Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities (NCT04731506), a randomized na study. The primary outcome is Child- Change in BMI Z-score at 12 Months From Baseline.

2. Clinical Question

3. Trial Design

The registry describes a randomized, open-label, parallel-group behavioral study of Family Connections, a technology-based pediatric weight-management intervention. The study record lists an enrollment of 76 and a terminated status. The listed start date is 2021-06-01, and the primary completion date is 2024-02-28. The reason for termination is not reported in the registry record.

The study had a cultural-adaptation aim and a randomized comparison aim. Planned adaptation activities included translating materials to Spanish, adding culturally relevant content and images, and using health-communication strategies intended to address different levels of health literacy. The study summary describes random assignment of parent-child dyads to Family Connections or a waitlist standard-care group. The posted outcome arms are titled Child- Standard Care and Child- Waitlist.

The Standard Care arm description includes an activity workbook promoting physical activity, healthy diets, and reduced screen time, as well as two in-person support sessions and 10 interactive voice response telephone calls over 12 months. The Waitlist description includes the workbook and a six-month delayed start to the full Family Connections program. The registry text does not fully describe the Waitlist arm beyond the available description, so the exact delivery schedule and content of all activities should not be inferred.

Masking is listed as none. In an open-label study, participants and study personnel are not described as masked to group assignment. The record does not report whether outcome assessors or analysts were masked. Although the primary outcome description says mixed-effect regression was used for BMI z-score, weight, and BMI, the posted comparison analysis is identified as a Mann-Whitney U test. The registry does not explain this difference in method descriptions.

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

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 Child- Change in BMI Z-score at 12 Months From Baseline, measured over 12 months.

The primary endpoint is the change in child BMI z-score at 12 months from baseline. BMI z-score expresses a child’s BMI relative to reference values for the child’s age and sex. The registry describes calculating it using age- and sex-specific reference parameters and explains that a z-score indicates how many standard deviations a value is from the mean. This standardization is useful when assessing children at different ages and of different sexes, because the reference distribution accounts for those characteristics.

The endpoint is continuous: it can take a range of values rather than classifying each child into a simple event or no-event outcome. A change from baseline describes movement in the measure during follow-up; a negative change indicates a lower recorded z-score at follow-up than at baseline, while a positive change indicates a higher one. The posted arm values are -0.158 for Standard Care and -0.031 for Waitlist. Their reported spread is a standard deviation of 0.133 and 0.276, respectively.

The registry also describes weight-status categories using z-score ranges, but the primary endpoint is the continuous z-score change, not a count of children crossing a category boundary. The rationale for choosing this endpoint beyond the stated interest in reducing child BMI z-scores is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean change describe?

As a general statistical explanation, a mean is an average that summarizes the center of a set of measurements. For this trial, the reported endpoint is change in BMI z-score from baseline to 12 months. A negative average change describes a decline in the measured z-score across the children contributing to that arm’s summary. The mean alone does not show how individual children’s measurements varied, which is why the registry also reports a standard deviation.

A standard deviation describes how dispersed measurements are around their mean. It is not the same as a confidence interval: the standard deviation describes variation among observations, whereas a confidence interval describes uncertainty around an estimated quantity. The outcome record reports standard deviations of 0.133 for Standard Care and 0.276 for Waitlist. The record does not give confidence intervals for the individual arm means.

What does the Mann-Whitney U test assess?

The registry identifies the reported comparison method as a Mann-Whitney U test. As a general explanation, this is a rank-based method for comparing observations between independent groups. It evaluates how the values in one group tend to rank relative to values in the other group. It does not require the data to follow a normal distribution in the same way that some mean-based tests do.

The posted analysis labels its estimate “Mean Difference (Net),” but the registry does not explain how that estimate was calculated alongside the rank-based test. It also does not report details such as the test statistic, whether a continuity or tie correction was used, or whether the confidence interval was constructed by a method aligned with the test. These details are not reported in the registry record and should not be assumed.

How should the confidence interval be read?

As a general statistical explanation, a confidence interval represents uncertainty around an estimated effect under the analysis and its assumptions. The reported 95% interval extends from -0.353 to 0.099. Because it contains zero, the result does not rule out no difference between the groups. It also includes estimates in both negative and positive directions, so the data do not pin down the direction of the underlying contrast with precision. The interval is not a range containing 95% of individual children’s changes.

What does the p-value say?

The reported p-value is 0.286. As a general explanation, a p-value describes how unusual data at least as incompatible with a specified null model would be if that model and the test assumptions held. It is not the probability that the null hypothesis is true, nor the probability that the intervention is beneficial. Interpretation should include the estimated effect and its interval, not the p-value alone. The registry labels the analysis as a superiority analysis but does not report a prespecified threshold for statistical significance.

How do the method descriptions fit together?

The primary outcome description states that mixed-effect regression was used for BMI z-score, weight, and BMI, regardless of whether the participants were adults or children. The specific posted comparison, however, is identified as a Mann-Whitney U test. The record does not explain whether the model statement concerns other analyses, how it relates to the posted primary comparison, or whether the analysis changed. It is therefore appropriate to describe both statements without selecting an unreported reconciliation.

Randomization is intended, in general, to create groups that are comparable on average at assignment. It does not guarantee balance in every characteristic, especially in a small study. The registry does not report details of sequence generation, allocation concealment, stratification, or any baseline characteristics for the outcome groups. Those features cannot be assessed from the posted outcome summaries.

What can planning calculations tell readers?

As a general explanation, a planning calculation can illustrate how many participants per arm might be needed under stated assumptions to detect a specified effect. The registry describes its planning approach as using a two-sided significance level of 0.05, equal allocation, a normal approximation, and a target effect expressed as a fraction of the observed effect. It specifies that non-time-to-event planning results are participants per arm. These are planning illustrations based on the observed effect, not observed power and not proof that the trial had adequate power. Numerical planning results are not reported in the registry record.

Over-dispersion, as a general concept, occurs when variation is greater than a statistical model expects; this can make standard errors too small if the model does not account for it. The posted outcome is continuous, and the registry does not report a model-based dispersion assessment. No conclusion about over-dispersion or model adequacy can be drawn from the stated summaries 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("Child- Standard Care", "Child- Waitlist")
n   <- c(8, 10)
m   <- c(-0.158, -0.031)
sp  <- c(0.133, 0.276)
sd  <- sp      # posted standard deviations
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  Child- Standard Care  8  -0.158  0.133  -0.269  -0.047
CARM  Child- Waitlist  10  -0.031  0.276  -0.228  0.166

11. Analyses Reported by the Sponsor

The registry’s own reported analysis is the Mann-Whitney U test, with a net mean difference of -0.127, a 95% confidence interval from -0.353 to 0.099, and p = 0.286. The outcome description separately mentions mixed-effect regression for BMI z-score, weight, and BMI, but the record does not explain how that description relates to the posted test. The reported comparison should therefore be understood as the sponsor’s posted analysis, with the method description retained as an unresolved feature of the record.

A separate recalculated two-arm estimate is not reported in the registry record. The arm-level means and standard deviations are descriptive summaries and are not a substitute for the sponsor’s inferential analysis. The registry does not provide enough detail to reconstruct the reported test and interval from those summaries alone. The record does not flag a discrepancy between the sponsor analysis and a recalculation. If a recalculated estimate is compared with the sponsor’s own analysis, the sponsor’s own analysis takes precedence under that circumstance.

The reported interval includes zero, while the p-value is 0.286. These statistics indicate uncertainty in the estimated comparison; they should not be read as proof of no effect or as a probability that the intervention works. The registry does not report a rationale for choosing this particular analysis or explain any analysis-plan changes.

12. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures and 2 analyses, but it posts no secondary outcome results. It does not report whether the primary comparison was selected in advance from a larger set of outcomes, whether other analyses were conducted, or whether any adjustment for multiple testing was planned or used. A multiplicity adjustment is therefore not reported in the registry record. Without that information, the reported p-value should be read as the result of the posted analysis, not as evidence that all possible comparisons were accounted for.

The outcome record gives group counts of 8 for Standard Care and 10 for Waitlist. It does not state whether the analysis followed an intention-to-treat approach, which participants were included in the analysis, or how participants with missing follow-up measurements were handled. The number and reasons for missing outcome measurements, methods for imputation, and sensitivity analyses are not reported in the registry record. The displayed counts should not be treated as a complete account of enrollment or follow-up.

The study description says dyads were randomly assigned, but the registry does not report details of the randomization process or whether the analysis accounted for the parent-child dyad structure. It also does not report baseline group characteristics or an analysis population definition. These omissions limit assessment of balance at baseline, potential clustering, and the impact of missing data.

The primary outcome description refers to mixed-effect regression, whereas the posted comparison names a Mann-Whitney U test. The record does not clarify whether these refer to different analyses, which method was prespecified for the primary endpoint, or whether any deviation occurred. No statistical analysis plan or interim-analysis information is reported in the registry record. These gaps constrain interpretation of the posted p-value and confidence interval, particularly when considering selective analysis or multiple comparisons.

13. 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 record lists zero serious events, zero other events, and zero deaths in each posted group. For Standard Care, the listed number at risk is 51; for Waitlist, it is 25. These safety figures are distinct from the smaller group counts reported for the primary outcome, and the registry does not explain the difference in the populations represented.

Zero reported events means that no events were recorded in the listed categories for the stated groups in the registry. It does not establish that the intervention is free of risk or that no event occurred outside the recorded safety data. The record does not describe how adverse events were collected, what period of observation was covered, the event definitions, or whether all participants were monitored in the same way. The serious-event terms list is empty. The available figures should therefore be read as the registry’s reported counts, with the limits of reporting and follow-up in mind.

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

The posted result describes a comparison of change in child BMI z-score at 12 months between Standard Care and Waitlist. The means were -0.158 and -0.031, respectively. The reported inferential analysis gives a net mean difference of -0.127, a 95% confidence interval from -0.353 to 0.099, and p = 0.286. The interval crosses zero, and the estimate is uncertain. The data do not establish a clear difference between the groups, but they also do not demonstrate that the groups are equivalent.

The findings apply to the outcome and analysis reported in the registry. They do not answer every question posed by the study. The stated aims included cultural relevance, usability, and acceptability, but results for these questions are not reported in the registry record. Nor does the posted primary outcome establish what families experienced or whether planned translation and cultural adaptation activities were completed.

The status is terminated, and the reason is not reported. The registry lists enrollment of 76, while the primary outcome summaries report 8 children for Standard Care and 10 for Waitlist. The record does not describe the relationship between those numbers, so the primary outcome summaries should not be assumed to represent all enrolled dyads. Missing-data handling and the analysis population are also not reported.

These results are not a basis for a broad conclusion about all rural Latino families, all pediatric weight-management programs, or other settings. The record describes a specific study and a particular comparison, with limited outcome counts and unresolved reporting details. It supports a cautious reading of the posted estimate and its uncertainty, not a claim that the intervention does or does not work.

15. Why This Trial Matters Statistically

This trial raises statistical questions that are especially relevant when a study combines cultural adaptation with an early comparison of a behavioral program. The primary endpoint is a continuous child BMI z-score change, while the study aims also concern whether materials and delivery are relevant, usable, and acceptable to rural Latino/Hispanic families. Those aims address different questions and require distinct outcome information. The registry posts the BMI z-score comparison but does not report results for the adaptation and acceptability questions.

The record also illustrates why statistical-method descriptions matter. The outcome description mentions mixed-effect regression, while the posted comparison is identified as a Mann-Whitney U test. Without an explanation of how these statements relate, readers cannot tell whether they refer to different analyses or what the primary analysis plan specified. Clear reporting of the analysis population, missing data, and outcome methods would help readers assess the strength and reach of the result.

The reported confidence interval spans values on either side of zero, so the estimate is not precise enough to settle the direction of the comparison. This is an important distinction from interpreting a nonsignificant p-value as proof of no effect. Planning calculations based on the observed effect may illustrate future study requirements, but they are not observed power and do not resolve uncertainty in this result.

Finally, the terminated status and the difference between enrollment and outcome group counts make transparent reporting of follow-up and participant flow important. The registry does not state the reason for termination or explain the outcome counts. These are not grounds for assuming a particular problem, but they limit what can be inferred about the completeness and intended scope of the analysis.

16. 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.

Several trial-specific reporting limitations affect interpretation. The registry lists a terminated status but does not report the reason. Although enrollment is listed as 76, the primary outcome summaries list 8 children in Standard Care and 10 in Waitlist. The record does not explain the relationship between enrollment and these outcome counts, or describe participant flow, follow-up completion, or reasons for missing measurements.

The analysis population and approach to missing data are not reported in the registry record. It is therefore unclear whether the posted analysis includes all randomized participants, only those with observed follow-up, or another defined group. The record does not report imputation, sensitivity analyses, or how the parent-child dyad structure was considered.

There is also an unresolved difference between the primary outcome description, which mentions mixed-effect regression, and the posted Mann-Whitney U test. The registry does not explain whether these methods refer to distinct analyses, identify a prespecified primary method, or describe any analysis changes. The net mean difference is reported, but the coding and construction of that contrast are not described.

The confidence interval is broad and includes zero, so the estimate remains uncertain. Baseline characteristics, allocation concealment, sequence generation, and assessor masking are not reported in the registry record. The study is listed as open-label, and no further masking details are given. The record also does not provide a clinical threshold for interpreting the magnitude of BMI z-score change.

Finally, results for cultural relevance, usability, and acceptability are not posted, even though these questions were part of the study aims. The Waitlist arm description is incomplete, and the record does not state whether every planned cultural adaptation was implemented. These limits restrict conclusions about both the comparative outcome and the feasibility aims.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities — NCT04731506.
• Registry record last updated 2026-02-06; status last verified 2025-05.
• Results first posted 2026-02-06.
• 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.

20. Record Summary

NCT04731506 is a randomized, open-label, parallel-group behavioral study of Family Connections for rural Latino communities. It lists an enrollment of 76, a start date of 2021-06-01, a primary completion date of 2024-02-28, and a terminated status. The reason for termination is not reported in the registry record.

The primary outcome is child BMI z-score change from baseline at 12 months. Mean changes were -0.158 for Standard Care and -0.031 for Waitlist. The posted Mann-Whitney U analysis reports a net mean difference of -0.127, a 95% confidence interval from -0.353 to 0.099, and p = 0.286. The interval includes zero, leaving the comparison uncertain.

The registry does not report the analysis population, missing-data approach, reason for termination, or results for the study’s cultural relevance, usability, and acceptability aims. The primary outcome counts are smaller than the listed enrollment, and the record does not explain the relationship.