Study of Produce Prescription Programs in Adults With Overweight or Obesity Experiencing Nutrition Insecurity: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of Produce Prescription Programs in Adults With Overweight or Obesity Experiencing Nutrition Insecurity (NCT06751563), a randomized na study. The primary outcome is Number of Participants Reached.

2. Clinical Question

3. Trial Design

The registry describes a randomized, single-masked, parallel pilot study with an enrollment of 48. Participants were assigned to one of two produce prescription implementation strategies. Both included behavioral text messages; one used weekly vouchers redeemable at a local vendor, while the other delivered produce boxes to participants’ homes. The study is listed as completed, and its phase is recorded as not applicable.

The intervention was intended to last 8 weeks. The stated aim was to understand implementation practices, including engagement and adherence, and to examine patterns of change in fruit and vegetable consumption and weight. Other listed outcomes include nutrition insecurity, blood pressure, and health self-efficacy. The primary endpoint concerns participant reach across stages from screening through retention, rather than a clinical efficacy comparison.

The record lists 221 people as having been screened and having completed the eligibility survey. It does not report the counts eligible, randomized, or retained in the primary outcome description. The safety record lists 23 participants at risk in the Produce Boxes group and 25 in the Produce Vouchers group. The identity of the masked party, the method used to generate the random allocation, allocation concealment, and any stratification factors are not reported in the registry record.

The study started on 2025-01-08 and had a primary completion date of 2025-04-04. Although the record is marked completed, it contains no primary outcome analyses. The results therefore do not permit a statistical comparison of the implementation strategies on reach, engagement, adherence, or changes in the listed health-related measures.

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: There were 221 individuals who were screened and completed the eligibility survey for the 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 Number of Participants Reached, measured over From screening up to 8 weeks.

The primary endpoint is the number of participants reached, measured from screening through retention. Its description specifies tracking screening completions, the number eligible, the number randomized, and the number retained. These counts describe how people move through recruitment and study participation, and can help characterize the feasibility of delivering a pilot intervention.

Reach is distinct from a measure of health change. It does not, by itself, indicate whether fruit and vegetable consumption, weight, or another health measure changed, nor does it establish that one delivery strategy caused a difference. Counts at successive stages can identify where participation narrows, but interpretation requires the underlying counts and clear definitions for each stage.

The record identifies 221 people who were screened and completed the eligibility survey, but it does not report the remaining primary endpoint counts or an analysis comparing the two groups. Thus, the endpoint’s intended role is clear, while its results cannot be evaluated from the registry record. In a randomized pilot, reach information can inform the practical conduct of later research; it should not be treated as evidence of comparative clinical benefit.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, parallel-group design. Randomization is intended, in general, to make treatment assignment independent of participants’ measured and unmeasured characteristics on average. It does not guarantee that groups will be identical, particularly in a pilot with limited enrollment. The record does not describe the sequence-generation method, allocation concealment, or any method used to maintain masking.

Single masking means that some party involved in the study was masked to assignment, but the record does not identify who. In general, masking can reduce the influence of knowledge of assignment on behavior or measurement. Its practical value depends on who is masked and whether masking can be maintained. For interventions involving visibly different delivery methods such as home delivery and vouchers, the record does not explain how masking was implemented.

The study is parallel: participants were assigned to one strategy rather than crossing between strategies. Each group therefore represents a different implementation approach, with behavioral text messages included in both. A valid comparative analysis would need to specify the outcome, the time point, the analysis population, and the treatment of participants with missing measurements. Those details are not reported in the registry record.

The primary endpoint is a count-based measure of reach, with counts planned at multiple participation stages. In general, counts are interpreted alongside their definitions and the population from which they arise. For example, a screening count and a retention count describe different stages and should not be treated as interchangeable outcomes. If the goal is to compare strategies, the analysis would also need to clarify which stages are compared and how participants are assigned to a group for the comparison. The registry record gives no such analysis plan or result.

Several secondary measures are listed, including nutrition insecurity, fruit and vegetable consumption, weight, blood pressure, and health self-efficacy. The record names instruments for nutrition insecurity, consumption, and self-efficacy, but does not report the statistical models or summary measures used to analyze them. In general, continuous outcomes may be summarized by group and time point, while changes over time can be assessed by comparing groups’ changes or by modeling follow-up values while accounting for baseline values. These are general approaches, not methods documented for this study.

Confidence intervals are a general way to express the precision of an estimated effect. A narrow interval indicates greater precision than a wide interval, while an interval that includes values on both sides of no difference can reflect uncertainty about direction and magnitude. No confidence intervals or comparative effect estimates are reported in the registry record, so precision cannot be assessed for the intended group comparisons.

For count outcomes, the choice of statistical model depends on how the counts arise and on the analysis question. General options can include direct comparisons of proportions or count models, but their assumptions differ. Counts of people progressing through recruitment stages may have different denominators at each stage; an analysis should make those denominators explicit. No model, test, or adjustment procedure for the primary endpoint is reported in the registry record.

Adverse-event counts are also descriptive unless paired with a defined comparative analysis. General interpretation should consider the number of participants at risk, the number with events, the duration of observation, and how events were collected. Sparse events can make estimated between-group differences imprecise. The registry provides group-level counts but no comparative safety estimate or uncertainty interval. These general statistical considerations do not fill in an analysis that is absent from the record.

The registry lists no analyses. It does not report a statistical analysis plan, a sample-size justification, interim analyses, adjustment for multiple outcomes, or the handling of missing data. Those omissions prevent assessment of whether the planned analyses were prespecified, how uncertainty was quantified, and how results might depend on analytic choices. No statistical conclusion about comparative performance should be inferred from the design description alone.

10. Multiplicity, Missing Data and Analysis Populations

The record lists a primary endpoint and several additional outcomes, including nutrition insecurity, fruit and vegetable consumption, weight, blood pressure, and health self-efficacy. It does not report how these outcomes were prioritized for statistical testing, whether any tests were planned as confirmatory, or how multiplicity was to be handled. In general, testing many outcomes can increase the chance of observing at least one apparently notable result by chance. Methods such as prespecifying a primary comparison or adjusting for multiple testing can address different aspects of this issue, but no such approach is reported for this study.

Missing-data methods are not reported in the registry record. The primary endpoint includes retention, but no retention count or analysis is provided. For the other outcomes, the record does not state how missing baseline or follow-up measurements would be handled, whether participants with incomplete data would be included, or whether any sensitivity analyses were planned. In general, missingness can affect interpretation when the likelihood of a missing measure is related to participant characteristics or outcomes.

The analysis populations are also not reported. The record does not say whether comparisons were intended to include all randomized participants, only participants who began the intervention, or another defined group. These choices can affect the question answered and the interpretation of adherence-related results. Because the record lists no analyses, multiplicity procedures, missing-data assumptions, and analysis populations cannot be evaluated against reported results.

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.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: the participant fell and broke their leg. (4.0%).

The safety record lists 23 participants at risk in the Produce Boxes group and 25 in the Produce Vouchers group. Serious adverse events were recorded for zero participants in the Produce Boxes group and one participant in the Produce Vouchers group. Other adverse events were recorded for zero participants in each group, and deaths were recorded as zero in both groups.

The registry lists “The participant fell and broke their leg.” among the serious adverse event terms, with 4.0% displayed. These are descriptive registry counts. They do not establish that the fall was caused by the assigned strategy, and the record does not report an assessment of relatedness, timing, or a statistical comparison of adverse-event rates.

In general, a small number of events can yield substantial uncertainty about differences between groups. A zero count does not prove that an event cannot occur, and a difference in observed counts alone does not establish a real difference in underlying risk. The registry record provides no confidence interval or comparative safety analysis, so these figures should be read as event reporting rather than a definitive safety comparison.

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

The registry record identifies a randomized pilot comparing two ways to deliver produce prescriptions alongside behavioral text messages. It describes a primary focus on participant reach and planned attention to engagement, adherence, and 8-week patterns of change in fruit and vegetable consumption and weight. It also lists additional health-related outcomes. These aims define questions the study was intended to address; they are not themselves evidence of an observed effect.

The reported information does not show whether one implementation strategy reached more participants, supported greater adherence, or was associated with a larger change in any listed outcome. No primary endpoint analysis or other outcome analysis is reported. Without estimates and measures of uncertainty, the size, direction, and precision of group differences cannot be determined from the registry record.

This absence of reported comparative results does not mean the two strategies were equivalent. Equivalence requires a defined statistical question and an analysis designed to assess whether differences fall within a prespecified range. Nor does the record establish that either strategy improved or worsened a health measure. The counts for serious adverse events are too limited to support a broad comparative safety conclusion, and the record does not include a comparative safety analysis.

The study is identified as a pilot, and its stated purpose emphasizes implementation practices. Pilot findings can be useful for understanding how a study is conducted, but conclusions depend on the data and analyses that are reported. Here, the registry record gives the design and some event counts but not the analyses needed to quantify implementation outcomes or changes in health measures. Interpretation should therefore remain at the level of study aims and recorded descriptive information.

Readers should distinguish the fact that the study is marked completed from the availability of results. Completion status does not supply missing endpoint counts, effect estimates, or uncertainty intervals. The record’s information is insufficient to rank the voucher and delivery approaches statistically or to determine whether any observed difference, if one occurred, was compatible with chance variation.

13. Why This Trial Matters Statistically

Implementation is an important statistical question when an intervention can be delivered in different ways. Comparing vouchers with home-delivered produce boxes can address whether the delivery strategy is associated with differences in participation and engagement, not just whether participants were assigned to an intervention. The primary endpoint’s focus on screening, eligibility, randomization, and retention reflects the importance of describing the path from initial contact to continued participation.

The distinction between reach and health outcomes matters. A strategy may be practical to deliver or may engage participants, while those process measures do not directly answer whether health-related outcomes changed. Conversely, an outcome comparison may be difficult to interpret if participation and follow-up are incompletely described. Reporting the counts at each stage, alongside outcome analyses and their uncertainty, would help readers understand both implementation and measurement.

The pilot framing also matters for statistical interpretation. Pilot studies can inform the feasibility of procedures and the planning of later research, but a pilot label does not by itself establish that an outcome was adequately measured or that a comparative effect is precise. The registry record gives no analysis results, so it cannot support estimates of comparative performance or the precision needed to judge those estimates.

Finally, the two arms share behavioral text messages and differ in produce delivery. This makes the study’s central comparison one of implementation strategies rather than intervention versus no intervention. Keeping that distinction clear prevents attributing any future group difference to a component that both groups received, without further evidence. The record’s limited results underline why complete outcome reporting is essential to learning from randomized implementation studies.

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 interpreting this record is that no outcome analyses are reported. Although the study is marked completed, the registry record does not provide the primary endpoint counts beyond the screening and eligibility survey figure, or comparative results for the listed secondary outcomes. It therefore does not permit assessment of the direction, magnitude, or precision of the intended comparisons.

The primary endpoint description includes several participation stages, but the record does not provide the counts for eligibility, randomization, or retention. Enrollment is listed as 48, but the record does not explain how this relates to each stage or to the safety denominators. That limits the ability to characterize study flow and evaluate the reach endpoint as defined.

Details important for assessing risk of bias and statistical methods are absent, including who was masked, how random allocation was generated or concealed, the analysis populations, the statistical analysis plan, and missing-data handling. The record also does not state how multiplicity across outcomes would be addressed. These omissions do not show that a particular method was or was not used; they mean it is not reported in the registry record.

The safety information contains few reported serious events and no comparative analysis. Event counts alone cannot establish causation or reliably characterize differences between strategies. In addition, the record gives no outcome results for the stated 8-week changes, so the intervention period cannot be used to infer that follow-up measures were complete or analyzed. These limitations are specific to the information reported and should not be read as evidence about unreported findings.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Study of Produce Prescription Programs in Adults With Overweight or Obesity Experiencing Nutrition Insecurity — NCT06751563.
• Registry record last updated 2026-07-06; status last verified 2026-06.
• Results first posted 2026-07-06.
• 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.

18. Record Summary

NCT06751563 is a completed randomized, single-masked, parallel pilot study with an enrollment of 48. It compared behavioral text messages paired with produce boxes delivered to the home against behavioral text messages paired with weekly produce vouchers. The intervention period was 8 weeks, and the primary endpoint was the number of participants reached across study participation stages.

The record states that 221 individuals were screened and completed the eligibility survey. It reports no analyses and does not provide comparative results for the primary or secondary outcomes. Safety counts include one serious adverse event in the Produce Vouchers group and none in the Produce Boxes group, with zero deaths recorded in either group. The registry record therefore describes the study design and limited safety information but does not establish which implementation strategy performed better.