Promoting Resilience to Food Commercials Decreases Susceptibility to Unhealthy Food Decision-Making: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Promoting Resilience to Food Commercials Decreases Susceptibility to Unhealthy Food Decision-Making (NCT04905498), a randomized na study. The primary outcome is Food Choice Change.

2. Clinical Question

The title states that promoting resilience to food commercials decreases susceptibility to unhealthy food decision-making. That wording is not a substitute for outcome estimates. The registry record’s description makes clear that the endpoint involved children’s stated willingness to choose foods on a computer program; it does not describe a measure of actual food consumption. The listed purpose includes children and parents, but no parent outcome is described among the primary endpoint details. Further information on parent participation or measures is not reported in the registry record.

3. Trial Design

The study is registered as a randomized, double-masked, parallel-group behavioral trial and is marked completed. The registry lists an enrollment of 49. Its record gives the study start as 2019-01-07 and primary completion as 2020-03-07. The phase is listed as NA, and the sponsor is the University of Kansas Medical Center.

There were two behavioral groups: Commercial Advertising Literacy Training and Control. Children in the intervention group were exposed to narrative statements shown and read aloud between commercials. Children in the control group were exposed to food commercials without narratives. The primary outcome description says that an experimenter assigned children to a group by randomly drawing cell numbers that had been pre-assigned for each group. Further information about sequence generation, concealment of assignment, or whether the groups were balanced on baseline characteristics is not reported in the registry record.

Although masking is recorded as double, the record does not identify which people were masked or explain how masking was maintained in a study involving visibly different exposure materials. It is therefore not possible to determine from the registry entry whether children, experimenters, outcome assessors, or analysts were masked.

The primary measure was collected before intervention and post intervention, with the latter described as day 7-10. The record does not give more detail about the intervention schedule, the duration or number of commercial exposures, or the timing of each post-intervention assessment. It lists one secondary outcome, self-control as measured by the Self-Control Scale, and reports four outcome measures overall. The registry lists zero analyses. It does not report a sample-size justification, a detailed statistical analysis plan, or whether analyses were conducted outside the registry record.

The enrollment figure describes the trial’s registered enrollment, not necessarily the number included in every outcome analysis. Analysis populations and outcome-specific participant counts 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The experimenter assigned children to one of two groups using a random assignment of drawing cell numbers pre-assigned for each group.

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 Food Choice Change, measured over Pre (day 0) and post intervention (day 7-10)..

The primary endpoint, Food Choice Change, is based on children’s ratings of whether they would choose to eat foods. Children rated 60 different foods on a 4-point Likert scale: 1-Strong No, 2-No, 3-Yes, and 4-Strong Yes. The foods were divided into 30 unhealthy and 30 healthy items. Higher values for unhealthy foods represented unhealthier food choices, while higher values for healthy foods represented healthier food choices.

The registry describes comparisons of mean scores for unhealthy foods between pre- and post-intervention, and separate comparisons of mean scores for healthy foods between those time points. The measure is therefore not a single undifferentiated score: the healthy and unhealthy food ratings have different interpretations, and the pre- and post-intervention measurements are distinct time points. The stated timing was pre (day 0) and post intervention (day 7-10).

Using separate food categories makes it possible to describe whether children’s stated choices shifted differently for healthy and unhealthy foods. A mean provides a group-level summary of the ratings, while the standard deviation describes how spread out individual ratings are around that mean. These are general interpretations of the chosen summaries; the registry does not report the actual means or standard deviations.

The endpoint records stated choice on a computer program, not food selection or consumption in a real-world setting. The registry does not report validation details for this particular measure, how item-level ratings were combined, or how missing item responses were handled.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary endpoint as a continuous measure summarized by a mean and standard deviation. In general, a mean is an average that describes the central level of a set of observations. A standard deviation describes the spread of observations around that mean. Reporting both can help distinguish a similar average with tightly clustered responses from one accompanied by substantial variation. The registry does not report the means or standard deviations for this endpoint.

Individual responses used a 4-point Likert scale, with ordered response categories from 1-Strong No through 4-Strong Yes. The record describes mean scores for groups of food items, but does not explain the exact aggregation from item ratings to the reported score. Treating a score as continuous for a mean-based analysis is a statistical choice; the registry marks the outcome as continuous but does not give the analysis model or justify that choice. This matters because an average summarizes responses but does not show their full distribution or how many children selected each response category.

The endpoint includes separate ratings for healthy and unhealthy foods. For unhealthy foods, a higher value is described as an unhealthier choice; for healthy foods, a higher value is described as a healthier choice. The two categories should therefore be read separately rather than collapsed into a single direction of benefit. The record describes pre-intervention and post-intervention measurements, but it does not specify whether the intended analysis compared post-intervention scores between groups, within-person changes between time points, or a model incorporating both group and time.

In general, repeated measurements on the same participant are related rather than independent. An analysis that uses both time points may need to account for that dependence. The registry does not report whether such a method was used. It also does not report whether baseline scores were included as covariates, whether the analysis was adjusted for any other variables, or how departures from model assumptions were assessed. No specific statistical test or model can be attributed to the study from the registry record.

Random allocation can, in general, support a fair comparison by distributing measured and unmeasured characteristics across groups on average. Here, assignment is described as random drawing of cell numbers pre-assigned for each group. The record does not describe the allocation sequence in further detail or report baseline characteristics by group. Randomization does not guarantee that every characteristic will be balanced in a particular trial, especially when the enrolled sample is limited; the registry does not provide the information needed to assess balance for this study.

The study is recorded as double-masked, but the people masked and the practical masking procedures are not reported in the registry record. In general, masking can reduce the risk that expectations influence participants’ responses, outcome assessment, or analytic choices. Its effect depends on who is masked and whether masking is credible. Because the intervention involved narratives and the control did not, the record’s masking label alone does not explain how participants or study personnel could remain unaware of group assignment.

The registry lists sample-size planning assumptions for an illustration based on the observed effect: a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation. The illustration is described as detecting a stated fraction of the observed effect. These assumptions describe a planning exercise, not the original trial’s design justification. The registry does not report a sample-size justification for the trial, nor does it provide the observed effect needed to interpret such an illustration. A planning calculation is not evidence that the trial had a particular probability of detecting an effect, and it should not be described as observed power.

In general, over-dispersion means that variation in the data is greater than a chosen statistical model expects. If present, it can make model-based standard errors too small and confidence intervals too narrow unless the analysis accounts for it. This concept is relevant to some models for discrete outcomes, but the registry does not report a model for these ratings or evidence of over-dispersion. No claim about it can be made for this trial.

The registry gives no analysis results and reports zero analyses. It does not report a statistical analysis plan, interim analyses, a prespecified primary contrast, confidence intervals, p-values, or model diagnostics. These absences mean that the analytic approach and its assumptions cannot be evaluated from the posted record. They do not establish that no analysis was performed; they indicate only that analyses are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome description involves healthy and unhealthy food ratings and measurements taken before and after intervention. The registry explicitly does not reduce those categories or time points to one comparison. It also lists four outcome measures overall and identifies self-control, measured by the Self-Control Scale, as a secondary outcome. A collection of outcomes and contrasts can raise multiplicity concerns because repeated statistical testing can increase the chance of at least one apparently unusual result. That is a general statistical issue, not evidence that any particular finding in this study is false.

The registry reports zero analyses. It does not report a prespecified hierarchy among the outcome measures, a multiplicity adjustment, or which comparisons were intended to be confirmatory. It is therefore not possible to determine how the investigators handled multiple outcomes or contrasts, or whether the title’s claim corresponds to a prespecified analysis. The analysis plan is not reported in the registry record.

Missing-data information is also absent. The record does not state how many children completed each time point or contributed usable ratings, whether any item responses were incomplete, why data might be missing, or how missing observations were handled. It does not describe an intention-to-treat population, a per-protocol population, or another analysis population. Enrollment alone cannot establish the number analyzed for a particular endpoint.

In general, missing data can affect both the amount of information available and the interpretation of an estimate, particularly if the reasons for missingness differ across groups or relate to outcomes. Without participant flow, outcome-specific counts, and the analysis method, the extent or direction of any such effect cannot be assessed. Interim analyses and stopping rules are not reported in the registry record.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The adverse-event record lists serious adverse events for the Control group among 19 participants at risk, with 0 affected, and for the Intervention group among 30 participants at risk, also with 0 affected. Deaths are listed as 0 in each group. The record also lists 19 participants at risk for other adverse events in Control and 30 in Intervention, with 0 affected in either group.

These figures describe what is posted for the recorded categories; they do not establish that no other safety information exists. The registry does not provide event narratives, the method of event collection, or details about the period during which events were monitored. No serious-event terms are listed. The number at risk in these adverse-event fields should not be assumed to be the number contributing to the primary outcome, because outcome-specific analysis counts are not reported.

Zero recorded events in these groups means that the registry lists no affected participants in these categories. It does not prove that an intervention has no risk, and it does not permit a precise comparison of safety between groups. The record does not report a statistical safety analysis or confidence intervals. Interpretation is limited to the event counts and denominators entered in the registry.

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

The trial record describes a randomized comparison of children exposed to food commercials with narrative statements and children exposed to commercials without narratives. It specifies a primary measure based on children’s stated willingness to choose healthy and unhealthy foods, assessed before and after intervention. Those details clarify the question the study was designed to address.

The registry record does not report the primary outcome estimates or analyses. It therefore cannot establish whether ratings changed, whether changes differed between groups, how large any difference was, or how precisely it was estimated. The trial title should not be treated as a substitute for those results. The absence of posted results in the registry record is not evidence that the intervention had no effect; it means the effect cannot be determined from this record.

The measure concerns ratings made on a computer program, not observed food purchases, eating behavior, or longer-term health outcomes. Even if outcome estimates were available, interpretation would need to remain tied to the measure and time points described. The registry does not report whether any rating changes persisted beyond the stated post-intervention timing, or whether results generalized to other settings or populations.

In general, statistical evidence and practical importance are distinct. A statistically detectable difference may be small in practical terms, while an uncertain estimate may include effects that could matter as well as effects close to no difference. Assessing these possibilities requires estimates and uncertainty measures, neither of which is reported for the primary endpoint. No medical advice or treatment conclusion follows from the information in this registry entry.

The posted information supports a description of the design, intervention contrast, and intended outcome. It does not support a conclusion about the effectiveness of narrative statements, the magnitude of any change in food-choice ratings, or the reliability of a treatment-group difference.

13. Why This Trial Matters Statistically

This study raises a useful statistical distinction between a behavioral exposure and the outcome used to evaluate it. The intervention changed what children encountered between commercials, while the primary outcome captured their stated choices about food items. Clear interpretation depends on keeping that measurement close to the question: ratings of intended choice are not interchangeable with actual eating behavior.

The endpoint also has more than one meaningful dimension. Healthy and unhealthy food ratings have opposite interpretations for higher scores, and each was measured before and after intervention. Describing these components separately is important for avoiding an overly simple summary that could obscure different patterns. The registry does not report results for these components, but it does make their structure clear.

Randomization offers a design framework for comparing groups, but it does not by itself resolve questions about analysis populations, missing responses, outcome multiplicity, or precision. Those questions require transparent reporting of participant counts, outcome estimates, uncertainty, and the analysis plan. The registry lists enrollment and a random assignment process, yet does not report the primary outcome analysis or the relevant data needed to evaluate its precision.

The record also illustrates why a strongly worded title is not a statistical result. Readers need estimates, uncertainty, and a clearly specified comparison to judge what the study found. With those details absent, the most accurate interpretation is that the design is described but the primary findings are not reported in the registry record.

These distinctions matter for clinical researchers because statistical conclusions are shaped not just by the intervention and sample, but also by how outcomes are defined, analyzed, and reported. Here, the outcome description is specific enough to identify the intended question, while the missing results prevent assessment of its answer.

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 principal limitation for interpreting this trial from the registry record is that outcome results and analyses are not reported. There are no group-specific means, standard deviations, changes, confidence intervals, or p-values for the primary endpoint. This prevents assessment of effect direction, size, precision, and statistical compatibility with a null hypothesis.

The endpoint description leaves important measurement details unspecified. Although children rated 60 foods on a 4-point scale and the record distinguishes healthy from unhealthy foods, it does not explain exactly how item responses were combined, how incomplete ratings were handled, or whether the scoring method was validated for this use. The endpoint measures stated choice rather than observed food choice or consumption.

Participant flow and analysis populations are not reported. The registry lists 49 enrolled participants, but does not give the number with usable primary-outcome data at each time point or explain any exclusions or missingness. Consequently, the relationship between enrollment and the analyzed data cannot be assessed.

The record labels the trial double-masked but does not say who was masked or how masking was maintained. It also does not provide detail about the randomization process beyond the drawing of pre-assigned cell numbers. Baseline group characteristics, allocation concealment, intervention fidelity, and the exact exposure schedule are not reported.

Finally, four outcome measures are listed, but no analysis plan, multiplicity approach, or statistical results are reported. The registry does not clarify whether the title’s claim was based on a prespecified contrast or how the separate healthy and unhealthy ratings were interpreted together. These limitations concern what can be evaluated from the registry record; they do not establish that unreported procedures or analyses were absent from the conduct of the study.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Promoting Resilience to Food Commercials Decreases Susceptibility to Unhealthy Food Decision-Making — NCT04905498.
• Registry record last updated 2023-03-30; status last verified 2023-03.
• Results first posted 2022-12-01.
• 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

NCT04905498 is a completed randomized, double-masked, parallel behavioral study sponsored by the University of Kansas Medical Center. The registry lists enrollment of 49, a start date of 2019-01-07, and primary completion on 2020-03-07. The phase is recorded as NA, and the condition is Obesity, Adolescent.

The intervention used narrative statements shown and read aloud between food commercials; the control group saw commercials without narratives. The primary outcome was Food Choice Change, based on children’s ratings of healthy and unhealthy foods before and after intervention. Self-control, measured by the Self-Control Scale, is listed as a secondary outcome. Four outcome measures are recorded.

The registry describes the design and endpoint but lists zero analyses and does not report primary outcome estimates, statistical tests, or missing-data methods. Serious and other adverse events are recorded as 0 affected in both groups. The result of the primary clinical question cannot be determined from the registry record.