Tanglewood Trail Walking Program in Rural Kentucky 2020: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Tanglewood Trail Walking Program in Rural Kentucky 2020 (NCT05002985), a na na study. The primary outcome is Self-reported Fruit Intake.

2. Clinical Question

This is a question about a behavioral and community-based program, not a randomized comparison as registered. A change in fruit intake over time, if measured, would describe the observed participants. Without a reported comparator and analysis, such a change could not by itself distinguish a program effect from other explanations, such as changes over time or differences in who completed the measure. The record does not report whether the primary question was analyzed or what the results were.

3. Trial Design

The registry describes the Tanglewood Trail Walking Program to Increase Phytonutrient Intake and Physical Activity in a Rural Kentucky Town. The record lists the study as completed, with a start date of 2020-05-17 and a primary completion date of 2020-09-14. Enrollment is listed as 49. The condition is dietary habits, and the intervention is behavioral.

The registered design is single-group, with no masking and allocation recorded as not applicable. The only listed arm is the Walking Group, in which subjects participate in a walking group led by a community organizer to get to a local farmers market. The brief summary describes walking approximately 1 mile to the Whitesburg Farmers Market each Saturday and says the study aimed to compare healthier selections among people walking with a community health coach and a driving group. However, the registry lists no driving arm. The arrangement for any driving-group comparison is not reported in the registry record, so the registered design should not be read as a like-for-like controlled comparison.

The primary outcome is self-reported fruit intake, expressed as servings of fruit per day, with a 3 months timeframe. It is described as a mean with standard deviation. The record notes that not all participants completed this measure. Other registered outcomes include hours of vigorous exercise, moderate exercise, sitting, and walking per week, along with measures of understanding and beliefs concerning plant-based phytonutrients, healthy diets, and health protection. The record lists 12 outcome measures, but reports 0 analyses.

Specific eligibility criteria, the schedule of assessments, the planned statistical analysis, and the reason for the enrollment target are not reported in the registry record. Although a planning illustration is described using a two-arm framework, equal allocation, a two-sided significance level of 0.05, and a normal approximation, this does not establish that those assumptions were part of the study design. A registered single-group study is not converted into a two-arm trial by a planning calculation.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Not all participants completed this outcome measure.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Self-reported Fruit Intake, measured over 3 months.

The primary endpoint is self-reported fruit intake, measured in servings of fruit per day, with the assessment framed over 3 months. The registry describes the measure as a mean with standard deviation and says it is intended to assess whether walking combined with a voucher for fruits and vegetables changes reported intake.

Fruit intake is relevant to the stated program aim because the intervention brings participants to a farmers market, where food choices are part of the proposed pathway to dietary change. A continuous measure can capture variation in reported intake rather than reducing participants to categories such as improved or not improved. A mean describes the average reported intake, while a standard deviation describes the spread of participant measurements around that average. These are general interpretations of the stated summary measures; the registry record does not report the actual mean or standard deviation.

Self-report can make a dietary behavior measurable without the registry description specifying a direct observation or other measurement method. It also means the endpoint reflects participants’ reports, and the record does not describe validation procedures or how intake was elicited. The record explicitly notes that not all participants completed the outcome measure. The number with observed measurements, the amount of missing information, and the handling of missing responses are not reported in the registry record.

An endpoint definition alone does not establish that a change occurred. No baseline value, follow-up value, estimated change, uncertainty interval, or inferential result for fruit intake is reported in the registry record. Therefore, the posted record does not establish the direction, size, or precision of any change in this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods are useful only when they are connected to the design, outcome, and observed data. The registry identifies a single-group behavioral intervention and a continuous primary outcome, but it reports 0 analyses. The statistical analysis plan, if any, is not reported in the registry record. The explanations below describe general concepts relevant to this type of study; they are not descriptions of methods confirmed to have been used.

What does a mean describe?

For a continuous outcome such as servings of fruit per day, the mean is an average across the observations included in a calculation. It can be useful for describing the overall level of an outcome, but it does not show the range of individual values or whether the average represents every participant equally well. The registry specifies standard deviation as the dispersion measure. In general, a standard deviation describes how spread out observations are around the mean. Neither statistic is reported as an observed result for this study.

A mean also depends on which observations are included. Since the record says not all participants completed the primary measure, an analysis would need to define which available measurements contributed to each estimate and how incomplete data were handled. That information is not reported in the registry record. Reporting the number of observed measurements alongside an estimate can help readers understand its data basis, but the observed number is not reported.

How would change be assessed?

For a continuous outcome recorded at more than one time, an analysis might describe values at each time and estimate change within participants. The choice of method depends on the assessment schedule, the pattern of available data, and the scientific question. The record specifies a 3 months timeframe for the primary outcome, but it does not describe the assessment schedule, report baseline or follow-up measurements, or state whether an analysis of change was performed. No particular model or test should therefore be attributed to the study.

Even a clearly estimated within-group change would describe change among the observations analyzed. Without a suitable comparison, that change cannot isolate the program’s effect from other influences. The registered design is single-group. The brief summary refers to a driving group, but no such arm is listed. The record does not explain whether or how driving participants were observed or compared. This limits what a statistical analysis could establish, regardless of the sophistication of a model.

What does uncertainty mean?

In general, a confidence interval expresses the range of values compatible with the data and a specified statistical procedure. It conveys precision as well as direction and magnitude: a narrow interval indicates more precise estimation under the method’s assumptions, while a wide interval indicates greater uncertainty. A confidence interval does not correct design limitations, missing data, or measurement error. No confidence interval for the primary outcome is reported in the registry record.

A p-value, when used, describes how unusual data at least as incompatible with a stated null model would be under that model’s assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. No p-value or hypothesis test result is reported in the registry record. The planned significance level mentioned in the sample-size assumptions belongs to a planning illustration and is not evidence that a specific test was performed.

What is the role of the planning illustration?

The planning assumptions describe an illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They also state that the effect to detect is a stated fraction of the observed effect. Such a calculation can illustrate the sample size a hypothetical study might require under its assumptions. It is not an observed outcome, and it is not observed power. The record does not report the observed effect or the particular fractions used, so no numerical planning result can be interpreted from those assumptions alone.

The hypothetical two-arm, equal-allocation assumptions do not match the registered single-group model. They should not be treated as a description of the actual allocation or as evidence that the study was designed around a two-arm comparison. The enrollment of 49 is listed, but the reason for that enrollment target and a formal sample-size justification are not reported in the registry record.

Why does over-dispersion matter in general?

Over-dispersion occurs when observed variability is greater than a statistical model expects. If a model assumes less variability than the data have, its uncertainty estimates can be too small and its tests can appear more decisive than warranted. Methods that allow for extra variability may be appropriate in some settings. This is a general statistical point; the registry describes the primary endpoint as a continuous mean with standard deviation and does not report a model that would permit assessment of over-dispersion. No claim about over-dispersion in this study can be made from the record.

For this record, the central methods issue is not choosing among unreported models. It is that no outcome analyses or estimates are posted, the primary measure is incomplete for some participants, and the registered study is single-group despite the summary’s mention of a driving comparison. Those features constrain interpretation before any hypothetical statistical model is considered.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 12 outcome measures, including the primary fruit-intake measure and secondary measures of exercise, sitting, walking, understanding, and beliefs. When a study examines multiple outcomes or multiple analyses, the chance of finding at least one apparently unusual result can increase if each result is interpreted without accounting for the broader set of questions. General approaches to multiplicity include identifying a primary endpoint in advance, specifying which comparisons are confirmatory, or adjusting inference when appropriate. The statistical plan and any multiplicity strategy are not reported in the registry record. Since the record reports 0 analyses, there are no posted outcome findings from which to assess multiplicity in practice.

The record states that not all participants completed the primary outcome measure. The number with completed measurements, timing of missingness, reasons for noncompletion, and handling of missing data are not reported in the registry record. Missingness can affect both the precision and interpretation of an estimate. For example, an estimate based only on participants with complete measurements may not represent all enrolled participants if completion is related to the outcome or to participation. This is a general concern, not a demonstrated feature of this study.

The analysis populations are also not reported in the registry record. It is not stated whether any analysis was intended to include all enrolled participants, only those who began the program, or those who completed particular assessments. The record does not report an interim analysis plan, a prespecified analysis population, or a missing-data method. These omissions prevent assessment of whether the posted analysis, if one were available elsewhere, followed a declared plan. No such analysis is reported in this record.

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

The record describes a program that encourages community members to walk to a farmers market and a planned assessment of self-reported fruit intake. It gives a 3 months timeframe for the primary measure and identifies several secondary outcome topics. These details clarify the intended question and the kinds of behaviors and beliefs the study sought to measure.

The record does not report outcome results or analyses. It therefore does not show whether fruit intake changed, how large any change was, how precisely it was estimated, or whether exercise and other outcomes changed. It also does not establish that the walking program caused a change. No numerical effect estimate or inferential result should be inferred from the study description alone.

The registered design is single-group, with only a Walking Group listed. The brief summary mentions a driving group, but the registry record does not list it as an arm or explain how it was used. As a result, the registry does not document a controlled walking-versus-driving estimate. The primary outcome description refers to a voucher as well as walking, while implementation details for the voucher are not reported. Any effect of a combined activity could not be separated into component contributions using the information recorded.

These limitations do not make the program description uninformative. The record identifies a community-based intervention, the primary dietary measure, and other intended areas of measurement. But a study aim is not a finding, and an enrollment figure is not an outcome estimate. Because some participants did not complete the primary measure and the approach to missing data is not reported, even a future estimate would require careful attention to who contributed data and how missing observations were handled.

The adverse-event entries are recorded as zero for the listed at-risk and affected counts and deaths in the Walking Group. The registry does not describe monitoring procedures or provide information that supports a broader safety conclusion. Overall, the posted record is useful for understanding what was planned and registered, but it does not supply evidence to quantify benefits, harms, or comparative effects.

12. Why This Trial Matters Statistically

This study illustrates why design and analysis need to be read together. The stated community question evokes a comparison between walking and driving, yet the registered model is single-group and lists only the Walking Group. A comparison mentioned in a study aim is not equivalent to a registered comparator arm. Without a documented comparison and its analysis, readers cannot treat the record as evidence from a controlled walking-versus-driving study.

The endpoint also shows the difference between selecting a meaningful measure and reporting evidence about it. Self-reported servings of fruit per day aligns with the stated dietary aim, while the record identifies a 3 months timeframe. But a measure’s relevance does not tell readers what participants reported. The record lists 0 analyses, so there is no posted estimate to judge for size or precision.

Missing outcome completion matters even in a modest, community-based study. If participants with observed outcomes differ from those without them, an estimate based on available responses may not describe all enrolled participants. This is a general issue; the record does not report the extent or pattern of missingness or an approach to handling it.

The planning assumptions offer another important distinction. A hypothetical calculation using equal allocation between two arms is not a description of this registered single-group design. Planning illustrations can help explore design scenarios, but they do not provide observed results, demonstrate that a study had adequate power, or replace a design-specific rationale. The enrollment target’s justification is not reported in the registry record.

Taken together, these features make the record a useful example of how to separate program intent, registered design, and statistical evidence. Statistical interpretation depends not only on the type of endpoint but also on whether the comparison is defined, outcomes are available, missingness is addressed, and uncertainty is reported. Here, those elements are not sufficient to estimate the program’s effect.

13. 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 registry record leaves several trial-specific questions unresolved. It lists a single-group design and one Walking Group arm, while the brief summary describes a study aim involving a driving group. The record does not explain whether a driving group was recruited, how it was selected, or whether any comparison with it was analyzed. Thus, the intended comparison cannot be reconstructed from the registered arms.

The intervention description focuses on walking to the local farmers market with a community organizer. The primary outcome description additionally refers to a voucher for fruits and vegetables. The record does not explain the voucher’s details, whether it was given to all participants, or how it related to the walking intervention. This means the intervention components cannot be distinguished from the registered information.

The primary endpoint is self-reported, and the record does not describe the questions, recall period, validation, or measurement procedure. Not all participants completed it, but the number of completed assessments and reasons for noncompletion are not reported in the registry record. Those gaps prevent evaluation of measurement and missing-data concerns.

The registry gives an enrollment of 49 and identifies the study as completed, but it does not report outcome analyses or estimates. Eligibility criteria, participant characteristics, adherence to the walking program, and the rationale for enrollment are not reported in the registry record. The adverse-event entries list zero for the specified counts, but monitoring and ascertainment details are absent. These limitations are specific to the available record; they should not be mistaken for findings about what did or did not occur during the program.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Tanglewood Trail Walking Program in Rural Kentucky 2020 — NCT05002985.
• Registry record last updated 2021-11-05; status last verified 2021-10.
• Results first posted 2021-11-05.
• 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.

17. Record Summary

The registry record describes the Tanglewood Trail Walking Program to Increase Phytonutrient Intake and Physical Activity in a Rural Kentucky Town as a completed, single-group behavioral study. It lists enrollment of 49, a Walking Group led by a community organizer, and self-reported fruit intake in servings per day as the primary outcome, with a 3 months timeframe. The record notes that not all participants completed that outcome measure.

The brief summary describes walking to the Whitesburg Farmers Market and refers to a driving group, but no driving arm is listed. The registry lists 12 outcome measures and 0 analyses. It therefore reports no outcome estimate or statistical result for the primary endpoint. The record also does not report the analysis plan, handling of missing data, or enrollment justification.