Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management (NCT05544708), a na na study. The primary outcome is Feasibility: House Chat Leaders (HCL).

2. Clinical Question

In statistical terms, the central question is whether the community delivery approach can be implemented and assessed, rather than whether it outperforms another program. The record also lists acceptability outcomes for attendance and retention. It does not provide their results in the registry record for this analysis. Consequently, the posted information supports a description of the feasibility count but not a broader conclusion about reach, sustainability, weight change, or cardiometabolic outcomes.

3. Trial Design

The registry identifies NCT05544708 as a completed, single-group behavioral study of Wellness Engagement Intervention. The listed condition is obesity, and the recorded enrollment is 43. The study is sponsored by Virginia Commonwealth University. Its recorded start date is 2023-05-01, and its primary completion date is 2025-05-30. The registry lists phase as NA, allocation as NA, and masking as none.

The intervention centers on training Wellness Ambassadors to recruit and deliver a lifestyle intervention to members of their social networks. The arm description says that House Chat Leaders in the intervention group deliver the intervention immediately following baseline visits and randomization. However, the study model is recorded as single group, allocation is NA, and the registry explicitly cautions that this is not a randomized comparison. The narrative reference to randomization therefore should not be treated as evidence of a randomized control group or a between-group treatment estimate.

The stated purpose is to assess feasibility and acceptability of House Chats as a way to deliver a weight-management program in a community-based, real-world setting. The primary outcome is a count relating to House Chat Leaders, with an 18-month timeframe. Attendance and retention are listed as secondary acceptability outcomes. The record identifies 5 outcome measures and 0 analyses.

A single-group design can describe whether specified activities or outcomes were recorded among participants in the study. Without a concurrent comparison group, it cannot separate intervention-related changes from other explanations for change. The registry record does not report further details about study procedures, how participants were selected, or how completion was defined. Those details should not be inferred from the intervention description alone.

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: 7 House Chat Leaders completed this outcome

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: House Chat Leaders (HCL), measured over 18 months.

The primary endpoint is titled “Feasibility: House Chat Leaders (HCL).” It is a participant count, and the registry says that 7 House Chat Leaders completed this outcome during the timeframe of 18 months. The endpoint is intended to describe a practical aspect of delivering the intervention: whether House Chat Leaders participate in the training and recruitment-and-delivery role described in the study.

Feasibility outcomes are used to assess whether a program can be carried out as intended in its target setting. In a community delivery model, counts related to leaders can help describe implementation activity. A count alone, however, does not indicate the proportion of eligible or approached people who completed the outcome. The number of House Chat Leaders eligible, approached, trained, or expected to complete it is not reported in the registry record. Nor is a threshold for judging feasibility reported.

For that reason, the posted count is descriptive rather than a success rate or a test against a prespecified target. It does not by itself quantify program reach, sustainability, participant weight change, or the effect of the intervention on health outcomes. The study’s stated motivation includes these broader concerns, but the primary endpoint described in the record is specifically about House Chat Leaders.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Because the registry records a single-group study and 0 analyses, there is no reported inferential model to interpret for the primary outcome. The result is a count of House Chat Leaders who completed the feasibility outcome. Statistical methods can still help clarify what that type of result does and does not communicate, and how planning calculations differ from analysis of observed outcomes.

What does a count tell the reader?

A count reports how many events or people meeting a definition were recorded. Here, the outcome is expressed as participants, and the registry reports 7 House Chat Leaders completing the outcome. A count is straightforward to describe, but its context depends on a denominator and on a clear definition of completion. For example, a completion count could be interpreted differently if the number eligible or expected to complete varied. Those supporting quantities and the operational definition are not reported in the registry record.

A rate or proportion would require a stated numerator and denominator. It should not be reconstructed by assuming a denominator from the enrollment figure, because overall enrollment and the relevant House Chat Leader population are not established as the same group. No such rate is reported. The registry’s outcome wording supports reporting the count, not converting it to a percentage.

Why are confidence intervals useful?

General explanation: a confidence interval expresses uncertainty around an estimate under a specified statistical model and sampling process. It helps distinguish a precise estimate from one that is compatible with a broad range of values. A count may be accompanied by an interval when the question concerns an underlying event rate or population quantity, but that requires a defined estimand and an appropriate model. No confidence interval is reported for this endpoint, and the available record does not give the denominator needed to assess a completion rate. Therefore, precision around a rate cannot be evaluated from the reported count alone.

What would a model for counts assume?

General explanation: methods for count outcomes often begin with a probability model for event counts. A simple Poisson model assumes that the mean and variance are linked in a particular way. If the observed variability is greater than that assumption allows, over-dispersion may be present; standard errors from an overly restrictive model can then be too small, making uncertainty appear less than it is. Other models can allow extra variability, but their use depends on the design, outcome definition, and data. The registry record does not report a count model, a dispersion assessment, or an analysis of this endpoint. No model should be attributed to the study on that basis.

How should planning calculations be read?

General explanation: sample-size planning calculations ask how much information a future study might need under stated assumptions. They are not observed outcomes and do not establish that a completed study had a particular probability of detecting an effect. The planning illustration associated with this record assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; it considers effects expressed as stated fractions of an observed effect. For non-time-to-event outcomes, the convention is participants per arm for 80% power or another stated power level. Those assumptions describe an illustrative planning exercise, not the design of this single-group study.

A two-arm planning illustration does not turn a single-group record into a controlled comparison. Its relevance depends on the hypothetical future design and the effect assumption used. The registry record does not report a randomized allocation for this study, and no inferential analyses are listed. Sample-size illustrations should therefore remain planning scenarios rather than being interpreted as evidence about the observed intervention effect. No sample-size justification for the study itself is reported in the registry record.

What can a p-value establish?

General explanation: a p-value measures how incompatible data are with a specified null hypothesis under model assumptions. It does not measure the size or practical importance of an effect, and it is not the probability that a hypothesis is true. Interpreting one requires knowing the comparison, outcome definition, analysis population, and model. The registry record reports 0 analyses and does not report a p-value for the primary feasibility outcome. There is therefore no reported hypothesis test to interpret.

More broadly, a statistical method is only as interpretable as the estimand and data structure it addresses. For this study, the primary result is a descriptive count, with no denominator, uncertainty interval, comparison group, or inferential analysis reported. Statistical concepts can explain what additional information would be needed, but they cannot supply those missing elements or convert the count into a comparative treatment effect.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Intervention")
n      <- c(7)
events <- c(7)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Intervention  7  7  100.0  59.0  100.0  64.6  100.0  63.1  99.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 5 outcome measures, including the primary feasibility outcome and secondary outcomes for attendance and retention. It reports 0 analyses. No multiplicity procedure, hierarchy of secondary hypotheses, or approach to controlling the chance of false-positive findings is reported in the registry record. Since inferential analyses are not reported, there are no posted p-values to assess for multiplicity.

Missing-data methods are also not reported in the registry record. The record does not describe how missing attendance, retention, or feasibility information was handled, whether participants with incomplete measurements were included in any analysis, or whether sensitivity analyses were planned. The primary outcome is presented as a count of leaders who completed it, but the number expected to complete it and the handling of non-completion are not given. A completion count alone does not reveal whether missing observations occurred or how they might affect interpretation.

The analysis population is not reported in the registry record. Although enrollment is listed as 43, the record does not specify which enrolled participants contributed to each outcome or whether outcome-specific populations were defined. The serious-event listing has a separate at-risk count, and the record does not explain its relationship to enrollment. These details should not be inferred from the overall enrollment figure.

For a single-group feasibility study, transparent reporting of outcome definitions, denominators, missingness, and analysis populations is important even when the main purpose is descriptive. Without those details, readers can report the posted count but cannot assess whether it represents all eligible leaders, a selected group, or a particular analysis set. These reporting gaps limit reproducibility and the strength of conclusions about acceptability or implementation.

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 serious-adverse-event listing reports 0 serious events among 28 at risk in the intervention group, 0 other events among 28 at risk, and 0 deaths. These are the figures recorded for the listed group. They are counts, not estimates of comparative safety, and the registry record does not report a control group for a like-for-like comparison.

A zero count means that no event of the specified type was recorded in that listing; it does not prove that the true risk is zero or that an intervention is free of harm. How precisely a zero count informs risk depends on factors including the number observed, the event definition, the observation period, and completeness of reporting. The safety timeframe and further event ascertainment details are not reported in the registry record.

The serious-event at-risk count is 28, whereas the overall enrollment is 43. The registry record does not explain the relationship between these values, so the safety denominator should be read as reported and not substituted for overall enrollment or the House Chat Leader outcome population. The listed zero counts also do not address outcomes that were not included in the safety listing.

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

The result establishes a narrow descriptive fact: the registry reports that 7 House Chat Leaders completed the primary feasibility outcome during the timeframe of 18 months. This gives readers a count tied to the study’s implementation focus. It does not establish a completion rate because the relevant denominator is not reported. Nor does it show whether the count met a prespecified feasibility threshold, because no such threshold is reported in the registry record.

The study’s stated purpose is to examine feasibility and acceptability of House Chats as a community-based delivery model for weight management. The primary count speaks to one aspect of feasibility, but attendance and retention results are not reported in the registry record. The count also does not measure participant weight change, cardiometabolic outcomes, or the longer-term sustainability of the program. Those outcomes cannot be inferred from the study’s rationale or title.

The record identifies a single-group model and no randomized comparison. It therefore does not provide a direct estimate of how outcomes differ between the intervention and a control condition. Without a comparison group, changes observed during a study could not be separated from other possible influences using a between-group contrast. No inferential analyses are reported, so the record also does not provide a statistical test or a quantified uncertainty interval for the primary result.

These limits do not make the count uninformative. It documents that the feasibility outcome was completed by the reported number of House Chat Leaders and can contribute to a descriptive account of implementation. Its interpretation is simply bounded by the information available: the count lacks a denominator, benchmark, comparison, and reported inferential analysis. It should not be treated as proof that the model is effective, ineffective, acceptable, unacceptable, or sustainable.

14. Why This Trial Matters Statistically

Feasibility studies address questions that arise before or alongside questions of comparative effectiveness: can a delivery approach be implemented, and can relevant activities be measured in the intended setting? That distinction matters in community-based behavioral research. An intervention may have a clear rationale, yet its practical delivery, recruitment, attendance, and retention still need to be described. This record focuses on House Chats and the role of House Chat Leaders in delivering a lifestyle intervention through social networks.

The reported primary outcome is a count rather than a treatment-effect estimate. That is statistically appropriate to recognize as a different kind of evidence: it describes implementation activity, not a causal contrast. The count of 7 leaders completing the outcome can inform a descriptive account, but the absence of a denominator or feasibility benchmark limits how far the count can be interpreted. Readers should distinguish the documented activity from a claim that the delivery model has been shown to succeed.

The record also illustrates why design labels and narrative descriptions need to be read together. The arm description mentions randomization, while the study model is single group, allocation is NA, and the record cautions against treating the study as a randomized comparison. That distinction affects which statistical questions the posted results can answer. A planning illustration involving two hypothetical arms does not alter the design or create a comparative estimate.

Finally, the record’s focus on reach and sustainability makes transparent reporting especially relevant. Clear denominators, outcome definitions, missing-data handling, and follow-up information would help readers understand how the reported count relates to the intended implementation goals. The registry information supports a cautious description of the feasibility result, while leaving broader questions open.

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 registry record leaves several details necessary for interpretation unreported. For the primary outcome, it gives the count of House Chat Leaders completing the outcome but not the number eligible, approached, trained, or expected to complete it. It does not state an operational completion definition or a benchmark for judging feasibility. As a result, the count cannot be interpreted as a proportion or assessed against a stated target.

The record reports a single-group model, allocation NA, and no masking. It also contains an arm narrative referring to randomization, but explicitly cautions that the study is not a randomized comparison. No like-for-like control estimate is available in the record. The reported enrollment of 43 and the safety at-risk count of 28 have different values, and their relationship is not explained. Neither should be assumed to be the denominator for the House Chat Leader outcome.

Although 5 outcome measures are listed, the record reports 0 analyses. It does not provide effect estimates, confidence intervals, p-values, detailed outcome results for attendance or retention, or analysis-population definitions. Missing-data methods, multiplicity handling, sample-size justification, interim analyses, and a detailed statistical plan are not reported in the registry record. These absences limit assessment of precision, completeness, and the extent to which outcomes were analyzed as planned.

The safety listing reports zero serious events, other events, and deaths for the stated at-risk group, but its observation timeframe and further ascertainment details are not reported. The study’s title and rationale refer to reach and sustainability, yet the primary endpoint described is a count concerning House Chat Leaders; that count does not establish longer-term continuation or participant health effects. These limitations constrain interpretation to a descriptive feasibility finding.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Using Grassroots Wellness Coaching to Enhance Reach and Sustainability of Behavioral Weight Management — NCT05544708.
• Registry record last updated 2026-09-18; status last verified 2026-09.
• Results first posted 2026-09-18.
• 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

NCT05544708 is a completed, single-group behavioral study sponsored by Virginia Commonwealth University. It examines Wellness Engagement Intervention and the use of House Chats as a community-based way to deliver a weight-management program. The registry lists obesity as the condition, enrollment of 43, allocation as NA, and masking as none.

The primary feasibility outcome concerns House Chat Leaders. The registry reports that 7 House Chat Leaders completed the outcome during an 18-month timeframe. Attendance and retention are listed as secondary acceptability outcomes, but their results are not reported in the registry record. The record lists 5 outcome measures and 0 analyses.

The result is descriptive: the record supplies a completion count without a denominator, comparison group, uncertainty interval, or reported inferential analysis. It does not establish a comparative treatment effect or answer broader questions about weight outcomes, acceptability, or sustainability. The serious-adverse-event listing records 0 serious events, 0 other events, and 0 deaths among 28 at risk in the intervention group; the relationship between that at-risk count and overall enrollment is not explained.