Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children (NCT05994924), a randomized na study. The primary outcome is Number of Parents Who Viewed Videos Provided by Provider.

2. Clinical Question

The study description also asks how parents, providers, and facilitators experienced recruitment and intervention delivery. Parents were to complete a survey and interview after the second part of the intervention. Those questions focus on feasibility and acceptability rather than a direct test of whether the intervention changes obesity or feeding behavior. The registry record does not report qualitative findings or a result for the number of parents approached and consented.

3. Trial Design

This is a pilot randomized controlled trial with a parallel design and no masking. The registry lists the study as completed, with an enrollment of 60. The recorded start date is 2024-02-06 and the primary completion date is 2024-09-12. The phase is listed as NA, and Wake Forest University Health Sciences is the sponsor.

Three behavioral approaches are described: an educational handout, an online-only video series, and group discussion sessions. Parents in the handout arm received an educational handout at baseline. Parents in the online arm were given QR codes to watch videos on their own time, without discussion afterward. Parents in the group arm were to take part in 2 weekly sessions involving video viewing and group discussion. These are different delivery formats, not simply different doses of one format.

The primary outcome is a count of parents who viewed videos provided by the provider, assessed at Month 2. Since the registry says videos were only made available to the online-only arm, the primary measure is relevant to that arm; missing values in the other arms should not be read as evidence that nobody viewed videos. The posted secondary measures include parent feeding questionnaire scores, responsiveness and enjoyment scores, family mealtime practices, family meals, and intervention-delivery fidelity. Three secondary outcomes have posted arm summaries and recalculated comparisons in the record excerpt.

The brief study description emphasizes usefulness and acceptability in clinical and community settings, including recruitment and delivery experiences. The registry record does not report the randomization sequence method, allocation concealment, eligibility criteria, intervention materials, or a detailed statistical analysis plan. It also does not explain how the participant-level survey, interview, or quantitative data were analyzed.

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: Children were not consented and did not take part in the intervention. Data was collected only from parents who were consented.

Overall Study

Reasons for not completing this period:

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: Children were not consented and did not take part in the intervention. Data was collected only from parents who were consented.

6. Primary Endpoint

The registry lists the primary outcome as Number of Parents Who Viewed Videos Provided by Provider, measured over Month 2.

The primary endpoint is the number of parents who viewed videos provided by the provider, measured at Month 2. Its unit is participants. The registry describes the measure as tracking the number of videos viewed by each parent, while the endpoint title and posted result refer to the number of parents who viewed videos. These details indicate that the result is a count of parents, not a reported average number of videos per parent.

This measure is relevant to the online-only delivery approach because the registry states that videos were only made available to parents assigned to that arm. A count of parents who viewed the videos can describe whether the material was accessed by participants for whom it was available. It does not, by itself, establish how much of the material each parent watched, whether the content was understood, or whether viewing changed feeding practices or child health.

The online-only arm has a posted value of 16.0, with 16.0 participants in the reported result. The registry lists no applicable values for the handout-only and group-session arms. It does not report the number of videos watched by each parent, viewing completion, the timing of viewing, or a comparison of video access across delivery formats. Those distinctions matter: access is an implementation measure, while the secondary feeding-related measures address different questions.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record includes descriptive results and simple unadjusted recalculations for selected secondary outcomes. It does not report the sponsor’s statistical analysis method for those outcomes. The recalculated comparisons use posted summary statistics, rather than participant-level data, and should be read as exploratory descriptions rather than as a replacement for a prespecified trial analysis.

What does a mean difference describe?

For continuous outcomes, a mean is the average score in an arm. A mean difference compares the average in one arm with the average in another, using the order of comparison stated in the record. A positive value means the first named comparison arm has a higher observed mean than the reference arm; a negative value means it has a lower observed mean. Whether a higher score represents a favorable or unfavorable result depends on the scale’s scoring direction, which is not reported in the registry record. The differences should therefore not be translated into a claim of benefit or harm.

A standard deviation describes the spread of individual scores around an arm’s mean. It is not the uncertainty in the mean difference and does not indicate the range of all individual observations. The posted standard deviations show that scores vary within arms, but no participant-level distributions are reported. Differences in means alone cannot show whether changes occurred within individuals over time, since the registry does not provide paired change results.

How should confidence intervals be read?

In general, a confidence interval gives a range of estimates compatible with the observed data under the method used. A wider interval signals less precision than a narrower interval. For the three recalculated secondary comparisons, each interval spans zero, so the summaries do not rule out no mean difference. The intervals also include values in both directions. This is a statement about uncertainty in the estimated contrast, not proof that the approaches are equivalent.

The exact method used for a sponsor-reported confidence interval or hypothesis test is not reported in the registry record. The posted p values are labeled unadjusted and are recalculated from the summary statistics. A p value describes how unusual data at least as incompatible with a specified no-difference model would be, if that model and the calculation assumptions held. It is not the probability that the no-difference model is true, nor does it measure the practical importance of an observed difference. Because these are recalculations rather than reported analyses, the record’s absence of a sponsor analysis should remain clear.

Why are the primary data not a three-arm test?

The primary measure is a participant count for video viewing, but videos were available only in the online-only arm. The other two arms do not have applicable primary values. A comparison that treats those entries as ordinary zero counts would incorrectly assume that those participants had the opportunity to view the videos. The registry record says that a two-arm comparison was not estimable for this endpoint. The meaningful reading is therefore the reported access count in the eligible arm, not a treatment contrast.

What do the planning illustrations mean?

In general, sample-size planning translates an assumed effect and variability into a number of participants needed under specified design assumptions. The record’s illustrations use the observed effect or stated fractions of it, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They are planning illustrations, not observed power and not evidence that the trial was designed around those assumptions. The registry does not report the trial’s own sample-size justification, so the illustrations should not be presented as its original design calculation.

Planning for a fraction of the observed effect is a way to examine how requirements change when a future study aims to detect a smaller effect than the estimate in a pilot. Such calculations are sensitive to the effect and variability used. Estimates from small pilot samples can be unstable, so planning values based on them should not be taken as guaranteed requirements or as a formal recommendation for a future study.

What can the posted analysis support?

The posted material supports description of the available arm summaries and cautious interpretation of the recalculated contrasts. It does not provide evidence of a prespecified confirmatory analysis, adjustment for multiple outcomes, or a model accounting for baseline measures or other covariates. Those methods are not reported in the registry record. In general, randomization helps make treatment groups comparable on average, but it does not eliminate uncertainty in a small study, and it does not resolve missing outcome information or limitations in measurement.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Online-Only Video Series")
n      <- c(16)
events <- c(16)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Online-Only Video Series  16  16  100.0  79.4  100.0  80.6  100.0  80.5  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 21 outcome measures and 12 posted secondary outcomes. It lists 0 reported analyses. For the three secondary outcomes with comparative calculations, the comparisons are explicitly unadjusted recalculations from summary statistics. The registry record does not report whether the study had a prespecified primary analysis hierarchy, a multiplicity adjustment, or a plan for interpreting multiple secondary outcomes. Without that information, the p values should not be treated as confirmatory evidence across a family of outcomes.

In general, multiplicity matters because examining many outcomes creates more opportunities for chance findings. An adjustment can control some of that risk, while a prespecified hierarchy can clarify which findings are primary and which are exploratory. Neither approach is documented in the registry record. This absence does not establish that no such plan existed outside the record; it means that the plan cannot be assessed from the registry information.

Reported participant counts vary among the available arm summaries. The Month 4 secondary summaries list 17.0 participants for handout-only, 16.0 for online-only video, and 6.0 for group sessions. The primary video-viewing result lists 16.0 participants in the online-only arm. These counts should not be combined, because they refer to different outcomes and the registry record does not explain the disposition of participants across measures.

The record does not describe missing-data methods, reasons for missing measurements, imputation, or sensitivity analyses. It also does not identify the analysis population used for each result, such as whether analyses followed assignment regardless of participation or were limited to participants with observed data. The distinction between enrollment and the number with a reported outcome is important, but the record does not provide enough detail to explain it. For the primary endpoint, the other arms lack applicable values because videos were only made available in the online-only arm; that is a structural difference in the endpoint’s applicability, not ordinary missing outcome data.

12. 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 registry reports 20 participants at risk in each of the three arms for serious adverse events and 20 at risk in each arm for other adverse events. It records 0 serious adverse events, 0 other adverse events, and 0 deaths in each arm. No serious adverse-event terms are listed.

These are the counts recorded for the trial, not proof that an adverse event could not occur. In general, zero observed events in a study do not establish zero underlying risk, particularly when the number of participants observed is limited. The registry record does not provide event definitions, event-collection procedures, follow-up completeness, severity details beyond the serious-event category, or a narrative assessment of safety.

The adverse-event counts are separate from the primary video-viewing endpoint and the Month 4 secondary measures. They do not establish whether any intervention caused or prevented an event. The most direct interpretation is that no serious or other adverse events and no deaths were recorded in the listed arms during the reported safety assessment.

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

The primary finding describes uptake of an online video intervention: the registry records 16.0 parents as having viewed videos in the online-only arm at Month 2. This is useful as an implementation observation because access is necessary for a video-based approach to be received. The count does not say how many videos each parent viewed, whether the series was completed, or whether parents discussed or applied the material.

The result does not establish that the online format is more effective than a handout or group sessions. The primary outcome is not applicable to the other arms as described, and no comparison can be estimated from the posted values. Nor does the count establish whether the intervention changes responsive feeding, family mealtime practices, or obesity outcomes. Those are separate questions, and the registry does not provide a reported primary clinical effect analysis.

The secondary summaries add descriptive information about feeding-related measures at Month 4. The recalculated comparisons are uncertain, unadjusted, and not reported as sponsor analyses. They do not establish equivalence among approaches, and they should not be interpreted as proof of benefit or lack of benefit. The outcome scales’ scoring direction is not reported, further limiting claims about whether higher or lower scores represent a preferred result.

In general, a pilot trial can help determine whether an intervention and its evaluation procedures are workable, and can reveal practical issues worth studying further. It is not automatically designed or powered to settle clinical effectiveness. The registry’s stated emphasis on usefulness and acceptability, along with questions about recruitment and delivery, makes feasibility a central part of the study’s purpose. However, qualitative findings about parent, provider, or facilitator experiences are not reported in the registry record.

Accordingly, the posted evidence supports a narrow description of video viewing and selected secondary summaries. It does not support medical advice, a claim that a delivery approach prevents obesity, or a ranking of the three approaches. Further conclusions would require complete outcome reporting and an analysis plan appropriate to the questions being asked.

14. Why This Trial Matters Statistically

This trial is statistically interesting because its primary endpoint is an implementation count rather than a conventional clinical outcome. A count of parents who viewed videos can help describe whether an online intervention reached its intended participants. It also illustrates why an outcome’s applicability matters: the videos were available only to the online-only arm, so the primary measure cannot be read as a common outcome across all randomized groups.

The study also distinguishes access from engagement and from downstream response. The primary result records parents who viewed videos, while its description refers to tracking the number of videos viewed by each parent. The posted result does not provide that participant-level viewing distribution. This highlights how outcome definitions and reporting detail affect what can be inferred: a simple count can document uptake, but it may not capture completion or dose received.

The randomized three-arm design compares different ways of delivering educational material, but the reported secondary contrasts are limited to online-only video versus handout-only. Group-session results are descriptive in the posted secondary summaries and are not included in those recalculated comparisons. This matters statistically because a three-arm study does not automatically yield informative comparisons for every endpoint and every pair of arms.

The record also demonstrates the distinction between exploratory and confirmatory evidence. It lists many outcome measures, but no reported analyses, and the available secondary comparisons are unadjusted recalculations. Confidence intervals and p values can summarize uncertainty, but their interpretation depends on analysis choices and multiplicity plans that are not reported. The planning illustrations are useful as examples of how assumed effect sizes relate to future sample requirements, but they are not the trial’s own design justification or observed power.

These features make careful interpretation especially important. The study can inform how to measure uptake and which outcomes might merit fuller evaluation, while the registry record leaves important questions about analysis populations, missing data, and qualitative results unresolved.

15. 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.

Several limitations specific to this study constrain interpretation. The trial is described as a pilot, and the registry’s stated purpose emphasizes usefulness and acceptability. The record does not report the study’s own sample-size justification, so it is not possible to determine whether the enrollment was selected to estimate clinical effects with a particular precision. The enrollment of 60 should not be confused with the number contributing data to every outcome.

The primary endpoint is limited to video viewing in the online-only arm. The record does not report a participant-level distribution of videos viewed, viewing completion, or an applicable primary outcome for the other arms. As a result, the primary finding cannot compare the delivery strategies or establish the intensity of participants’ exposure.

The posted secondary comparisons cover only three of the listed measures and compare the online-only arm with handout-only. The group-session summaries are not part of those recalculated comparisons. Reported participant counts differ across the secondary summaries, and reasons for those differences are not reported. No sponsor analyses, missing-data methods, analysis populations, or multiplicity procedures are listed, so the risk of bias or chance findings cannot be evaluated fully from the record.

The design is listed as unmasked. The registry does not report how randomization was generated or concealed, or how outcome assessments were conducted. The scoring direction for the feeding-related scales is also not reported. Qualitative interviews and surveys are described in the study summary, but their results are not reported in the registry record. Finally, the record does not provide detailed eligibility criteria, participant characteristics, or a description of how intervention delivery fidelity was assessed. These gaps limit assessment of representativeness, implementation, and the relevance of results to other settings.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children — NCT05994924.
• Registry record last updated 2026-07-06; status last verified 2024-05.
• Results first posted 2026-07-06.
• 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.

19. Record Summary

NCT05994924 is a completed pilot randomized parallel-group trial sponsored by Wake Forest University Health Sciences. The registry lists an enrollment of 60, no masking, a start date of 2024-02-06, and a primary completion date of 2024-09-12. The study compares an educational handout, an online-only video series, and group discussion sessions.

The primary outcome is the number of parents who viewed provider-provided videos at Month 2. Videos were only made available to the online-only arm, where the posted result is 16.0 participants. The secondary outcomes include feeding-related scores, family mealtime practices, family meals, and intervention-delivery fidelity. Three Month 4 secondary measures have posted arm summaries and unadjusted recalculated online-only versus handout comparisons; reported sponsor analyses are listed as 0.

The posted results describe intervention uptake and selected secondary measures, but do not establish a comparative clinical effect. Qualitative findings, missing-data procedures, analysis populations, and the study’s statistical analysis plan are not reported in the registry record.