This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Southwest Harvest for Health Vegetable Gardening Intervention (NCT04251299), a na na study. The primary outcome is Feasibility of the Intervention.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04251299 |
| Phase | NA |
| Condition | Cancer Survivor |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of New Mexico |
| Results posted | Yes |
2. Clinical Question
The clinical question is whether a home-based, mentored vegetable gardening program can be delivered to cancer survivors in New Mexico and viewed favorably by participants and their gardening mentors. The primary endpoint concerns feasibility rather than a comparison of health outcomes between treatments. The registry record identifies four aspects: recruitment within a specified period, study completion, adherence to communication with a Master Gardener mentor, and participants’ ratings of their experience.
The registry describes the intervention as a 10-month program. Cancer survivors are paired with certified Master Gardeners from the Cooperative Extension System. The primary endpoint’s timeframe is through study completion, described as an average of 9 months. These are distinct descriptions in the record; it does not explain the difference between the intervention duration and the average endpoint timeframe.
The record also names secondary outcomes concerning vegetable and fruit intake, objectively measured physical activity, sleep quality, physical function, and physical performance. These outcomes address possible changes during participation, but the registry record does not report their results. The primary question remains whether recruitment, retention, adherence, and acceptability met the feasibility aims described in the record.
Population
Cancer survivors in New Mexico. The registry lists the condition as Cancer Survivor.
Intervention
A home-based, mentored vegetable gardening program pairing participants with certified Master Gardeners.
Comparator
There is no separate control group in this single-group study. The registry record does not report a like-for-like comparison group.
Primary question
How feasible and acceptable is the intervention, as assessed through recruitment, study completion, mentor communication adherence, and participant experience ratings?
3. Trial Design
Southwest Harvest for Health is registered as a completed, single-group behavioral intervention study sponsored by the University of New Mexico. The registry lists enrollment as 30. All participants were assigned to receive the mentored vegetable gardening intervention; the record does not describe a parallel control arm. Allocation is listed as not applicable, and masking is listed as none. This design therefore does not support a randomized comparison between intervention and control groups.
The intervention is home based and pairs cancer survivors with certified Master Gardeners from the Cooperative Extension System. The arm description characterizes the intervention as lasting 10 months. The primary endpoint timeframe is described as through study completion, an average of 9 months. The registry record does not explain why these duration descriptions differ or provide details about individual participation times.
The study start date is 2020-01-17, and the primary completion date is 2020-12-20. Its status is completed. These record details describe the study’s administrative timeline, but do not indicate whether the feasibility criteria were achieved. Results for recruitment, completion, adherence, and acceptability are not reported in the registry record.
The primary endpoint is feasibility. Secondary outcomes concern pre-post change in vegetable and fruit intake, objectively measured physical activity, sleep quality, physical function, and physical performance. The record lists six outcome measures overall, but detailed numerical results and analysis outputs are not reported. It also does not describe the precise assessment instruments, assessment schedule, or procedures used to collect these measures.
The single-group structure is important for interpreting any changes that might be reported. Without a control group, a before-and-after pattern alone would not establish that the intervention caused the change. Other influences over time cannot be separated from the intervention using a single-group comparison. The registry record does not report an analysis that addresses such influences.
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
| Stage | Single Arm |
|---|---|
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: (1) Percentage of participants recruited within 3 months; (2) percentage of participants who completed the study; (3) percentage of participants adhering to twice monthly communication with Master Gardener mentor; (4) percentage rating their experience with the intervention as very good or excellent.
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: Only the cancer survivors enrolled in the study completed the baseline and post-intervention assessments. The Master Gardener mentors delivered the intervention.
| Characteristic | Unit | Single Arm |
|---|---|---|
| Participants analysed | 30 | |
| Age, Continuous | years | 68 (SD 7.2) |
| Sex: Female, Male: Female | Participants | 21 |
| Sex: Female, Male: Male | Participants | 9 |
| Race/Ethnicity, Customized: Non-Hispanic White | participants | 22 |
| Race/Ethnicity, Customized: Hispanic White | participants | 6 |
| Race/Ethnicity, Customized: Other | participants | 2 |
| Region of Enrollment: United States | participants | 30 |
6. Primary Endpoint
The registry lists the primary outcome as Feasibility of the Intervention, measured over through study completion, an average of 9 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is labeled feasibility of the intervention and is expressed as a percentage of participants. It is not a clinical efficacy endpoint comparing health outcomes across treatment groups. Instead, it covers whether the program could recruit cancer survivors within the stated period, retain participants through study completion, support adherence to twice-monthly communication with a Master Gardener mentor, and receive favorable participant ratings.
The registry describes recruitment of 25 cancer survivors in 3 months, retention rates of 80%, adherence of 80%, and high acceptability for both participants and Cooperative Extension Master Gardeners as feasibility aims. The endpoint’s population description identifies the corresponding participant percentages: recruited within 3 months, completed the study, adhered to twice-monthly mentor communication, and rated their experience very good or excellent. The record does not state a numerical threshold for “high acceptability” or describe a Master Gardener rating measure in the listed participant percentages.
In general, feasibility measures help distinguish whether an intervention can be delivered and accepted from whether it changes a health outcome. Percentages make these criteria interpretable as proportions of participants meeting a specified condition. Their meaning depends on the denominator and on how missing responses or incomplete follow-up are handled. Those details and the observed percentages are not reported in the registry record.
Using feasibility as the primary endpoint is suited to a study focused on delivery and acceptability. It does not, by itself, establish that gardening improves diet, activity, sleep, function, or performance. Results for those secondary outcomes are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a completed study with enrollment listed as 30, but it does not report numerical results for the primary feasibility endpoint. It therefore cannot establish from the posted registry information whether the recruitment, retention, adherence, or acceptability aims were met. The stated targets describe what the study sought to assess; they are not outcome findings.
The primary endpoint is built from several distinct indicators. Recruitment asks whether enrollment occurred within the stated period. Completion concerns retention through study participation. Adherence concerns the specified mentor communication schedule. Acceptability is represented by participants rating their experience very good or excellent. These indicators capture different practical aspects of implementation, so evidence about one would not automatically answer the others. The registry record does not give a result for any of them.
The listed secondary outcomes concern pre-post changes in vegetable and fruit intake, objectively measured physical activity, sleep quality, physical function, and physical performance. No numerical changes, uncertainty intervals, hypothesis tests, or analysis details for these outcomes are reported in the registry record. Accordingly, the registry information does not support a conclusion about the direction, size, or precision of change in these measures.
The single-group design also shapes what a before-and-after result could mean. In general, observations from the same group over time can describe change during participation, but do not isolate the intervention’s effect from other events or influences occurring over the same period. A separate control group or another suitable design would be needed to address that causal question. No such comparison is described in this record.
The record lists no analysis entries. This does not demonstrate that no analyses were ever performed; it means that analyses are not reported in the registry record. The posted information also does not provide confidence intervals or other measures of statistical uncertainty for the primary or secondary outcomes. Without the outcome counts, denominators, and estimates, readers cannot assess precision or distinguish a stable estimate from one that might be highly uncertain.
The record’s planning targets should also be separated from observed results. It describes aims for recruitment, retention, adherence, and acceptability, but does not show whether participants reached them. Enrollment is an administrative study characteristic and should not be treated as evidence that the recruitment target was achieved within the stated time. The recruitment result itself is not reported in the registry record.
In short, the available registry description establishes the question, intervention, single-group design, and intended measures. It does not provide the outcome evidence needed to judge feasibility performance or changes in the secondary measures. The appropriate interpretation is therefore limited to what the study was designed to examine, rather than a conclusion about what it found.
9. Statistical Methods Explained
What does a percentage endpoint represent?
In general, a percentage endpoint expresses the number of participants meeting a defined condition relative to the relevant participant denominator. Here the conditions include completing the study, following the mentor communication schedule, and reporting a favorable experience. Each condition needs a clear definition and denominator to be interpretable. For example, a completion percentage might use all enrolled participants or only those who began the intervention; those choices answer different questions. The registry record does not report the denominators used for the outcome calculations.
Recruitment is also expressed as a percentage in the population description, while the feasibility description includes a target of recruiting 25 cancer survivors in 3 months. A target is a planning criterion, not a measured result. The registry record does not report the number recruited within that period or the observed recruitment percentage. It is therefore not possible to determine whether the recruitment aim was met from this record.
How should uncertainty be considered?
In general, an estimate is more informative when accompanied by a measure of uncertainty, such as a confidence interval. A confidence interval describes a range of values compatible with the observed data under the method used; it is not a guarantee that the true value falls in that range. For a percentage, uncertainty depends on both the estimated proportion and the number of observations contributing to it. The registry record does not provide confidence intervals, standard errors, or the counts underlying the feasibility percentages.
Because the outcome is binary at the participant level—meeting or not meeting a defined condition—the analysis may be framed as estimating a proportion. That general description does not identify which statistical procedure was used. The registry record does not report the specific estimator, interval method, or any adjustment procedure. No method should be attributed to the investigators without that information.
What does the single-group design imply?
In general, a single-group pre-post design can describe how measurements differ over time within the enrolled group. It does not include a concurrent comparison group to indicate what might have happened over the same period without the intervention. Changes may reflect the intervention, but could also be related to other influences. This is a design limitation for causal interpretation, not a statistical defect that can be resolved simply by calculating a more precise percentage.
The primary endpoint is about feasibility, so a within-group description can still address practical questions such as completion and adherence. However, it does not establish comparative benefit. The listed secondary outcomes could describe changes in intake, activity, sleep, function, or performance, but their numerical results and analysis methods are not reported in the registry record.
How should planning illustrations be read?
In general, a sample-size calculation is a planning exercise about how much information a future study might need under stated assumptions. The planning assumptions associated with this record specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They describe an effect to detect as a stated fraction of the observed effect. These are planning assumptions, not evidence that this single-group study used a two-arm design.
The planning description specifies participants per arm for outcomes other than time-to-event outcomes, and a total event count for time-to-event planning. Those conventions concern the interpretation of planning quantities, not the enrollment or results of the present study. The current trial is registered as single group, while the illustration assumes equal allocation between two arms. It should therefore not be read as a reconstruction of the trial’s actual design or as a report of its observed power.
In general, observed power is not a substitute for an effect estimate and its uncertainty. A planning calculation based on an observed effect is conditional on that effect and on the assumptions used. The registry record does not report the observed outcome effects, the rationale for the trial’s enrollment, or a protocol-based sample-size justification. The planning illustration does not fill those gaps.
What can be inferred from the registry analysis listing?
The registry record lists no analysis entries. This means that statistical analysis details and results are not reported there. It does not identify the model used for any endpoint, how repeated measurements were handled, how missing values were treated, or whether any analyses were adjusted. Those methods are necessary context for evaluating estimates, but they cannot be inferred from the endpoint labels alone.
General statistical interpretation should therefore remain modest: the record tells readers which feasibility indicators and secondary outcomes were intended, but not how the data were analyzed or what estimates resulted. The figures and calculations associated with the registry description should be interpreted as planning or descriptive aids only when identified as such, not as a replacement for unreported trial results.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary endpoint and several secondary outcome areas. Considering multiple outcomes can raise a multiplicity issue: in general, the more statistical comparisons made, the greater the chance that at least one result may appear notable by chance. Researchers may address this through a prespecified hierarchy, adjustment procedure, or careful emphasis on estimation rather than isolated tests. The registry record does not report a multiplicity strategy, a testing hierarchy, or analysis results.
The number of outcome measures is listed as six, while the record names secondary outcomes for vegetable and fruit intake, objectively measured physical activity, sleep quality, physical function, and physical performance. The record does not provide detailed results for these measures or clarify the analysis plan for them. Their presence should not be taken as evidence that each was analyzed or that any particular comparison was statistically significant.
Missing data are important for feasibility outcomes because participants who do not complete follow-up may differ from those who do. In general, the way missing responses are handled can affect both the denominator and interpretation of a percentage. The registry record does not report the amount of missing outcome data, reasons for missingness, imputation methods, or whether analyses used all enrolled participants or another analysis population.
The record also does not define an intention-to-treat, per-protocol, or other analysis population. Such labels should not be inferred from the single-group design. Without the analysis population and missing-data procedures, the reported endpoint definitions alone cannot establish how incomplete observations would have affected the estimates. Numerical findings and these methodological details are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Single Arm | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Single Arm | 0 of 30 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Single Arm | 0 of 30 |
The serious adverse event figures are reported for the single arm. The registry lists 30 participants at risk for serious events, 0 participants with a serious event, and 0 deaths. It lists no top serious event terms. These entries describe the serious-event information recorded for the arm; they do not provide a detailed account of all health events during participation.
A zero count in a registry field should be read narrowly. It means that the record reports no serious adverse events in that field for the group during the reported period. It does not establish that the intervention has no risks, nor does it show that no non-serious events occurred. Information about non-serious adverse events, event definitions, collection procedures, and the observation period for safety reporting is not reported in the registry record.
Because this is a single-group study, the serious-event count cannot be compared with a concurrent control group in this record. The figures should not be interpreted as a comparative estimate of safety. They are descriptive entries, and their scope is limited to the serious events and deaths reported in the registry.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study examined a mentored, home-based vegetable gardening intervention for cancer survivors, using feasibility as its primary endpoint. It also documents the single-group design, the intervention description, the intended feasibility indicators, and secondary outcome areas. Those details define the study question and its context.
The record does not report the primary endpoint results. Readers therefore cannot determine from the posted registry information whether recruitment occurred within the target period, whether participants completed the study, whether mentor communication adherence reached the intended level, or whether participants rated their experience favorably. The aims described in the registry are not evidence that those aims were met.
Likewise, no numerical results for the secondary outcome measures are reported in the registry record. There is no basis in this record to describe observed changes in vegetable and fruit intake, objectively measured physical activity, sleep quality, physical function, or physical performance. The listed outcomes indicate what the study intended to assess, not what it found.
Even if pre-post changes were available, a single-group design would not by itself show that the intervention caused them. In general, a before-and-after difference describes change over time in the observed group; without an appropriate comparison, other influences over that time remain possible explanations. The registry record does not present a control-group comparison.
The serious adverse event entries report 0 serious events and 0 deaths for the single arm, with 30 participants at risk. These are limited descriptive safety data and do not establish an absence of all adverse events or a comparative safety profile. Overall, the record supports a description of the study’s design and intended measures, but not a conclusion about effectiveness, successful feasibility, or comprehensive safety.
13. Why This Trial Matters Statistically
Feasibility studies address a practical question that can precede evaluation of health outcomes: can an intervention be delivered, and will participants engage with it? For a home-based gardening program paired with Master Gardeners, recruitment, retention, communication adherence, and acceptability are relevant dimensions of delivery. Treating these as explicit outcomes makes the implementation question visible rather than assuming that enrollment alone demonstrates feasibility.
The study also illustrates why endpoint type matters. A percentage meeting a feasibility criterion answers a different question from a change in physical activity or physical function. Neither kind of measure automatically answers whether the program improves health relative to another option. Keeping feasibility findings distinct from clinical outcome findings helps avoid overstating what a study design can establish.
The single-group design is also a useful reminder that descriptive change and causal effect are not interchangeable. Measurements collected before and after participation may characterize what happened among participants, but a concurrent comparison is needed to distinguish intervention-related change from other changes over time. This distinction applies even when an intervention is appealing or its delivery appears practical.
Finally, registry completeness affects statistical interpretation. Without reported endpoint results, denominators, uncertainty estimates, missing-data procedures, and analysis details, readers cannot evaluate whether the intended feasibility criteria were achieved or how precise any estimate might be. The record is informative about study purpose and structure, while its lack of posted outcomes limits conclusions. That separation is important when reading feasibility research and planning any subsequent evaluation.
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.
Several limitations specific to this registry record constrain interpretation. Most importantly, it does not report numerical results for the primary feasibility endpoint or the listed secondary outcomes. The intended targets and measurement descriptions cannot substitute for observed percentages or changes. The registry record also lists no analysis entries, so the statistical methods used for any outcome are not available there.
The single-group design has no like-for-like control comparison described in the record. As a result, any pre-post change, if reported elsewhere, would not by itself isolate an intervention effect. Allocation is listed as not applicable and masking as none. The registry does not describe a comparison group, randomization, or masking procedures beyond those entries.
Important endpoint details are not reported, including the outcome denominators, handling of missing responses, exact measurement procedures, and the definition or assessment of high acceptability for Master Gardeners. The record gives participant experience ratings as very good or excellent, but does not provide the observed ratings. It also does not explain the difference between the 10-month intervention description and the average 9-month endpoint timeframe.
The registry record does not report a protocol-based sample-size justification, an analysis population, a multiplicity approach, or interim analyses. These omissions should not be filled by assumptions. The planning assumptions described for sample-size illustrations do not establish the design rationale for this single-group study. The serious-event entries are limited to serious events and deaths and do not describe non-serious events or provide a comparative safety assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Southwest Harvest for Health Vegetable Gardening Intervention — NCT04251299.
- Registry record last updated 2025-03-11; status last verified 2025-02.
- Results first posted 2025-03-11.
- 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.
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18. Record Summary
Southwest Harvest for Health is a completed, single-group behavioral intervention study sponsored by the University of New Mexico. The registry lists enrollment as 30 and describes a home-based, mentored vegetable gardening program for cancer survivors. Participants were paired with certified Master Gardeners from the Cooperative Extension System.
The primary endpoint is feasibility, assessed through recruitment, study completion, twice-monthly mentor communication adherence, and participant experience ratings. Secondary outcomes concern pre-post change in vegetable and fruit intake, objectively measured physical activity, sleep quality, physical function, and physical performance.
The registry record does not report numerical outcome results or analysis entries. It lists 0 serious adverse events and 0 deaths for the single arm, with 30 participants at risk. These safety entries are descriptive and do not cover all adverse events or provide a comparison with another group.