Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce CVD Risk: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce CVD Risk (NCT06671652), a na na study. The primary outcome is Blood Pressure.

2. Clinical Question

3. Trial Design

This is a completed, single-group project titled “Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce CVD Risk.” Its stated focus combines adapting a participatory research project with implementing a community program intended to build community connection and historical knowledge within Cherokee communities on the Cherokee Nation reservation. The registry record lists Blood Pressure as a condition and University of Missouri-Columbia as sponsor.

The brief description divides the project into Phase I and Phase II. Phase I used an online convenience sample to collect health and preference information for the intervention phase, alongside community partnership to co-create an intervention. Phase II was an intervention involving consultation with Cherokee cultural and historical experts. The intervention is named Duyugoda igalenisodi (Starting again the right way) and is classified as behavioral.

For Phase II, participants were to meet with experts in self-selected community groups approximately 1 x month for 5 months, complete homework assignments for each meeting, and complete a final activity. The registry record does not report further details about the final activity, how groups were formed, or how attendance and participation were recorded.

The study is listed as completed, with a start date of 2023-09-24 and a primary completion date of 2024-06-01. The phase is listed as NA, allocation as NA, and masking as none. The record lists enrollment of 42. Because the design is single-group and has no like-for-like control comparison, the pre-to-post measurements can describe change over time in the observed group but cannot isolate the program’s effect from other explanations. Results for the primary outcome are not 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

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Blood Pressure, measured over Pre; Post (study completion; within 6 months).

The primary endpoint is blood pressure, measured in millimeters of mercury (mmHg). The registry description specifies systolic and diastolic blood pressure and identifies the summary parameter as a mean with standard deviation. Systolic and diastolic readings represent different parts of the blood pressure measurement; considering both gives a more complete description than reporting only one component. This is a general explanation of the measure, not a claim about the project’s findings.

The planned measurement occasions are pre and post, with post measurement at study completion within 6 months. A pre-to-post comparison can describe whether the group’s mean measurements differ between those occasions. The mean indicates the group’s average measurement, while the standard deviation describes variation among measurements around that average. Reporting both can help readers distinguish the average level from the spread of individual observations.

The registry record does not report the actual pre- or post-intervention blood pressure values, the change in mean, or a measure of uncertainty for that change. It also does not describe the measurement device, measurement conditions, repeated-reading procedure, or rationale for selecting blood pressure as the primary endpoint. Without the observed data, the direction, size, and precision of any pre-to-post difference cannot be evaluated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is identified as blood pressure, with systolic and diastolic measurements in mmHg. The registry record specifies a mean as the summary parameter and standard deviation as the measure of dispersion. These choices describe different features of continuous measurements: the mean represents the average level, while the standard deviation describes how spread out observations are around that average. This is a general explanation of the statistics named in the record. The record does not include the numerical summaries needed to interpret them for this study.

What does a pre-to-post comparison describe?

A pre-to-post comparison contrasts measurements taken before and after participation. In a single-group study, that contrast describes how the measured group changed over time. It is not the same as comparing an intervention group with a concurrent control group. Without a like-for-like control, other changes over time can coincide with the intervention and cannot be separated from it by the pre-to-post contrast alone. This is a general limitation of uncontrolled before-and-after designs, not a finding about this project.

The registry record states that blood pressure was measured pre and post, with post measurement at study completion within 6 months. It does not report whether the same participants contributed measurements at both occasions, the number of usable measurements at either occasion, or whether the comparison was based on paired observations or group-level summaries. Those details matter because analysis choices and the available observations determine what a pre-to-post estimate represents.

How should a mean and standard deviation be read?

A mean is a measure of central tendency: it condenses a set of readings into an average. A standard deviation gives information about variation across readings. A mean alone cannot show whether observations are tightly grouped or widely spread. Conversely, a standard deviation does not describe the direction of a change in the mean. Together they can help characterize a continuous outcome, but they do not by themselves provide a direct estimate of pre-to-post change or its precision.

A confidence interval, in general, expresses uncertainty around an estimated quantity under the assumptions of the statistical method used. It helps readers judge which values are reasonably compatible with the data and method. The registry record does not report a confidence interval for blood pressure or a numerical change estimate. No conclusion about precision can therefore be drawn from the reported endpoint description alone.

Why does the design matter for interpretation?

The study is listed as single-group, and allocation is recorded as NA. This means the registry record does not describe random assignment or a control arm for a direct comparison. In general, a control group can help distinguish changes associated with an intervention from changes that might also occur without it. In its absence, a pre-to-post pattern is descriptive and is vulnerable to alternative explanations. This does not make the measurement meaningless; it limits the causal interpretation that can be supported.

The Phase I online convenience sample and community partnership are described as part of preparation and co-creation. Phase II involved self-selected community groups and consultation with Cherokee cultural, linguistic, and historical experts. These features give context to how the program was organized. They do not, by themselves, establish how representative participants were, how consistently the intervention was delivered, or whether participation influenced the recorded outcome. Those implementation and selection details are not reported in the registry record.

What does over-dispersion mean in general?

Over-dispersion refers to observed variability that is greater than a statistical model assumes. It is especially relevant to outcomes modeled as counts or rates, because underestimated variability can make statistical uncertainty appear too small. The primary outcome in this record is continuous blood pressure summarized by a mean and standard deviation, not a count outcome. The registry record does not describe a model or report an over-dispersion assessment, so there is no basis for saying that over-dispersion was examined or affected the analysis. This general concept should not be mistaken for a reported feature of this trial.

How should planning estimates be interpreted?

The record describes a sample-size planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence about the result. The listed design is single-group, so an equal-allocation, two-arm planning framework is not a description of the study’s actual comparison. The registry record does not report the outcome estimate needed to evaluate the effect-based illustration, and it does not report that these assumptions were the study’s original design justification.

More broadly, the registry record does not report a detailed statistical analysis plan, model specification, adjustment strategy, confidence intervals, or a rationale for the selected summaries. These absences limit reproducibility and independent assessment of the analysis. They do not establish that a particular method was or was not used; the relevant details are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 4 outcome measures and 3 analyses. It identifies blood pressure as the primary outcome and names the Keyes Mental Health Continuum, Short Form, also known as the Positive Mental Health Scale, among secondary outcomes. It does not report the full analysis plan, how the remaining outcome measures relate to the stated outcomes, or how the analyses map to particular endpoints and time points.

Multiplicity arises when several outcomes, contrasts, or analyses are examined: the more opportunities there are to find an apparently notable result, the more important it is to understand whether and how the analysis accounted for that. The registry record does not report a multiplicity adjustment, a hierarchy of tests, or a plan for interpreting multiple outcomes. It is therefore not possible to determine whether multiplicity was addressed. This is an uncertainty about reporting, not evidence that a particular adjustment was omitted in the study conduct.

The outcome timeframe is pre and post, with post measurement at study completion within 6 months. The registry record does not report missing-data counts, reasons for missingness, imputation procedures, or a sensitivity analysis. It also does not report the number of participants contributing data to each outcome or analysis. Enrollment of 42 is not enough to establish the analysis population for any endpoint.

Definitions of intention-to-treat, per-protocol, or other analysis populations are not reported in the registry record. Nor does the record say whether all enrolled participants were included in each analysis. These omissions make it difficult to assess the influence of missing observations or differences in participation on any outcome estimate. Because the blood pressure results themselves are not reported, neither the impact of missing data nor the interpretation of multiple analyses can be evaluated from 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 registry record lists 42 participants at risk for serious adverse events and 0 affected. It also lists 42 at risk for other adverse events and 0 affected, with 0 deaths. These are the posted adverse-event counts for the intervention group. They describe what the registry record reports; they should not be read as proof that no event occurred outside the recording or reporting process.

The registry record does not report the adverse-event observation window, event definitions, collection methods, severity grading, or whether events were assessed as related to the intervention. It also lists no serious adverse event terms. Without these details, readers cannot assess how events were solicited, classified, or followed, or whether reporting covered the same period for all participants.

Zero reported affected participants is a count, not a complete description of safety. The record does not provide event-level narratives or information about non-serious events beyond the count. These figures should be interpreted as the adverse-event information recorded in the registry, alongside the limitations in reporting detail, rather than as a broader claim about safety.

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

The study description establishes that a community-based, single-group program was undertaken and that blood pressure was selected as the primary outcome. It identifies the intended pre-to-post measurement timeframe and the intervention’s community-building focus. The registry record does not provide the blood pressure measurements or estimates of change. Accordingly, it does not support a conclusion about whether blood pressure changed, the direction of any change, its size, or its precision.

Even if a numerical pre-to-post difference were available, the single-group design would limit causal interpretation. A before-and-after contrast can describe change among observed participants, but without a like-for-like control it cannot show whether the intervention caused that change. Other influences over time and changes in who contributes measurements could also be relevant. These are general considerations for this design, not claims about what happened in this project.

The project also has a participatory and cultural dimension: Phase I involved community partnership and co-creation, while Phase II involved Cherokee cultural, linguistic, and historical experts and self-selected community groups. These elements describe the intended approach and context. The registry record does not report implementation fidelity, participant experience, or results for community connection and historical knowledge, so those outcomes cannot be assessed from the available information.

The listed enrollment and completion status do not replace outcome reporting. Likewise, the adverse-event counts provide a limited registry summary and do not answer the primary blood pressure question. The most supportable interpretation is therefore about study structure and planned measurement, not about efficacy or clinical impact. The record does not report enough outcome or analysis information to determine what the study observed or how precisely it was estimated.

13. Why This Trial Matters Statistically

This study is statistically notable because its design places community adaptation and implementation alongside a clinical measurement. The intervention was developed through community partnership and involved Cherokee cultural, linguistic, and historical experts. That context matters when interpreting what the program was intended to do and the setting in which it was delivered. It also makes clear that a blood pressure endpoint captures only one aspect of the project’s stated aims.

The design is single-group, and the primary outcome is framed as pre-to-post measurement. This makes the distinction between describing change and attributing change especially important. A measured difference over time, if reported, would not by itself establish that the program produced it. The registry record does not report the outcome estimate, so even the descriptive change cannot be assessed.

The record also illustrates why statistical interpretation depends on transparent reporting beyond a named endpoint. Readers need observed summaries, uncertainty measures, analysis populations, missing-data information, and a clear account of the analyses to assess results. The registry record lists 4 outcome measures and 3 analyses but does not explain their full relationship or report the corresponding blood pressure results. Those gaps constrain independent interpretation.

The project’s participatory purpose and the statistical limits of its design can both be recognized. The former provides important context for the intervention, while the latter sets boundaries on causal conclusions. No inference about the program’s effectiveness or broader applicability can be drawn from the registry record’s design description alone.

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 registry record does not report numerical blood pressure results, including pre- and post-measurement means, standard deviations, a change estimate, or an uncertainty interval. This prevents assessment of the primary outcome’s direction, magnitude, and precision. Although enrollment is listed as 42, the number contributing data to each measurement occasion or analysis is not reported.

The single-group design has no like-for-like control comparison described. Any pre-to-post difference would therefore be open to explanations other than the intervention. Allocation is recorded as NA, and masking as none. The registry record does not describe a plan to address confounding or other time-related influences.

The project includes an online convenience sample in Phase I and self-selected community groups in Phase II. The record does not report detailed eligibility criteria, participant characteristics, recruitment flow, or how participants who did not complete the program were handled. These omissions limit assessment of selection and of how well findings might apply beyond the participants described.

Details of the blood pressure measurement procedure are not reported in the registry record. This includes equipment, measurement conditions, repeat readings, and the handling of measurements taken at different times. The record also does not report implementation fidelity, attendance, homework completion, or details of the final activity.

Finally, the statistical analysis plan, missing-data methods, analysis populations, and approach to multiple outcomes are not reported. The adverse-event summary lacks the observation window and event-collection details. These reporting gaps do not establish that procedures were absent; they limit what can be independently assessed from the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Adaptation and Implementation of a Cherokee-based Participatory Research Project to Reduce CVD Risk — NCT06671652.
• Registry record last updated 2026-03-13; status last verified 2026-01.
• Results first posted 2026-03-13.
• 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

NCT06671652 is listed as a completed, single-group behavioral project sponsored by University of Missouri-Columbia. It concerns adaptation and implementation of a Cherokee-based participatory research project to reduce CVD risk. The record lists Blood Pressure as a condition, enrollment of 42, a start date of 2023-09-24, and a primary completion date of 2024-06-01.

Phase I involved an online convenience sample and community partnership to co-create an intervention. Phase II involved Duyugoda igalenisodi (Starting again the right way), a community-building program with Cherokee cultural, linguistic, and historical experts. The primary outcome is systolic and diastolic blood pressure in mmHg, measured pre and post at study completion within 6 months.

The registry record does not report the primary blood pressure results, the analysis details, or missing-data information. It lists 0 serious adverse events, 0 other adverse events, and 0 deaths among 42 at risk for each adverse-event category.