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 Walking to School Supports (NCT04089020), a na na study. The primary outcome is Acceptability of Intervention: "Satisfaction Questionnaire".
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04089020 |
| Phase | NA |
| Condition | Health Behavior |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 32 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Children's Mercy Hospital Kansas City |
| Results posted | Yes |
2. Clinical Question
Population
The study focused on 4th-6th graders who did not already walk to school, with family involvement in the intervention and its evaluation. The registry describes an intervention for up to 8 youth and records enrollment of 32. It also says that 14 participant families were relevant to the satisfaction questionnaire, and that 13 were successfully contacted to complete it. These figures describe different parts of the record; the registry does not explain the relationship between them.
Intervention
The behavioral intervention combined family-based telephone coaching, ongoing SMS text messaging, and study website content over 6 weeks. Coaching and messages addressed goal setting, monitoring, motivation, problem solving, and related skills. The intervention was intended to support walking to and from school.
Comparator
There was no randomized comparison group. The registry lists a single-group model and no allocation. The record therefore does not set out a like-for-like control group against which to estimate a between-group effect.
Primary question
The primary outcome asked how families rated the intervention immediately after its completion. Parent and child responded together to a satisfaction questionnaire at 6 weeks. The questionnaire included 5 items rated on a 10-pt scale, with higher values indicating greater satisfaction, as well as two open-ended questions about what families liked most and least. The registry also identifies Frequency of Walking to School as a secondary outcome, but does not report its results.
3. Trial Design
Walking to School Supports (NCT04089020) is recorded as a completed pilot study sponsored by Children's Mercy Hospital Kansas City. The registry lists a start date of 2019-09-25 and a primary completion date of 2019-12-31. Its stated purpose was to test feasibility and acceptability of enhanced individual-level support intended to increase walking to and from school among 4th-6th graders who did not already walk to school.
The intervention was behavioral and delivered over 6 weeks. It included family-based telephone coaching, ongoing SMS text messaging, and study website content. The arm description characterizes the coaching and messages as addressing goal setting, monitoring, motivation, problem solving, and related skills. The registry describes an intended enrollment of up to 8 youth in its brief summary, while its enrollment field records 32. The registry does not explain this difference or specify how many participants actually received the intervention.
The design is listed as single-group, with allocation recorded as NA and masking as NONE. No randomized control or other comparator group is listed. Consequently, the design can describe participant experience and outcomes during the intervention, but does not establish a controlled estimate of the intervention's effect relative to an alternative. The record identifies acceptability as the primary outcome and Frequency of Walking to School as a secondary outcome. It lists 2 outcome measures and 0 analyses. Numerical outcome results and a statistical 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.
Overall Study
| Stage | Psychosocial Intervention |
|---|---|
| STARTED | 32 |
| COMPLETED | 31 |
| NOT COMPLETED | 1 |
Analysis population for the primary outcome, as defined in the registry: The satisfaction questionnaire was completed by the families (parent and child responding together). Of the 14 participant families, 13 were successfully contacted to complete the questionnaire.
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: This study included parent/child dyads, however no data was collected at baseline for parents.
| Characteristic | Unit | Psychosocial Intervention |
|---|---|---|
| Participants analysed | 18 | |
| Age, Categorical: <=18 years | Participants | 18 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 12 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: United States | participants | 18 |
6. Primary Endpoint
The registry lists the primary outcome as Acceptability of Intervention: "Satisfaction Questionnaire", measured over at 6 weeks, immediately after completion of the intervention.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is acceptability of the intervention, measured using a satisfaction questionnaire immediately after completion of the intervention, at 6 weeks. The record says that families, with parent and child responding together, answered 5 items on a 10-pt scale. Higher values indicate greater satisfaction. Two additional open-ended questions asked which parts families liked most and least; the registry says these qualitative responses would be summarized.
Acceptability is relevant to a pilot because an intervention's practical value depends in part on whether participants and families find its content acceptable. In general, responses can help describe participants' experience and identify aspects that may warrant further consideration. This endpoint does not directly measure whether walking behavior changed, nor does a satisfaction rating establish that an intervention caused a change in behavior.
The registry specifies the intended summary as a mean and Standard Deviation for a score on a scale. It does not report the observed score, its Standard Deviation, the handling of the individual items, or the qualitative responses. The questionnaire was completed by 13 of the 14 participant families that the record says were contacted or eligible in this description. The registry does not explain the noncompletion or report how missing questionnaire responses were handled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a focused pilot question: whether families found a 6-week psychosocial intervention for walking to school acceptable. It specifies a satisfaction questionnaire as the primary outcome and describes how families were asked to respond. However, the numerical satisfaction result is not reported in the registry record. The mean, Standard Deviation, and any confidence interval or other estimate of uncertainty are also not reported. Without those results, the degree of reported satisfaction and its precision cannot be characterized from the registry record.
The study's single-group structure is central to interpretation. There is no randomized comparator, and no like-for-like control group is listed. Any observed change during a single-group intervention would not, by itself, distinguish an intervention effect from other explanations such as changes over time or differences in who completed follow-up. The record does not report a numerical change in walking frequency, so even a description of before-and-after walking behavior cannot be made from the registered results.
The record reports that 13 of 14 participant families completed the satisfaction questionnaire. This indicates that questionnaire responses are not recorded for every family in that group, but the record does not explain why a response is missing or whether the respondents differed from the nonrespondent. General statistical concern: if missing responses are associated with satisfaction, a mean among respondents may not represent the experience of all families. No missing-data approach is reported, so the extent of any such influence cannot be assessed.
The registry lists 2 outcome measures and 0 analyses, but does not report an analysis plan, outcome estimates, or inferential results. It is therefore not possible to assess statistical significance, effect size, or precision for the primary or secondary outcome from the registry record. No conclusion about intervention efficacy follows from a study description alone. The posted information supports describing the intended intervention, endpoint, and response process; it does not supply the outcome data needed to quantify acceptability or changes in walking.
In general, a confidence interval describes a range of estimates compatible with the data under a specified statistical method and conveys uncertainty more directly than a point estimate alone. No confidence interval is reported for this endpoint. The registry's stated mean and Standard Deviation would describe the questionnaire score distribution if the score and variability were reported, but neither is available. Thus, neither the magnitude of satisfaction nor how precisely it was estimated can be evaluated.
9. Statistical Methods Explained
What does a mean and Standard Deviation describe?
The registry describes the primary outcome as a score on a scale and specifies a mean with Standard Deviation as its summary. In general, a mean represents the arithmetic center of observed scores, while a Standard Deviation describes how spread out scores are around that center. Together, they can help readers understand both the typical score and variation among respondents. They do not show the full score distribution, and a mean alone does not reveal whether scores cluster together or vary substantially.
The questionnaire's 5 items were rated on a 10-pt scale, with higher values indicating greater satisfaction. The record does not say whether responses were combined into a single score, whether any items were weighted, or how incomplete item responses were treated. It is therefore not appropriate to assume how the reported score would be constructed. Although the registry names a mean and Standard Deviation, it does not report either numerical value.
What would an uncertainty interval add?
General statistical explanation: a confidence interval expresses uncertainty around an estimated quantity under a specified analysis method. A narrow interval indicates greater precision than a wide interval, but does not establish that an estimate is free of bias or that it has practical importance. The registry record does not report a confidence interval for the satisfaction outcome. Without a numerical estimate and its uncertainty, the acceptability result cannot be assessed for either magnitude or precision.
A confidence interval for a mean would also require clarity about the analyzed observations and method. For this study, the record says that 13 of 14 participant families completed the questionnaire, but does not describe an analysis population, missing-data method, or interval procedure. No particular method should be inferred from the outcome's planned summary alone.
Why does the single-group design matter?
In general, a single-group study can describe outcomes among participants receiving an intervention, but it does not provide a concurrent control group for estimating what would have happened without that intervention. An outcome observed after participation can reflect many influences, including the intervention, ordinary changes over time, and the characteristics of people who participate or remain available for follow-up. Without a comparator, those explanations cannot be separated through a randomized between-group contrast.
Here, the registry lists a single-group model, allocation as NA, and masking as NONE. It does not describe a randomized comparison. The design is consistent with a pilot focused on feasibility and acceptability, as stated in the brief summary, but the registry does not report feasibility results or a detailed feasibility analysis. The listed secondary outcome, Frequency of Walking to School, has no numerical result in the record.
What is the role of statistical significance?
In general, a p-value is a measure of how compatible observed data are with a specified null model, conditional on the analysis assumptions. It is not the probability that a treatment works, nor does it measure the size or practical importance of an effect. No p-value, test result, or inferential analysis is reported in the registry record. The record lists 0 analyses, so there is no registered analysis result to interpret statistically.
General caution: small pilot studies are often most informative about the procedures and outcomes they directly report. A sample-size calculation for a future study is not an observed result and does not establish that a pilot had adequate power to detect an effect. The record gives planning assumptions for an illustrative sample-size exercise elsewhere in the statistical material, including a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects defined as fractions of the observed effect. However, the record does not report the observed endpoint effect needed to interpret those illustrations, and the trial itself is single-group. Such planning illustrations cannot be read as observed power or as evidence that a treatment effect was established.
Why does the questionnaire completion count matter?
The record says that 13 of 14 participant families completed the questionnaire. A response summary based on completed questionnaires would describe those respondents unless an analysis method addressed missing responses. General statistical explanation: missing data can affect an estimate when the likelihood of responding is related to the outcome, and the risk depends on the reason for nonresponse and the analysis approach. Neither the reason for noncompletion nor a method for handling it is reported. The effect of that missing response on the result cannot therefore be evaluated.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies the satisfaction questionnaire as the primary outcome and Frequency of Walking to School as a secondary outcome. It lists 2 outcome measures and 0 analyses. The record does not report numerical results for either outcome or specify which analyses, if any, were planned for them.
Multiplicity refers, in general, to the interpretive issue that can arise when several outcomes, time points, or statistical comparisons are examined. The more analyses considered, the more important it can be to clarify which were primary and whether any adjustment or prespecified hierarchy was used. The registry names a primary and secondary outcome, but does not report a multiplicity adjustment, testing hierarchy, or detailed statistical plan. It is not possible to determine from the record whether or how multiplicity was addressed.
The registry reports questionnaire completion by 13 of 14 participant families. It does not state how missing responses were handled, why the remaining family did not complete the questionnaire, or whether any imputation or sensitivity analysis was performed. It also does not report how missing values for the secondary walking outcome were treated. General statistical explanation: complete-case summaries can be affected if the people with observed outcomes differ systematically from those without them. The direction and size of any such influence cannot be inferred without further information.
An analysis population is the defined set of participants whose data contribute to a particular analysis. The record does not report an analysis population, nor does it explain the relationship between the enrollment field of 32, the brief summary's description of up to 8 youth, and the 14 families associated with the questionnaire. These figures should not be treated as interchangeable denominators. The registry also does not report exclusions from analysis, adherence definitions, or the handling of participants who did not complete the intervention.
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 |
|---|---|---|---|
| Psychosocial Intervention | 0 | 18 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Psychosocial Intervention | 0 of 18 |
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 |
|---|---|
| Psychosocial Intervention | 0 of 18 |
The registry lists a Psychosocial Intervention group with 18 participants at risk for serious adverse events and 0 serious adverse events. It also lists 18 at risk for other adverse events and 0 other adverse events. Deaths are recorded as 0, and no serious adverse event terms are listed.
These are registry safety counts, not a comparison between intervention and control groups. The study is recorded as single-group, and no control group is listed. The registry does not explain the relationship between the safety denominators and the enrollment figure of 32, or provide additional information about the safety observation period or event-collection procedures. The counts should therefore be read as recorded, rather than used to infer details of exposure or follow-up that are not stated.
In general, observing no events in a recorded group does not establish that the underlying risk is zero. Interpretation depends on the number of people observed, duration and completeness of observation, event definitions, and how actively events were sought. The registry does not report enough detail to evaluate those aspects. The figures describe the events recorded in the registry; they do not establish a broader safety conclusion.
12. What the Result Does, and Does Not, Mean
The record describes a completed pilot intended to examine feasibility and acceptability of psychosocial support for walking to school. It identifies a family satisfaction questionnaire as the primary outcome, gives the response format and timing, and states that 13 of 14 participant families completed it. Those details clarify what the primary measure was intended to capture and how families were asked to respond.
The record does not report the questionnaire's numerical result, its Standard Deviation, or an uncertainty interval. It also does not report numerical results for the secondary outcome, Frequency of Walking to School. As a result, the posted information does not establish how satisfied families were on average or whether walking frequency changed. The absence of numerical results in the registry record is not evidence that satisfaction was low or high, and does not show that walking did or did not change.
The single-group design also limits what could be concluded even if outcome values were available. Without a comparator, outcomes among participants cannot by themselves establish what would have happened in the absence of the intervention. The registry does not report a randomized comparison, inferential results, or a detailed statistical analysis.
General statistical interpretation: a pilot can contribute information about whether an intervention and its measurement procedures are feasible, but those conclusions depend on the results actually reported. Here, the study's stated intent is available, but numerical feasibility findings are not reported in the registry record. The record therefore supports an account of the intervention and its intended evaluation, not a quantified claim about acceptability, behavior change, or comparative effect.
13. Why This Trial Matters Statistically
This study raises several statistical interpretation issues that matter in behavioral pilot research. First, it distinguishes an acceptability endpoint from a behavioral outcome. A family satisfaction questionnaire records participants' views about the intervention; Frequency of Walking to School concerns behavior. These outcomes address different questions and should not be treated as interchangeable evidence. The registry names both, but reports no numerical results for either.
Second, the design determines the scope of a conclusion. A single-group study can describe an intervention experience, but it cannot make a randomized comparison when no control group is listed. This is particularly important when the intended outcome is behavior, which may change for reasons beyond the intervention. The study description and its outcomes must be interpreted within that design rather than as a controlled effectiveness test.
Third, the record illustrates why outcome reporting and missing-data information are important. It states that 13 of 14 participant families completed the questionnaire, but does not explain the missing response or how it was handled. Without the actual scores and an account of analysis, neither the outcome's magnitude nor its precision can be judged.
Finally, the record lists 0 analyses and does not report a detailed statistical plan. That makes it impossible to assess how outcomes were summarized or whether multiple outcomes were handled according to a prespecified approach. Clear reporting of estimates, uncertainty, analysis populations, and missing-data methods would make the evidence easier to interpret. These are general statistical considerations; the registry record does not report the missing details.
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 record constrain interpretation. The most direct is that numerical results for the primary satisfaction questionnaire are not reported in the registry record. Although the intended summary is a mean and Standard Deviation, neither is stated. There is also no reported confidence interval, test result, or numerical estimate for Frequency of Walking to School.
The design is single-group, with allocation recorded as NA and masking as NONE. No comparator is listed, so the registry does not support a controlled estimate of intervention effect. The record also does not report details of any statistical analysis; it lists 0 analyses. No analysis population, missing-data procedure, multiplicity approach, or interim analysis is reported in the registry record.
The enrollment information is difficult to reconcile from the record alone. The enrollment field states 32, the brief summary describes enrollment of up to 8 youth, and the questionnaire description refers to 14 participant families, 13 of whom completed it. The record does not explain how these counts relate to one another. They should not be assumed to describe the same population or analysis denominator.
The questionnaire's scoring details are incomplete: the record identifies 5 rated items and two open-ended questions, but does not explain whether or how item responses were combined into the score. It also does not say why a family did not complete the questionnaire. Safety counts are reported, but event-collection procedures and the relationship between their denominators and enrollment are not explained. These omissions limit the conclusions that can be drawn from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Walking to School Supports — NCT04089020.
- Registry record last updated 2023-08-18; status last verified 2022-10.
- Results first posted 2023-08-18.
- 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
NCT04089020, titled Walking to School Supports, is recorded as a completed, single-group behavioral pilot sponsored by Children's Mercy Hospital Kansas City. The intervention paired family-based telephone coaching, SMS text messaging, and study website content over 6 weeks. It was intended to support walking to and from school among 4th-6th graders who did not already walk to school.
The primary outcome was family acceptability measured with a satisfaction questionnaire immediately after the intervention. The registry describes 5 rated items and two open-ended questions, and says that 13 of 14 participant families completed the questionnaire. Frequency of Walking to School is listed as a secondary outcome. Numerical results for either outcome and a detailed statistical analysis are not reported in the registry record.
The design has no listed control group. The record lists 32 enrolled, while its brief summary describes up to 8 youth; it does not explain the relationship between these counts and the families associated with questionnaire completion. The safety record lists 0 serious adverse events, 0 other adverse events, and 0 deaths among the recorded group counts.