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 Exploring Life Experience and Lifestyle Intervention Program Among Patients With CKD (NCT01194518), a randomized na study. The primary outcome is The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01194518 |
| Phase | NA |
| Condition | Chronic Kidney Diseases, Health Behaviors, Patient Education |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 120 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cheng Kung University |
| Results posted | Yes |
2. Clinical Question
Population
Patients with early-stage chronic kidney disease (CKD) were the intended population. The registry record describes the primary analysis population as the intention-to-treat population: all participants assigned to the intervention or control group. Enrollment was 120. The record does not give further eligibility details or describe the clinical characteristics of participants at baseline.
Intervention
The intervention was a lifestyle counseling program using tailored, transtheoretical model-based (TTM-based) approaches. Participants completed assessments of their stage of change and readiness to change. Counseling was tailored around physical activity and lifestyle change, with assessments or intervention contacts described at baseline and at 6, 12, 18, 24, and 30 months.
Comparator
The control group received usual care. The registry record does not define the content or frequency of usual care, so the precise contrast between counseling and usual care cannot be reconstructed from the record alone.
Primary question
The primary outcome was estimated glomerular filtration rate (eGFR), reported as a mean with standard deviation at baseline and at follow-up visits through 30 months. The stated purpose was to compare the groups on kidney-function biomarkers and a wider set of health and behavioral measures. The registry record does not report the eGFR values at the visits or a numerical between-group estimate. It therefore does not establish from the posted results whether the groups differed, or how precisely any difference was estimated.
3. Trial Design
The study was a randomized, single-masked, parallel-group trial. It was registered as phase NA and is listed as completed. Enrollment was 120, with the safety record listing 60 participants at risk in each group. The registry record gives a start date of 2010-08 and a primary completion date of 2013-07. The sponsor was National Cheng Kung University.
A parallel-group design assigns participants to one of the study groups and follows those groups over time. Random allocation can, in general, help balance measured and unmeasured participant characteristics at the start of a trial, but it does not guarantee exact balance. The registry record does not describe the allocation sequence or concealment procedures. It also does not specify who was masked. The single-masked label alone is not enough to identify whether participants, clinicians, outcome assessors, or another group were masked.
The intervention group received tailored lifestyle counseling, while the control group received usual care. The stated intervention approach used assessments of stage of change and readiness to change, with counseling related to physical activity and lifestyle change. The record describes assessment or intervention time points at baseline and at 6, 12, 18, 24, and 30 months. It does not give further detail about the counseling content, its duration, or how consistently it was delivered.
The primary outcome was eGFR at the listed time points, and the record identifies the intended population for that outcome as all participants assigned to either group. The protocol details, statistical analysis plan, and rationale for the enrollment target are not reported in the registry record. The record also does not describe interim analyses or give a detailed account of follow-up completion.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Research assistant explained the study purpose and procedure and obtained written informed consent. After completion baseline collecting, the research assistant used a paper ballot to randomly assign subjects to either the tailored intervention or a usual-care intervention in a ratio of 1:1. The subjects provided baseline data, and physical
Overall Study
| Stage | Lifestyle Counseling Program | Usual Care |
|---|---|---|
| STARTED | 60 | 60 |
| COMPLETED | 52 | 51 |
| NOT COMPLETED | 8 | 9 |
Reasons for not completing this period:
| Reason | Lifestyle Counseling Program | Usual Care |
|---|---|---|
| Lost to Follow-up | 8 | 9 |
Analysis population for the primary outcome, as defined in the registry: Intend to Treat population (all participants assign to intervention or control group).
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.
| Characteristic | Unit | Intervention Group | Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 60 | 60 | 120 | |
| Age, Continuous: age | years | 55.6 (SD 10.78) | 61.0 (SD 10.98) | 58.3 (SD 11.17) |
| Sex: Female, Male: Female | Participants | 21 | 13 | 34 |
| Sex: Female, Male: Male | Participants | 39 | 47 | 86 |
| Glomerular filtration rate (eGFR) | ml/min/1.73m2 | 55.2 (SD 19.2) | 54.6 (SD 18.0) | 54.87 (SD 18.49) |
| Body Weight | kg | 74.3 (SD 8.8) | 78.7 (SD 14.1) | 76.5 (SD 12.9) |
| Waist circumference | cm | 93.2 (SD 8.6) | 98.6 (SD 9.4) | 95.9 (SD 9.35) |
| Hip circumference | cm | 102.2 (SD 7.5) | 104.3 (SD 8.1) | 103.3 (SD 7.9) |
| Health Promotion Lifestyle Behaviors | units on a scale | 2.77 (SD 0.51) | 2.62 (SD 0.49) | 2.69 (SD 0.50) |
| Quality of Life ( WHOQOL-BREF): physical health QOL domain | units on a scale | 14.37 (SD 2.34) | 14.51 (SD 2.50) | 14.44 (SD 2.41) |
| Quality of Life ( WHOQOL-BREF): psychological health QOL domain | units on a scale | 13.72 (SD 2.88) | 13.69 (SD 2.67) | 13.71 (SD 2.76) |
| Quality of Life ( WHOQOL-BREF): social relationships QOL domain | units on a scale | 14.28 (SD 2.37) | 13.62 (SD 2.64) | 13.95 (SD 2.52) |
| Quality of Life ( WHOQOL-BREF): environment QOL domain | units on a scale | 14.55 (SD 2.36) | 14.38 (SD 2.23) | 14.46 (SD 2.29) |
| Disease-specific knowledge of renal protection checklist (RPK) | units on a scale | 94.61 (SD 8.24) | 92.30 (SD 10.87) | 93.47 (SD 9.70) |
| Perceived self-efficacy | units on a scale | 53.48 (SD 16.99) | 50.98 (SD 18.06) | 52.23 (SD 17.51) |
| perceived benefits of physical activity | units on a scale | 71.28 (SD 7.17) | 68.98 (SD 10.20) | 70.13 (SD 8.85) |
| Perceived barriers of physical activity | units on a scale | 44.13 (SD 15.82) | 44.22 (SD 14.32) | 44.18 (SD 15.02) |
6. Primary Endpoint
The registry lists the primary outcome as The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months, measured over The baseline and at 6, 12, 18, 24, and 30 months post intervention.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | ml/min/1.73 m2 |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was estimated glomerular filtration rate (eGFR), expressed in ml/min/1.73 m2. The registry record says it was estimated using the Modification of Diet in Renal Disease (MDRD) formula, which uses serum creatinine and age and includes a sex-specific term. The endpoint was to be summarized as a mean with standard deviation at baseline and at 6, 12, 18, 24, and 30 months.
In general, eGFR is used as an estimate of kidney filtration. Repeated measurements can describe how the measured kidney-function indicator changes over follow-up, while comparing groups can address whether their observed patterns differ. Such comparisons are most informative when the analysis accounts appropriately for the correlation between measurements from the same participant and for missing follow-up data.
The registry record names the endpoint and its measurement method but does not report the group means, standard deviations, changes from baseline, or a between-group estimate at any visit. It also does not give a confidence interval or p-value for the primary outcome. Consequently, the endpoint definition is available, but its observed results and the precision of any group comparison are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies eGFR as the primary outcome and describes a randomized comparison of tailored lifestyle counseling with usual care. Its planned presentation was the mean and standard deviation at baseline and at 6, 12, 18, 24, and 30 months. However, the record does not report any of those eGFR values, nor does it report a numerical contrast between the groups. The posted results therefore do not allow a reader to determine the direction or size of an observed difference in eGFR.
That distinction matters: knowing which outcome was measured is not the same as knowing what the trial found. Without group estimates and a defined comparison, there is no basis in the registry record for describing a treatment effect, its clinical importance, or whether the data are compatible with no difference. No result should be inferred from the trial title, intervention description, or completion status.
Precision also cannot be assessed from the available primary-outcome information. In general, a confidence interval gives a range of values compatible with the data and the analysis assumptions; a narrower interval indicates greater precision than a wider one. The registry record does not report a confidence interval for eGFR. It also does not give a p-value or the model used to compare the groups. The absence of these quantities in the record is not evidence that the comparison was null; it means the result is not reported there.
The primary outcome is longitudinal, with observations scheduled across follow-up. In general, a comparison at one visit answers a different question from a comparison of the overall pattern across visits. The registry record does not state whether the main analysis focused on a particular visit, change from baseline, or a model of trajectories. It describes an intention-to-treat population, but does not provide participant counts contributing data at each visit or explain how missing observations were handled.
The registry lists 12 outcome measures and 12 analyses. This indicates that multiple outcomes were recorded, but does not reveal whether the analyses were prespecified in a statistical plan or whether multiplicity was addressed. No conclusion about the primary endpoint or other outcomes can be drawn from counts alone. The appropriate reading is therefore limited: the registry describes the study question and design, while the numerical primary results and their uncertainty are not reported in the registry record.
9. Statistical Methods Explained
The registry record describes a randomized, single-masked, parallel-group study and identifies eGFR as a continuous primary outcome. It says results were to be presented as means and standard deviations at baseline and follow-up visits. The record does not specify the statistical model used for the primary comparison, so the methods below explain relevant concepts generally rather than asserting that this trial used any particular approach.
What do the mean and standard deviation describe?
In general, the mean summarizes the center of a set of measurements. The standard deviation describes how spread out individual measurements are around that mean. They answer different questions: a group mean is a summary of the typical measured level, while a standard deviation reflects variation among participants. Neither quantity on its own is a comparison between randomized groups. To interpret a group contrast, the estimate of that contrast and its uncertainty are also needed. Those numerical results are not reported in the registry record for eGFR.
Why do repeated measurements matter?
Participants were to have eGFR summarized at baseline and at 6, 12, 18, 24, and 30 months. In general, repeated observations from the same participant tend to be related; they are not equivalent to measurements from entirely separate participants. Analyses of repeated measures need to account for this within-participant correlation. A model can also distinguish differences between groups at particular visits from differences in their patterns over time. The registry record does not say which time-based comparison or model was used.
Baseline measurements can describe the groups before follow-up, while later measurements describe outcomes during follow-up. In general, comparing follow-up values while accounting for baseline can differ from comparing raw changes from baseline. The record does not report which approach was used, and it does not provide the baseline or follow-up eGFR summaries needed to reproduce a comparison.
How should uncertainty be read?
In general, an estimate is a summary of the observed data under a specified analysis, while a confidence interval conveys uncertainty around that estimate. A p-value addresses how compatible the observed data are with a null hypothesis under the model assumptions; it does not measure the size or importance of a difference. These quantities should be interpreted alongside the estimate and study design. For the primary eGFR outcome, the registry record does not report an estimate of the group contrast, a confidence interval, or a p-value.
Randomization supports a causal comparison when assignment is preserved and analysis is appropriate, but it does not remove uncertainty or solve problems caused by missing data, deviations from assigned treatment, or limitations in outcome measurement. The registry record labels the primary population as intention-to-treat, meaning the described target population includes participants assigned to either group. It does not report how that population was implemented in the analysis or how unavailable measurements were treated.
What can the planning assumptions tell us?
The registry record describes a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation; the target effect is expressed as a fraction of the observed effect. Such calculations are hypothetical planning exercises, not observed results or observed power. The record explicitly distinguishes the illustration from the trial's own design. It does not report a sample-size justification for the original study, and no planning outcome can substitute for the missing primary estimates.
The record gives 120 as enrollment and the safety listing gives 60 at risk in each group. These counts do not show how many participants contributed eGFR data at each visit. A complete statistical interpretation would require the outcome estimates, the analysis method, uncertainty measures, and information about missing observations. Those details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 12 outcome measures and 12 analyses. The study summary describes a broad set of outcomes, including kidney-function biomarkers, physical indicators, lifestyle behaviors, kidney disease knowledge, self-efficacy, perceived benefits and barriers to physical activity changes, and quality of life. Considering several outcomes can be useful for describing different aspects of an intervention, but it also creates a multiplicity issue: when many statistical comparisons are made, the chance of at least one apparently notable result can increase.
In general, a prespecified statistical analysis plan can define which outcome is primary, which comparisons are confirmatory, and whether any adjustment or hierarchy is used to interpret multiple tests. The registry record names eGFR as the primary outcome but does not report a multiplicity strategy, the full analysis plan, or whether outcome comparisons were adjusted. It would therefore be inappropriate to assume that results across outcomes were treated as independent confirmations or that a particular adjustment was applied.
The primary outcome population is described as intention-to-treat: all participants assigned to the intervention or control group. This indicates the intended analysis population, but the registry record does not explain how participants with missing measurements, treatment deviations, or incomplete follow-up were handled. It does not give eGFR participant counts at each visit, the amount or pattern of missing data, or any imputation method. These details matter because the interpretation of a longitudinal comparison can depend on who contributes measurements and how missing outcomes are addressed.
Interim analyses and stopping rules are not reported in the registry record. The registry record also does not report whether the statistical plan was finalized before outcome data were examined. These omissions limit assessment of analysis choices and selective reporting, without establishing that any particular problem occurred.
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 |
|---|---|---|---|
| Intervention Group | 0 | 60 | 0.0% |
| Control Group | 0 | 60 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention Group | 0 of 60 |
| Control Group | 0 of 60 |
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 |
|---|---|
| Intervention Group | 0 of 60 |
| Control Group | 0 of 60 |
The safety record lists 60 participants at risk in each group. For the intervention group, it records 0 serious adverse events, 0 other adverse events, and 0 deaths. For the control group, it likewise records 0 serious adverse events, 0 other adverse events, and 0 deaths. These are the posted safety counts.
In general, an adverse-event count should be read alongside the number of participants assessed, the observation period, and the rules used to collect and classify events. The registry record does not give further details about the safety collection process, event definitions, or participant-level follow-up for safety. The listed zero counts therefore describe what is recorded in the registry; they do not prove that no events occurred outside the recorded data or that an intervention has no safety risks.
The safety counts also do not establish the primary eGFR result. Safety outcomes and kidney-function measurements address different questions, and the registry record does not report the numerical eGFR results. The safety listing should be interpreted as a record of reported counts, not as evidence about the magnitude or precision of an eGFR comparison.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized comparison was conducted between a tailored lifestyle counseling program and usual care among patients with early-stage CKD. The intervention used stage-of-change and readiness-to-change assessments and was linked to physical activity and lifestyle counseling. The primary outcome was eGFR, with measurements intended at baseline and at follow-up visits through 30 months. These details define the clinical question and the measurement schedule.
They do not establish whether the intervention changed eGFR relative to usual care. The primary group means, standard deviations, between-group estimates, and measures of uncertainty are not reported in the registry record. It is therefore not possible to characterize the size, direction, or precision of the primary outcome result from the posted information. This is a limitation of what the record reports, not a finding that there was no difference.
Likewise, the registry description of the intervention does not show how much counseling participants received, whether they adhered to it, or whether the intended lifestyle changes occurred. The record identifies a range of behavioral and patient-reported outcomes but does not provide their numerical results in the information available. No conclusion about those outcomes should be inferred from the aims or intervention description.
In general, a trial result applies most directly to its enrolled population and the way the intervention and comparator were implemented. The registry record gives limited detail about eligibility, usual care, masking, and follow-up completeness, so the reach of any result cannot be evaluated fully. The appropriate conclusion is bounded: the record describes a completed randomized study and its intended primary measure, but the numerical results needed to judge comparative outcomes are not reported in the registry record.
13. Why This Trial Matters Statistically
This study raises a useful statistical question because it combines random assignment, a behavioral intervention, and repeated measurement of a continuous kidney-function indicator. For biostatisticians and clinical researchers, the design highlights that defining an outcome is only the first step. A longitudinal endpoint requires clarity about the comparison of interest, the treatment of baseline values, the role of time, and the relationship among measurements from the same participant.
The registry record also illustrates the distinction between an analysis population label and a complete analysis description. It identifies an intention-to-treat population, but does not explain the handling of missing measurements or report visit-specific participant counts. In general, those details are important for understanding the assumptions behind an estimate and judging whether the analyzed participants remain representative of the randomized groups.
The broad set of listed outcomes makes multiplicity relevant. A primary endpoint can help focus interpretation, while secondary outcomes can describe other domains; however, the interpretation depends on a prespecified strategy for handling multiple comparisons. The registry record does not report such a strategy. The listed 12 outcome measures and 12 analyses indicate scope, not the strength or consistency of evidence across outcomes.
Most importantly, this record demonstrates why transparent numerical reporting matters. Without group summaries, contrasts, and uncertainty measures for eGFR, readers cannot evaluate the primary comparison's magnitude or precision. The design and outcome definitions remain informative, but they cannot replace the results needed for statistical interpretation.
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 most direct limitation is that the registry record does not report the numerical results for the primary eGFR outcome. Although it specifies mean and standard deviation summaries across visits, it gives no group-level values, estimated contrast, confidence interval, or p-value. The primary result therefore cannot be interpreted quantitatively from the record.
Important analysis details are also not reported in the registry record. The statistical model, the primary time-based contrast, treatment of baseline measurements, and approach to repeated observations are unspecified. The record labels the target population as intention-to-treat but does not describe how missing outcomes or incomplete follow-up were handled. It also does not provide the number of participants contributing measurements at each visit.
The description of the control condition is limited to usual care, without details about its content. The registry record does not state who was masked, how the allocation sequence was generated or concealed, or how adherence to counseling was assessed. Further eligibility criteria and baseline characteristics are not reported in the information available. These gaps constrain assessment of implementation, balance, and generalizability, but do not establish that the trial had a particular flaw.
The record lists 12 outcome measures and 12 analyses but does not report whether multiplicity was addressed or whether the analysis plan was prespecified. It also does not report a sample-size justification for the trial, interim analyses, or stopping rules. The planning illustration described in the record is distinguished from the original study design and cannot fill these gaps. Finally, the posted safety counts do not include further detail about event ascertainment or the safety observation process.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Exploring Life Experience and Lifestyle Intervention Program Among Patients With CKD — NCT01194518.
- Registry record last updated 2026-05-28; status last verified 2023-01.
- Results first posted 2026-05-28.
- 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
NCT01194518 is a completed randomized, single-masked, parallel-group study sponsored by National Cheng Kung University. Enrollment was 120. The intervention was tailored lifestyle counseling based on stage-of-change and readiness-to-change assessments; the comparator was usual care. The registry record describes follow-up at baseline and at 6, 12, 18, 24, and 30 months.
The primary outcome was mean eGFR, with standard deviation, estimated using the MDRD formula. The intended primary population was all participants assigned to either group. The registry record does not report the numerical eGFR results or a between-group estimate. Its safety listing records 0 serious adverse events, 0 other adverse events, and 0 deaths in each group, with 60 participants at risk per group. Details of the statistical plan, multiplicity handling, and missing-data methods are not reported in the registry record.