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 Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) (NCT05824741), a na na study. The primary outcome is Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05824741 |
| Phase | NA |
| Condition | Cardiovascular Diseases, Infant ALL, Maternal Behavior |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Penn State University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns mothers and infants in the Northern Appalachian region of Central Pennsylvania, in the context of the Nurse-Family Partnership home visitation program. The registry describes the pilot as involving 15 participants and notes that participants were to be enrolled in the intervention arm. It does not provide further eligibility criteria or a detailed account of who contributed data to each measure.
Intervention
The intervention was an Infant Cardiovascular Health Promotion module, described as behavioral and intended to be added to the existing Nurse-Family Partnership program. Trained nurses delivered home visits. The central implementation concern was whether nurses could successfully deliver the new materials and whether the curriculum was acceptable to nurses and participants.
Comparator
There was no control group or like-for-like comparison. The registry identifies a single-group model, with all participants assigned to the intervention arm. Allocation is recorded as not applicable. The study therefore does not estimate a difference between the module and usual care or another intervention.
Primary question
The primary question was whether a cardiovascular health module could be integrated into Nurse-Family Partnership home visiting. The registry describes feasibility in terms of qualitative feedback from nurses and participants, including acceptability of the curriculum and nurses’ ability to deliver the materials. The primary outcome is also labeled as a number of participants receiving the intervention, so its operational description is not purely a numeric count. Results for the primary measure are not reported in the registry record.
3. Trial Design
This was a completed, single-group pilot study of the Infant Cardiovascular Health Promotion behavioral intervention. The registry records enrollment of 15. Its arm description says all participants would be enrolled in the intervention arm. Allocation is listed as not applicable, and masking is listed as none. There is no control arm, so the design does not support a randomized or controlled comparison of the intervention with another condition.
The study focused on integrating a cardiovascular health module into the existing Nurse-Family Partnership home visitation program. The registry describes delivery by trained nurses in Northern Appalachian Central Pennsylvania. The primary outcome timeframe is 6 months. The study start date is 2023-08-01, the primary completion date is 2024-06-30, and the status is completed. These dates and status indicate the registry’s recorded study timeline; they do not establish that every planned measure was collected or analyzed.
The registry identifies four secondary outcomes: the number of mothers consenting for their infants to participate, the utility of a foot-worn actigraphy device for infant sleep data collection, the number of participants completing maternal feeding data collection, and participant acceptability. These outcomes indicate a focus on feasibility, data collection, and acceptability rather than a controlled estimate of cardiovascular or health effects. The record does not provide detailed eligibility criteria, recruitment procedures, visit schedules, or outcome-specific assessment procedures.
The record does not report a phase designation beyond NA, a randomized allocation process, or a masking procedure. It also does not describe a comparator intervention. Because the study was single-group, any reported observations would describe experience within the intervention group, not establish what would have happened without the module. No protocol rationale for the enrollment target is 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
| Stage | Intervention Infants |
|---|---|
| STARTED | 15 |
| COMPLETED | 14 |
| NOT COMPLETED | 1 |
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.
| Characteristic | Unit | Intervention Group Infants |
|---|---|---|
| Participants analysed | 15 | |
| Age, Categorical: <=18 years | Participants | 14 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 10 |
| Sex: Female, Male: Male | Participants | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 12 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 9 |
| Race (NIH/OMB): More than one race | Participants | 4 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program., measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants receiving intervention |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled as the feasibility of integrating a cardiovascular health module into the existing Nurse-Family Partnership home visiting program. The registry gives a timeframe of 6 months and labels the outcome as a number, with the unit described as participants receiving the intervention. However, the accompanying description defines feasibility through qualitative group discussion about curriculum acceptability, along with nurses’ feedback on whether they could deliver the new materials to home-visiting clients. The description therefore combines an intervention-receipt count label with qualitative implementation evidence.
This type of endpoint is used to assess whether an intervention can be delivered and accepted in its intended service setting. For a pilot, such information can identify practical issues relevant to later evaluation, such as delivery by nurses and acceptability to participants. It is distinct from an endpoint that estimates a change in health or compares outcomes between intervention and control groups.
The registry record does not report the primary outcome’s observed value, qualitative findings, coding approach, or criteria for judging feasibility. It therefore does not show whether the module met any predefined feasibility threshold. The primary outcome’s label and narrative should be read together, while recognizing that the record does not clarify how the qualitative feedback was translated into the stated numeric outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a pilot designed to examine feasibility and acceptability, not a randomized test of clinical effectiveness. Its single-group structure has no concurrent comparator, so the design cannot isolate an effect of the cardiovascular health module from other influences. The record also reports no analysis results for the primary or secondary outcomes. As a result, there is no posted estimate of feasibility, acceptability, infant sleep-data collection utility, maternal feeding-data completion, or mothers’ consent for infant participation.
The listed primary endpoint combines a numeric outcome label with a qualitative description. It is described as a number of participants receiving the intervention, while feasibility is to be determined through group discussion and nurses’ feedback. Without reported results or an explanation of how these elements were assessed together, readers cannot determine what evidence supported a feasibility judgment. The registry record does not state an acceptance threshold or report qualitative themes.
The record reports zero serious adverse events among 15 participants at risk, zero other adverse events among 15 at risk, and zero deaths. These are the posted safety counts. They should be interpreted as the recorded counts for the intervention group, not as proof that no adverse experiences occurred outside the recorded categories or observation period. The record does not provide event descriptions or additional information about safety ascertainment.
The status is completed, but completion status is not a substitute for posted outcome data. The registry reports five outcome measures and zero analyses. Thus, the record supplies the study’s aims, design and selected counts, but not estimates with which to assess the primary feasibility question or the secondary outcomes. Neither a positive nor a negative conclusion about feasibility can be drawn from the absence of reported analysis results.
For general interpretation, pilot feasibility measures are usually descriptive: their purpose is to characterize recruitment, delivery, data collection, and acceptability in the setting being studied. In a single-group pilot, such findings can guide questions for future research, but they do not establish comparative benefit. The registry record does not report enough outcome detail to assess the precision or completeness of those feasibility observations.
9. Statistical Methods Explained
The registry describes a single-group, unmasked pilot, with allocation recorded as not applicable. General statistical interpretation starts by matching the analysis to that design. Since all participants were in the intervention arm and no comparator is listed, there is no between-group treatment contrast to estimate. Descriptive counts or qualitative findings could characterize what happened during delivery, but they would not show what would have happened under a different program or without the module.
What does a single-group design allow?
In general, a single-group design can describe participation, intervention delivery, data collection, and reported experiences within the enrolled group. It cannot separate the intervention’s contribution from other changes or circumstances that occur during the study. This matters especially when interpreting health outcomes: a change observed over time, if one were reported, would not by itself establish that the module caused it. The registry record does not report a comparative effect estimate or an analysis of change over time.
How should the primary measure be understood?
The primary outcome is labeled as a number of participants receiving the intervention, while its narrative describes qualitative group discussion and nurses’ feedback about delivery and acceptability. These are different forms of information. A count can be reported numerically; discussion and feedback require a qualitative approach to collection and interpretation. General qualitative methods can organize accounts into themes or categories, but the registry record does not report a coding method, assessment criteria, or results. It is therefore not possible to tell how these components were combined to determine feasibility.
The timeframe for the primary outcome is 6 months. A timeframe identifies the period attached to an outcome in the registry, but it does not by itself specify the precise assessment schedule, follow-up completeness, or the point at which each participant’s information was collected. Those details are not reported in the registry record.
What do counts and uncertainty mean?
For general statistical interpretation, a count describes the number of recorded occurrences in the defined group and period. A confidence interval, when reported, gives a range of values compatible with the data and the method used, under the assumptions of that method. It communicates uncertainty rather than guaranteeing that the true value lies within the range. No confidence intervals or outcome estimates are reported for this study’s feasibility or secondary measures, so their precision cannot be assessed from the registry record.
Likewise, a significance test is used in general to assess how compatible observed data are with a specified null model. It does not measure the size or practical importance of an effect. The registry reports zero analyses, and no p-values or inferential test results are reported. Consequently, there is no basis for a statistical significance interpretation of the listed outcome measures.
What does the planning illustration represent?
The registry record includes assumptions for a planning illustration computed from an observed effect, not from the trial’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. For time-to-event calculations, the illustration is described as using total events; other calculations are described as participants per arm. These are planning conventions, not a description of this single-group pilot’s allocation or observed results.
General sample-size calculations estimate the amount of information needed for a future design under chosen assumptions. Such calculations depend on the effect selected, variability, statistical method, and allocation. If an assumed effect is smaller, more information is generally needed to detect it under otherwise comparable assumptions. This is a general principle, not a result specific to this study. The registry record does not report a protocol-based sample-size justification, and the planning illustration should not be read as observed power or as the pilot’s original design.
Over-dispersion is a general concern when count outcomes vary more than a simple model assumes. If ignored, uncertainty estimates from that model may be too narrow. The registry provides no count-distribution analysis, variance estimate, or model specification for these outcomes, so it is not possible to determine whether over-dispersion was assessed or relevant to any analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures, including the primary feasibility measure and four secondary outcomes. The secondary measures concern mothers consenting for infants to participate, the utility of a foot-worn actigraphy device for infant sleep data collection, completion of maternal feeding data collection, and participant acceptability. The registry reports zero analyses, so it does not provide outcome-specific estimates or tests for these measures.
Multiplicity is a general issue when several outcomes or statistical tests are evaluated. The more tests considered, the greater the chance that at least one result may appear notable by chance if each is interpreted independently. A prespecified testing hierarchy or adjustment can address this concern, depending on the study’s goals. The registry record does not report a multiplicity strategy, any adjustment, or a statistical analysis plan. It is therefore not possible to tell whether the outcomes were intended to be tested, ranked, or interpreted descriptively.
Missing-data handling is also not reported in the registry record. There is no information about incomplete questionnaires, missed assessments, device non-use, reasons for non-completion, or methods for addressing missing observations. The secondary outcomes include measures that could involve consent, device-based data collection, and completion of maternal feeding data collection, but the record does not give outcome-specific denominators or completion results.
The analysis population is not defined in the registry record. It does not state whether analyses were intended to include all enrolled participants, only those who received the module, or a subset with available outcome data. The arm description states that all participants would be enrolled in the intervention arm, but that does not resolve how each outcome was to be analyzed. Without analysis populations and missing-data procedures, the completeness and representativeness of any outcome results cannot be assessed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Intervention Group | 0 | 15 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention Group | 0 of 15 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Intervention Group | 0 of 15 |
The registry reports zero serious adverse events among 15 participants at risk in the intervention group. It also reports zero other adverse events among 15 at risk and zero deaths. No serious adverse event terms are listed. These are counts recorded for the group, not comparisons against a control group.
For general interpretation, adverse-event counts describe events recorded under the study’s safety definitions and observation procedures. A count of zero means no events in that category were reported in the registry; it does not establish that all possible events were actively sought, that every participant had identical observation, or that an intervention has no risk. The record does not describe the safety collection method, the observation period for these counts, or how events were classified.
The primary outcome timeframe is 6 months, but the registry does not state whether that timeframe was also used for safety collection. Nor does it provide event-level descriptions or other details that would explain the scope of ascertainment. Because the study is single-group, the posted safety counts cannot be used to compare event rates with another treatment or with usual care. They should be read narrowly as the reported counts for this intervention group.
12. What the Result Does, and Does Not, Mean
The study addresses an implementation question: whether a cardiovascular health module can be incorporated into Nurse-Family Partnership home visiting in Northern Appalachian Central Pennsylvania, and whether nurses and participants find the curriculum acceptable. The intervention was intended for delivery by trained nurses as part of an existing home-visitation program. Those aims make delivery and participant engagement central to the study’s purpose.
The registry record does not report results for the primary feasibility measure or the secondary outcomes. It therefore does not establish whether integration was feasible, whether the curriculum was acceptable, or whether data collection using infant actigraphy and maternal feeding measures was successful. The record also does not report health-effect estimates. No conclusion about a change in cardiovascular health, infant sleep, feeding, or childhood obesity can be drawn from the posted information.
The single-group design is important to the scope of possible conclusions. It provides no controlled comparison, so it cannot determine whether observed experiences or outcomes were caused by the module. The study is identified as a pilot with enrollment of 15, and the registry reports zero analyses. The completed status alone does not fill the gap in outcome reporting or show that the study met a feasibility criterion.
For general research planning, a pilot may help investigators refine delivery procedures, outcome collection, and the design of a later evaluation. Such value depends on detailed reporting of what was attempted and what was learned. Here, the registry’s stated aims identify the implementation questions, but the absence of posted findings means readers cannot assess the answers. The record supports describing the study’s purpose and design, not a claim that the module does or does not work.
13. Why This Trial Matters Statistically
Feasibility pilots ask whether a proposed intervention can be delivered and evaluated in its intended setting. That is a distinct statistical and practical question from whether the intervention changes a clinical outcome. This study’s focus on nurse delivery, curriculum acceptability, infant sleep-data collection, maternal feeding-data completion, and consent for infant participation reflects the kinds of process measures that can inform a later evaluation.
The design also illustrates why the research question and analysis need to align. A single-group study can describe the experiences and observations of participants in the intervention arm, but it cannot provide a controlled estimate of the module’s effect. If the goal is implementation learning, clear definitions of success and complete reporting of delivery and data-collection outcomes are especially useful. The registry describes qualitative feedback as central to feasibility, yet does not report the assessment approach or findings.
The study’s record also highlights the distinction between a planning calculation and a trial design. A planning illustration based on an observed effect and two-arm assumptions is not the same as the design used in this single-group pilot. Keeping those purposes separate prevents a calculation intended for future planning from being mistaken for evidence about the pilot’s results or precision.
Statistically, the important information for readers is not only whether an analysis reports a result, but also which participants and observations contribute, how incomplete data are handled, what outcome definitions are used, and how multiple measures are interpreted. The registry does not report these details. The study’s stated implementation focus remains clear, but the absence of outcome analyses limits what can be learned from the posted record.
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 main limitation for interpretation is that the registry reports no analyses for the five outcome measures. There are no posted results for the primary feasibility question or the secondary measures, and no confidence intervals, tests, or qualitative findings are given. The completed status does not indicate whether planned data were collected or what conclusions the study team reached.
The primary outcome description is not fully operationalized in the record. It is labeled as a number of participants receiving the intervention, but the narrative says feasibility will be determined through qualitative discussion and nurses’ feedback. The registry does not explain how the numeric label relates to the qualitative assessment, what criteria define success, or how feedback was analyzed. Without these details, the primary measure cannot be independently interpreted.
The single-group design has no comparator and does not support a controlled treatment-effect estimate. Allocation is listed as not applicable, and masking is listed as none. The registry does not describe eligibility criteria, recruitment procedures, outcome-specific denominators, assessment schedules, or the intended analysis population. Missing-data methods, statistical analysis plans, and multiplicity procedures are not reported in the registry record.
The safety record gives zero serious adverse events, zero other adverse events, and zero deaths, but does not describe ascertainment procedures or the safety observation period. The four secondary outcomes are named, but the record does not report their results or explain how each was measured. Finally, no protocol-based sample-size justification is reported. The planning illustration is explicitly separate from the trial’s design and cannot resolve the absence of outcome estimates.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) — NCT05824741.
- Registry record last updated 2025-05-29; status last verified 2025-05.
- Results first posted 2025-05-29.
- 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.
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18. Record Summary
The registry identifies NCT05824741 as the Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) pilot, with the official title Promoting Cardiovascular Health of Northern Appalachian Mother-Infant Dyads: PSU Infant Pilot Study. Penn State University is listed as sponsor. The study is recorded as completed, with enrollment of 15, a start date of 2023-08-01, and a primary completion date of 2024-06-30.
The study used a single-group, unmasked design with allocation recorded as not applicable. Its behavioral intervention was an Infant Cardiovascular Health Promotion module added to the Nurse-Family Partnership home visitation program. The primary outcome concerned feasibility of integration over 6 months, with qualitative feedback described as part of the assessment.
The registry lists four secondary outcomes and reports zero analyses. It reports zero serious adverse events among 15 at risk, zero other adverse events among 15 at risk, and zero deaths. Outcome findings, analysis methods, missing-data procedures, and a protocol-based sample-size justification are not reported in the registry record.