Healthy Immigrant Community: Mobilizing the Power of Social Networks: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Healthy Immigrant Community: Mobilizing the Power of Social Networks (NCT05136339), a randomized na study. The primary outcome is Change in Weight.

2. Clinical Question

3. Trial Design

This completed study, NCT05136339, is titled “Healthy Immigrant Community: Mobilizing the Power of Social Networks.” Mayo Clinic is listed as the sponsor. The registry record gives an enrollment of 475 and describes the allocation as randomized, the masking as double, and the model as parallel. The recorded phase is NA. The study start date is 2022-04-23, and the primary completion date is 2024-08-30.

The intervention is behavioral: community-based mentoring and education sessions. The immediate arm was to begin receiving the sessions after enrollment. The delayed arm was to receive them approximately 12 months after enrollment. This arrangement distinguishes the arms by timing of access to the intervention. Details about how randomization was generated, whether allocation was concealed, and which people were masked are not reported in the registry record.

The study objective is described as leveraging existing social networks for health behavior change relevant to obesity and cardiovascular risk among immigrant populations in Southeast Minnesota. Weight loss is the listed condition. The primary outcome concerns weight change from baseline to 6 months and from baseline to 12 months. Other listed outcomes include systolic and diastolic blood pressure, fasting glucose, LDL, dietary quality, and physical activity.

The completed status describes the study’s registry status, not whether the intervention achieved its objective. The registry record does not report outcome estimates, an analysis plan, or results comparing the immediate and delayed arms. It therefore supports a description of the planned comparison and measured outcomes, but not a conclusion about the size or direction of any 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: The units of randomization were social networks defined by a Health Promoter and their network members. Randomization occurred after all participants were enrolled and baseline measures completed. Constrained randomization was used with the assignment selected from a set of allocations balanced on ethnicity, age, network size, and sex of the HPs. The period titles are referring to the time after starting intervention.

0-5 Months

6-11 Months

12-24 Months

Analysis population for the primary outcome, as defined in the registry: The health promoters are enrolled participants and included in this outcome measure.

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.

Population: The health promoters are enrolled participants and included in the baseline characteristic data.

6. Primary Endpoint

The registry lists the primary outcome as Change in Weight, measured over Baseline, 6 months, 12 months.

The primary endpoint is change in weight, measured in kilograms. The registry record defines it as the difference in weight from baseline to 6 months and from baseline to 12 months. It identifies the outcome as continuous, with the mean as the summary measure and the standard deviation as the measure of dispersion. The record also states that health promoters are enrolled participants and are included in this outcome measure.

Weight is relevant to the study’s stated focus on health behavior change related to obesity and cardiovascular risk. Measuring change from baseline expresses how an individual’s observed weight differs from their starting measurement; comparing such changes between randomized arms can help estimate the intervention’s effect relative to delayed access, if the analysis is properly specified and reported. The recorded time points can also describe whether changes are observed at different stages of follow-up.

These are general interpretations of the endpoint, not claims about findings. The registry record does not report mean weight changes, between-arm estimates, confidence intervals, p-values, or the number of participants with outcome measurements at either follow-up. The endpoint definition alone cannot establish the magnitude, precision, or direction of any observed change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the continuous outcome description mean?

The registry record identifies weight change as a continuous outcome, summarized using a mean and standard deviation. In general, a mean describes the average observed value in a group. A standard deviation describes how spread out individual measurements are around that average. These summaries answer different questions: the mean concerns the group’s central value, while the standard deviation concerns variability among measurements. Neither is reported as an outcome result in the registry record.

The recorded endpoint is a change from baseline, assessed at 6 months and 12 months. In general, a change score compares a participant’s follow-up measurement with their baseline measurement. A comparison of average change between randomized arms can be useful, but the meaning of that contrast depends on the defined analysis population, handling of missing follow-up measurements, and statistical model. Those choices are not reported in the registry record.

How should randomization be understood?

Random allocation is intended to create groups that can be compared without assigning participants according to their expected outcomes. In general, randomization supports causal interpretation when the allocated groups are analyzed appropriately and follow-up and outcome ascertainment are sufficiently complete. It does not guarantee that every characteristic is balanced, and it does not remove uncertainty from an estimate.

The record says the study was randomized and parallel, with an immediate-intervention arm and a delayed-intervention arm. It does not report the randomization method, allocation concealment procedures, stratification factors, or detailed masking procedures. “Double” is the recorded masking designation, but the identities of the people masked and the practical masking arrangements are not reported in the registry record. No further claims about these procedures can be made.

What would an estimate and confidence interval show?

As a general statistical concept, an estimated between-arm contrast describes the observed difference in outcomes under a specified analysis. A confidence interval expresses the range of values reasonably compatible with the data and the statistical model at the stated confidence level. Narrower intervals generally indicate greater precision than wider intervals, but precision is not the same as importance. A confidence interval can also help distinguish a potentially meaningful range of effects from one that remains too uncertain to interpret.

The registry record does not report a primary-outcome estimate or confidence interval. It also does not report p-values or an analysis model. Thus, readers cannot judge the observed magnitude, its precision, or whether the results are compatible with a range of possible effects.

Why can repeated measurements require a specified model?

General statistical methods for repeated measurements account for the fact that observations from the same participant are related rather than independent. A model may estimate changes over time, compare groups at particular follow-up times, or test a group-by-time pattern. The choice should match the scientific question and prespecified analysis plan. Different approaches can answer different questions, especially when treatment begins at different times in the arms.

The primary endpoint includes follow-up at 6 months and 12 months. The registry record does not state whether analyses were conducted separately at these times, jointly across time, or with another approach. It also does not explain how measurements taken after the delayed arm began receiving sessions were interpreted.

What do the planning assumptions mean?

The registry record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The target effect is described as a stated fraction of the observed effect. Such calculations are planning illustrations: they estimate sample-size requirements under assumptions about the effect and analysis. They are not observed power, and they do not show that the study had a particular probability of finding an effect after the results are known.

The underlying outcome estimates and numerical planning results are not reported in the registry record. Consequently, the effect used for the illustration cannot be evaluated from the record alone. The planning assumptions should not be mistaken for the trial’s own design justification; that justification is not reported in the registry record.

Why does dispersion matter?

In general, greater variability in a continuous outcome can make it harder to estimate a group contrast precisely, while lower variability can make estimates more precise, all else being equal. This is one reason the registry record’s description of standard deviation is relevant. But without the observed means, standard deviations, and analysis results, the contribution of variability to this study’s precision cannot be assessed. Statistical methods explain how to read results; they cannot supply findings that are absent from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 10 outcome measures, including weight change as the primary outcome and secondary outcomes concerning systolic blood pressure, fasting glucose, LDL, dietary quality, physical activity, and diastolic blood pressure. Considering multiple outcomes or multiple follow-up comparisons can raise a general multiplicity issue: when many statistical tests are conducted, the chance of at least one apparently notable result can increase. Researchers may address this through a prespecified hierarchy, adjustment procedures, or by treating secondary analyses as exploratory. Which approach, if any, was used is not reported in the registry record.

The primary weight outcome includes changes from baseline at 6 months and 12 months. The record does not report whether these were treated as separate primary comparisons, combined in a longitudinal analysis, or governed by a testing hierarchy. It also does not report an analysis plan or multiplicity adjustment. The registry lists 0 analyses, and no outcome estimates or test results are reported, so the statistical handling of the listed outcomes cannot be evaluated.

Missing outcome data can affect both precision and validity. As a general matter, interpretation depends on how much data are missing, why measurements are missing, and what assumptions or methods are used to address them. The number of participants with outcome measurements at follow-up, reasons for missingness, imputation procedures, and sensitivity analyses are not reported in the registry record.

The record states that health promoters are enrolled participants and included in the primary outcome measure. It does not further define the analysis population, describe exclusions after randomization, or report whether analyses followed randomized assignment. These omissions leave uncertainty about which participants contributed to any analysis and how missing observations were handled.

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 reports serious adverse event figures separately for the immediate and delayed arms. For the immediate arm, 246 were at risk and 0 were affected by a serious adverse event; deaths were 0. For the delayed arm, 229 were at risk and 0 were affected by a serious adverse event; deaths were 0. The registry also reports 0 affected by other adverse events in each arm, with the same at-risk figures.

These entries describe what was recorded in the registry, not a complete account of how safety events were collected or reviewed. The definitions of serious and other adverse events, the observation period, and the completeness of event reporting are not reported in the registry record. The figures therefore should not be interpreted as proof that no event occurred; they indicate that no affected participants or deaths were entered in these registry fields.

The at-risk figures should not be treated as outcome follow-up counts for weight or other endpoints. The record does not explain whether the safety observation period matched the outcome follow-up period or whether participants contributed equally to safety surveillance. The figures also do not establish a comparative safety effect. No statistical comparison of adverse events is reported in the registry record.

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

The registry record establishes that a randomized, parallel-group study of community-based mentoring and education sessions was completed and that weight change was designated as its primary outcome. It also describes immediate and delayed intervention timing and lists other health behavior and cardiovascular-related outcomes. These details identify the study question and the outcomes intended for evaluation.

They do not establish what happened to participants’ weight or whether the immediate and delayed arms differed. No primary-outcome estimates, secondary-outcome results, uncertainty intervals, or statistical tests are reported in the registry record. It is therefore not possible to describe the direction, magnitude, or precision of an intervention effect from these entries.

A completed study is not necessarily a study with interpretable results in its registry record. Nor does a listed outcome establish that the outcome changed. The absence of analysis results is not evidence that the intervention had no effect, just as the study’s stated objective is not evidence that it had an effect.

In general, a randomized comparison can inform the effect of an intervention when the contrast, analysis, follow-up, and missing-data handling are clearly reported. For this study, the timing of the delayed arm makes the definition of the comparison especially important when interpreting measurements over time. Those analysis details are not reported in the registry record.

The safety entries show zero recorded serious adverse events and zero deaths in each arm, alongside the respective at-risk counts. They should be read as registry entries, not as a definitive statement about all events or as a comparative safety conclusion. Overall, the record supports description of the study design and planned outcomes but does not support a conclusion about efficacy, lack of efficacy, or a quantified benefit or harm.

13. Why This Trial Matters Statistically

This study raises a useful statistical question about evaluating a behavioral intervention delivered through social networks. The stated objective links community-based mentoring and education with health behavior change relevant to obesity and cardiovascular risk among immigrant populations in Southeast Minnesota. The randomized comparison of immediate and delayed intervention timing provides the basic framework for evaluating changes over time, while the primary endpoint focuses on weight.

Statistically, the endpoint and timing need to be interpreted together. Weight is measured at baseline, 6 months, and 12 months, while the delayed arm is described as beginning sessions approximately 12 months after enrollment. A clear analysis definition would help readers understand which arm contrast each estimate represents and how repeated observations were used. Those details are not reported in the registry record.

The record also names outcomes spanning blood pressure, glucose, LDL, diet, and physical activity. Such a range can help characterize multiple dimensions of health behavior and cardiovascular risk, but it creates questions about prioritization and multiplicity. Without a reported analysis plan and results, readers cannot determine how the primary endpoint was distinguished from secondary or exploratory comparisons.

The record’s completed status and enrollment information are useful for describing the study, but interpretation ultimately depends on transparent outcome reporting. Estimates paired with measures of uncertainty, clear analysis populations, and explanations of missing data would allow readers to assess both the size and precision of the findings. In their absence, the most statistically responsible reading is descriptive: the design and outcomes are recorded, while the results needed to evaluate the primary question are not reported in the registry record.

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 central limitation for interpretation is that the registry record reports no analysis results. It gives no primary weight estimate, no between-arm contrast, and no measure of uncertainty. This prevents assessment of the direction, magnitude, or precision of the primary outcome and leaves the listed secondary outcomes uninterpretable as findings.

The outcome is defined at baseline, 6 months, and 12 months, but the statistical model and the exact primary comparison are not reported. The record does not explain how repeated measurements were handled or how the delayed arm’s intervention timing was reflected in the analysis. Randomization and double masking are recorded, but operational details of randomization, allocation concealment, and masking are absent.

Participant characteristics and detailed eligibility criteria are not reported in the registry record. This limits assessment of how closely the enrolled population represents the immigrant populations described in the study objective. The record also does not report the number with outcome data at follow-up, reasons for missing measurements, or methods used to address missingness.

The registry lists multiple outcome measures, but a multiplicity strategy and analysis hierarchy are not reported. The analysis population and post-randomization exclusions are also unspecified. For safety, adverse-event definitions and surveillance details are not reported, so the zero counts in the registry fields cannot be treated as a complete safety assessment. These limitations concern what can be learned from the registry record; they do not establish that the underlying study lacked procedures or analyses that were not recorded there.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Healthy Immigrant Community: Mobilizing the Power of Social Networks — NCT05136339.
• Registry record last updated 2026-01-27; status last verified 2026-01.
• Results first posted 2026-01-27.
• 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

NCT05136339 is a completed randomized, double-masked, parallel-group study sponsored by Mayo Clinic. The registry record gives enrollment as 475 and describes community-based mentoring and education sessions for immigrant populations in Southeast Minnesota, with immediate and delayed intervention arms.

The primary outcome is mean change in weight, measured in kilograms, from baseline to 6 months and from baseline to 12 months, with standard deviation as the dispersion measure. Listed secondary outcomes include blood pressure, fasting glucose, LDL, dietary quality, and physical activity. The registry record reports no analyses or outcome results, so the primary comparison and its precision cannot be assessed.