This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Active Video Games and Appetite Control in Adolescents (NCT01655901), a randomized na study. The primary outcome is Energy Intake and Energy Expenditure (Over 24 Hours and Over 3 Days).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01655901 |
| Phase | NA |
| Condition | Active Video Games and Appetite Control |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Children's Hospital of Eastern Ontario |
| Results posted | Yes |
2. Clinical Question
Population
Adolescents were the intended study population. The registry record lists an enrollment of 30, but does not report detailed eligibility criteria or a fuller description of the participants in the primary outcome record.
Intervention
Active video gaming, described as playing Kinect. The study objective was to examine acute effects on energy intake and energy expenditure, including whether changes in intake or subsequent activity might offset changes associated with gaming.
Comparator
The other listed conditions were passive video gaming, described as playing Xbox 360, and resting, described as staying seated on a comfortable chair. The registry record labels the study randomized and crossover, but does not report the condition order or other sequence details.
Primary question
How do energy intake and energy expenditure during and after active video gaming compare with passive gaming and rest? The primary outcome covers an acute period of 24 hours and a subsequent 3-day period. The registry record does not report comparative results.
The study’s stated rationale is that active games may increase energy expenditure, while changes in food intake or spontaneous physical activity could affect the overall energy balance. Its stated hypothesis proposes that compensatory adjustments might offset the increase in expenditure. This is a hypothesis, not a reported finding.
The endpoint description combines measurements taken around the experimental conditions with measures covering the remainder of the day and the subsequent days. That scope is relevant to the question: a measurement confined to the gaming session would not, by itself, describe intake and expenditure across the whole observation period. The registry record does not report the actual measurements or estimates for any condition.
3. Trial Design
The registry record describes a randomized crossover study with no masking. It lists three behavioral conditions: active video gaming, passive video gaming and resting. The active condition involved playing Kinect; the passive condition involved playing Xbox 360; and the resting condition involved sitting on a comfortable chair. The record does not give the randomization sequence, explain how condition order was handled, or describe any period between conditions.
The listed enrollment is 30. This is the registered enrollment figure, not an outcome-specific analysis count. The safety record separately lists 26 participants at risk for each condition. The registry record does not explain the relationship between these figures, or report the number contributing data to each primary outcome measure.
The primary outcome is titled “Energy Intake and Energy Expenditure (Over 24 Hours and Over 3 Days).” It uses kJ as the unit and lists the summary measure as a mean with standard error as the dispersion measure. The stated timeframe is acute (24 hours) and short-term (3 days). Energy intake was assessed using an ad libitum test meal immediately following the three experimental conditions, a food menu for the remainder of the day and a dietary record for the subsequent 3-day period. Energy expenditure was measured by indirect calorimetry during the conditions and by Actical accelerometer for the subsequent 3-day period.
The registry lists appetite sensation, stress marker and levels of appetite-related hormones as secondary outcomes. The sponsor is Children’s Hospital of Eastern Ontario. The recorded study start is 2012-09, primary completion is 2014-09, and status is completed. These design and registration details describe what was planned or recorded; they do not supply the outcome estimates or establish how the analysis was conducted. The analysis population, handling of missing measurements and statistical model are not reported in the registry record.
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.
First Intervention (Hour 1)
| Stage | Kinect, Then Xbox360, Then Sitting | Kinect, Then Sitting, Then Xbox360 | Xbox360, Then Sitting, Then Kinect | Xbox360, Then Kinect, Then Sitting | Sitting, Then Kinect, Then Xbox360 | Sitting, Then Xbox360, Then Kinect |
|---|---|---|---|---|---|---|
| STARTED | 5 | 5 | 5 | 5 | 5 | 5 |
| COMPLETED | 5 | 5 | 5 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Washout (1 Week)
| Stage | Kinect, Then Xbox360, Then Sitting | Kinect, Then Sitting, Then Xbox360 | Xbox360, Then Sitting, Then Kinect | Xbox360, Then Kinect, Then Sitting | Sitting, Then Kinect, Then Xbox360 | Sitting, Then Xbox360, Then Kinect |
|---|---|---|---|---|---|---|
| STARTED | 5 | 5 | 5 | 5 | 5 | 5 |
| COMPLETED | 5 | 5 | 5 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Second Intervention (Hour 2)
| Stage | Kinect, Then Xbox360, Then Sitting | Kinect, Then Sitting, Then Xbox360 | Xbox360, Then Sitting, Then Kinect | Xbox360, Then Kinect, Then Sitting | Sitting, Then Kinect, Then Xbox360 | Sitting, Then Xbox360, Then Kinect |
|---|---|---|---|---|---|---|
| STARTED | 5 | 5 | 5 | 5 | 5 | 5 |
| COMPLETED | 5 | 5 | 5 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Washout (1 Week)
| Stage | Kinect, Then Xbox360, Then Sitting | Kinect, Then Sitting, Then Xbox360 | Xbox360, Then Sitting, Then Kinect | Xbox360, Then Kinect, Then Sitting | Sitting, Then Kinect, Then Xbox360 | Sitting, Then Xbox360, Then Kinect |
|---|---|---|---|---|---|---|
| STARTED | 5 | 5 | 5 | 5 | 5 | 5 |
| COMPLETED | 5 | 5 | 5 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
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: Completers analyzed
| Characteristic | Unit | Video Game Condition |
|---|---|---|
| Participants analysed | 26 | |
| Age, Continuous | years | 14.5 (SD 1.4) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 26 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: Canada | participants | 26 |
| BMI (kg/m2) | kg/m2 | 21.8 (SD 5.0) |
| Waist circumference (cm) | cm | 74.1 (SD 12.7) |
| Resting metabolic rate (kJ/day) | kJ/day | 7101 (SD 1224) |
| Tanner puberty stages (self-assessed by questionnaire) | units on a scale | 3.5 (SD 0.9) |
| Physical Activity Questionnaire score | units on a scale | 2.3 (SD 0.5) |
| Cohen's Perceived Stress Scale score | units on a scale | 13.0 (SD 5.4) |
| Pittsburgh Sleep Quality Index score | units on a scale | 4.8 (SD 2.3) |
| Levels of appetite-related hormones | mmol/L | — |
6. Primary Endpoint
The registry lists the primary outcome as Energy Intake and Energy Expenditure (Over 24 Hours and Over 3 Days), measured over Acute (24 hours) and short-term (3 days).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Error |
| Unit | kJ |
| Endpoint classification | Continuous Endpoint |
The primary outcome concerns energy intake and energy expenditure across an acute observation period and a short-term follow-up period. Intake was assessed with an ad libitum meal following the experimental conditions, a food menu covering the rest of the day, and a dietary record for the subsequent 3-day period. Expenditure was assessed with indirect calorimetry during the conditions and an Actical accelerometer for the subsequent 3-day period. The listed unit is kJ.
These measures are used to examine different parts of the energy-balance question raised by the study. Intake records address food consumed, while expenditure measurements address energy used during the experimental conditions and the days that followed. The study rationale also raises the possibility of compensatory changes after gaming. The record therefore describes measures extending beyond the immediate activity, rather than an endpoint limited to energy expenditure during a game.
General statistical context: a mean summarizes the average measured value in a group or condition. A standard error describes the precision of an estimated mean, not the spread of individual observations. The registry lists mean and standard error as the summary and dispersion formats, but does not report the values, participant-level variability, or comparisons between conditions. The reported endpoint description also does not specify how the different intake and expenditure components were combined, if at all. That detail is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives the study question, conditions and measurement plan, but it does not report the primary outcome results. It contains no listed analyses. Consequently, there are no posted condition-specific means, estimated differences, confidence intervals or p-values to interpret. The study’s hypothesis about possible compensation is not evidence that compensation occurred, and the design description alone cannot establish the direction or size of any effect.
The recorded primary outcome is a mean of continuous measurements, with standard error listed as the dispersion format. If condition-level estimates and comparisons were available, their interpretation would depend on both the estimated difference and its uncertainty. General statistical context: a confidence interval expresses a range of values compatible with the data and model at a stated confidence level. A narrow interval indicates greater precision than a wide interval, but neither the interval nor its confidence level is reported in the registry record.
The crossover label is important for understanding the intended design, but it does not reveal the analysis. General statistical context: in a crossover study, comparisons may use within-participant information, which can account for stable differences between people. Valid interpretation can also depend on condition order, period effects and whether effects persist into later periods. The registry record does not describe the sequence, any washout arrangements, or a model addressing these considerations. It is therefore not possible to determine from this record whether or how these features were incorporated.
The enrollment figure of 30 describes the registered study enrollment. It does not establish how many participants contributed complete measurements to each endpoint or comparison. The safety record lists 26 at risk for each condition, but that does not supply an analysis denominator for the energy measures. Outcome-specific sample sizes and analysis populations are not reported in the registry record.
The registry includes planning assumptions for sample-size illustrations: a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. These are planning assumptions, not a description of the trial’s own design justification. The record does not report the trial’s sample-size justification, and no numerical planning results are available. Such illustrations must not be read as observed power or as evidence about whether the study detected a difference.
In short, the record supports a description of the randomized crossover question and its measurement approach. It does not support a conclusion about whether active gaming, passive gaming or rest was associated with higher or lower intake or expenditure, or about the precision of any comparison. Those results are not reported in the registry record.
9. Statistical Methods Explained
The registry identifies the study as randomized and crossover, and describes continuous energy-intake and energy-expenditure outcomes. It lists the summary parameter as a mean and the dispersion as standard error. It does not report an inferential analysis, model, confidence interval, p-value or outcome estimate. The explanations below describe general statistical ideas, not methods confirmed as having been used in this trial.
What does a mean describe?
General: a mean is an average of measured values. It can summarize energy intake or expenditure for a condition and observation period, provided the underlying measurements and analysis population are specified. A mean alone does not show how much participants differed from one another, whether the distribution was symmetric, or how precisely a condition comparison was estimated. Although the registry lists means as the summary measure, it does not give the condition-specific values.
What does a standard error describe?
General: a standard error describes the sampling precision of an estimated quantity, such as a mean. It is not the same as a standard deviation, which describes variation among individual observations. A standard error can help communicate uncertainty, but its interpretation depends on what was estimated and on the analysis design. The registry lists standard error as the dispersion format but does not provide numerical standard errors or explain whether they refer to condition means or contrasts.
Why does the crossover design matter?
General: a crossover design can compare conditions using measurements from the same participant, rather than treating all observations as if they came from unrelated people. This can be useful when participants differ in their usual energy intake or expenditure. The comparison still needs to account appropriately for the repeated measurements. The order of conditions, changes over time, and carryover from an earlier condition may matter. The registry record does not report the order, period structure, washout details, or an analysis model, so it is not possible to say whether these factors were addressed.
How should condition comparisons be read?
General: an estimated contrast describes the difference between conditions under a defined analysis. Its uncertainty is as important as its point estimate. A confidence interval communicates a range of plausible values under the statistical model; a p-value addresses compatibility with a specified null hypothesis under that model. Neither measure, by itself, establishes clinical importance. This record does not report contrasts, confidence intervals or p-values. It also does not specify which pairwise comparisons were intended or whether the primary question was an overall comparison across conditions.
Why can multiple outcomes and comparisons matter?
General: when many outcomes, time periods or pairwise comparisons are examined, the chance of at least one apparently notable result can increase if no multiplicity strategy is used. Approaches to multiplicity can include defining a primary comparison in advance or adjusting the inferential procedure. The registry lists a primary outcome and secondary outcomes, but does not report a multiplicity plan or analysis results. The presence of several measurement components does not establish which were tested or how they were interpreted.
What does over-dispersion mean?
General: over-dispersion refers to variability greater than a model assumes. It is particularly relevant for certain count-data models, where underestimated variability can make uncertainty appear too small. The primary outcome is described as continuous and summarized by means, so the record does not establish that a count model or an over-dispersion issue applies. Whether the continuous measurements required a particular variance model is not reported in the registry record.
What can planning illustrations tell us?
General: a sample-size calculation depends on assumptions about the effect to detect, variability, allocation and statistical procedure. A planning illustration is not an observed result and does not show the probability that a completed study found an effect. The registry’s stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation, with the target effect defined as a fraction of the observed effect. The record does not provide numerical illustration results. It also does not report the study’s own sample-size justification. The registered crossover design and three conditions should not be conflated with a two-arm planning scenario.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies a primary outcome and lists appetite sensation, stress marker and levels of appetite-related hormones as secondary outcomes. The primary outcome itself includes energy intake and energy expenditure measured over an acute 24-hour period and a subsequent 3-day period. These multiple domains and timeframes could create more than one possible analysis question. The registry record does not report which comparisons were designated as primary, how secondary outcomes were handled, or whether any multiplicity adjustment was planned or used.
Missing-data handling is also not reported in the registry record. The entry does not describe how incomplete food records, absent measurement periods or other missing observations were treated. It does not state whether an analysis required complete measurements across conditions, used available observations, or applied another approach. No analysis population is described.
The enrollment figure is 30, while the safety rows list 26 at risk for each condition. The record does not explain whether these counts refer to the same set of participants or how many contributed to the primary endpoint. They cannot be used to reconstruct the missing-data approach or outcome-specific denominators. The registry lists no analyses, so there are no posted analysis results from which to assess how multiplicity or missingness affected estimates. These omissions limit interpretation of both the precision and the comparability of any potential condition estimates.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Kinect | 0 | 26 | 0.0% |
| Xbox360 | 0 | 26 | 0.0% |
| Sitting | 0 | 26 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Kinect | 0 of 26 |
| Xbox360 | 0 of 26 |
| Sitting | 0 of 26 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Kinect | 0 of 26 |
| Xbox360 | 0 of 26 |
| Sitting | 0 of 26 |
The safety record lists three condition rows: Kinect, Xbox360 and Sitting. For each row, it reports 26 at risk, 0 serious adverse events, 0 other adverse events and 0 deaths. These are the figures recorded for the listed conditions; they are not efficacy results.
General statistical context: a count of zero recorded events does not establish that the underlying risk is zero. It describes what was recorded within the listed group and observation context. The registry record does not provide further detail about event definitions, collection procedures, observation duration for safety, or whether the same participants contributed to each condition’s safety count. In a crossover study, condition rows should not automatically be treated as independent groups of different people.
The record lists no serious adverse-event terms. It does not provide additional narrative safety results or explain how adverse events were attributed to a condition. These figures should therefore be read as the registry’s recorded counts, not as proof that no adverse events could occur or as a comparative safety analysis.
12. What the Result Does, and Does Not, Mean
This record documents a randomized crossover study asking whether active video gaming, passive video gaming and rest are associated with differences in energy intake and expenditure in adolescents. It specifies an active gaming condition using Kinect, a passive gaming condition using Xbox 360, and a resting condition. It also describes intake and expenditure measurements spanning the experimental conditions and the following days.
What the record does not provide is the primary outcome data. There are no reported condition means, comparative estimates, confidence intervals or p-values, and no analyses are listed. The study’s hypothesis that compensatory changes might offset an increase in energy expenditure is a proposed explanation to investigate, not a result. The completed status and study dates do not fill that evidence gap.
General statistical context: an estimate without a measure of uncertainty can be difficult to interpret, while an uncertainty interval without a clearly defined comparison may also be uninformative. Here, neither estimates nor uncertainty measures are reported. It is not possible to assess the size, direction or precision of differences between conditions from the registry record.
The design and measurement descriptions still clarify the question the study set out to address. The intake assessment included a meal, the remainder of the day and a subsequent dietary record; the expenditure assessment included measurements during the conditions and accelerometer measurement over the subsequent period. Those details describe the intended scope of measurement, not evidence that one condition changed energy balance.
Accordingly, this page can explain the study’s design and endpoint but cannot say whether active gaming increased or decreased intake or expenditure, whether any change persisted, or whether the hypothesized compensatory responses occurred. Those findings are not reported in the registry record.
13. Why This Trial Matters Statistically
The study is statistically interesting because its question spans more than the activity itself. It asks about energy intake and expenditure during and after three behavioral conditions, with measurements extending from the experimental conditions to the subsequent 3-day period. That design makes the distinction between an immediate measurement and a broader observation period central to interpreting the endpoint.
The crossover label also matters. General statistical context: repeated measurements can allow comparisons that account for stable participant-level differences, but a suitable analysis needs to reflect the within-participant structure and consider order or period effects. The registry record does not provide enough detail to assess whether or how the analysis did so. This is an important reason not to infer an analysis from the design label alone.
The registry also separates a primary outcome from secondary measures of appetite sensation, stress markers and appetite-related hormones. That structure makes it important to know which contrasts and outcomes were prespecified, and how multiple analyses were handled. The record does not report those details or any analysis results. The absence of posted estimates means the central statistical questions—effect direction, magnitude and precision—remain unanswered in this record.
Finally, the record illustrates why enrollment, safety counts and outcome analysis counts are not interchangeable. Enrollment is listed as 30, the safety rows list 26 at risk for each condition, and no analyses are listed. Without outcome-specific denominators and missing-data information, these figures cannot reconstruct the analyzed sample. The trial description is useful for understanding what was measured, but the registry record alone does not allow a statistical assessment of the primary findings.
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 main limitation for interpreting this trial from the registry record is that it does not report primary outcome estimates or analyses. There are no condition-specific results, contrasts or uncertainty measures available to assess the energy-intake and energy-expenditure question. Although the record marks the study completed, completion status is not a substitute for results.
Several design and analysis details are also absent. The record does not report condition sequence, period structure, washout arrangements, the statistical model, or how the crossover structure was handled. It does not describe the analysis population, outcome-specific denominators or the handling of missing measurements. These omissions make it impossible to evaluate the role of incomplete data or potential order and period effects from this record.
The endpoint description includes multiple measurement components and timeframes, but the record does not explain whether they were analyzed separately or combined, or identify the intended primary contrast among the conditions. A multiplicity plan is not reported. Detailed eligibility criteria and participant characteristics are also not reported in the primary outcome record, limiting assessment of who contributed to the results.
The safety rows list the same at-risk count for each condition, but the record does not explain the relationship between those counts and registered enrollment or clarify whether participants recur across conditions. Finally, the record does not report a sample-size justification. These limitations concern what can be learned from the registry record; they do not establish that the study itself lacked procedures or analyses that were not recorded there.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Active Video Games and Appetite Control in Adolescents — NCT01655901.
- Registry record last updated 2019-08-19; status last verified 2019-07.
- Results first posted 2019-08-19.
- 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.
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18. Record Summary
This completed study is registered as a randomized, unmasked crossover study of active video gaming, passive video gaming and resting in adolescents. The listed enrollment is 30. The active condition involved Kinect, the passive condition Xbox 360, and the resting condition sitting on a comfortable chair.
The primary outcome concerns energy intake and expenditure over an acute 24-hour period and a subsequent 3-day period. Intake measures included an ad libitum meal, a food menu for the remainder of the day and a dietary record; expenditure measures included indirect calorimetry during the conditions and an Actical accelerometer for the subsequent period. Secondary outcomes include appetite sensation, stress markers and appetite-related hormones.
The registry record lists no analyses and does not report outcome estimates or statistical comparisons. It therefore describes the question and measurement approach, but does not establish the findings. Safety rows list 0 serious adverse events, 0 other adverse events and 0 deaths for each condition, with 26 at risk in each row.