Binge Eating Syndrome Treatment for Older Women (BESTOW): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Binge Eating Syndrome Treatment for Older Women (BESTOW) (NCT05806788), a na na study. The primary outcome is Feasibility - Usage Rating Profile - Intervention.

2. Clinical Question

BESTOW is a pilot implementation trial of a behavioral intervention for women aged 60 or older with binge eating. The central question is whether participants who complete the intervention report that it is feasible, as measured by the Usage Rating Profile – Intervention. The registry record describes intervention content and planned assessments, but it does not report the observed feasibility scores or an analysis of them. This means the posted information describes what the study set out to assess, not what participants’ scores showed.

The study description also says participants were to complete assessments at baseline, post-intervention, and two follow-up timepoints, with weekly binge-eating frequency collected during the intervention. These planned observations provide context for the pilot, but they do not create a comparison group. Without a control condition, changes over time cannot be separated from other explanations using this design alone. The registry record does not report numerical outcome results, so the clinical question can be described but not answered from the posted results.

3. Trial Design

The registry record identifies BESTOW as a completed, single-group pilot implementation trial. It lists an enrollment of 20 and describes participants as women aged 60 or older. The intervention is behavioral and is named Binge Eating Syndrome Treatment (BESTOW). The record lists the study condition as binge eating. It does not describe a randomized allocation or a masked comparison; allocation is listed as NA and masking as none.

The intervention description focuses on behavioral strategies intended to reduce binge eating and improve health behaviors. Content includes body-image strategies, regulation of eating behaviors, and integration of physical activity with an emphasis on body function, health, and longevity. These are descriptions of intervention content, not evidence of its effects.

The study summary describes assessment at baseline, post-intervention, and two follow-up timepoints. Weekly binge-eating frequency was to be collected during the intervention period to monitor progress. The primary outcome timeframe is 6 weeks post-intervention and a 2 month follow-up. The primary measure is the Usage Rating Profile – Intervention, summarized as a mean with standard deviation among post-assessment completers.

The registry lists the study start as 2023-02-17, primary completion as 2023-11-14, and status as completed. Those dates describe the record’s study timeline; they do not establish that all planned assessments were completed or that every outcome was analyzed. The record lists four outcome measures and 0 analyses. It does not report a protocol-level sample-size justification, detailed statistical analysis plan, or reasons for the selected design. The tables and plots should therefore be read as displays of the posted information, not as evidence of a randomized treatment comparison.

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

Analysis population for the primary outcome, as defined in the registry: Post-assessment completers

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 Feasibility - Usage Rating Profile - Intervention, measured over 6 weeks (post), and 2 month follow-up.

The primary endpoint is the Usage Rating Profile – Intervention, a patient-reported measure of perceived intervention feasibility. The registry description says the scale gathers views about matters such as time needed, quality of materials, and simplicity. It has six items, with total scores ranging from 1-6; higher scores indicate greater reported feasibility. The planned summaries are a mean and standard deviation, and the named population is post-assessment completers.

Feasibility is relevant to a pilot implementation study because it describes participants’ experience of carrying out the intervention, rather than directly measuring whether the intervention changes binge eating or another health outcome. A feasibility rating can help characterize acceptability and practical demands as experienced by respondents. It is not, by itself, a comparison of outcomes against usual care or another intervention.

The registry lists measurement at 6 weeks post-intervention and at a 2 month follow-up. The record does not report the actual mean, standard deviation, number of respondents at either timepoint, or a comparison between timepoints. It also does not report how the scale was handled if a participant omitted an item. As a result, readers can understand the endpoint’s purpose and scoring direction, but cannot assess the observed ratings or their precision from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a single-group behavioral pilot and identifies a continuous primary outcome summarized by a mean and standard deviation. The posted record does not include the numerical outcome results or a detailed statistical analysis plan. The explanations below describe how to understand the stated design and planned summaries in general; they do not imply that a particular analysis was performed.

What does a single-group design show?

A single-group study observes participants who receive the intervention without a concurrent control group. It can describe experiences and outcomes within the enrolled group, including feasibility ratings at planned assessment points. It cannot directly compare outcomes under BESTOW with outcomes under an alternative condition. Even if measurements differ over time, the design alone cannot determine whether the difference was caused by the intervention. Other influences, including changes over time or the act of repeated measurement, may also matter.

Here, allocation is listed as NA, masking as none, and the model as single group. Those fields indicate that the record does not describe a randomized, masked comparison. The study is identified as a pilot implementation trial, so its primary endpoint concerns reported feasibility. The registry record does not report a protocol-level explanation of how the pilot’s enrollment was selected or a statistical justification for that enrollment.

What do the mean and standard deviation summarize?

A mean is a measure of the center of a set of scores. A standard deviation describes how dispersed individual scores are around that center. Together, they can summarize the average reported feasibility and how much participant ratings vary. The usefulness of those summaries depends on how many people contributed scores and whether the observed responses represent the intended group. The record names post-assessment completers as the primary endpoint population but does not report the number of completers or the resulting summaries.

The scale’s stated score range is 1-6, and higher total scores indicate greater reported feasibility. A mean should be interpreted in light of that scale and the respondents contributing data. It does not show that all participants had a similar experience: variation, missing responses, and the distribution of individual scores can matter. The registry record gives no distributional information or item-level results.

How should a confidence interval be understood?

In general, a confidence interval communicates uncertainty around an estimated quantity under the assumptions of the analysis. It is not a guarantee that a particular interval contains the true value, and it does not establish causality. For a mean, interval width is influenced by the variability of the scores and the amount of usable data. No interval for the primary feasibility outcome is reported in the registry record, so its precision cannot be evaluated.

What do the sample-size illustrations represent?

The page includes calculated sample-size material, which should be read as planning illustrations rather than as observed power or as a description of the trial’s original design. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a stated fraction of the observed effect. Those assumptions describe the illustration; they do not match the posted BESTOW design, which is single group. The registry record does not report the trial’s own sample-size justification. The illustrations are not evidence that the completed study had a particular probability of detecting an effect.

More generally, sample-size planning depends on the study question, outcome, variability, target effect, and analysis assumptions. Changing those assumptions changes the planning result. A planning table can show how hypothetical requirements vary under its stated conditions, but it cannot establish that a study’s observed data were adequate for a particular conclusion. The sample-size section should therefore be separated from any interpretation of the unreported trial outcomes.

Why does over-dispersion matter in general?

Over-dispersion is a general issue for count outcomes when their variability exceeds what a chosen statistical model expects. If it is ignored, standard errors can be too small and intervals or tests can give an overly optimistic impression of precision. The registry summary mentions weekly binge-eating frequency collection, but it does not report a count model, an over-dispersion assessment, or an analysis of those observations. This general concept should not be read as a claim that over-dispersion occurred in BESTOW.

More broadly, a statistical method can only answer the question its design and data support. The registry record identifies planned measures and timelines, but reports no analyses. Without results, an analysis population, or uncertainty estimates, readers cannot assess the numerical behavior of the endpoints or verify which methods were used.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures, including the primary Usage Rating Profile – Intervention and the secondary Binge Eating Score and Geriatric Depression Scale Score (CES-D). It does not identify all four outcome titles in the information, and it reports 0 analyses. No multiplicity strategy is reported in the registry record. In general, when several outcomes or comparisons are examined, the chance of at least one apparently notable finding can increase; a prespecified approach helps readers understand how such results were handled. Without posted analyses or a stated strategy, no adjustment or unadjusted interpretation can be attributed to this trial.

The primary endpoint is defined for post-assessment completers. That defines the named population for its planned summary, but does not say how many people completed the assessment or how incomplete records were treated. Missing-data methods, rules for incomplete scale items, and sensitivity analyses are not reported in the registry record. The record also does not state whether all enrolled participants contributed to the secondary outcomes or follow-up measures.

The study summary describes baseline, post-intervention, and two follow-up assessments, as well as weekly monitoring during the intervention. The number of observations available at each timepoint and any reasons for missing observations are not reported in the registry record. Without those details, readers cannot assess attrition patterns or whether the analyzed participants may differ from those without outcome data.

The registry record does not report analysis populations such as an intention-to-treat population or a per-protocol population. It also does not provide a detailed statistical plan that would establish which participants, timepoints, or outcomes were included in each analysis. These omissions limit reproducibility and make it difficult to distinguish prespecified analyses from analyses selected after data collection.

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 posted safety figures list the BESTOW Behavioral Intervention group with 20 participants at risk for serious adverse events and 0 affected. For other adverse events, the record likewise lists 20 at risk and 0 affected. Deaths are listed as 0, and no serious adverse-event terms are listed.

These figures describe what is recorded in the registry safety fields. They do not mean that the intervention is proven to be risk-free. A zero count in a group of this size can coexist with the possibility of uncommon events, and the registry record does not provide event narratives, event severity details beyond the serious-event category, or an explanation of how events were collected and reviewed. The figures also do not establish whether every participant completed every safety assessment.

The single-group design offers no concurrent control group for comparing event counts. Accordingly, the posted counts should not be interpreted as a comparative safety estimate or as evidence that the intervention caused or prevented an event. They are a limited summary of the safety information reported in the registry record.

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

This record describes a completed pilot implementation trial of BESTOW for women aged 60 or older with binge eating. Its primary outcome was participant-reported feasibility, measured with the Usage Rating Profile – Intervention. The intervention description gives examples of its behavioral content, and the study summary outlines planned assessments and weekly monitoring. These details clarify the study’s purpose and structure.

The record does not report numerical results for the primary endpoint or for the secondary outcomes. It gives no feasibility mean or standard deviation, no outcome-specific completion counts, and no inferential analysis. The listed status of completed does not substitute for posted results. Therefore, the record does not establish what participants thought of the intervention’s feasibility or whether scores changed over time.

It also does not establish whether binge-eating frequency, Binge Eating Score, or CES-D scores changed. Those measures appear in the study description, but their values and analyses are not reported in the registry record. The zero counts for adverse events are a limited report of the safety fields, not proof of an absence of risk.

Because there is no control group, the design cannot estimate a treatment effect relative to another intervention or usual care. Even if outcome values were available, within-group observations would not by themselves provide a causal comparison. The registry record also does not report confidence intervals or other measures that would show the precision of any outcome estimate.

In short, the posted information supports an account of what BESTOW was designed to evaluate and how the study was organized. It does not support a conclusion about efficacy, comparative effectiveness, the magnitude of any outcome change, or the precision of an outcome estimate. The tables and plots should be read alongside these limits, rather than as a substitute for unreported trial results.

13. Why This Trial Matters Statistically

BESTOW is statistically interesting because it focuses on feasibility in an older population and uses a single-group pilot implementation design. A feasibility endpoint asks a different question from an efficacy endpoint: it captures participants’ reported experience of the intervention rather than estimating a controlled treatment contrast. Keeping those questions distinct helps avoid treating a process measure as evidence of clinical benefit.

The record also illustrates why a completed study status and a detailed study description are not the same as a complete results report. The registry describes the scale, timepoints, and intended summaries, but lists 0 analyses and does not report numerical outcome results. Without estimates, variability, completion counts, and uncertainty, readers cannot judge how well the observed data support the feasibility question.

The single-group structure further clarifies the boundary of inference. The study can be designed to describe the experience of participants who receive BESTOW, but it does not provide a randomized comparison against a control condition. Statistical interpretation needs to follow that design rather than imply a causal contrast that was not conducted.

Finally, the sample-size material shown on the page is a planning illustration based on stated assumptions, including equal allocation between two arms. Those assumptions are not the posted single-group design, and the illustrations should not be mistaken for observed power or for the trial’s own sample-size justification. This distinction is important whenever planning calculations appear alongside results from a design to which the assumptions do not directly correspond.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The most important trial-specific limitation for interpretation is the absence of numerical outcome results in the registry record. Although the record marks the trial completed, it does not report the primary feasibility score, its standard deviation, or the number of post-assessment completers. The secondary outcome values and analyses are also not reported. This prevents readers from assessing the direction, magnitude, or precision of the observed outcomes.

The trial is single group, with no randomized control condition. This limits causal interpretation and prevents a direct estimate of how outcomes compare with an alternative condition. The record lists no masking. It does not report a detailed statistical analysis plan, the approach to missing data, outcome-specific analysis populations, or a multiplicity strategy. These details are important for judging reproducibility and how completely the posted outcomes represent the planned study.

The primary endpoint is based on post-assessment completers, but the registry record does not give the number of respondents at each assessment or describe how incomplete questionnaires were handled. Although the study summary describes baseline, post-intervention, follow-up, and weekly monitoring, the amount of data available at each point is not reported. The record also does not report whether the intervention was delivered as intended or whether participants’ exposure varied.

Finally, the safety summary is limited to event counts and does not provide event narratives or detailed collection procedures. The sample-size illustrations use assumptions for a two-arm design that differ from the posted single-group design; they are not evidence of the trial’s own planning rationale. Each of these gaps narrows what can be concluded from the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Binge Eating Syndrome Treatment for Older Women (BESTOW) — NCT05806788.
• Registry record last updated 2025-01-07; status last verified 2024-12.
• Results first posted 2025-01-07.
• 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

BESTOW (NCT05806788) is listed as a completed, single-group pilot implementation trial of a behavioral intervention for women aged 60 or older with binge eating. Enrollment is listed as 20. The intervention includes strategies related to body image, eating behaviors, and physical activity, with emphasis on body function, health, and longevity.

The primary outcome is the Usage Rating Profile – Intervention, a six-item feasibility scale scored from 1-6, with higher scores indicating greater reported feasibility. The registry describes the primary summary as a mean and standard deviation among post-assessment completers, at 6 weeks post-intervention and a 2 month follow-up. Secondary outcomes include Binge Eating Score and CES-D. The record lists four outcome measures and 0 analyses.

Numerical outcome results and analysis details are not reported in the registry record. The safety fields list 0 serious adverse events, 0 other adverse events, and 0 deaths among 20 participants at risk.