Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity (NCT05586269), a randomized na study. The primary outcome is Study Feasibility: Randomization.

2. Clinical Question

The registry describes the study goals as piloting the feasibility of a meal kit delivery intervention in families and children with food insecurity and obesity, and evaluating implementation. Those aims put practical delivery and study conduct at the center of the primary question. The posted primary outcome does not report a treatment-effect comparison or a clinical benefit endpoint.

The trial was randomized, and randomization occurred by caregiver after consent. The crossover structure means participants were assigned to a sequence in which both intervention approaches appeared at different stages. The registry record does not report results that would establish how many participants were enrolled in each month, or whether the prespecified feasibility goal was met. It also does not report outcome estimates comparing the approaches.

3. Trial Design

The InFoRM study is listed as a randomized, unmasked crossover trial and is marked completed. Boston Children's Hospital is the sponsor. The registry lists phase as not applicable. Enrollment is recorded as 59. The study start date is 2023-02-13, and the primary completion date is 2023-11-02.

Participants were caregiver-child dyads. Randomization occurred by caregiver after the caregiver completed consent. The registry reports that 30 children and 29 caregivers were enrolled, and that one caregiver had two children enrolled. These counts describe enrolled caregivers and children; they should not be read as an additional count of independently randomized caregivers beyond what the registry states.

In one sequence, dyads received weekly healthy meal kits with fresh ingredients and simple recipes for 6 weeks, followed after the second study visit by a newsletter and food pantry referral. In the other sequence, dyads received the newsletter and food pantry referral first, then meal kits after the second study visit. The registry identifies both interventions as behavioral. Masking is listed as none.

A crossover design places different interventions in sequence for participants, allowing observations from different periods to be considered in relation to the intervention received. General statistical considerations for this design include possible period effects, effects carried over from an earlier intervention, and changes in outcome measurement over time. The registry record does not report whether a washout period was used or whether the analysis accounted for period, sequence, or carryover effects.

The primary outcome is a feasibility count: participants enrolled per month, then subject to randomization, at baseline. The registry also lists secondary outcomes concerning household food insecurity at the first, second, and third study visits, and changes in child BMI and BMI percentage of the 95th percentile among children with BMI assessments at all visits. Outcome results and a formal comparative analysis are not reported in the registry record.

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: Dyad (caregiver + child) eligibility was based child criteria and caregiver language (see Study Design). The child and their primary caregiver were enrolled in the study. There were 30 children and 29 caregivers enrolled in the study. One caregiver had two children enrolled in the study.

First Intervention (6 Weeks)

Reasons for not completing this period:

Second Intervention (6 Weeks)

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All participants who met eligibility criteria after being screened.

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: Dyad (caregiver + child) eligibility was based child criteria and caregiver language (see Study Design). The child and their primary caregiver were enrolled in the study. There were 30 children and 29 caregivers enrolled in the study. One caregiver had two children enrolled in the study.

6. Primary Endpoint

The registry lists the primary outcome as Study Feasibility: Randomization, measured over At baseline.

The primary endpoint measures the number of participants enrolled per month who were then subject to randomization. The registry describes the relevant population as all participants, caregivers and children, who consented to participate. Randomization occurred by caregiver after consent, and the endpoint is specified at baseline.

This is a feasibility measure rather than a clinical outcome. Enrollment and randomization counts can help describe whether a study is reaching and assigning participants as intended. For a pilot study evaluating implementation, such information is relevant to the practical conduct of the intervention and a larger study. The endpoint does not itself measure changes in food insecurity, BMI, or obesity.

The registry record does not report monthly enrollment counts or a summarized result for this endpoint. It therefore does not establish the observed enrollment pace or whether a feasibility threshold was reached. The record also does not report a specific target enrollment rate or a criterion defining successful feasibility. Without those details and the outcome values, the endpoint's result cannot be interpreted against a stated benchmark.

The endpoint description refers to participants enrolled per month and then randomized, while randomization is described as occurring by caregiver. These details identify the intended process but do not supply the monthly counts or clarify how caregiver-child dyads were represented in each monthly count. Further reporting would be needed to describe those operational details and assess the result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a count of participants enrolled per month and then subject to randomization. A count describes how many people meet the specified event definition in a stated period. Here, the event is enrollment followed by randomization, and the registry places the measure at baseline. The monthly results themselves are not reported in the registry record.

What does randomization contribute?

In general, randomization assigns participants to study groups using a chance-based process. When implemented as planned, it can reduce systematic differences between assigned groups at the point of assignment. In this study, the record says randomization occurred by caregiver after consent. It does not report the allocation sequence method, whether allocation was concealed, or details of the allocation process beyond assignment by caregiver.

The trial is described as a crossover. In general, a crossover design assigns participants to intervention sequences, with participants receiving interventions in different periods. This can make within-participant comparisons possible, but observations across periods may be related. The interpretation can also be affected by the order of interventions, changes over time, and lingering effects from an earlier period. The record describes the two sequences and says the switch followed the second study visit, but does not report a washout period or a statistical model for crossover effects.

How should a count endpoint be read?

A count of participants is not automatically a rate. To interpret a monthly enrollment count as a recruitment pace, the time interval and counting rules need to be clear, including how participants are assigned to months and how the caregiver-based randomization relates to caregiver-child dyads. The registry defines the endpoint in terms of participants enrolled per month and then randomized, but does not provide its monthly values or additional counting rules. No rate or total should be inferred from the enrollment figure alone.

General statistical methods for count outcomes depend on how the outcome is distributed and on the exposure period. Some count models allow variability beyond what a simple Poisson model assumes; this is called over-dispersion. If over-dispersion is present, standard errors from an overly restrictive model may be too small, making uncertainty appear lower than it is. This is a general consideration, not a claim about the model used in this trial. The registry record does not report a model, assessment of over-dispersion, or analysis estimate for the primary endpoint.

What do confidence intervals and tests convey?

In general, a confidence interval gives a range of values compatible with the data under specified assumptions and an analysis method. Its width conveys precision: wider intervals indicate greater uncertainty, while narrower intervals indicate more precise estimates. A hypothesis test addresses compatibility between observed data and a specified null hypothesis under its assumptions. Neither an interval nor a test result appears for the primary endpoint in the registry record, and no comparative test is reported for the listed secondary outcomes.

A p-value, when reported, does not measure the size or practical importance of an effect. Nor does a nonsignificant result establish equivalence or absence of an effect. Those interpretations require the estimate, uncertainty, analysis assumptions, and a clearly stated question. The registry record does not report the estimates or tests needed for such an interpretation.

How do planning calculations differ from observed results?

The registry describes a sample-size planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes planning for a stated fraction of the observed effect. This is explicitly an illustration, not the trial's own design calculation. Such planning values are hypothetical estimates of sample size under stated assumptions; they are not observed participant counts and are not observed power. The registry record does not report a trial-specific sample-size justification.

General power calculations are prospective planning tools. They depend on assumptions about the effect to detect, variability, allocation, and analysis. A calculation based on an observed effect is especially dependent on that estimate, which can be uncertain in a pilot. It should not be treated as proof that the completed study had a particular probability of detecting an effect. No planning value or observed comparative effect is reported for the primary endpoint in the registry record.

The study includes repeated visits and secondary outcomes that may involve measurements on the same children or households. General analysis of repeated measurements needs to account for dependence when applicable. The registry record lists the outcome topics but does not report the analysis models, treatment contrasts, handling of repeated observations, or estimates. Those methods and results are therefore not available for statistical evaluation.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists several secondary outcome measures: household food insecurity at the first, second, and third study visits, as well as changes in child BMI and BMI percentage of the 95th percentile for children with BMI assessments at all visits. It reports 20 outcome measures overall. Testing or estimating many outcomes can raise a multiplicity issue: when multiple questions are examined, the chance of at least one apparently unusual result can increase. General approaches include prespecifying a primary question, adjusting inference, or treating secondary findings as exploratory. The registry record does not report a multiplicity strategy.

The primary outcome description concerns enrollment per month followed by randomization, and the registry indicates that this outcome has several categories or time points and was not reduced to one comparison. No single result or inferential comparison is reported. The number of analyses is listed as 0, so the registry record does not provide analysis results on which to assess multiplicity handling.

Missing-data methods are not reported in the registry record. The record does not say how missing visits, incomplete BMI assessments, or unavailable food insecurity measurements were handled. It also does not report the amount or pattern of missing data for any outcome. For outcomes defined among children with assessments at all visits, the record identifies that assessment condition but does not report how many children met it.

The primary population is described as all participants, caregivers and children, who consented to participate; randomization occurred by caregiver after consent. The analysis populations for secondary outcomes and any modified or per-protocol populations are not reported in the registry record. Without those definitions and participant flow by outcome, the relationship between enrollment and the analyzed observations cannot be determined.

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 reports safety figures separately for caregivers and children under each intervention label. For Meal Kit Delivery, 0 of 25 caregivers and 0 of 26 children are listed as affected by serious adverse events. For Newsletter plus Food Pantry Referral, 0 of 25 caregivers and 0 of 26 children are listed as affected by serious adverse events. The same group counts are listed for other adverse events, with 0 affected in each group. Deaths are listed as 0 in each group.

These are counts of participants affected, not a complete description of event timing, severity, or causal relation to an intervention. The registry lists no serious adverse event terms. The entries therefore indicate what was reported in these safety fields; they do not establish that no adverse events occurred outside the definitions or reporting process used.

In general, a zero count in a limited study does not prove that an intervention carries no risk. The registry record does not provide detailed safety definitions, ascertainment procedures, exposure duration by participant, or narrative information about events. The crossover design also means the listed intervention labels should not be taken, without additional reporting, as proof of independent parallel safety groups.

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

The registry record establishes that InFoRM was a completed randomized crossover pilot focused on meal kit delivery and newsletter plus food pantry referral for families and children with food insecurity and obesity. It identifies enrollment and randomization feasibility as the primary outcome and lists household food insecurity and child BMI-related secondary outcomes. These details describe the study question and design, not the findings.

The record does not report the monthly enrollment and randomization results, outcome estimates, comparative effects, confidence intervals, or test results. It therefore cannot show whether the study met a recruitment or implementation objective, whether either intervention sequence was associated with changes in food insecurity or BMI, or how precisely such changes were estimated. The absence of reported results should not be interpreted as evidence of no effect.

Nor does the record establish that one intervention is superior to the other. The study compares sequences in a crossover design, and the registry does not report an analysis addressing sequence, period, or possible carryover effects. A design description alone cannot substitute for a treatment-effect estimate and its uncertainty.

The safety entries report zero participants affected by serious and other adverse events in each listed group, and zero deaths. These figures are limited to the registry's safety reporting and do not establish the absence of risk. More complete safety methods and event details are not reported in the registry record.

The most defensible interpretation is therefore descriptive: the record identifies a pilot trial, its intervention sequences, population, feasibility endpoint, secondary outcome topics, and posted safety counts. It does not provide enough outcome information to judge efficacy, effectiveness, recruitment performance, or statistical precision.

13. Why This Trial Matters Statistically

This trial is statistically notable because its primary question concerns feasibility rather than a direct treatment effect. Recruitment and randomization are part of whether a study can be implemented, especially when the intervention involves meal kits and family participation. A clearly defined feasibility endpoint can inform the planning of later research, but interpretation depends on the observed recruitment pattern and a stated benchmark. Those results and benchmarks are not reported in the registry record.

The crossover structure also highlights why design labels alone do not determine the correct analysis. In general, repeated observations within participants can be correlated, and the order or timing of interventions can matter. A valid comparison may need to account for those features. The registry describes intervention sequences but does not report the analysis approach or results needed to evaluate a crossover comparison.

Another important statistical distinction is between planning and evidence from the completed study. The registry describes a sample-size illustration under stated assumptions. Such an illustration can show how planning depends on the effect size and analysis assumptions, but it does not represent observed power or a trial-specific design justification. It does not replace reported outcome estimates and uncertainty.

The trial also collects outcomes at multiple visits and includes several secondary measures. This makes clear why prespecification, multiplicity, missing-data handling, and analysis-population definitions matter. The registry record does not report those methods or outcome analyses. Recognizing what is absent is an essential part of interpreting a clinical trial record: the design can be described, but the intervention effects cannot be inferred without results.

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 main limitation for statistical interpretation is that the registry record does not report results for the primary endpoint or the listed secondary outcomes. Monthly enrollment counts, outcome estimates, uncertainty intervals, and comparative tests are not reported. This prevents assessment of recruitment pace, intervention effects, and precision.

The primary outcome is described as participants enrolled per month and then subject to randomization, but the monthly values and a benchmark for feasibility are not reported. The record states that randomization occurred by caregiver and describes caregiver-child enrollment, including one caregiver with two children, but does not explain how the endpoint's monthly participant count represented those dyads.

Although the study is identified as a crossover, the registry record does not report whether a washout period was used or whether the analysis addressed period, sequence, or carryover effects. It also does not report the statistical model or the handling of repeated observations. These omissions limit what can be concluded about how a future comparative estimate should be interpreted.

Missing-data procedures, the number of observations contributing to each outcome, and analysis populations beyond the primary population description are not reported in the registry record. The registry lists several outcome measures but does not report a multiplicity approach. Consequently, the completeness and inferential context of any outcome analysis cannot be evaluated from the record.

Safety reporting is limited to group counts of participants affected and deaths. Event definitions, ascertainment details, exposure-specific timing, and narrative descriptions are not reported in the registry record. The reported zero counts should therefore be read narrowly rather than as a comprehensive assessment of safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity — NCT05586269.
• Registry record last updated 2025-05-22; status last verified 2025-05.
• Results first posted 2025-05-22.
• 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

The registry identifies NCT05586269 as the InFoRM Childhood Obesity study, sponsored by Boston Children's Hospital. It is listed as a completed, randomized, unmasked crossover study, with enrollment of 59. The start date is 2023-02-13, and the primary completion date is 2023-11-02.

The study compares two intervention sequences involving weekly meal kits and a newsletter plus food pantry referral. Its primary outcome concerns participants enrolled per month and then subject to randomization. Listed secondary outcomes concern household food insecurity at three study visits and changes in child BMI and BMI percentage of the 95th percentile.

The registry record reports no analysis results for these outcomes. Safety entries list zero participants affected by serious or other adverse events and zero deaths in each listed caregiver and child group. The record describes the study design and outcomes, but does not report the results needed to assess feasibility, intervention effects, or their precision.