Childhood Risk Reduction Program in Hispanics: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Childhood Risk Reduction Program in Hispanics (NCT03903146), a randomized na study. The primary outcome is Exclusive Breastfeeding (EBF).

2. Clinical Question

3. Trial Design

The registry describes NCT03903146 as a randomized, double-masked, parallel-group trial. Its status is completed, with enrollment of 40. The listed phase is NA. The study start date is 2016-03-23, and the primary completion date is 2018-10-31. The sponsor is Ana Maria Linares.

Participants were assigned to an intervention group or a control group. The intervention was a behavioral support program delivered by a bicultural/bilingual peer counselor and lactation consultant team. Its listed components include individual prenatal, in-hospital, and home postpartum visits, as well as free phone calls. The control group received traditional clinic prenatal care and usual breastfeeding educational material through WIC in the participant’s proficient language. Further intervention and control procedures are not reported in the registry record.

Although the registry labels the trial double-masked, it does not report which people were masked or how masking was maintained. The method used to generate the random assignment sequence, allocation concealment procedures, and the planned allocation ratio are not reported in the registry record. The fact that the arms are described separately does not establish those procedural details.

The registry lists eight outcome measures, including exclusive breastfeeding and secondary outcomes concerning intention to breastfeed, social support, breastfeeding knowledge, and breastfeeding self-efficacy. It does not list analyses for the posted outcomes. A completed trial status indicates a recorded administrative status, but it does not itself establish that every planned analysis or outcome result is available 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: 1 participant withdrew

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 Exclusive Breastfeeding (EBF), measured over At hospital discharge.

The primary outcome is titled Exclusive Breastfeeding (EBF), with participants as the unit of measurement and a timeframe of hospital discharge. The registry says infant feeding status at discharge was determined through medical chart review. It also describes post-discharge follow-up based on mothers’ reports, using feeding categories that include exclusive breastfeeding, predominant breast milk, mixed feeding, predominant formula milk, and exclusive formula milk. Mothers were also asked about water, juice, other liquids, or solids, and, when additional foods were reported, about introduction timing and portions.

Exclusive breastfeeding is used as a defined feeding-status outcome, rather than as a measure of later growth or obesity. A discharge assessment gives the endpoint a specific time point, while the described follow-up questions capture feeding practices after discharge. Those follow-up details do not change the stated primary timeframe. The registry does not report a single comparison of the primary outcome across groups, and the number of participants meeting the exclusive breastfeeding definition in each group is not reported in the registry record. The population note says one participant withdrew; the withdrawal’s group and the handling of that participant’s outcome are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation depends on what outcome was measured, how groups were compared, and how uncertainty was represented. For this trial, the registry identifies a randomized, double-masked, parallel design and describes exclusive breastfeeding as the primary outcome. It does not report an outcome analysis or a single comparison for that endpoint. The concepts below explain what would ordinarily be needed to interpret a trial result; they do not describe analyses as having been performed in this trial.

What does a group comparison tell us?

A randomized comparison is intended to assess whether observed outcomes differ between assigned groups. For a categorical feeding outcome, a report might show the number of participants in each category for each group and an explicitly defined contrast. The contrast could be expressed on a scale suited to categorical data, but the choice of scale and analysis method should be stated. A count in one arm alone would not establish a between-group difference. For this trial, group-specific exclusive breastfeeding counts and a primary comparison are not reported in the registry record.

Random assignment can support a fair comparison when the allocation process is implemented as intended and the analysis preserves the relevant assignment groups. It does not remove the need to report the allocation method, outcome data, participant flow, and analysis population. Details of sequence generation, concealment, and the primary analysis population are not reported in the registry record. The registry classification of double masking also does not identify who was masked or how masking worked.

What would a confidence interval add?

General statistical explanation: a confidence interval communicates the uncertainty around an estimated effect under the assumptions of the analysis. It is useful to consider both the range of effects compatible with the data and whether that range includes effects that would matter scientifically. A narrow interval is generally more precise than a wide interval, but precision does not determine whether an effect is important. A confidence interval cannot be interpreted without a defined estimate and analysis. Neither a comparative estimate nor its confidence interval is reported for the primary outcome in the registry record.

How should a p-value be read?

General statistical explanation: a p-value describes how incompatible the observed data are with a specified null model, under the assumptions of the statistical procedure. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. A p-value should be read alongside an effect estimate, its uncertainty, the outcome definition, and the analysis plan. No primary-outcome p-value is reported in the registry record, so there is no basis for interpreting statistical significance for exclusive breastfeeding.

What can the planning assumptions establish?

The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. It characterizes the effect to detect as a stated fraction of the observed effect. These are planning assumptions, not a description of the trial’s own design justification. The record does not report the trial’s sample-size justification, and the planning illustration must not be interpreted as observed power or as evidence that an effect was detected. Sample-size planning addresses the amount of information a study might need under specified assumptions; it does not replace the observed estimate and its uncertainty.

Why does the outcome structure matter?

The primary outcome description includes multiple feeding categories and follow-up time points, while the stated primary timeframe is hospital discharge. A valid analysis must make clear which category or contrast is being tested, at which time point, and how participants with missing status are handled. Choosing a single contrast after examining the observed data can affect the interpretation of statistical evidence. The registry explicitly indicates that the primary outcome was not reduced to one comparison, and it does not report the analysis that would connect the broader feeding-status information to a specific primary estimate.

For a binary outcome, an analysis may compare the proportion meeting a prespecified definition in each group, but this trial’s registry description includes more than two feeding categories. The analysis would therefore need to specify whether categories were combined, analyzed separately, or handled through another model. Such choices are not interchangeable: each addresses a different question and may use the available information differently. The intended statistical approach is not reported in the registry record.

General statistical explanation: over-dispersion matters when observed variability exceeds what a model assumes. It can make model-based uncertainty too small if ignored. The registry does not report a dispersion measure or a model for the primary endpoint, so there is no basis to determine whether over-dispersion was relevant to the trial’s outcome analysis. More broadly, statistical methods should follow the outcome scale and design, and their assumptions should be stated rather than inferred from a registry label.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists eight outcome measures. The named secondary outcomes are intention to breastfeed, social support, knowledge of breastfeeding, and breastfeeding self-efficacy. The primary outcome description also includes several feeding categories and refers to follow-up after discharge, although the stated primary timeframe is hospital discharge. Considering multiple outcomes, categories, or time points can create multiplicity: the more comparisons examined, the greater the opportunity for apparently notable findings to arise by chance. This is a general statistical concern, not a statement that a particular adjustment was or was not used in an analysis.

Whether the investigators prespecified a hierarchy of outcomes, selected a single primary contrast, or adjusted for multiple comparisons is not reported in the registry record. No outcome analyses are listed. The analysis plan and any multiplicity procedure are not reported in the registry record, so the statistical status of any secondary findings cannot be evaluated from the registry information.

The population note for the primary outcome records one participant withdrawal. The participant’s assigned group, timing of withdrawal, availability of feeding-status data, and treatment in the analysis are not reported in the registry record. The record also does not report missing outcome counts by group or methods for handling missing data. These details matter because exclusions or missing outcomes can affect both the comparison and the uncertainty around it.

The registry does not state whether the primary analysis included all randomized participants according to assigned group, used only participants with observed outcomes, or followed another analysis population. The analysis population and missing-data approach are not reported in the registry record. Without these details and outcome estimates, robustness to missing data or alternative analysis choices cannot be assessed.

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 reports serious adverse events for the control and intervention groups separately. For the control group, 20 participants were listed at risk for serious adverse events and 0 were affected. For the intervention group, 19 participants were listed at risk and 0 were affected. The record also lists 20 and 19 participants, respectively, at risk for other adverse events, with 0 affected in each group. Deaths are listed as 0 in both groups.

These are event counts as recorded in the registry, not a comparison adjusted for exposure time or other factors. Zero reported events means that no affected participants are listed in these registry fields; it does not establish that every possible adverse event was absent or that the groups had identical safety experience. The registry does not report further details about adverse-event collection, definitions, monitoring period, or severity beyond the serious-event classification. The figures should therefore be read as the safety counts reported in the registry record, not as a complete account of all possible harms.

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

The record establishes that a randomized, double-masked, parallel behavioral trial was conducted, with enrollment of 40, to assess an early childhood obesity risk-reduction program in Hispanics. The intervention involved support from a bicultural/bilingual peer counselor and lactation consultant team, while the control group received traditional prenatal care and usual breastfeeding education through WIC. The primary outcome was exclusive breastfeeding at hospital discharge, with feeding status described through chart review at discharge and maternal report during follow-up.

Those design and measurement details do not establish the intervention’s effect. A single primary outcome comparison, its estimate, and its uncertainty are not reported in the registry record. The record says that the primary outcome has several categories or time points and was not reduced to one comparison. It is therefore not possible to determine from the posted primary outcome information whether the groups differed in exclusive breastfeeding at discharge, or by how much.

The absence of a reported comparison is not evidence that there was no difference. It also does not support a conclusion that the intervention changed feeding outcomes. Those conclusions require outcome data and an interpretable analysis. A completed status, the randomized design label, and the stated endpoint cannot substitute for group-specific results.

The primary outcome concerns feeding status at discharge, not a measured childhood obesity outcome. The study title and program rationale refer to obesity risk reduction, but the primary endpoint described in the registry is breastfeeding. The registry record does not report a primary result for a later obesity outcome. The safety fields list zero serious adverse events and zero other adverse events among the participants recorded at risk, but those counts alone do not establish the absence of all possible harms.

Overall, the record supports a description of the trial’s design, intervention, comparator, and outcome measurement. It does not provide enough primary outcome or analysis information to quantify the program’s effect or its precision.

13. Why This Trial Matters Statistically

This trial raises statistical questions that are common in behavioral and clinical research. The outcome is not simply a single reported yes-or-no measure across all observations: the registry describes multiple feeding categories and follow-up assessments, while naming hospital discharge as the primary timeframe. A clear analysis must distinguish the primary time point from later measurements and specify exactly which feeding status is being compared.

The intervention and control conditions also differ in the support described. Interpretation depends on a transparent description of the assigned care, how adherence and follow-up were assessed, and whether the analysis compares participants according to randomized assignment. Some intervention and control details are recorded, but further procedures and the analysis population are not reported in the registry record.

Reporting a result requires more than stating an outcome title and its measurement procedure. Group-specific data, a defined effect estimate, and a measure of uncertainty allow readers to judge both the direction and precision of a comparison. Those primary outcome results are not reported as a single comparison in the registry record. The listed outcomes and described categories also make prespecification and multiplicity relevant, yet the analysis and any approach to multiple comparisons are not reported.

The record further illustrates why participant flow and missing-data handling matter even in a modestly enrolled trial. One participant is recorded as having withdrawn, but the group, timing, outcome availability, and analysis treatment are not stated. Without that information, readers cannot assess whether the outcome comparison uses the intended analysis population or how missing status could affect the estimate.

These are statistical reporting issues, not judgments about the importance of breastfeeding support or the program’s intent. The registry enables readers to identify the research question and design, but the absent comparative outcome result prevents an assessment of the primary effect and its uncertainty.

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 most direct limitation is that the registry does not provide a single comparative result for the primary outcome. Exclusive breastfeeding is named as the primary measure, but the record notes multiple categories or time points and does not reduce the information to one comparison. Group-specific outcome counts and an effect estimate are not reported in the registry record.

The primary timeframe is hospital discharge, while the measurement description also discusses post-discharge feeding reports. The record does not specify a primary contrast across those feeding categories or explain how follow-up assessments relate to the primary endpoint. It also does not report whether outcome assessors were masked, despite the trial’s double-masked classification.

The registry records one withdrawal but does not identify the participant’s group, the timing of withdrawal, or whether primary outcome data were available. Group-specific missingness, the analysis population, and the missing-data method are not reported in the registry record. Randomization and masking labels alone do not resolve these uncertainties.

Further design and analysis details are unavailable in the registry record, including the randomization procedure, allocation concealment, the sample-size justification, the statistical analysis plan, and any multiplicity procedure. The record lists eight outcome measures but no analyses. It is therefore not possible to judge whether analysis decisions followed a prespecified plan or whether estimates for secondary outcomes are appropriately interpreted.

The intervention description identifies several support components, but additional delivery and adherence details are not reported. The available record consequently supports a limited description of the trial and its outcome measurement, rather than a full assessment of conduct or findings.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Childhood Risk Reduction Program in Hispanics — NCT03903146.
• Registry record last updated 2025-01-14; status last verified 2025-01.
• Results first posted 2025-01-14.
• 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

NCT03903146, titled Childhood Risk Reduction Program in Hispanics, is listed as a completed randomized, double-masked, parallel trial with enrollment of 40. Its phase is listed as NA. The study started on 2016-03-23, and primary completion was recorded on 2018-10-31.

The behavioral intervention consisted of individual support by a bicultural/bilingual peer counselor and lactation consultant team. The control group received traditional clinic prenatal care and usual breastfeeding education through WIC. Exclusive breastfeeding at hospital discharge was the primary outcome; the record describes chart review at discharge and maternal reports during later follow-up.

The registry lists eight outcome measures and four named secondary outcomes. It records one participant withdrawal and no affected participants in the reported serious or other adverse-event fields. A single comparative primary outcome result, the analysis population, and methods for missing data and multiplicity are not reported in the registry record.