Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone (NCT01785680), a randomized na study. The primary outcome is Recovery Under the Integrated Program and the Standard Protocol.

2. Clinical Question

The registry’s stated hypothesis is that integrated management would achieve greater community coverage and a greater individual recovery rate than standard care. These are hypotheses, not findings. The primary endpoint is individual recovery as defined by MUAC; the registry also lists community coverage as part of the broader research objective, but does not provide a reported comparison for coverage in the record.

The comparison is clinically framed around two approaches to treating acute malnutrition in children during humanitarian emergencies. The record describes the existing approach as separating MAM and SAM care, with different agencies overseeing them, and notes that breastfeeding is often overlooked. These descriptions provide context for the intervention rationale, but they do not establish how consistently either protocol was delivered or whether the stated challenges occurred for participants in this trial.

Most importantly, the registry record does not report the number of participants who recovered in either group, a between-group effect estimate, or a confidence interval for the primary endpoint. Therefore the central comparative question cannot be answered from the reported primary outcome information. The treatment definitions and design can be described, but the posted record does not establish whether recovery differed between groups or how precisely any difference was estimated.

3. Trial Design

This was a randomized, parallel-group trial comparing an Integrated Protocol with the Current Protocol in Sierra Leone. The registry lists the allocation as randomized and masking as none. It reports enrollment of 1957 and marks the study as completed. The recorded start is 2013-01, and primary completion is 2013-11. The phase is listed as NA, which is a registry designation rather than a description of a clinical phase.

The study’s stated long-term objective was to develop and demonstrate an integrated and streamlined way to treat MAM and non-complicated SAM in children during humanitarian emergencies. The registry describes the comparator as standard care for moderate malnutrition, involving a fortified cereal supplement until MUAC was above 12.5 cm. It also says that MAM and SAM were managed separately and overseen by different agencies. The intervention is named Integrated Protocol, but the registry description does not provide a complete operational account of its components.

The primary outcome was recovery by the end of treatment, with recovery defined as MUAC reaching ≥12.5 cm. The description says subjects would return to clinic every 2 weeks until reaching that threshold or until 12 weeks had elapsed. Secondary outcomes listed in the record are change in growth rates, duration of treatment, and change in recovery status after 12 weeks. The registry identifies 4 outcome measures, but the information available does not provide their complete results.

The analysis note identifies the design as cluster-randomized and cautions that a simple individual-level re-analysis would be misleading. The record does not report the unit of randomization, the number or structure of clusters, or details of how clustering was handled in the sponsor’s analysis. The sponsor’s own analysis is not included in the posted result information used for this interpretation. No masking was used according to the record, and the methods for allocation concealment or outcome assessment are not reported in the registry record.

Although enrollment and trial timing are recorded, the registry does not describe the basis for choosing the enrollment target. The available record also does not explain whether all enrolled participants were included in each endpoint analysis, or whether the analysis followed an intention-to-treat principle. These omissions limit what can be concluded about the design and analysis beyond the randomized, parallel comparison and the stated outcome definitions.

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: Recovery was defined as mid upper arm circumference ≥12.5 cm.

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 Recovery Under the Integrated Program and the Standard Protocol, measured over 12 weeks.

The primary endpoint is recovery by the end of treatment. Recovery is defined as a child’s mid upper arm circumference (MUAC) reaching ≥12.5 cm. The outcome is recorded as a count of participants, so its intended form is the number meeting the recovery definition in each treatment group. The registry specifies a follow-up period of 12 weeks and describes clinic visits every 2 weeks until the MUAC threshold is reached or the follow-up period elapses.

MUAC provides a measurable threshold for classifying whether a participant has reached the registry’s stated recovery criterion. A threshold-based endpoint can make the outcome easier to interpret and apply consistently than a less explicit judgment of recovery, provided measurement and follow-up are carried out consistently. That is a general statistical and measurement consideration; the registry record does not report measurement procedures, assessor training, or whether outcome assessors were independent of treatment delivery.

The endpoint addresses individual recovery, not every goal named in the study rationale. The broader hypothesis also refers to community coverage, while secondary outcomes include growth-rate change, treatment duration, and recovery status after 12 weeks. Those outcomes may describe different aspects of program performance, but they do not replace the primary recovery definition.

The record gives the endpoint definition but does not report the group-specific recovery counts or a comparative estimate. Consequently, the measurement rule is clear, while the observed primary outcome and the precision of the treatment comparison are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry information allows the research question and design to be described, but it does not provide a complete statistical analysis. General explanations below clarify what the design and planned comparisons would ordinarily require; they should not be read as a description of methods actually used unless the registry record states them.

What does a randomized parallel comparison mean?

Random allocation is intended to make treatment assignment independent of participants’ measured and unmeasured characteristics, on average. This can support a causal comparison when allocation is properly implemented and when outcome ascertainment and analysis are appropriate. Randomization does not guarantee that groups will be identical, particularly for individual characteristics or when allocation is organized by clusters. The registry says the trial was randomized and parallel-group, but the information does not describe the sequence-generation process, allocation concealment, or the precise unit assigned.

A parallel design means that participants are assigned to one treatment approach and followed under that assignment rather than crossing between protocols. The registry names Integrated Protocol and Current Protocol arms. It also states that masking was none. Without masking, participants and study staff may know the assigned approach; in general, this can affect treatment delivery, co-interventions, reporting, or outcome measurement. The primary outcome uses a stated MUAC threshold, but the record does not say whether measurement was performed by masked assessors or under standardized procedures.

Why does the cluster-randomized designation matter?

The analysis note explicitly cautions against a simple individual-level re-analysis because the design is cluster-randomized. In general, cluster assignment places participants in groups—such as service or community units—rather than randomizing each participant independently. Outcomes within a cluster can be correlated because participants share care settings, staff, local conditions, or delivery practices. This correlation is called intracluster correlation.

When outcomes are correlated within clusters, the information contributed by a set of participants is less than it would be if every participant were statistically independent. Appropriate analyses account for the cluster structure, for example through cluster-level summaries or models that represent within-cluster correlation. The details depend on the design and outcome. The registry record does not report cluster identifiers, cluster counts, cluster sizes, or the method used by the sponsor. Without those details, the sponsor’s comparative estimate and its uncertainty cannot be independently assessed. The record’s warning is therefore consequential: an unadjusted participant-level calculation should not be treated as a valid substitute.

What would an outcome comparison convey?

For a binary endpoint such as recovery status, a comparison could report the number meeting the threshold in each arm and an effect estimate with a confidence interval. The estimate would describe the direction and magnitude of the group contrast, while its confidence interval would convey uncertainty under the analysis assumptions. A confidence interval is not a guarantee that the true value lies within the observed interval; it is a range produced by a method with a defined long-run coverage property when its assumptions hold. For a cluster-randomized trial, that method must account for clustering.

A p-value, if reported, would describe how incompatible the observed data are with a specified null model, given the analysis assumptions. It does not measure the probability that the null hypothesis is true, nor does it indicate whether an effect is important in practice. The registry information does not provide a p-value or an effect estimate for recovery. No such result should be inferred from the trial’s completion status or hypothesis statement.

How should the planning illustration be understood?

The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect, and that non-time-to-event illustrations refer to participants per arm. These are planning assumptions, not evidence of the trial’s original design or its analysis. The record explicitly characterizes the calculation as an illustration rather than the trial’s own design.

A planning sample size is a prospective estimate of how many participants might be needed under specified assumptions to achieve a chosen power for detecting a target effect. It is not observed power and does not establish that the trial was adequately powered. In particular, calculations based on an observed effect can be unstable because the observed effect itself is uncertain. For a cluster-randomized design, planning also depends on cluster structure and within-cluster correlation; the available planning description does not state those inputs. The illustration should therefore be interpreted only within its stated assumptions, not as a definitive assessment of design adequacy.

What is not documented?

The record does not report the sponsor’s statistical model for the primary comparison, the treatment of missing outcomes, the analysis population, covariate adjustment, or any handling of clustering. It also does not give a sample-size justification for the original trial, despite describing a separate planning illustration. Without these details and the primary outcome results, it is not possible to reproduce or evaluate the intended comparative analysis. General statistical principles can explain what would matter, but they cannot fill in methods that are not reported in the registry record.

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("Integrated Protocol", "Current Protocol")
n      <- c(1100, 857)
events <- c(910, 682)
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  Integrated Protocol  1100  910  82.7  80.4  84.9  80.4  84.8  80.4  84.8
ARM  Current Protocol  857  682  79.6  76.7  82.2  76.8  82.1  76.7  82.1

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and several secondary outcomes, including change in growth rates, duration of treatment, and change in recovery status after 12 weeks. It does not report how the analyses were prioritized beyond identifying the primary outcome, or whether any adjustment for multiple comparisons was planned. When several outcomes or repeated comparisons are tested, the chance of obtaining at least one apparently notable result can increase. General methods for addressing this include prespecifying a hierarchy, adjusting significance thresholds, or treating secondary analyses as exploratory. The registry record does not say which approach, if any, was used.

Missing data are also important for a recovery outcome assessed during follow-up. Participants may not have an observed MUAC measurement at the intended time, may stop attending visits, or may have incomplete outcome records. Such cases can affect the estimated recovery proportions, and the direction of bias depends on why measurements are missing and how the analysis handles them. The registry record does not report the extent of missing primary outcome data, reasons for missingness, imputation methods, or sensitivity analyses. It is therefore not possible to judge whether missingness could have influenced the comparison.

The record does not identify the analysis population, such as whether the primary analysis included everyone as randomized or only participants with available outcome measurements. Nor does it state whether participants were analyzed according to assigned group if treatment delivery differed from assignment. These distinctions matter because excluding participants or changing group membership can weaken the protections intended by randomization.

Finally, the analysis note identifies a cluster-randomized design and says a simple individual-level re-analysis would be misleading. Details of cluster adjustment are not reported. The registry record also lists 0 analyses in the information available for this interpretation. Multiplicity, missing-data handling, analysis populations, and cluster-aware modeling therefore remain unreported rather than demonstrated to have been absent from the original study.

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 0 serious adverse events in the Integrated Protocol group and 0 in the Current Protocol group. It also reports 0 other adverse events in each group. These are event counts as recorded in the registry, with at-risk group counts of 1100 for the Integrated Protocol and 857 for the Current Protocol. The record separately lists deaths: 42 in the Integrated Protocol group and 35 in the Current Protocol group.

These figures should not be converted into comparative rates without an appropriate analysis and a clear definition of follow-up and event ascertainment. The registry information does not report whether every death was classified as an adverse event, how deaths were reviewed, or the timing of events. It also does not provide a statistical comparison or uncertainty interval for the death counts. A count alone cannot establish whether groups differed in risk, particularly when exposure time and follow-up completeness are not described.

The absence of reported serious or other adverse events is not the same as proof that no such events occurred; it describes the registry’s reported counts. Safety interpretation depends on how events were defined, collected, and reported. Those procedures are not described in the registry record. The death counts are presented separately from the adverse-event fields and should not be combined with them or treated as a causal comparison.

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

The record establishes that a randomized comparison was registered between an integrated approach to managing MAM and SAM and a current protocol, with recovery defined by MUAC reaching ≥12.5 cm. It also describes a follow-up period of 12 weeks and names additional outcomes relating to growth, treatment duration, and later recovery status. These details make the intended clinical question understandable.

They do not establish whether the integrated protocol improved recovery, whether the current protocol performed better, or whether the groups had similar outcomes. The registry record does not report the primary recovery counts, an effect estimate, a confidence interval, or a statistical test. The stated hypothesis is not a result. Likewise, the fact that the study is marked completed does not provide evidence about the direction or precision of an outcome difference.

The record’s cluster-randomized designation means that a valid comparison needs to account for the dependence that may arise among participants within the same cluster. The note warns that simple individual-level re-analysis would be misleading, while the sponsor’s analysis details are not reported in the information available. Thus, a reader should not substitute a calculation that treats every participant as independent for a cluster-aware analysis.

The safety fields report no serious or other adverse events in either arm, and list deaths separately. These counts are descriptive and do not support a comparative safety conclusion without more information about event definitions, follow-up, and analysis. They also do not resolve the primary recovery question.

In short, the registry record supports interpretation of the trial’s aims, comparison, endpoint definition, and reported safety counts. It does not support a claim that either protocol did or did not change recovery or coverage. It also does not establish the precision, clinical importance, or generalizability of any treatment effect. Those judgments require comparative results and analysis details that are not reported in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically notable because its research question combines individual recovery with a broader program objective: greater community coverage. These are related but distinct outcomes. A protocol could be evaluated in terms of whether individual children reach the MUAC recovery threshold, while program coverage concerns access and reach across a community. The registry’s primary endpoint focuses on individual recovery, and the record does not provide a reported coverage analysis. Keeping those questions separate is essential when interpreting the stated rationale.

The cluster-randomized designation is also central. In cluster trials, assignment and outcome dependence occur at the level of groups as well as individuals. A participant-level analysis that ignores clustering can overstate the amount of independent information and understate uncertainty. The registry note explicitly cautions against a simple individual-level re-analysis, making the analytic unit and cluster adjustment important for interpreting any eventual estimate. Yet the details needed to evaluate that adjustment are not reported in the registry record.

The endpoint is an explicit threshold, MUAC reaching ≥12.5 cm, rather than a vague judgment of recovery. A clear outcome definition can improve interpretability, but its value depends on consistent measurement and complete ascertainment. The registry describes clinic follow-up every 2 weeks until the threshold is reached or 12 weeks have elapsed; it does not describe measurement procedures or missing follow-up data. Thus, endpoint clarity and outcome completeness are separate considerations.

Finally, this record illustrates why registration details and outcome reporting serve different purposes. The stated hypothesis, outcome definitions, and design explain what investigators set out to study. Comparative estimates and uncertainty are needed to learn what the data show. Because those efficacy results are not reported in the available registry information, the scientific importance lies in recognizing the design and interpretation requirements without treating aims as findings.

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 principal limitation for interpreting efficacy is that the registry record does not report group-specific recovery counts, an effect estimate, a confidence interval, or a test for the primary outcome. The primary endpoint is defined, but the posted information does not show its observed results. Secondary outcome names are listed without corresponding results in the information available.

The record identifies the design as cluster-randomized, but does not describe the randomization unit, cluster structure, cluster sizes, or sponsor analysis. The note cautions that a simple individual-level re-analysis would be misleading. This limits independent statistical assessment and prevents a reader from evaluating how clustering affected the estimate or its precision.

Intervention information is incomplete. The Current Protocol description gives some features of standard care, while the Integrated Protocol description does not fully specify its components. The record therefore does not allow a detailed assessment of intervention fidelity, differences in treatment delivery, or how consistently the approaches were implemented. Masking is listed as none, but the record does not describe outcome assessor masking or measurement procedures.

Participant characteristics, the analysis population, missing-outcome handling, and reasons for loss to follow-up are not reported in the information available. The record also does not give the original sample-size justification, a detailed statistical analysis plan, or an account of multiplicity handling. These omissions matter for assessing representativeness, bias, precision, and the robustness of comparisons.

The safety record gives adverse-event and death counts but does not report event definitions, follow-up time by participant, adjudication, or comparative analyses. As a result, the counts should not be interpreted as rates or causal effects. Finally, although the study concerns a humanitarian emergency setting in Sierra Leone, the registry record does not provide enough contextual detail to determine how well findings would apply to other settings—even if outcome results were available.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone — NCT01785680.
• Registry record last updated 2020-03-26; status last verified 2020-03.
• Results first posted 2020-03-26.
• 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 record describes a completed, randomized, parallel-group trial in Sierra Leone comparing an Integrated Protocol with a Current Protocol for children with MAM or non-complicated SAM. Enrollment is listed as 1957; masking is listed as none. The study start is recorded as 2013-01 and primary completion as 2013-11. The primary outcome is recovery by the end of treatment, defined as MUAC reaching ≥12.5 cm, with follow-up described through 12 weeks.

The record also lists secondary outcomes for growth-rate change, treatment duration, and recovery status after 12 weeks. It identifies the design as cluster-randomized and cautions that simple individual-level re-analysis would be misleading. The available information does not report primary comparative results, sponsor analysis details, missing-data methods, or the analysis population.

Safety fields report 0 serious adverse events and 0 other adverse events in each arm; deaths are listed separately as 42 for the Integrated Protocol and 35 for the Current Protocol. These counts are descriptive and are not accompanied by comparative estimates or uncertainty measures. The record defines the question and outcomes, but does not report enough efficacy analysis to determine the comparative recovery result.