A Sugar-Sweetened Beverage Reduction Intervention for Native American Men: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Sugar-Sweetened Beverage Reduction Intervention for Native American Men (NCT06029517), a non-randomized na study. The primary outcome is Change in SSB Intake for Men Affiliated With Native American Athletic Communities.

2. Clinical Question

3. Trial Design

The registry describes a completed, non-randomized study with a single-group model and no masking. Enrollment was 48. The study is listed as phase NA and was sponsored by Roswell Park Cancer Institute. The registry dates are 2022-07-20 for study start and 2025-09-15 for primary completion.

The intervention is Indigenous SIPin, a culturally appropriate educational program for reducing sugar-sweetened beverage consumption among men affiliated with Native American athletic communities. The registry describes two arms, but they do not form a randomized intervention-versus-control comparison. Arm 1 participants receive the intervention over 6 months. Its educational sessions are in-person and/or virtual, weekly over 30 minutes for 12 weeks; text message communications are BIW for 12 weeks and monthly thereafter up to month 6. Arm 2 observes the intervention over 6 months and provides qualitative feedback.

The distinction between the arms matters for interpreting the primary outcome. Only Arm 1 is included in the primary analysis. The registry says Arm 2 participants are excluded because they provided qualitative feedback and endpoint data was not collected for them. Thus, the primary outcome concerns change within the intervention group; it is not a direct estimate of the difference between intervention and control groups.

The registry lists three interventions as other: Education Intervention, Observation of Indigenous SIPin Intervention, and Discussion. It also lists Dietary Intake and Change in Body Weight as secondary outcomes. The conditions recorded include Cardiovascular Disorder, Coronary Artery Disease, Diabetes Mellitus, Obesity-Related Malignant Neoplasm, and obesity-related concerns in the study summary. The registry does not report a randomized allocation procedure, a masked assessment process, or a control group suitable for estimating a comparative treatment effect.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Only qualitative data was collected from participants in Aim 1 for the purpose of culturally adapting the intervention. The qualitative data analysis generated themes and codes rather than prespecified quantitative outcome measures or statistical comparisons. Therefore, this group was not included.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Only patients in Arm 1 are included in the primary analysis. Arm 2 participants are not included because they only provided qualitative feedback data. Endpoint data was not collected for this group.

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 Change in SSB Intake for Men Affiliated With Native American Athletic Communities, measured over up to 6 months.

The primary endpoint is the change in sugar-sweetened beverage intake per day from baseline to 6 months among men affiliated with Native American athletic communities who are in Arm 1. Intake is expressed in kcal per day. The endpoint is described as a mean, with standard error as its dispersion measure, and its timeframe is up to 6 months.

This measure focuses on a behavior the educational program is intended to address. A change from baseline describes how intake in the intervention group differs at follow-up from that group’s starting level. It does not, on its own, show what would have happened over the same period without the intervention. Since the study is non-randomized and Arm 2 does not contribute endpoint data, the primary endpoint is not a between-arm comparison.

In general, a mean summarizes the average outcome across the participants contributing data. A standard error describes the statistical precision of an estimated mean; it is not the spread of individual participants’ measurements. The registry record does not report the numerical mean change or its standard error, nor does it report a confidence interval or p-value for this outcome. As a result, the direction, magnitude, and precision of the primary endpoint cannot be characterized from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as a mean of a continuous measure. The measure is change in daily sugar-sweetened beverage intake from baseline to 6 months, expressed in kcal per day, among Arm 1 participants. Standard error is the listed measure of dispersion. No numerical estimate or standard error is reported in the registry record.

What a mean change represents

In general, a mean change summarizes the average change in the outcome for participants included in an analysis. It is distinct from a comparison of two groups: the endpoint concerns change in Arm 1 from baseline, while Arm 2 does not have endpoint data for this analysis. The registry record does not provide details about how individual measurements were combined to produce the reported change, including whether the estimate uses only participants with observed measurements at both time points.

A mean can make an overall pattern easier to describe, but it may not capture all variation in individual responses. In general, a continuous outcome can have substantial variation across participants even when the average is comparatively small. The registry record does not report the distribution of individual intake values or changes, so that variation cannot be assessed.

What the standard error means

In general, the standard error describes how much an estimated mean would vary across repeated samples under the assumptions of the statistical model. It is a measure of precision for an estimate, not a description of how spread out individual participants’ intake values are. A standard error is often used to construct a confidence interval or to conduct a statistical test. The registry record does not report the primary endpoint’s standard error, confidence interval, or test result, so none of those aspects can be interpreted for this study.

In general, uncertainty depends on both the amount of information in the data and the variability in the outcome. Missing observations, the number of participants with usable follow-up, and the method used to account for repeated measurements can affect the estimate and its uncertainty. The registry record does not report these analysis details for the primary endpoint.

Why the design affects interpretation

The registry lists the allocation as non-randomized and the model as single-group. Arm 1 receives Indigenous SIPin; Arm 2 observes the intervention and provides qualitative feedback. Because the registry says endpoint data was not collected for Arm 2, the primary analysis does not compare outcome changes between those arms. The primary endpoint can therefore describe change in the intervention group, but it cannot by itself separate intervention-related change from other changes over time.

In general, random allocation can help make treatment groups comparable at the start of a study, while a suitable concurrent comparison group can help distinguish an intervention’s effect from time trends and other influences. Those general design considerations do not turn a within-group change into a causal estimate. The registry does not report an alternative comparative analysis for the primary endpoint.

Precision, testing, and practical interpretation

In general, a confidence interval places uncertainty around an estimated effect, and a p-value evaluates data relative to a stated statistical hypothesis. A small p-value alone would not convey the size or practical importance of a change; the estimate and its uncertainty are also needed. Since no primary estimate, confidence interval, or p-value is reported in the registry record, the statistical evidence and its precision cannot be evaluated.

The record includes planning assumptions for an illustration based on an observed effect: 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. These are described as planning assumptions, not as the trial’s own design. Numerical planning results and the observed effect used for that illustration are not reported in the registry record. Such planning figures, in general, are not observed power and do not replace analysis of the study’s outcome data.

For continuous data, general methods may also need to account for the outcome’s distribution and the structure of repeated observations. Over-dispersion, in general, means that observed variability is greater than a model assumes; if ignored, standard errors can be too small and statistical uncertainty understated. The registry record does not report whether over-dispersion was assessed, which model was fitted, or whether repeated-measure methods were used. No specific modeling choice should be inferred from the endpoint description alone.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Arm 1 - Indigenous SIPin")
n   <- c(30)
m   <- c(0.18)
sp  <- c(87.31)
sd  <- sp * sqrt(n)      # standard errors converted to SDs
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Arm 1 - Indigenous SIPin  30  0.180  478.217  -178.389  178.749

11. Multiplicity, Missing Data and Analysis Populations

The registry lists Dietary Intake and Change in Body Weight as secondary outcomes, alongside the primary outcome of change in sugar-sweetened beverage intake. It reports three outcome measures and zero analyses. The record does not report numerical results for the primary or secondary outcomes, or explain which statistical tests or models were used.

Multiplicity arises in general when several outcomes, time points, or statistical tests are considered: the more opportunities to identify a result, the greater the chance of an apparently notable result occurring by chance. Methods such as prespecifying a primary outcome or adjusting significance thresholds can address this concern, but the registry record does not report a multiplicity strategy. It also does not report whether additional outcomes or analyses were conducted beyond the registry listings.

The population for the primary analysis is partly specified: only Arm 1 participants are included, while Arm 2 participants are excluded because endpoint data was not collected. The registry does not report the number of Arm 1 participants with usable baseline and follow-up intake data. It does not report how missing observations in Arm 1 were handled, whether participants were analyzed according to any other population definition, or whether sensitivity analyses were performed. Those details are important because the analysis population and missing-data approach can affect both an estimate and its uncertainty.

In general, missing-data methods rely on assumptions about why measurements are unavailable and how the observed data relate to unobserved values. Different assumptions can lead to different estimates. The registry record does not report those assumptions or a method for assessing their influence. As a result, the completeness and robustness of the primary analysis cannot be evaluated from the record.

12. 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 safety figures separately for the two listed arms. For Arm 1, 30 participants are recorded as at risk for serious adverse events and 0 as affected; 30 are recorded as at risk for other adverse events and 0 as affected. Deaths are recorded as 0. For Arm 2, 18 participants are recorded as at risk for serious adverse events and 0 as affected; 18 are recorded as at risk for other adverse events and 0 as affected. Deaths are recorded as 0. No top serious-event terms are listed.

These figures describe what the registry reports for the listed risk groups. They do not establish that no adverse events occurred outside the recorded categories or reporting period, and they do not show whether every participant was observed for the same length of time. The registry record does not provide additional detail about event definitions, event collection procedures, or the timing of safety assessments.

In general, a zero count in a registry safety field means that no events are recorded in that field; it does not prove that the risk of an event is absent. These counts should also not be used to compare safety between the arms: the study is non-randomized, and the arms have different roles, with Arm 2 providing qualitative feedback rather than serving as a like-for-like control group.

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

The registry record describes an educational intervention and defines a primary outcome focused on sugar-sweetened beverage intake. It identifies the intended population, the follow-up timeframe, the measurement unit, and the fact that the primary analysis includes Arm 1 only. These details clarify what the study set out to assess.

However, the numerical primary result is not reported in the registry record. There is no reported mean change in intake, standard error, confidence interval, or p-value. The posted results therefore do not allow readers to determine the direction or magnitude of change or how precisely it was estimated. The study’s completion status and enrollment figure do not provide a substitute for those outcome data.

Even if a within-group change were reported, the design would need to be kept in view. The registry describes a non-randomized, single-group primary analysis. Arm 2 did not contribute endpoint data and was not a like-for-like control comparison. A change from baseline in Arm 1 would not, by itself, establish that the intervention caused that change.

The record does not report the number of participants with complete primary outcome data, the handling of missing observations, or the statistical model used. It also does not provide numerical results for the listed secondary outcomes. These gaps limit assessment of both the findings and their robustness.

In general, an outcome’s statistical significance and practical importance are different questions. Statistical uncertainty concerns how precisely a change is estimated; practical interpretation concerns the relevance of the size and context of that change. Without a numerical estimate and a measure of its uncertainty, neither can be judged from the posted results. No conclusion about whether the intervention reduced intake or affected health outcomes can be drawn from the registry information alone.

14. Why This Trial Matters Statistically

This study is statistically noteworthy for the way its primary question is framed: it assesses change in daily sugar-sweetened beverage intake among men affiliated with Native American athletic communities, using a culturally appropriate educational program. Its focus and population are explicit in the registry, and the intervention description records a mix of educational sessions and text message communications over 6 months.

It is equally important to distinguish the primary analysis from a controlled treatment comparison. Although the registry lists two arms, the primary outcome is limited to Arm 1. Arm 2 observes the intervention and contributes qualitative feedback, and endpoint data was not collected for that group. The non-randomized, single-group primary analysis can describe change over time if outcome results are available, but does not on its own provide a causal comparison.

Statistical interpretation also depends on results being reported with their uncertainty. The registry defines a continuous endpoint and lists standard error as its dispersion measure, but does not report the primary estimate or its uncertainty. Without those quantities, readers cannot assess magnitude, precision, or whether the data are compatible with a range of possible changes. Enrollment alone cannot answer those questions.

The record also illustrates why analysis populations and missing-data methods matter. It specifies that Arm 2 is excluded, but does not report how many Arm 1 participants contributed usable follow-up data or how missing observations were handled. These details are needed to understand which participants inform the estimate and how dependent it may be on analysis assumptions.

More broadly, culturally relevant intervention research can pose a focused behavioral question while still requiring transparent outcome reporting and careful design interpretation. The registry provides useful information about the intervention and intended endpoint, but its posted outcome details are insufficient to quantify or evaluate the primary change.

15. 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 record does not report the numerical result for the primary endpoint. The mean change, standard error, confidence interval, and p-value are not reported, so neither the magnitude nor the precision of the outcome can be assessed. Numerical results for the secondary outcomes are also not reported.

The primary analysis is non-randomized and described as single-group. Arm 2 is a feedback group, not a like-for-like control group for the primary endpoint, because endpoint data was not collected for those participants. The primary outcome therefore cannot be interpreted as a randomized comparison between the arms, and a within-group change would not establish causation.

The registry reports enrollment of 48 but does not report the number of participants included in the primary endpoint analysis. It does not specify the amount of missing baseline or follow-up data, how missing values were handled, or whether any sensitivity analyses were conducted. These omissions make it difficult to assess how representative the analyzed participants might be of those enrolled.

The record does not describe the statistical model, the method for estimating change, or the assumptions used to calculate the standard error. It does not report whether the analysis accounted for repeated measurements, or how any departures from model assumptions were evaluated. It also does not report a multiplicity strategy for the primary and secondary outcomes.

The registry’s planning assumptions describe an illustration rather than the trial’s own design, and numerical planning results are not reported in the registry record. Finally, the safety counts are not accompanied by details about event definitions, collection procedures, or observation time. These limitations constrain interpretation of the record; they do not establish that unreported analyses or procedures were absent.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Sugar-Sweetened Beverage Reduction Intervention for Native American Men — NCT06029517.
• Registry record last updated 2026-07-28; status last verified 2026-06.
• Results first posted 2026-07-28.
• 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.

19. Record Summary

The registry describes a completed, non-randomized, single-group study of Indigenous SIPin among men affiliated with Native American athletic communities. Enrollment was 48. Arm 1 received the intervention over 6 months; Arm 2 observed the intervention and provided qualitative feedback.

The primary outcome is mean change in sugar-sweetened beverage intake per day from baseline to 6 months among Arm 1 participants, measured in kcal per day, with standard error listed as the dispersion measure. Arm 2 was excluded from the primary analysis because endpoint data was not collected for that group.

The numerical primary result and its uncertainty are not reported in the registry record. Dietary Intake and Change in Body Weight are listed as secondary outcomes, but their numerical results are also not reported. The record reports zero affected participants for serious and other adverse events in both arms, and zero deaths.