Effect of Sport Education in University Required PE on Students' Perceived Physical Literacy and Physical Activity Level: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of Sport Education in University Required PE on Students' Perceived Physical Literacy and Physical Activity Level (NCT03888885), a randomized na study. The primary outcome is Self-report Physical Activity Levels.

2. Clinical Question

The trial’s stated focus is the effect of implementing a Sport Education Model in required university physical education. The primary outcome concerns self-reported physical activity, rather than an objectively recorded activity measure. The registry describes a globally standardized and validated questionnaire and identifies vigorous activity, moderate activity, walking, and sitting as the generic items included in its measurement approach.

The registry also lists secondary outcomes covering motivational climate, situational motivation, perceived physical literacy, enjoyment of physical activity, and fitness instruction time in physical education lessons. These outcomes give context to the intervention’s educational and motivational aims, but the record does not report results for them. It also does not report primary outcome results. Accordingly, the clinical question can be described from the trial’s stated design and outcome definitions, but the registry record cannot establish what effect was observed or how precisely it was estimated.

3. Trial Design

The registry identifies this as a randomized, parallel-group, single-masked trial and describes the study as cluster randomized. The intervention was the Sport Education Model, delivered through required physical education lessons over 10 lessons. The control group attended normal physical education classes over the same period and was described as receiving no intervention treatment.

The registry lists enrollment as 410. It does not report the number or size of clusters, the unit used for cluster allocation, or how participants were distributed across the arms. Those details matter because participants within a cluster may have more similar outcomes than participants in different clusters. The registry also does not say who was masked; “single” masking alone does not identify whether students, instructors, outcome assessors, or another group were masked.

The study start is recorded as 2019-01-07, and primary completion as 2019-04-18. The primary outcome timeframe describes change from baseline at the 10th lesson (11th week), with follow-up at the 13th lesson (15th week). The registry does not report the actual timing of individual assessments or whether all participants completed them.

The record is marked completed, but completion status does not by itself mean that results are available. The record lists 7 outcome measures and 0 analyses. It gives no sample-size justification, detailed analysis plan, cluster-adjusted effect estimate, confidence interval, or primary-outcome result. A simple individual-level recalculation would be misleading for a cluster-randomized design; the registry record does not include sponsor analysis results to interpret in its place.

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

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 Self-report Physical Activity Levels, measured over Change from Baseline Self-report Physical Activity Levels at the 10th lesson (11th week) and Follow-up at the 13th lesson (15th week).

The primary endpoint is titled “Self-report Physical Activity Levels” and is measured in MET-minutes/week. The registry describes the measure as the globally standardized and validated International Physical Activity Questionnaire - short form. Participants were asked about vigorous activity, moderate activity, walking, and sitting, with questions about activity in the last 7 days and duration of activity lasting at least 10 uninterrupted minutes.

The registry states that the activity scoring uses 8 METs for vigorous activity, 4.0 METs for moderate activity, and 3.3 METs for walking. It describes calculating MET-minutes/week from intensity-specific activity minutes and days. Sitting is listed among the questionnaire items, but the registry does not describe sitting as part of the stated activity-score formula.

Using a common activity measure gives the trial a way to compare reported activity across its assessment occasions. A change-from-baseline outcome is intended to express how a participant’s measured value differs from their own baseline value. In general, self-report can capture activities that are not continuously monitored, but it depends on recall and interpretation of the questions. The registry record does not provide evidence about reporting accuracy in this trial, nor does it report endpoint values, change estimates, or uncertainty.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization contribute?

In general, random allocation is used to make treatment groups comparable in expectation with respect to measured and unmeasured characteristics. The record states that allocation was randomized and identifies the study as cluster randomized. In a cluster-randomized study, allocation occurs by groups rather than by treating every participant as an independently randomized unit. The registry does not report which groups were randomized or how many clusters were involved, so those design details cannot be evaluated.

Why does clustering affect uncertainty?

In general, people in the same class, institution, or other cluster may share circumstances that make their outcomes more alike. This within-cluster similarity reduces the amount of independent information relative to an analysis that assumes every participant is unrelated to every other participant. Statistical methods for cluster trials account for this dependence, often by adjusting standard errors or modeling cluster-level variation. The exact approach used in this trial is not reported in the registry record. The record explicitly cautions that simple individual-level recalculation would be misleading, so a participant-level analysis should not be substituted for the sponsor’s cluster-aware analysis.

What does a change-from-baseline outcome mean?

In general, a change score compares a follow-up measurement with the same participant’s baseline measurement. This can describe how the measured outcome shifted over time, but an intervention effect requires a comparison that accounts for what happened in the control group as well. Change scores can also be analyzed in different ways, including direct comparison of changes or models that adjust follow-up values for baseline. These approaches can yield different estimates and precision. The registry record does not state which method was planned or used, and it does not report the results required to examine that choice.

How should the endpoint be understood?

The outcome is a continuous measure expressed in MET-minutes/week. The registry describes its source as the International Physical Activity Questionnaire - short form and specifies weighted scoring for vigorous activity, moderate activity, and walking. A continuous outcome retains information about the magnitude of reported activity rather than reducing it to a category. In general, its interpretation depends on how the distribution behaves and whether the analysis assumptions are reasonable. Self-reported activity may also be affected by recall and reporting behavior; the record does not report trial-specific validation or measurement error estimates.

Why is dispersion relevant?

The registry identifies the outcome parameter as a mean and the dispersion measure as a standard deviation. In general, the mean describes the average observed value, while the standard deviation describes variability among observations around that average. Both are needed to understand the scale and spread of a continuous outcome. A standard deviation is not the same as the standard error, which describes uncertainty in an estimate. The registry does not report the means or standard deviations for the arms or assessment occasions, so those characteristics cannot be interpreted.

What does a confidence interval add?

In general, an effect estimate gives the size and direction of a comparison, while a confidence interval communicates its statistical precision under the analysis assumptions. A confidence interval does not establish that an effect is clinically important, and a broad interval may include values with different interpretations. For a cluster-randomized trial, valid intervals must reflect the clustered design. No primary effect estimate or confidence interval is reported in the registry record.

What do the planning illustrations mean?

The registry describes sample-size illustrations based on a fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. These are planning illustrations, not observed power and not the trial’s own design justification. In general, power calculations describe the chance of detecting a specified effect under a set of assumptions; they do not reveal whether the trial’s observed result is precise or valid. The record does not report a sample-size justification for the trial or the primary outcome estimate on which an observed-effect illustration would depend.

Can the analysis be reproduced?

Reproducing an analysis requires details such as the outcome model, handling of clusters, baseline adjustment, missing-data approach, and analysis population. The registry record does not report these details. It lists 0 analyses, so a sponsor estimate cannot be checked against an independent recalculation. In general, reproducing calculations from summary statistics would not resolve omitted clustering or other design features. For this study, interpretation should remain limited to the registered design and endpoint definition until the cluster-aware results and methods are reported.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and secondary outcomes covering motivational climate, situational motivation, perceived physical literacy, enjoyment of physical activity, and fitness instruction time. It also lists 7 outcome measures. When a study examines multiple outcomes or assessment occasions, the chance of at least one apparently unusual result can increase if each is tested separately. In general, a prespecified hierarchy, adjustment procedure, or clear distinction between primary and exploratory analyses can help readers understand how multiplicity was handled.

The registry record does not report a multiplicity plan, a hierarchy among the secondary outcomes, or which secondary outcomes were analyzed. It also does not report analyses for the primary outcome. Consequently, there is no basis for assessing whether the reported testing, if any, controlled the risks associated with multiple comparisons.

Missing-data methods and analysis populations are also not reported in the registry record. It does not state how missing questionnaire responses, incomplete follow-up, or participants without usable outcome measurements were handled. Nor does it identify whether analysis followed assignment regardless of participation, used a per-protocol population, or applied another definition. These omissions matter because exclusions and missing outcomes can affect both the estimated group comparison and its precision, particularly when the extent or reasons for missingness differ across groups.

The enrollment entry does not establish how many participants contributed data to each outcome or assessment. No denominators, completion counts, or outcome-specific analysis populations are reported. Results should therefore not be interpreted as complete follow-up, and the record does not permit assessment of attrition or the sensitivity of findings to missing-data assumptions.

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

The registry record establishes that the trial was designed to compare a Sport Education Model in required university physical education with normal physical education classes. It identifies self-reported physical activity as the primary outcome and defines assessment occasions by lesson and week. It also documents several motivational, literacy, enjoyment, and lesson-time secondary outcomes.

Those design details do not show what happened to physical activity in either group. The record does not report arm-level values, changes, a between-group estimate, or uncertainty. It is therefore not possible to infer whether reported activity increased, decreased, or remained similar, or whether any observed comparison was precise. Trial completion and randomization do not fill that information gap.

In general, a statistically detectable difference is not automatically an important difference to students, and an imprecise result is not proof that groups are equivalent. Interpreting a result requires the magnitude of the comparison, its uncertainty, the outcome’s measurement properties, and the analysis’s alignment with the cluster design. The registry record does not report those result details or a threshold for judging importance.

The endpoint is self-reported, and its stated scoring focuses on vigorous activity, moderate activity, and walking. It should not be treated as a direct measure of all physical activity or as an objective activity-monitor reading. The registry’s questionnaire description does not establish how accurately participants recalled their activity in this particular trial.

The adverse-event entries list zero serious events, other events, and deaths in both groups. That record entry is not enough to establish that no harms occurred in practice, because surveillance and reporting completeness are not described. In short, the trial’s registered purpose and methods can be outlined, but its effect and safety conclusions cannot be determined from the results reported in the registry.

12. Why This Trial Matters Statistically

This trial raises a statistical issue that is central to interpreting education and other group-delivered interventions: the unit of allocation may differ from the person whose outcome is measured. The registry identifies a cluster-randomized design. Analyses that ignore clustering can treat correlated responses as if they offered more independent information than they do, producing uncertainty estimates that are too small. The record itself cautions against an individual-level recalculation, underscoring why design-aware analysis is essential.

The primary outcome also illustrates the difference between a clearly defined measure and a reported result. The registry specifies a continuous self-reported activity measure, its units, broad questionnaire content, scoring weights, and assessment occasions. That detail helps readers understand what the investigators intended to measure. But without results, standard deviations, an effect estimate, or an interval, the measure’s actual behavior and the precision of the comparison remain unknown.

The record further shows why completion status is distinct from results availability. A completed trial can still have no primary outcome analysis reported in its registry entry. Without the analysis method, missing-data approach, or analysis population, readers cannot assess whether the statistical procedure matches the design or how much information contributed to the outcome.

For clinical researchers, the practical statistical lesson is to evaluate design, measurement, analysis, and reporting together. Cluster-aware methods, transparent outcome reporting, and explicit handling of missing data are necessary for a credible interpretation. This registry entry provides the design and measurement framework, but not the information needed to judge the primary comparison.

13. 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.

A central limitation of the available record is the absence of primary outcome results. The registry lists 0 analyses and gives no group means, standard deviations, change estimates, effect contrast, confidence interval, or p-value. Thus, the magnitude and precision of the primary comparison cannot be assessed.

Although the study is described as cluster randomized, the registry does not report the cluster unit, number of clusters, cluster sizes, or allocation details beyond randomized assignment. It also does not name the statistical method used to account for clustering. This prevents evaluation of whether the analysis appropriately reflected the design. The stated warning against a simple individual-level recalculation reinforces that limitation.

The masking entry is “single,” but the person or group masked is not reported. The record does not describe participant characteristics, adherence, intervention delivery fidelity, or whether the control classes differed in any way beyond the stated absence of the intervention. These details would help readers assess the context and implementation of the comparison.

Outcome follow-up is described at the 10th lesson (11th week) and at the 13th lesson (15th week), but the record does not report outcome completion by assessment occasion. Missing-data handling and the analysis population are not reported. The study’s multiplicity strategy for its several listed outcomes is also absent.

Finally, the primary measure is self-reported, and the registry does not report trial-specific evidence on recall, response quality, or measurement error. These limitations concern the registry information available for interpretation; they do not establish that the trial itself lacked procedures that were not recorded.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Effect of Sport Education in University Required PE on Students' Perceived Physical Literacy and Physical Activity Level — NCT03888885.
• Registry record last updated 2022-07-18; status last verified 2022-07.
• Results first posted 2022-07-05.
• 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.

17. Record Summary

The registry record describes a completed, randomized, parallel-group, single-masked cluster trial of Sport Education in university required physical education. The intervention group received lessons using the Sport Education Model over 10 lessons; the control group attended normal physical education classes over the same period. Enrollment is listed as 410.

The primary outcome is self-report physical activity in MET-minutes/week, with change from baseline at the 10th lesson (11th week) and follow-up at the 13th lesson (15th week). Secondary outcomes include motivation, perceived physical literacy, enjoyment, and fitness instruction time.

The record does not report primary outcome results, analysis methods, missing-data procedures, or analysis populations, and it lists 0 analyses. Because the study is cluster randomized, the record cautions that simple individual-level recalculation would be misleading. The available information therefore supports description of the trial design and measurement plan, but not an estimate or conclusion about the intervention’s effect.