison between means.

In the registry record, GPA is calculated from course scores weighted by course credit load. This definition establishes what the outcome is intended to summarize. It does not tell readers whether score distributions were approximately normal, whether there were influential observations, or whether the model used assumptions suitable for the recorded data. Those diagnostics and additional modeling details are not reported in the registry record.

What is a mean difference?

A mean difference expresses the average value in one group relative to another, with the sign depending on which group is subtracted from which. The simple recalculation uses physical education relative to the Health and Wellness Program. Its estimate is -2.26. A negative value therefore indicates that the posted physical education mean is lower under that contrast definition. The comparison is unadjusted: it is calculated from the arm summaries rather than from a model that controls for other variables.

An unadjusted comparison is easy to relate to the group summaries, but it may not match a sponsor analysis that uses regression, adjustments, or a different contrast definition. The registry record does not give enough detail to determine which features account for the discrepancy between the recalculation and the sponsor’s reported analyses.

What does a confidence interval convey?

General explanation: a confidence interval describes the range of estimates that are reasonably compatible with the data and the statistical procedure used, under that procedure’s assumptions. It conveys precision as well as the direction and size of an estimate. A wide interval reflects more uncertainty than a narrow one. An interval that includes zero for a mean difference does not prove that there is no difference; it means that no difference is among the values compatible with the interval.

For the unadjusted GPA recalculation, the confidence interval includes zero. This means the posted summaries do not estimate the comparison precisely enough to rule out no mean difference using that interval. The sponsor’s posted regression intervals differ across analyses, but their outcome mapping is not specified in the registry record. The intervals should be read alongside the definitions and models that produced them, not treated as several versions of one clearly identified GPA estimate.

What does a p-value tell readers?

General explanation: a p-value describes how unusual data at least as discrepant from a specified null hypothesis would be if that null hypothesis and the model assumptions held. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of a result. A p-value also does not account for whether many outcomes or analyses were examined unless an appropriate multiplicity procedure is applied.

The recalculated GPA comparison has an unadjusted p-value of 0.168. The three posted regression analyses have p-values of 0.54, 0.08, and 0.009, respectively. Because the registry record does not connect each regression slope to a named outcome in the information available, those values cannot be taken as a set of tests of the primary GPA question. The record also does not report whether the sponsor adjusted for multiple testing.

Why do the sponsor analysis and recalculation differ?

A recalculation based on group means and standard deviations is a simple, unadjusted analysis of the posted summary statistics. A sponsor model may use a different statistical approach, include covariates, account for baseline values, or estimate a different contrast. Those are general reasons analyses can differ; the registry record does not establish which, if any, explains this trial’s discrepancy. The record’s sponsor analyses are regression slopes, but the specific model terms and outcome mapping are not reported.

When the sponsor’s own result conflicts with a simple recalculation, the sponsor’s analysis takes precedence as the trial’s reported analysis. The recalculation remains useful for understanding the posted summaries, but it should not be presented as if it were the sponsor’s adjusted estimate. To assess the difference fully would require clearer model specifications and a mapping between each reported analysis and its outcome.

What does intent to treat mean?

General explanation: an intent-to-treat analysis aims to analyze participants according to the groups to which they were assigned, regardless of whether they followed the assigned intervention. This preserves the comparison created by random assignment, subject to the availability and handling of outcome data. The registry describes the primary outcome analysis as intent to treat and states that data from all participants were available at baseline and at the end of the study. It does not provide further detail about analysis sets, adherence, or missing-data procedures.

Finally, a randomized design can reduce certain forms of confounding in expectation, but randomization does not ensure that all characteristics are balanced in the realized groups. Information about baseline balance and the specific analysis adjustments is not reported in the registry record. These limitations matter when interpreting both the primary comparison and the posted regression results.

11. Confidence Intervals and Precision

Precision is about how narrowly an estimate identifies the range of values compatible with the data and analysis. The recalculated GPA mean difference is -2.26, with a confidence interval from -5.475 to 0.955. Because the interval includes zero and covers values on both sides of it, the unadjusted comparison does not pin down the direction of the mean difference with high precision. The estimate is also not the sponsor’s reported inferential result, because the record flags a discrepancy.

A confidence interval is not a guarantee that the true effect lies in its endpoints. General explanation: its usual interpretation depends on the statistical method and assumptions used to construct it. The interval helps show which values are relatively compatible with the data under those assumptions; it does not establish that all values in it are equally likely or that values outside it are impossible.

The group standard deviations, 8.44 for the Health and Wellness Program and 8.79 for physical education, describe variation among individual GPA observations. They should not be read as confidence intervals. The posted recalculation also reports standard errors for the arm means, but the central interpretive quantity is the uncertainty around the contrast, not the spread of individual scores alone.

The regression analyses have their own 95% confidence intervals, but the registry record does not identify the outcomes corresponding to each slope in the information available. Their precision can be described numerically, but they cannot be confidently interpreted as estimates of the primary GPA comparison without that mapping. The presence of multiple reported analyses also makes a single interval an incomplete account of uncertainty across the full analysis set.

Precision is distinct from importance. Even a precise estimate would need substantive context to assess its relevance, and an uncertain estimate does not prove that an important difference exists. The registry record does not provide a threshold for an academically meaningful GPA difference or enough information about the sponsor’s model to judge the sponsor estimate’s precision in relation to such a threshold.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total participants and not total events. This is a continuous-outcome comparison, so the planning entries are expressed as participants per arm. The total-events convention applies to time-to-event planning displays, not to this comparison.

The planning illustration uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It considers effects equal to 100%, 75%, and 50% of the observed effect. Within each effect assumption, the 80% power column gives the approximate number of participants per arm for a design with an 80% chance of detecting an effect of that assumed size under the planning model. The 90% column gives the corresponding per-arm planning figure for a 90% chance under that model.

These are planning illustrations computed from the observed effect, not the trial’s original design assumptions. The original sample-size assumptions and justification are not reported in the registry record. The figures are not observed power: observed power is not a useful substitute for interpreting the estimate and its confidence interval after the trial has been completed.

Rows that assume a smaller fraction of the observed effect require more participants per arm, because smaller differences are harder to distinguish from background variation under the same planning assumptions. The illustration is therefore useful for seeing how a future study’s size depends on the target effect and desired power. It does not show that the current trial was adequately or inadequately designed, because its own original design assumptions are not reported.

The curve should be read as a planning aid showing how the required per-arm sample size changes as the effect targeted for detection changes, under the stated assumptions. It is not a forecast of what a future trial will observe, and it does not determine whether a particular effect is important. Planning estimates based on an observed effect can also be unstable when that observed estimate is uncertain, as the GPA interval indicates.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -2.260; pooled standard deviation σ = 8.642.
2. n = 2 × (1.96 + 0.842)² × 8.642² / -2.260² = 229.5, rounded up to 230 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -2.25999999999999                      # observed difference in means
sigma <- 8.64218906401508                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2329015)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 230 (80% power), 308 (90% power)
 75% of observed effect: n per arm = 409 (80% power), 547 (90% power)
 50% of observed effect: n per arm = 919 (80% power), 1,230 (90% power)
power.t.test: 230.5 
Simulated power at n = 230 per arm: 0.795 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry record posts three regression slopes for analyses involving the two trial groups. Their reported values are 0.58, 1.67, and 2.70, with 95% confidence intervals and p-values recorded for each. The information available does not identify which outcome corresponds to each slope or describe the exact regression models. It is therefore not appropriate to treat any one of these slopes as the sponsor’s clearly identified estimate of the primary GPA contrast.

The simple recalculation uses the posted GPA means and standard deviations to estimate an unadjusted mean difference of -2.26, with a confidence interval from -5.475 to 0.955 and an unadjusted p-value of 0.168. The registry record flags a discrepancy between the sponsor’s analysis and the recalculation. The sponsor’s own analysis takes precedence when describing the trial’s reported inferential result; the recalculation is a separate, unadjusted check based on the summaries.

The difference should not be attributed to a specific adjustment or modeling choice because those details are not reported in the registry record. Nor should the regression analyses be combined with the recalculation as if they estimate the same quantity. A clearer account would identify the outcome and contrast for each model, the model terms, and any adjustment variables. Without that information, the sponsor analysis can be acknowledged as the authoritative reported analysis while the recalculated result remains a transparent but limited comparison of the posted arm summaries.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when investigators assess several outcomes, time points, groups, or statistical models. General explanation: as the number of tests grows, the opportunity for at least one result to appear unusual by chance can grow as well. Methods such as a prespecified testing hierarchy or an adjustment for multiple comparisons can address this concern, but the registry record does not report whether such methods were planned or used.

The record lists six outcome measures and four analyses. It names the Response to Stress Questionnaire and Warwick Edinburgh Mental Well Being Scale among secondary outcomes, and posts three regression analyses for the two groups without identifying the corresponding outcomes in the available information. The primary endpoint is identified as GPA, but the registry record does not explain how the analyses were prioritized, whether all analyses were prespecified, or whether the sponsor adjusted for multiplicity. This makes isolated p-values difficult to interpret as confirmatory evidence.

For missing data, the primary outcome description states that the analysis was intent to treat and that data from all participants were available at baseline and at study end. This is useful information about the stated primary endpoint. It does not specify the precise analysis set, whether any imputation was used, or whether other sources of missingness arose. For the detailed Warwick Edinburgh results, the arm counts are 39 and 53, whereas the primary outcome arm summaries report 48 and 64. The reasons for the differing counts and the handling of missing secondary observations are not reported in the registry record.

Baseline and end-of-study availability for the primary outcome does not establish that all other measures were complete, nor does it show how missing secondary observations might affect estimates. General explanation: when outcome data are missing, the impact depends on how much is missing and why it is missing, as well as on the analysis method. The registry record does not provide enough information to assess those features for the secondary measures.

The primary population is described as intent to treat, but intervention adherence and deviations from assigned programs are not reported. The registry record also does not describe baseline adjustment, covariate selection, sensitivity analyses, or how the sponsor’s regression estimates relate to the primary endpoint. These omissions limit assessment of robustness and make it especially important to distinguish the sponsor’s reported analyses from the unadjusted recalculation.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry record reports zero serious adverse events and zero other adverse events in the Health and Wellness Program group, with 48 participants at risk in each category. For the physical education group, it reports zero serious adverse events and zero other adverse events, with 64 participants at risk in each category. These entries describe the adverse-event counts posted for the trial.

Zero recorded events should be interpreted as a report about the registry entries, not as proof that no unwanted events occurred or that the programs carry no risk. The record does not describe how adverse events were defined, collected, monitored, or attributed to an intervention. It also does not report deaths; the deaths field is not populated in the record. That is different from a recorded count of zero deaths.

The safety figures are limited to the recorded participants at risk and the categories shown. They do not establish whether every possible adverse event was actively sought or whether events outside those categories were captured. The registry record lists no serious-event terms. These entries can be stated descriptively, but they do not support broader conclusions about safety or comparative risk.

17. What the Result Does, and Does Not, Mean

The posted data describe a randomized comparison of a yoga-informed health and wellness program with physical education among middle and high school students in New York City schools. For the primary endpoint, the arm means are 85.71 and 83.45. The simple unadjusted recalculation estimates a mean difference of -2.26 for physical education relative to the Health and Wellness Program, with a confidence interval that includes zero. This is a summary of the posted data and does not replace the sponsor’s own analysis.

The registry record flags a discrepancy between the sponsor’s analysis and the recalculation, so the sponsor’s reported analysis takes precedence when describing the trial’s inferential findings. However, the posted regression slopes are not mapped to specific outcomes in the available information. This prevents a confident interpretation of those slopes as the primary GPA estimate. Greater detail about outcomes, contrasts, and model specifications would be needed to resolve that ambiguity.

The results do not establish that either program caused a change in academic performance. Randomization is an important design feature, but the recorded information does not provide all details needed to assess allocation procedures, masking, implementation, adherence, or the sponsor’s model. The interval around the recalculated contrast is compatible with no mean difference as well as differences in either direction; it is not evidence that the programs are equivalent.

The registry’s secondary information provides context about psychosocial measures, but multiplicity and incomplete mapping of analyses limit the weight of isolated findings. A secondary result should not be treated as confirmation of the GPA result without a clear analysis plan and appropriate consideration of multiple testing. Similarly, the adverse-event entries report no recorded events in the listed categories but do not establish that no events occurred or that the programs have no risks.

The soundest reading is therefore descriptive and bounded: the registry records group averages, selected regression results, secondary measures, and adverse-event counts for a completed school-based trial. The available results are not sufficient to settle the academic comparison or to support broad causal or safety conclusions.

18. Why This Trial Matters Statistically

This trial is statistically interesting because it evaluates a behavioral program in a school setting using an academic outcome, while also recording psychosocial measures. Such studies often involve outcomes that are influenced by many features of a student’s environment and experience. The statistical task is not only to compare averages, but also to make clear what each estimate represents and how much uncertainty surrounds it.

The registry gives a primary outcome definition and arm summaries, which allow a transparent unadjusted comparison to be recalculated. At the same time, it flags a discrepancy with the sponsor’s analysis. That makes a distinction between descriptive summaries and model-based inference especially important. The sponsor analysis takes precedence for the trial’s reported inferential result, but the missing mapping between regression slopes and outcomes limits how precisely those results can be interpreted.

The record also illustrates why a confidence interval adds information beyond a single estimate or p-value. The recalculated GPA interval includes zero and spans values on either side of no difference. That uncertainty should remain visible in interpretation rather than being reduced to a binary claim. The planning illustrations likewise show that sample-size requirements depend on the effect a future study aims to detect, and smaller target effects require more participants under the stated assumptions.

Finally, the record demonstrates the importance of reporting decisions about multiple outcomes, analysis populations, missing data, and model specifications. The trial includes several outcomes and analyses, but the registry does not describe a multiplicity strategy or map each regression result to its outcome. Clearer reporting would make it easier for readers to distinguish confirmatory findings from exploratory ones and to assess how robust the conclusions are.

19. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations specific to this trial follow from what is and is not reported in the registry record. The study is described as randomized and single-masked, but the randomization procedure, allocation concealment, and identity of the masked party are not reported. The record also does not describe baseline characteristics, making it difficult to assess group balance or understand which characteristics may have been considered in analysis.

The intervention descriptions identify a yoga-informed Health and Wellness Program and a physical education class, but do not provide enough detail to assess curriculum content, session frequency, intervention duration, instructor preparation, adherence, or delivery fidelity. The nature and amount of exposure to each program are therefore unclear from the record.

The central statistical limitation is the discrepancy between the sponsor’s reported analysis and the unadjusted recalculation, alongside the lack of outcome mapping for the posted regression slopes. Model specifications, covariates, contrast definitions, and the relationship between the regression analyses and GPA are not reported. The sponsor’s analysis takes precedence, but readers cannot fully evaluate how it was obtained from the available description.

The registry lists multiple outcomes and analyses without reporting a multiplicity plan or hierarchy. Although the primary endpoint is identified, the analysis-selection process and the role of the several regression results are not clear. The record also does not report the original sample-size justification or whether any interim analyses occurred.

Primary outcome data are described as available at baseline and study end for all participants, but the registry does not explain the handling of missing data for secondary measures. The detailed Warwick Edinburgh results have fewer participants than the primary arm summaries, and the reason is not reported. Finally, adverse-event collection methods and definitions are not described, and the deaths field is not populated. These reporting gaps constrain conclusions about efficacy, robustness, and safety.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools — NCT02329015.
• Registry record last updated 2016-11-04; status last verified 2016-09.
• Results first posted 2016-11-04.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

The registry record describes a completed, randomized, single-masked, parallel-group Phase 1 study in New York City schools, with enrollment of 112. It compares a yoga-informed Health and Wellness Program with physical education and identifies GPA at the one-year timeframe as the primary outcome.

The posted GPA means are 85.71 for the Health and Wellness Program and 83.45 for physical education. The unadjusted recalculation estimates a mean difference of -2.26 for physical education relative to the Health and Wellness Program, with a confidence interval from -5.475 to 0.955. The record flags a discrepancy, so the sponsor’s own analysis takes precedence; the posted regression slopes are not mapped to specific outcomes in the available information.

The registry also names psychosocial secondary measures and records zero serious and zero other adverse events in both arms. Multiplicity handling, secondary missing-data procedures, detailed model specifications, and the identity of the masked party are not reported in the registry record.