Promoting The Self-Regulation Of Energy Intake: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Promoting The Self-Regulation Of Energy Intake (NCT01513343), a randomized na study. The primary outcome is Children's BMI Percentiles.

2. Clinical Question

In statistical terms, the question is whether the distribution of children across the stated weight-status categories differed between the randomized groups at follow-up. This is a categorical outcome, not a single continuous BMI measure or a reported change from baseline. The registry record gives the measurement and classification approach, but the category-specific outcome values and a statistical comparison are not reported in the registry record.

3. Trial Design

The study, titled “Promoting The Self-Regulation Of Energy Intake,” was registered as NCT01513343 and sponsored by Baylor College of Medicine. It is described as randomized, with a parallel-group model and single masking. The registry record does not identify who was masked. The phase is listed as NA.

The planned comparison assigned families to parent-and-child classes focused on self-regulation of eating or to treatment as usual. The intervention is described as a behavioral program. The program's stated aim was to develop and test a scientifically based, culturally competent, seven-session, parent-directed obesity-prevention program focused on parental feeding strategies that support young children's self-regulation of intake. The record does not give further details about session delivery, attendance, or the treatment-as-usual condition.

Enrollment is listed as 255. The registry record gives a start date of 2014-08, a primary completion date of 2017-12-27, and a completed status. These study-level details do not establish how many participants contributed data to each outcome or analysis. For the primary outcome, the record identifies 76 children assessed in the prevention group and 71 assessed in the treatment-as-usual control group at 12-month follow-up.

The primary endpoint is children's BMI percentile categories at 12-month follow-up. Parental feeding behaviors are listed as a secondary outcome, but corresponding results are not reported in the registry record. The record does not report a protocol, allocation concealment procedures, a detailed statistical analysis plan, or the rationale for the enrollment target. Those omissions limit assessment of how the trial was planned and how its analyses were conducted.

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: No significant events occurred in this study after participant enrollment.

Group Allocation

Reasons for not completing this period:

Post Data Collection

Reasons for not completing this period:

6-month Follow-up

Reasons for not completing this period:

12-month Follow-up

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Prevention group: 76 children assessed at 12-months. Treatment as usual control group: 71 children assessed at 12-months.

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: A total of 255 parent/child dyads participated in the study (255 parents and their children). We report age, gender, and ethnicity for children and parents separately, thus there are 2 entries each for age, gender, and ethnicity (one for children and one for parents). All analyses were intention-to-treat analyses. Specifically, data from parents and children were analyzed on the basis of the condition to which they were initially assigned, regardless of the number of classes they attended.

6. Primary Endpoint

The registry lists the primary outcome as Children's BMI Percentiles, measured over 12-month follow-up.

The primary endpoint is recorded as a count of participants classified by children's BMI percentile category at 12-month follow-up. The registry record says that measured height and weight data were collected, and that two height and weight measures were averaged for each child. Age- and gender-specific BMI z-scores were calculated, then children were classified using Centers for Disease Control and Prevention standards.

The stated categories are healthy weight, from the 5th to <85th percentile; overweight, from ≥85th to <95th percentile; and obese, at ≥95th percentile. These categories express a child's position relative to age- and gender-specific reference values rather than reporting weight alone. Using categories can make a result easier to interpret in terms of the distribution of weight status, but it also discards detail within each category. Children close to a threshold may be placed in different categories despite having similar underlying measurements.

The 12-month assessment supplies a follow-up time point, but the record does not provide baseline category counts or a change-from-baseline outcome. Nor does it report the number of children in each category by randomized group. Consequently, the endpoint's definition is available, while the primary comparison's result is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is categorical: each child is placed in one of three weight-status categories using an age- and gender-specific BMI percentile. In general, categorical outcomes are described with counts and proportions in each category. A comparison between randomized groups could assess whether the distribution across categories differs, or focus on a particular category contrast. Those approaches answer different questions, so the analysis and estimand need to be clear. The registry record does not report which comparison or statistical method was used for this endpoint.

In general, a confidence interval describes a range of values compatible with the observed data under a specified statistical model. It communicates estimation uncertainty, not the probability that a treatment effect is inside a particular interval. The registry record does not report an effect estimate or confidence interval for the primary outcome, so its precision cannot be evaluated from the posted results. An assessment count alone cannot supply that information.

Why does the categorical outcome matter?

The endpoint does not report a mean BMI or a mean change in BMI. Instead, it groups children by thresholds. A statistical analysis of these categories should preserve the distinction between them and account for the way category counts are distributed. Collapsing the categories into a binary outcome would change the question and lose information; no such reduction is reported in the registry record. The categories also depend on cutoffs, so children with similar measurements near a cutoff may fall into different groups.

In general, methods for categorical outcomes may compare category distributions or model the probability of belonging to a category. Which method is appropriate depends on the study question, data structure, and assumptions. For example, a model that uses the ordering of categories makes different assumptions from an analysis that treats each category as unrelated. The registry record does not report whether categories were treated as ordered or unordered, nor does it describe model assumptions or adjustment variables.

What does over-dispersion mean in general?

Over-dispersion occurs when observed variability is greater than a statistical model expects. It is a concern in some count or probability models because underestimated variability can make uncertainty appear too small. It does not automatically apply to every outcome, and whether it is relevant depends on the model and the data. The registry record does not identify an analysis model for the primary endpoint or report an over-dispersion assessment. No conclusion about its presence or absence can be made from the posted information.

How should planning illustrations be read?

In general, a sample-size planning illustration asks how much information might be needed to detect an assumed effect under stated conditions. It is not a result observed in the trial, and it is not observed power. The planning assumptions described for this study use a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and an effect set to a stated fraction of the observed effect. The registry record does not report a primary outcome effect estimate that can be used to assess those illustrations against category-specific results.

Such illustrations are conditional on their assumptions. A normal approximation may not closely represent every categorical outcome, especially when some category counts are small; whether that issue arose cannot be determined without the category counts. Equal allocation is a planning assumption and does not imply equal numbers assessed at follow-up. The listed assessment counts differ between groups, but no explanation for that pattern is reported in the registry record.

In general, the significance level sets a decision threshold for a specified test; it does not measure the size or importance of an effect. A p-value, if reported, would describe how incompatible the observed data are with a specified null model under the analysis assumptions. It would not by itself show the effect's magnitude, precision, or practical importance. For this trial, a primary outcome p-value and the associated analysis are not reported in the registry record.

Finally, a randomized design supports a planned comparison between assigned groups, but interpretation still depends on outcome reporting, missing-data handling, and the analysis population. Randomization does not fill in absent category counts or establish that all randomized participants were included in an outcome analysis. The registry record does not give enough detail to evaluate these features for the primary endpoint.

10. Multiplicity, Missing Data and Analysis Populations

The registry record identifies children's BMI percentile categories as the primary outcome and parental feeding behaviors as a secondary outcome. It lists two outcome measures and two analyses, but does not describe the analysis plan, the number of statistical tests conducted, or how multiplicity was handled. Multiplicity arises when several outcomes, time points, groups, or contrasts are tested; in general, considering many tests can increase the chance of at least one apparently notable result. No correction or prespecified testing hierarchy is reported in the registry record.

The record gives the primary endpoint time frame as 12-month follow-up and reports the children assessed at that time: 76 in the prevention group and 71 in the treatment-as-usual control group. These assessment counts do not explain whether other randomized participants lacked measurements, were excluded, or were handled in another way. Reasons for missing outcome data, imputation methods, and sensitivity analyses are not reported in the registry record.

The analysis population is also not specified. The registry record does not say whether the primary comparison used all randomized participants, only those with observed outcome measurements, or another defined population. It does not report whether participants were analyzed according to randomized assignment. These details matter because exclusions or missing-data assumptions can affect the interpretation of a randomized comparison.

Accordingly, neither the multiplicity strategy nor the impact of missing data can be evaluated from the posted record. The reported counts indicate follow-up assessment, not the completeness or analytic handling of the trial data.

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 registry record reports serious adverse event figures separately for the prevention group and treatment-as-usual control group. Each group's entry lists the number at risk and the number affected. For the prevention group, 136 were at risk and 0 were recorded with a serious adverse event; for the treatment-as-usual control group, 119 were at risk and 0 were recorded with a serious adverse event. Deaths are listed as 0 in both groups. Other adverse events are also listed as 0 in each group.

These are the registry's recorded figures. A zero entry means that no event was recorded in that category in the registry record; it does not establish that an event was impossible or that the intervention has no risks. The record does not provide event descriptions, severity detail beyond the serious-event classification, or an explanation of how events were collected and adjudicated. It also does not describe the duration of safety follow-up or provide a comparative statistical analysis of the safety data.

The at-risk figures are not the same as the numbers assessed for the primary BMI outcome at 12-month follow-up. Safety and efficacy outcomes can have different observation and reporting populations. The safety entries should therefore be read as registry-reported counts, not as a complete account of all possible harms or as evidence of a treatment effect.

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

The registry record establishes that the study was designed as a randomized, parallel-group comparison of a parent-and-child program focused on self-regulation of eating with treatment as usual. It defines a primary follow-up outcome using children's BMI percentile categories and reports assessment counts. These details clarify the question and measurement approach, but they do not reveal the primary outcome result.

The primary category counts, between-group estimate, uncertainty interval, and statistical test are not reported in the registry record. Therefore, the posted results do not show whether the category distribution differed between the groups, how large any difference was, or how precisely it was estimated. A completed study status and stated enrollment cannot substitute for these results. Nor can the follow-up assessment counts be interpreted as evidence that outcomes improved or worsened.

In general, a statistically detectable difference and a practically meaningful difference are separate concepts. The former depends on the estimate, its uncertainty, and the specified analysis; the latter requires context about the size and relevance of the difference. Neither can be assessed for this primary outcome from the registry information reported. The same limitation applies to the secondary outcome of parental feeding behaviors, for which results are not reported in the registry record.

The safety entries record zero serious adverse events, zero other adverse events, and zero deaths in both groups, with the listed at-risk counts. These entries describe what was recorded, but without further event-collection details they should not be treated as proof that no harms occurred. They also do not establish comparative safety.

Overall, the record supports a description of the intervention, comparator, study structure, endpoint definition, follow-up assessment counts, and safety entries. It does not support a conclusion that the program did or did not change children's BMI category distribution or parental feeding behaviors. A result-level interpretation would require outcome values and the statistical analyses used.

13. Why This Trial Matters Statistically

This trial is statistically notable as a randomized comparison of a family-focused behavioral program with treatment as usual, with a categorical child weight-status endpoint at follow-up. It highlights why defining an outcome is not the same as reporting its result. The measurement procedure and thresholds are described, yet the category-specific outcome values and comparison are absent from the registry record.

For categorical endpoints, readers need the count in each category for each group, along with a clear statement of the comparison being estimated. Those data help distinguish a change in the overall distribution from a difference limited to one category. They also allow readers to assess whether estimates are precise or whether sparse categories may complicate interpretation. Without those details, the analysis cannot be independently understood from the posted record.

The distinction between enrollment and follow-up assessment is also important. The record lists enrollment as 255, while separately identifying children assessed at 12-month follow-up in each arm. Enrollment alone does not tell readers which participants contributed to the endpoint analysis or how missing data were handled. Transparent reporting of the analysis population and missingness would help readers judge the reach and limitations of the result.

Finally, the record illustrates the value of reporting statistical methods alongside numerical outcomes. A defined category scheme, prespecified contrast, effect estimate, uncertainty interval, and missing-data approach together make a result interpretable. The registry record includes useful design and measurement information, but the absence of outcome estimates means that the central comparison remains unresolved in the posted results.

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.

Several trial-specific limitations of interpretation follow from what is and is not reported in the registry record. Most importantly, the primary endpoint is described as a multi-category outcome, but no category-specific counts or between-group statistical result are included. This prevents assessment of the direction, size, and precision of the primary comparison.

The registry record gives the numbers of children assessed at 12-month follow-up but does not state how many were assigned to each group, give reasons for missing outcome measurements, or explain how missingness was handled. The listed enrollment does not resolve these questions. The analysis population and whether participants were analyzed according to randomized assignment are not reported.

Although the trial is described as single-masked, the record does not identify who was masked. It does not provide details of allocation concealment, intervention adherence, or what treatment as usual involved. These omissions make it difficult to assess implementation and possible differences between groups beyond the assigned program.

The endpoint uses BMI percentile categories, which are based on thresholds. Categorization can make results accessible but loses variation within each category and may make classification sensitive to values near a cutoff. The record does not provide continuous BMI results or baseline category data that could help characterize the follow-up groups.

The analysis plan, multiplicity handling, and results for the secondary parental-feeding outcome are not reported in the registry record. Safety reporting is limited to the recorded event counts, without event descriptions or collection details. These gaps do not establish that the study was conducted improperly; they limit what can be evaluated from the registry information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Promoting The Self-Regulation Of Energy Intake — NCT01513343.
• Registry record last updated 2023-05-15; status last verified 2022-06.
• Results first posted 2023-05-15.
• 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

NCT01513343 is a completed randomized, parallel-group study sponsored by Baylor College of Medicine. It compared parent-and-child classes focused on self-regulation of eating with treatment as usual, with Latino preschoolers and their families as the stated focus. The registry record lists enrollment as 255, a start date of 2014-08, and a primary completion date of 2017-12-27. Masking is listed as single, but who was masked is not reported in the registry record.

The primary outcome was children's BMI percentile categories at 12-month follow-up, based on measured height and weight and age- and gender-specific BMI z-scores. The record reports 76 children assessed in the prevention group and 71 in the control group, but not their category counts or a statistical comparison. Parental feeding behaviors are listed as a secondary outcome, without results. Serious adverse events, other adverse events, and deaths are each recorded as 0 in both groups. The posted information describes the trial and its measures but does not report the primary outcome finding.