Effects of Active Video Games in Physically Inactive Children: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effects of Active Video Games in Physically Inactive Children (NCT03720938), a randomized na study. The primary outcome is Weight in Kilograms.

2. Clinical Question

3. Trial Design

The record describes a randomized, parallel-group pilot trial with no masking. It lists an enrollment of 106 and a completed status. The study start is recorded as 2013-02, and primary completion as 2013-05. The sponsor is Abant Izzet Baysal University. The registered title is “Effects of Active Video Games in Physically Inactive Children”; the official title describes a pilot randomized trial of active video games in inactive children.

Children assigned to the intervention played active video games in a laboratory environment for 50-60 min, 3 days a week, over 12 weeks. The control group is described as physically inactive children who did not play active video games. The registry record does not give further details about the randomization procedure, allocation concealment, recruitment, eligibility criteria, or the conduct of follow-up. Those details should not be inferred from the randomized label alone.

Weight was assessed at baseline and 12 weeks. The stated measurement used a Seca 767 scale and recorded weight to the nearest 0.01 kg. The record also lists secondary outcomes involving reaction times and dimensions of physical self-perception. It records 20 outcome measures and 50 analyses, but does not provide a single reduced primary-outcome comparison for interpretation. The analytic methods, analysis population, and handling of missing measurements are not reported in the registry record. The pilot designation describes the trial, but the record does not state its design rationale or a sample-size justification.

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.

Before assignment: The discrepancy between the enrolled (918) and assigned (n=106) numbers of children could be attributed to strict "inclusion" and "exclusion" criteria, and particularly to dropped out children due to technological preoocupation and physical inactivity as well as problems interfering physical activity and self-perception.

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.

Population: Techologically preoccupation and low physical activity

6. Primary Endpoint

The registry lists the primary outcome as Weight in Kilograms, measured over Baseline, 12 weeks.

The primary endpoint is weight in kilograms, a continuous measure of body mass. The registry describes measurement at baseline and 12 weeks, using a Seca 767 scale with readings to the nearest 0.01 kg. The first measurement was taken before the games and the second after the games.

Weight can be used to describe body size and to assess how a measured quantity changes over time. In a randomized comparison, the relevant question is not only whether weight changed within either group, but whether the outcome differed between the groups under the assigned conditions. A baseline measurement can help describe the starting values and may be used in an analysis of follow-up outcomes, but the registry record does not state which analytic approach was used.

The endpoint is reported as a mean with standard deviation as its dispersion measure. In general, a mean describes the average in a group, while a standard deviation describes how spread out individual measurements are around that average. The record does not contain the endpoint values, a between-group estimate, or an uncertainty interval. It also does not identify a threshold for a meaningful weight difference. Therefore, the measurement plan can be described, but the magnitude and precision of the primary-outcome result cannot be interpreted from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous primary outcome summarized as a mean with standard deviation. These terms convey different features of the data. The mean is the arithmetic average of the observed measurements in a group; the standard deviation describes how variable individual measurements are around that average. Neither quantity, on its own, gives the uncertainty of a between-group effect estimate. An effect estimate and an uncertainty measure, such as a confidence interval, are needed to describe both the estimated contrast and its precision.

Weight was measured at baseline and 12 weeks. For a study with repeated measurements, an analysis might compare follow-up values between randomized groups, compare changes from baseline, or model measurements over time. These approaches can answer related but not identical statistical questions and can rely on different assumptions. The registry record does not say which approach was used, so no particular method should be attributed to the trial.

In general, a confidence interval describes a range of values compatible with the data and the method's assumptions. A narrower interval indicates greater precision than a wider interval, but does not by itself determine whether an effect is important. A p-value addresses compatibility between the observed data and a specified statistical model under a null hypothesis; it is not a measure of effect size or the probability that a treatment works. The registry record does not report a confidence interval or p-value for the primary weight comparison.

Randomization is intended to make the assigned groups comparable on average, including on factors that were not measured, but the label alone does not show how the allocation sequence was generated or protected. The record identifies the study as randomized and parallel-group and says masking was absent. It does not report the randomization procedure, allocation concealment, or details of who knew assignments during measurement and analysis. These omissions limit what can be assessed about possible sources of bias.

For a continuous outcome, a comparison of group means may be affected by distributional features such as skewness or unusually influential observations. General statistical practice is to examine whether the chosen model and uncertainty calculation are reasonable for the data. The record does not provide distributions, individual measurements, diagnostics, or the analysis method, so the suitability of any particular model cannot be evaluated. The standard deviation describes spread; it does not demonstrate that a normal model is appropriate.

Multiplicity refers to the interpretive challenge created when many outcomes, time points, or statistical tests are considered. In general, looking across many tests can increase the chance that at least one result appears notable by chance, depending on the testing strategy. The registry lists 20 outcome measures and 50 analyses, but does not state whether or how multiplicity was addressed. The number of listed measures does not establish that every possible comparison was conducted, nor does it reveal which analyses were primary or exploratory beyond the stated primary endpoint.

The record's sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is specified as a fraction of the observed effect. Such illustrations are planning calculations, not observed power and not evidence about the precision of the trial's actual primary comparison. The record does not include the reduced primary effect needed to interpret such planning values, and does not report that these assumptions were the trial's own design basis. A design justification is not reported in the registry record.

Over-dispersion is a general concern when data vary more than a statistical model assumes. If a model understates variability, its uncertainty estimates may be too small and its intervals too narrow. This concept is relevant to some kinds of count or clustered data; weight is recorded as a continuous measure, and the registry does not report an analysis that would establish over-dispersion as an issue. More broadly, the analysis should reflect the actual outcome distribution and study structure, but those details are not available in the record.

Interpretation also depends on which participants are included in the analysis and how missing observations are handled. An analysis based on assigned groups can preserve the logic of randomization, while an analysis restricted to those with complete measurements may be affected if missingness relates to outcomes or assignment. These are general considerations, not descriptions of the trial's method: the analysis population, missing-data methods, and reasons for any missing measurements are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 20 outcome measures and 50 analyses. It includes weight as the primary outcome and lists secondary outcomes involving visual and auditory reaction times and physical self-perception. When multiple outcomes or tests are considered, general statistical interpretation requires attention to whether results were prespecified, whether any adjustment was used, and how readers should distinguish confirmatory from exploratory findings. The registry record does not report a multiplicity strategy or a statistical analysis plan. The listing of outcomes and analyses does not by itself establish which comparisons were performed or how their results were interpreted.

The record specifies weight assessments at baseline and 12 weeks, but does not report the number of measurements available for the primary analysis, any missingness, or reasons for missing data. It also does not describe imputation, complete-case analysis, or other missing-data methods. No particular approach can therefore be attributed to the study.

The analysis population is not reported in the registry record. It is not stated whether participants were analyzed according to randomized assignment, according to the intervention received, or using another population definition. These distinctions can matter because exclusions after randomization may affect the comparability created by assignment.

Because the primary outcome is not reduced to a single comparison and the analysis details are absent, multiplicity, missing-data handling, and population selection cannot be evaluated from the registry record. These are reporting gaps, not evidence that a specific method was or was not used in practice.

11. 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 lists serious and other adverse events separately for the control and intervention groups. For each group, the record lists 53 participants at risk for serious events and 0 affected; it also lists 53 at risk for other events and 0 affected. These are the figures recorded in the adverse-event fields.

The deaths field is null for both groups. A null value is not a reported zero, so deaths should not be described as absent on the basis of this record. The registry also lists no top serious-event terms. That listing does not provide detail about how events were collected, what criteria were used, or whether all event information was reported.

In general, an event count is interpreted in light of its definition, ascertainment period, completeness, and the number of participants observed. The record does not give further safety-collection details or a separate safety follow-up schedule. The listed zeros should therefore be read as registry-reported counts, not as proof that no events occurred outside the information captured in the record. These figures do not establish a broader safety conclusion.

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

The record establishes that this was a randomized, parallel-group pilot trial in physically inactive children, comparing an active-video-game group with a control group that did not play active video games. It describes the intervention schedule and identifies weight at baseline and 12 weeks as the primary outcome. Those details define the comparison the study set out to make.

The record does not provide a single reduced primary weight comparison or numerical endpoint results. It therefore does not show how much weight differed between the groups, which direction any difference took, or how precise an estimate might be. It also does not report a primary-outcome confidence interval or p-value. The absence of those results should not be interpreted as evidence of no difference.

The study's pilot designation and enrollment value do not establish that it was adequately powered for a particular effect. The registry record does not report the sample-size justification or intended precision. Nor does it supply enough information to assess adherence, missing measurements, the analysis population, or the statistical model used.

The registered secondary outcomes indicate that the study also considered reaction time and self-perception measures, but their inclusion does not show what those outcomes were or whether they changed. The adverse-event entries report zero affected for the listed serious and other event categories in each group, while the deaths fields are null. These entries should be interpreted as registry-recorded data rather than a complete characterization of all possible safety outcomes.

In short, the registry documents the trial question and broad design, but not the primary result needed to estimate the effect on weight. It does not establish that active video games do or do not change weight, nor does it support a conclusion about the broader effects of the intervention.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of why a registered question and a reported result are different things. The record identifies random assignment, a parallel-group comparison, the intervention schedule, and a primary measurement. Those details help readers understand the intended contrast. But without a group-level result and an uncertainty estimate, the central quantitative question remains unanswered in the registry record.

The distinction is especially important for a continuous outcome measured at more than one time. A baseline and follow-up schedule does not specify whether investigators compared follow-up means, changes, or another model-based quantity. Each can yield a different estimand and interpretation. Without the analysis description and result, readers cannot tell what contrast is being summarized.

The registry also lists many outcome measures and analyses. This makes clear why transparent statistical planning matters: readers need to know which outcomes and comparisons were primary, what was exploratory, and how multiplicity was considered. The record does not report those details, so the listed count alone cannot indicate how strongly any particular result should be interpreted.

Finally, safety counts and a completed status are not substitutes for a full account of outcome data, missingness, and analysis decisions. The record supports a careful description of the study design and the limits of its reported results. It does not support a quantitative conclusion about the primary weight effect.

14. 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.

The central limitation for interpretation is that the registry record does not provide a single reduced comparison for the primary endpoint, weight in kilograms. It gives the measurement schedule and method, but not group means, a between-group estimate, or a measure of uncertainty. Consequently, the direction, magnitude, and precision of the primary result cannot be assessed.

Details needed to assess conduct and analysis are also not reported in the registry record. These include the randomization procedure, allocation concealment, analysis population, missing-data handling, adherence, and statistical model. The record identifies the trial as unmasked, but does not describe how outcome measurement or analysis was conducted in relation to group assignment.

The registry lists 20 outcome measures and 50 analyses, yet does not report a statistical analysis plan or a multiplicity approach. This makes it difficult to identify the intended status of analyses beyond the stated primary endpoint. The record also does not report the criteria used to define physical inactivity, the children's age range, or further eligibility information.

The intervention description gives its schedule and laboratory setting, but details about what the control group did beyond not playing active video games are not reported. Safety reporting is limited to the recorded event fields; the deaths values are null, and the record does not give additional safety-collection details. These limitations concern what can be evaluated from the registry record and do not establish what was or was not done outside it.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Effects of Active Video Games in Physically Inactive Children — NCT03720938.
• Registry record last updated 2020-04-29; status last verified 2020-04.
• Results first posted 2020-04-29.
• 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.

18. Record Summary

The registry record describes a completed, randomized, parallel-group pilot trial with no masking, sponsored by Abant Izzet Baysal University. Enrollment is recorded as 106. The study start is listed as 2013-02 and primary completion as 2013-05.

Physically inactive children in the intervention group played alternating Nintendo Wii active video games for 50-60 min, 3 days a week, for 12 weeks in a laboratory environment. The control group did not play active video games. The primary outcome was weight in kilograms measured at baseline and 12 weeks using a Seca 767 scale.

The registry lists 20 outcome measures and 50 analyses, along with secondary measures of reaction time and physical self-perception. It does not provide a single reduced primary weight comparison, the analysis population, missing-data methods, or the statistical plan. The primary outcome's direction and precision therefore cannot be determined from the registry record.