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Obesity NA Continuous Endpoint NCT02470949

Influence of a Monopoly Game on Subtle Behaviors: Complete Statistical Analysis

The registry record describes a randomized crossover study of low and high perceived social status conditions created through a Monopoly game. The posted primary outcome is mean calories consumed at a lunch following each experimental condition.

Trial start: 2014-09  ·  Enrollment: 9  ·  Sponsor: University of Colorado, Denver
Scope of this record

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 Influence of a Monopoly Game on Subtle Behaviors (NCT02470949), a randomized na study. The primary outcome is Calories Consumed Following the Experimental Manipulation.

9
Enrollment
NA
2
Arms
In the primary outcome
n/a
Effect
No re-analysis shown
n/a
95% CI
See limitations
FeatureRegistry value
ClinicalTrials.gov identifierNCT02470949
PhaseNA
ConditionObesity, Eating Behavior
AllocationRandomized
Design modelCrossover
MaskingSingle
Enrollment9
Arms in the primary outcome2
Lead sponsorUniversity of Colorado, Denver
Results postedYes

2. Clinical Question

Population

The registry describes a study of people in a project concerning perceived social standing, eating behavior, and obesity risk. It lists obesity and eating behavior as conditions and reports enrollment of 9 participants. The characteristics of the participants, eligibility criteria, and recruitment details are not reported in the registry record.

Intervention

The behavioral condition labeled Low Social Status was described as the low social status condition in a Monopoly game. The primary outcome description says participants were offered an ad libitum lunch for 20 minutes after completing their manipulated social status condition. Further details of the manipulation, including how the game produced the intended perception and how fidelity was assessed, are not reported in the registry record.

Comparator

The comparator was the behavioral condition labeled High Social Status, also described as a condition in a Monopoly game. The registry identifies the study as randomized and crossover, but the order in which participants experienced the conditions, the allocation procedure, and any period or washout details are not reported in the registry record.

Primary question

The primary outcome was calories consumed, measured in kcal, at the lunch following the experimental manipulation. The posted summaries report a mean of 647.5 kcal (standard deviation 252.8; n=8) for Low Social Status and a mean of 520.9 kcal (standard deviation 231.2; n=7) for High Social Status. These are descriptive summaries. The registry reports no analysis for a two-arm comparison, so it does not provide an inferential estimate of the contrast or its precision.

3. Trial Design

The registry identifies this as a randomized, single-masked, crossover behavioral study, with enrollment of 9. The conditions were Low Social Status and High Social Status, both described as conditions in a Monopoly game. The listed phase is NA. The study status is completed, and the sponsor is the University of Colorado, Denver. The registry gives a start of 2014-09 and primary completion of 2015-12.

A crossover design generally compares conditions experienced by the same participants, rather than assigning different participants to each condition for the entire study. This can make within-participant comparisons relevant, since each participant can serve as their own comparator. That general feature also means that the order of conditions, repeated measurements, and the association between a participant's results under different conditions can matter to analysis.

The record's crossover designation does not supply the operational details needed to understand those features. The condition sequence, randomization method, masking details, washout interval, period effects, and whether all participants completed both conditions are not reported in the registry record. The primary outcome timeframe says the conditions were administered 30 days apart, but it does not explain the order or provide further details about the interval.

The primary outcome is reported separately by condition, with n=8 for Low Social Status and n=7 for High Social Status. The record does not explain why those counts differ from one another or from enrollment of 9, and does not establish whether they represent complete paired observations. The posted summaries therefore describe the available condition-specific observations, but do not reveal the participant-level structure needed to reconstruct a crossover analysis.

There are 3 outcome measures listed, but no secondary outcomes are posted. No analysis is listed for the primary comparison. The sample-size justification, planned analysis, analysis populations, and any interim analysis 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

StageLow Social Status, Then High Social StatusHigh Social Status, Then Low Social Status
STARTED45
COMPLETED45
NOT COMPLETED00

Washout Period for a Minimum of 4 Weeks

StageLow Social Status, Then High Social StatusHigh Social Status, Then Low Social Status
STARTED45
COMPLETED45
NOT COMPLETED00

Second Intervention

StageLow Social Status, Then High Social StatusHigh Social Status, Then Low Social Status
STARTED42
COMPLETED42
NOT COMPLETED00

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.

CharacteristicUnitAll Study Participants
Participants analysed9
Age, Continuousyears22.3 (SD 1.6)
Sex: Female, Male: FemaleParticipants6
Sex: Female, Male: MaleParticipants3
Region of Enrollment: United Statesparticipants9
BMIkg/m^222.8 (SD 2.8)

6. Primary Endpoint

The registry lists the primary outcome as Calories Consumed Following the Experimental Manipulation, measured over Administered 30 days apart.

ElementRegistry entry
Result typeMean
Measure of spreadStandard Deviation
Unitkcal
Endpoint classificationContinuous Endpoint

The primary endpoint is titled Calories Consumed Following the Experimental Manipulation. It measures the amount of food consumed, in kcal, during an ad libitum lunch offered for 20 minutes after participants completed a manipulated social status condition. The registry describes the endpoint as a mean with standard deviation and gives the timeframe as conditions administered 30 days apart.

In general, measuring consumption after a behavioral manipulation can provide a quantitative outcome related to eating behavior under the study conditions. The endpoint is a continuous measure: a participant's result can take a range of values, rather than being only a yes-or-no outcome. A mean describes the center of the observed values, while a standard deviation describes their spread around that mean.

The measure does not, by itself, explain why participants consumed a particular amount. Nor does it directly establish a longer-term pattern of eating or a change in obesity risk. The registry record does not report additional measurement details, such as how the consumed amount was determined, whether assessors were masked, or how incomplete meals were handled. It also does not provide a prespecified clinically meaningful difference for this endpoint.

The posted condition-specific means and standard deviations are descriptive summaries. Because the registry provides no comparison analysis, they should not be treated as a reported estimate of the within-participant effect of changing the social status condition.

7. Why No Re-analysis Is Shown

Reported as posted, not recalculated. Values missing or not estimable for a two-arm comparison (continuous endpoint). A result is recalculated only when the posted data support a clean two-arm comparison, so no result is shown beyond what the sponsor posted.

8. Statistical Interpretation

Clinical Biostats interpretation

The posted primary outcome summaries are a mean of 647.5 kcal with standard deviation 252.8 for Low Social Status (n=8), and a mean of 520.9 kcal with standard deviation 231.2 for High Social Status (n=7). These figures describe the observations recorded under each condition. They do not include a reported test of the contrast, a confidence interval, or an adjusted estimate.

The registry record specifically does not provide values for a two-arm comparison of this continuous endpoint because values are missing or not estimable for that comparison. It lists no analyses. Consequently, the record does not state whether the observed condition summaries are compatible with a range of possible effects, nor how precise any difference between conditions might be. No p-value or confidence interval for the primary comparison is reported in the registry record.

This limitation is particularly important for a crossover study. In general, the comparison may depend on how each participant's outcomes under the two conditions relate to each other, not simply on the separate condition means and standard deviations. The posted summaries do not show those paired values or their covariance. The record does not report whether all participants contributed observations under both conditions, how the differing condition-specific sample counts arose, or how the analysis handled incomplete pairs. A within-participant contrast cannot be recovered from the reported summaries alone.

The enrollment was 9, while the outcome summaries report n=8 for Low Social Status and n=7 for High Social Status. Those counts indicate the observations included in the condition summaries; the record does not explain why they differ or whether the reasons involve missing measurements, eligibility, or another circumstance. No explanation should be inferred from the counts alone.

The standard deviations show that participant-level values varied within each condition, but they are not uncertainty intervals for the mean or for a treatment contrast. General statistical interpretation distinguishes variability among observed results from uncertainty about an estimated effect. The registry does not report a confidence interval that would quantify the latter for this comparison.

The results therefore support a limited descriptive statement: the recorded mean calories consumed differed numerically between the condition summaries. Without a reported analysis that accounts for the crossover structure and available paired observations, the magnitude, precision, and statistical compatibility of the condition contrast are not established in the registry record. The summaries also do not establish whether the observed pattern reflects the manipulated status condition, other study features, or chance variation.

These are behavioral study results on a single listed primary outcome. They do not establish an effect on obesity or longer-term eating behavior, and the registry does not report outcomes that would support those broader conclusions. No medical conclusion should be drawn from these descriptive summaries alone.

9. Statistical Methods Explained

The record labels the primary measure as continuous and reports a mean and standard deviation for each condition. It also identifies the study as randomized and crossover, but does not list an analysis for the primary comparison. The general concepts below explain what an analysis could address; they are not a description of analyses documented for this study.

What do the mean and standard deviation describe?

For a continuous outcome, the mean is the arithmetic average of the observed measurements in a group or condition. Here, the outcome is calories consumed in kcal after the experimental manipulation. The standard deviation describes how dispersed individual measurements are around the mean. A larger standard deviation generally indicates more variability among the observed measurements. It does not say how accurately the mean estimates a broader population value, and it is not a confidence interval.

The registry reports a mean of 647.5 and standard deviation 252.8 for Low Social Status, and a mean of 520.9 and standard deviation 231.2 for High Social Status. These summaries alone do not describe the distribution's shape, identify unusual observations, or show which participants contributed values in both conditions. They are useful descriptive quantities, but they do not substitute for a comparison estimate and its uncertainty.

Why does the crossover designation matter?

In general, a crossover design measures participants under more than one condition. An analysis can then use the within-participant differences, which may account for stable participant characteristics shared across measurements. The statistical precision of that comparison depends in part on the relationship between a participant's measurements in the different conditions. Separate means and standard deviations do not contain enough information to recover that relationship.

A crossover analysis may also need to consider condition order and period. For example, participants may respond differently over time, or the effect of one condition may carry into a later period. These are general design considerations, not claims that such effects occurred in this study. The sequence, period-specific results, and any washout or carryover assessment are not reported in the registry record. Nor does the record specify a model or test for the repeated measurements.

Randomization can help reduce systematic differences in assigned condition order, but the registry's use of the term does not disclose the randomization procedure or sequence allocation. Single masking is listed; who was masked and how masking was maintained are not reported in the registry record. These missing details limit evaluation of how the design was implemented.

What would a confidence interval add?

In general, a confidence interval gives a range of values compatible with the observed data and the assumptions of the analysis. For a condition contrast, it would communicate the estimate's precision as well as its direction and scale. A narrow interval indicates greater precision than a wide interval, under the specified method. A confidence interval does not remove design limitations, and its interpretation depends on the validity of the analysis and its assumptions.

No confidence interval for the primary contrast is reported. The registry also gives no inferential analysis or p-value. It is therefore not possible to describe the estimated contrast's statistical uncertainty from the posted condition summaries alone. The label “not estimable” for a two-arm comparison is not evidence that the conditions are equivalent; it indicates that a comparison result is not available in the registry record.

How do sample size and planning relate to these results?

In general, a sample-size calculation uses assumptions about a target effect, variability, significance level, allocation, and the planned analysis to illustrate the number of observations that may be needed for a desired precision or probability of detecting an effect. Such calculations are planning illustrations, not observed results and not proof that a study had adequate power. A calculation based on an observed effect is especially dependent on that estimate and should not be confused with the trial's design justification.

The registry describes planning assumptions based on the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. However, no planning participant counts are reported in the record, and the trial's own sample-size justification is not reported in the registry record. The planning assumptions therefore cannot establish the original design rationale or the precision of the posted findings.

What is not available for an independent analysis?

The record does not report participant-level results, paired differences, analysis methods, model covariates, missing-data methods, or analysis populations. It does not give confidence limits or an inferential result for the primary comparison. Recalculating an unadjusted comparison from separate means and standard deviations would not recover the paired crossover analysis, and no such comparison is reported. The appropriate statistical reading remains descriptive unless a documented analysis that respects the study design is available.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

ArmParticipantsMeanStandard deviation95% CI for the mean
Low Social Status8647.500252.800436.154 to 858.846
High Social Status7520.900231.200307.076 to 734.724

R code and output

arm <- c("Low Social Status", "High Social Status")
n   <- c(8, 7)
m   <- c(647.5, 520.9)
sp  <- c(252.8, 231.2)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}
CARM  Low Social Status  8  647.500  252.800  436.154  858.846
CARM  High Social Status  7  520.900  231.200  307.076  734.724

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 3 outcome measures, but no secondary outcomes are posted and no analyses are listed. The record does not report a multiplicity plan, such as which outcomes were primary for inference or how statistical testing across outcomes would be handled. Without posted secondary results or an analysis plan, it is not possible to determine whether multiplicity was addressed or whether additional outcome analyses were conducted.

Multiplicity is a general concern when several outcomes or comparisons are tested: the chance of at least one apparently notable finding can increase as the number of tests increases. Statistical approaches can control or describe that issue, but the appropriate approach depends on the planned questions and analysis. The absence of a reported approach should not be interpreted as evidence that no additional analyses occurred; it means the approach is not reported in the registry record.

The primary outcome counts are n=8 for Low Social Status and n=7 for High Social Status, whereas enrollment is 9. The registry does not explain the differing counts, report how missing measurements were handled, or identify the participants included in an analysis population. It is not possible to determine from the record whether the condition-specific results are based on complete cases, available observations, or another rule.

For a crossover study, missingness can affect the paired comparison if a participant has a result in one condition but not the other. General methods may use complete pairs or make assumptions to use incomplete data, but the choice and its assumptions need to be described. Neither the handling of incomplete pairs nor an imputation method is reported in the registry record. No intention-to-treat or per-protocol population is specified.

These gaps prevent assessment of whether the posted summaries reflect all randomized participants or how missing data might influence the comparison. They also prevent evaluation of the intended analysis population and any adjustment for multiple outcomes.

12. Safety Results

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

ArmParticipants with serious adverse eventsParticipants at riskPercentage
Low Social Status080.0%
High Social Status070.0%

Other (non-serious) adverse events

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

ArmParticipants affected of at risk
Low Social Status0 of 8
High Social Status0 of 7
Do not overextend the safety comparison. Serious-adverse-event counts are safety observations, not efficacy outcomes, and should not be combined with the primary result into a single benefit-risk number.

The adverse-event record lists 0 serious events among 8 participants at risk in the Low Social Status group and 0 among 7 at risk in the High Social Status group. It also lists 0 other adverse events in each group, with the same respective at-risk counts. Deaths are not reported in the registry record.

These figures are counts recorded for the groups and should be read as such. In general, observing no recorded events in a small study does not establish that the underlying risk is absent. The number of participants at risk is limited, and the record does not provide event-level descriptions, follow-up details, or a broader safety analysis. The counts also do not establish whether events were actively solicited or how event attribution was determined; those details are not reported in the registry record.

The study conditions were behavioral Monopoly game manipulations, and the endpoint concerned calories consumed at a lunch. The safety figures do not answer the primary behavioral question, and the calorie summaries do not substitute for safety reporting. No medical advice or broader safety conclusion follows from the recorded counts alone.

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

The posted results describe the mean calories consumed after each social status condition in this randomized crossover study. The condition-specific summaries are 647.5 kcal (standard deviation 252.8; n=8) for Low Social Status and 520.9 kcal (standard deviation 231.2; n=7) for High Social Status. They provide information about the observed values, but not a reported inferential comparison.

The record does not report a confidence interval, p-value, adjusted estimate, or analysis accounting for paired measurements. Accordingly, the summaries do not establish the precision of the contrast or whether the apparent difference is distinguishable from chance variation under a specified statistical model. They also cannot demonstrate equivalence between conditions: absence of an estimable comparison is not the same as evidence of no effect.

The crossover structure matters because condition observations may be linked within participants. The posted group summaries do not reveal those participant-level links. With unequal condition-specific counts and no explanation of the available data, it is also not possible to know how many participants contributed complete pairs. The registry record does not report the analysis population, missing-data strategy, or details of condition order.

The study's stated aim concerned experimentally manipulated perceived social standing and eating behavior in relation to obesity risk. The primary endpoint, however, is a single lunch measurement after each experimental condition. It does not by itself establish persistent eating behavior, changes in body weight, or obesity risk. No such results are posted as secondary outcomes.

The result can therefore be read as a descriptive record of calories consumed in the observed conditions, with variation among participants. Broader claims about causal effects, generalizability, or longer-term outcomes would require information and analyses that are not reported in the registry record. The reported means should be interpreted within the small study's documented design and the limits of its available summary data.

14. Why This Trial Matters Statistically

This study is statistically interesting because it uses a randomized crossover design for a behavioral manipulation, while the registry posts only separate condition-level summaries. The design label raises a specific analytical issue: comparisons may depend on how each participant's outcomes across conditions are paired. Without paired results or an analysis that incorporates them, the displayed means and standard deviations cannot fully represent the design's intended comparison.

The different condition-specific sample counts, n=8 and n=7, also make transparent reporting important. Enrollment is 9, but the registry does not explain which participants contributed outcome data under each condition or why the counts differ. In a crossover study, clear reporting of completed periods, missing measurements, and the analysis population helps readers understand whether the main contrast uses comparable data.

The record's absence of an inferential result is itself useful to note. Descriptive statistics can show the observed center and spread, but they cannot answer how precise a contrast is. A confidence interval and a clearly specified paired analysis would address different questions from the separate summaries. No such result is reported in the registry record, so claims should remain descriptive.

More generally, the record illustrates why design details and analysis details need to accompany outcome summaries. Randomization, masking, and crossover labels alone do not reveal the randomization method, masked parties, sequence, treatment of period effects, or handling of incomplete pairs. The posted information identifies the study question and some outcome data, while leaving those analytical details unreported. That distinction helps readers avoid treating an incomplete inferential record as a definitive test of the behavioral hypothesis.

15. Limitations

The registry record leaves several trial-specific uncertainties. It identifies the design as randomized, single-masked, and crossover, but does not report who was masked, how randomization was performed, or how the condition sequences were assigned. The conditions were administered 30 days apart, but the record does not describe the sequence, period structure, or any washout procedure.

Although the study enrolled 9 participants, the primary summaries include n=8 for Low Social Status and n=7 for High Social Status. The reason for these different counts is not reported. The registry does not state whether participants completed both conditions, how many complete pairs were available, or whether missing results were excluded or handled another way. That is a central limitation for interpreting a crossover comparison.

No primary comparison analysis is posted, and no confidence interval or p-value is reported. The registry does not describe a statistical model, covariate adjustment, analysis population, or assumptions about repeated measurements. The sample-size justification and the trial's own design rationale are not reported in the registry record. Although planning assumptions are described, no planning participant counts are available in the reported information.

The record lists 3 outcome measures but posts no secondary outcomes or analyses. It does not report how outcome multiplicity was considered. It also does not provide participant characteristics, eligibility criteria, recruitment details, or further information on how calorie consumption was measured. These omissions limit assessment of generalizability, endpoint measurement, and potential sources of bias.

Finally, the reported endpoint concerns a lunch following an experimental manipulation. The registry does not post longer-term eating or obesity outcomes. The available information therefore does not support conclusions beyond the descriptive condition-specific summaries for the recorded endpoint.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

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19. Record Summary

NCT02470949 is a completed randomized, single-masked crossover study sponsored by the University of Colorado, Denver. It enrolled 9 participants and compared behavioral Low Social Status and High Social Status conditions created in a Monopoly game. The listed conditions are obesity and eating behavior, and the study phase is recorded as NA.

The primary outcome was mean calories consumed in kcal during an ad libitum lunch offered for 20 minutes after the manipulation. The condition-specific summaries were 647.5 kcal (standard deviation 252.8; n=8) for Low Social Status and 520.9 kcal (standard deviation 231.2; n=7) for High Social Status. The conditions are described as administered 30 days apart.

No primary comparison analysis, confidence interval, or p-value is reported. The reason for the differing outcome counts, the handling of missing observations, and the crossover analysis details are not reported in the registry record. No secondary outcomes are posted. The adverse-event record lists 0 serious and 0 other adverse events in each condition; deaths are not reported.

Clinical Biostats