Culturally Tailored Diabetes Education on Self-Management of Adult Hispanic Males With Type 2 Diabetes Mellitus: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Culturally Tailored Diabetes Education on Self-Management of Adult Hispanic Males With Type 2 Diabetes Mellitus (NCT06897618), a na na study. The primary outcome is Healthy Eating.

2. Clinical Question

This is a question about behavior measured by self-report, not a question about a clinical measure such as blood glucose or diabetes complications. The stated purpose is to examine the effect of culturally tailored education on self-management behaviors in the specified population. Without a comparator, any observed before-and-after change would describe the participants’ scores over time; it would not by itself isolate the program’s effect from other explanations. The posted record gives the study’s rationale and measurement plan, but does not report results that answer the primary question.

3. Trial Design

The registry describes a single-group behavioral study of culturally tailored diabetes self-management education. Its listed enrollment is 40. The record gives a start date of 2025-09-12 and a primary completion date of 2025-12-19, and its status is terminated. A reason for termination is not reported in the registry record. The listed phase and allocation are NA, consistent with the record’s description of a study without a randomized comparison. Masking is listed as none.

The intervention is described as five weeks of culturally tailored diabetes self-management education modeled after the Association of Diabetes Care and Education Specialists Seven-item Framework. The registry’s summary identifies adult Hispanic males with type 2 diabetes living in the Middle Atlantic Region as the population of interest, with the stated age range of 18-64 years. The outcome timeframe is baseline and right after the five-week intervention.

The design does not include a separate control arm. Consequently, the record does not support a between-group treatment comparison, and the intervention cannot be separated from changes that might occur over time or alongside participation. The registry does not report a protocol for enrollment or follow-up beyond the descriptions in the study summary and outcome entry. The reason the study was terminated, the number of participants who completed the post-survey, and the number with paired baseline and follow-up measurements are not reported in the registry record.

The record lists three outcome measures, but no analyses. It does not report a statistical analysis plan, a sample-size justification for the study, planned interim analyses, or a specified method for handling repeated measurements. Any sample-size illustrations associated with the posted results are planning illustrations based on an observed effect, not evidence that the trial was designed with those assumptions or that a particular power was achieved.

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: Participants completing the post-survey are included

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: Enrolled participants

6. Primary Endpoint

The registry lists the primary outcome as Healthy Eating, measured over At baseline and right after the 5 week educational intervention.

The primary endpoint is healthy eating, measured as a score on a scale at baseline and right after the five-week educational intervention. The registry describes self-reported diet adherence using the Spanish version of the Summary of Diabetes Self-Care Assessment. Items 1-5 concern dietary behaviors, including how many of the last seven days a participant followed a healthful eating plan. The scoring method takes the mean number of days across those items, with a reverse score for item 4. The stated score range is 0 to 7, with higher scores corresponding to higher levels of self-care activity performance.

This measure focuses on a behavior that the educational program is intended to address. Self-report can capture participants’ accounts of daily practices that may not be directly observable in a brief study visit. At the same time, the score reflects reported behavior, not an independent confirmation of dietary intake or a clinical outcome. The endpoint is therefore useful for describing the targeted self-management behavior, while its meaning depends on how participants understand and report the questions.

The registry specifies the median and full range as the summary statistics for this outcome. It identifies participants completing the post-survey as the population for the primary outcome. Numerical scores, the full range, and a baseline-to-follow-up comparison are not reported in the registry record, so the magnitude and precision of any change cannot be assessed from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a single-group study with measurements planned at baseline and right after a five-week educational intervention. The primary outcome is summarized as a median and full range. No inferential analysis is reported, and the registry lists zero analyses. The explanations below describe general statistical concepts relevant to this design; they do not imply that these methods were used in the study.

What does the median describe?

In general, the median is the middle value after observations are ordered. It is often useful when scores are skewed or when extreme observations could pull the arithmetic mean away from the typical value. The full range gives the minimum and maximum observed scores. Together, these summaries provide a compact description of the distribution, but they do not show every participant’s score or how much scores overlap between timepoints. The posted record specifies these summary measures but does not give the corresponding values.

How should a before-and-after outcome be interpreted?

In general, measurements from the same participant at two timepoints are paired. A comparison of those measurements should account for that pairing, because each person’s follow-up score is related to that person’s baseline score. Analyses based on independent groups would not reflect the repeated-measures structure. The registry does not report which statistical test or estimation method, if any, was planned for the primary outcome, so no particular approach can be attributed to this study.

A change score can describe the difference between an individual’s follow-up and baseline measurements, and a group summary can then describe those changes. General methods may estimate the typical change or its uncertainty. However, the registry does not report an estimate of change, a confidence interval, or a test result. No new estimate can be reconstructed from the available record because the underlying outcome summaries are absent.

What does a confidence interval contribute?

In general, a confidence interval describes the statistical uncertainty around an estimate under the assumptions of the method used. A narrow interval indicates greater precision than a wide interval, although precision does not establish that an estimate is unbiased or that a treatment caused the observed pattern. The registry record does not report a confidence interval for the primary outcome. Therefore, the precision of any possible change cannot be judged.

Why is the lack of a comparator important?

In general, a concurrent comparison group helps distinguish changes associated with an intervention from changes that might occur without it. In a single-group pre-post design, the observed difference includes all influences that coincide with the period between measurements. These can include background changes, participant expectations, other care or education, and measurement effects. This is a design limitation, not a statistical defect that can necessarily be removed by choosing a different test. The record does not list a comparator, and its design is explicitly single group.

Because there is no randomized comparison, two-arm comparisons are not part of the study design described in the registry. Planning illustrations based on equal allocation between two arms are not a description of the actual study. The posted sample-size assumptions identify such calculations as illustrations based on an observed effect. They are not observed power, do not demonstrate that the study was adequately powered, and do not substitute for a reported analysis of the primary endpoint. The sample-size justification for the actual study is not reported in the registry record.

What does the score measure?

The endpoint uses self-reported days of dietary behavior from items 1-5 of a Spanish-language self-care assessment. The scoring description specifies the mean number of days for those items and reverse scoring for item 4. In general, a scale score condenses responses across items into a measure that can be compared across observations. Interpretation depends on consistent administration, comprehension, and response. The registry describes the scoring range and direction but does not report reliability, validation results in this study population, or an assessment of measurement properties. Those details are not reported in the registry record.

With bounded scores, the possible values have limits; the registry states a 0 to 7 range. In general, scores near a boundary may have less room to move in one direction than scores near the middle. The posted record does not give the observed distributions, so it is not possible to judge whether a boundary affected the results. The median and full range would help describe the observed values, but those numerical summaries are not reported.

What do planning illustrations mean?

In general, a sample-size calculation estimates the amount of information needed to detect a specified effect under stated assumptions. The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of an observed effect. Those assumptions describe a planning illustration rather than the single-group design. Sample-size illustrations are not observed study outcomes and do not show the probability that this completed study detected an effect. The registry record does not report the study’s own sample-size justification, and the numerical outcome needed to assess the illustration is not reported.

Statistical significance, when reported, would address compatibility of data with a statistical model and a null hypothesis; it would not by itself establish practical importance or causation. The record gives no p-value for the primary outcome. Since neither an effect estimate nor its uncertainty is reported, the statistical interpretation must remain descriptive of the design and planned measurement rather than of an observed treatment effect.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures. It does not report how the outcomes were prioritized beyond identifying healthy eating as the primary outcome, nor does it report a plan for controlling the chance of false-positive findings across multiple outcomes. The number of analyses listed is zero. Consequently, there are no reported analysis results from which to assess whether multiple testing was conducted or how it was handled. A multiplicity adjustment or testing hierarchy is not reported in the registry record.

For the primary outcome, the population is described as participants completing the post-survey. That definition makes follow-up completion relevant to interpretation. The number of post-survey completers and the number with paired baseline and post-intervention data are not reported. The record does not describe whether participants with incomplete data were excluded, whether any values were imputed, or whether sensitivity analyses were planned. A missing-data assumption or method is not reported in the registry record.

In general, missingness can affect an estimate when the participants with observed outcomes differ from those without observed outcomes. Restricting the outcome population to people completing the post-survey may be appropriate for a particular analysis, but it does not by itself show whether those participants represent everyone enrolled. The record does not provide enough information to assess the extent or potential consequences of incomplete follow-up.

The enrollment entry is 40, but that entry should not be treated as the analysis denominator for the primary endpoint. The outcome population is described by post-survey completion, and the corresponding count is not reported. Similarly, the registry status of terminated does not explain the pattern of missingness or indicate why results are absent. The reason for termination and any resulting impact on outcome availability are not reported in the registry record.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The adverse-event entries describe one intervention group. The registry lists 40 participants at risk for serious adverse events and zero affected, and it separately lists 40 at risk for other adverse events and zero affected. Deaths are listed as zero. These are the safety figures in the registry record; they should be read as recorded counts, not as proof that no event could have occurred outside the recorded reporting period or reporting scope.

The record does not list any serious adverse-event terms. It also does not give a narrative description of safety monitoring, event definitions, collection methods, or the duration of safety follow-up. Those details are not reported in the registry record. The intervention is described as educational, but that description does not replace a review of the recorded safety information.

Because this is a single-group study, the adverse-event entries do not provide a comparison of event frequency against another group. The counts also do not establish whether events were related to the intervention. The registry record does not report an attribution assessment. The listed at-risk counts should be interpreted within the registry’s reporting, without inferring additional safety conclusions from the absence of listed events.

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

The registry record shows that the study was intended to assess self-reported healthy eating around a five-week culturally tailored education program for adult Hispanic males with type 2 diabetes. It describes the measure, the scoring direction, and the participants included in the primary outcome population. It also records a single-group design, termination status, and safety counts. These registry entries help clarify what the study set out to measure and what its design could address.

The record does not report primary outcome values or analyses. It therefore does not show whether healthy eating scores increased, decreased, or remained similar from baseline to the post-intervention assessment. It gives no estimated amount of change and no measure of uncertainty for a change. The listed zero analyses are not evidence of no effect; they indicate that analysis results are not reported in the registry record.

Even if change estimates were available, a single-group before-and-after comparison would not by itself establish that education caused a change. Without a separate comparator, other influences over the same period cannot be ruled out by a direct group contrast. The self-reported nature of the endpoint also means that its interpretation concerns reported behavior, rather than independently measured dietary intake or a clinical outcome.

The posted information does not establish whether the program improves diabetes outcomes, prevents complications, or changes health beyond the stated behavioral measure. It also cannot establish whether the findings would apply to people outside the stated target population or to other educational programs. The number who completed the post-survey, the reason for termination, and the analysis population size are not reported.

Thus, the most supportable interpretation is about the study’s design and reporting status, not an intervention effect. The registry record documents the planned question and available safety entries, but it contains no numerical primary outcome results from which to judge the direction, magnitude, or precision of any change.

13. Why This Trial Matters Statistically

This study addresses a population and behavior that the registry identifies as important: adult Hispanic males with type 2 diabetes and self-management practices related to diet. The intervention is described as culturally tailored and community-oriented in its rationale. From a statistical perspective, clearly defining the population, intervention, outcome, and measurement timepoints is essential for understanding the question a study can answer.

The endpoint is a structured self-report score rather than an informal description of behavior. The registry specifies the Spanish version of the assessment, the dietary items, the reverse-scoring rule, and the score direction. Those details help readers understand what is being summarized and what a higher value represents. Reporting the actual distribution and analysis would be necessary to judge how the measure behaved in the study.

The single-group design is also statistically important. It can describe participants’ outcomes over time, but it cannot provide the same direct contrast as a randomized study with a concurrent control group. Recognizing that distinction prevents a before-and-after pattern from being mistaken for a causal estimate. In this case, the registry does not report the outcome values or analysis, so even a descriptive change cannot be evaluated.

The status of terminated and the absence of reported analyses make transparent reporting especially important for interpreting what is known. The registry lists enrollment and safety counts, yet does not report how many participants completed the primary outcome assessment or why the study was terminated. These gaps constrain conclusions independently of the intervention’s subject matter. Statistically, the key contribution of the record is to define the intended measurement and reveal the limits on evaluating results from the information it reports.

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 trial-specific limitation is the absence of reported numerical results for the primary outcome. Although the registry specifies a median and full range at baseline and after the five-week intervention, those values are not reported in the registry record. No estimate of change, confidence interval, or test result is listed, and the record lists zero analyses. This prevents assessment of both the observed pattern and its precision.

The single-group design lacks a concurrent comparator. Any observed change would therefore be difficult to separate from other events or influences occurring between baseline and follow-up. The self-reported endpoint also depends on participant recall and reporting. The registry does not report a measurement-property assessment in this study, so the performance of the score in the study population cannot be evaluated from the record.

The primary outcome population is defined by completing the post-survey, but the number of completers is not reported. Neither the extent of missing outcome data nor its handling is described. Enrollment of 40 does not establish how many participants contributed to the primary outcome. The reason for the terminated status and its implications for recruitment, follow-up, and analysis are not reported in the registry record.

The record lists three outcomes but does not report a multiplicity approach or statistical analysis plan. It also does not report the study’s sample-size justification, interim-analysis plan, or a method for handling repeated measurements. These omissions make it impossible to assess whether the planned statistical methods aligned with the design or how the investigators intended to account for uncertainty.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Culturally Tailored Diabetes Education on Self-Management of Adult Hispanic Males With Type 2 Diabetes Mellitus — NCT06897618.
• Registry record last updated 2026-05-22; status last verified 2026-05.
• Results first posted 2026-05-22.
• 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

The registry record describes a terminated, single-group behavioral study of five weeks of culturally tailored diabetes self-management education for adult Hispanic males with type 2 diabetes. The intervention is modeled after the Association of Diabetes Care and Education Specialists Seven-item Framework. Listed enrollment is 40; the record gives a start date of 2025-09-12 and a primary completion date of 2025-12-19.

Healthy eating is the primary outcome. It is measured by self-report using dietary items from the Spanish version of the Summary of Diabetes Self-Care Assessment, with a median and full range specified at baseline and right after the intervention. The outcome population is described as participants completing the post-survey.

The registry lists three outcome measures and zero analyses. Numerical primary outcome results, the number completing the post-survey, the reason for termination, and the study’s analysis plan are not reported in the registry record. Safety entries list zero serious adverse events, zero other adverse events, and zero deaths.