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 Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus (NCT02093702), a randomized na study. The primary outcome is Mean Change in Hemoglobin A1c (HbA1c) Levels.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02093702 |
| Phase | NA |
| Condition | Type 2 Diabetes Mellitus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 5 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Royal Victoria Hospital, Canada |
| Results posted | Yes |
2. Clinical Question
The study asks whether structured physical-activity education and behavior counseling, compared with standard education about physical activity and exercise, are associated with changes in hemoglobin A1c for people with type 2 diabetes. The primary outcome is mean change in hemoglobin A1c, measured from baseline to 12 months and reported in mmol/mol. The registry also describes blood pressure, lipid profile, body mass index, waist circumference, and adherence to physical-activity recommendations as study interests.
Population
Patients with type 2 diabetes mellitus. The record lists enrollment of 5; the posted outcome groups report 2 participants in the standard-education arm and 3 in the structured-education arm.
Intervention
Structured physical-activity and exercise education with behavior counseling from a Registered Kinesiologist. The arm description also mentions access to a community health and fitness centre, exercise instruction, and ongoing support and motivation.
Comparator
Unstructured or standard physical-activity and exercise education delivered by a Certified Diabetes Educator.
Primary question
What mean change in hemoglobin A1c was reported from baseline to 12 months in each education group?
The registry describes the study as a pilot and frames its objective as assessing potential effects on disease-related measures as well as compliance and retention in a structured exercise program. The posted results do not provide a formal comparative estimate or a statistical test for the primary outcome. Consequently, the arm-specific means describe what was recorded, but do not by themselves establish the size or precision of a between-group effect.
3. Trial Design
The registry identifies NCT02093702 as a completed, randomized, parallel-group pilot study sponsored by Royal Victoria Hospital, Canada. The listed start date is 2014-04 and primary completion date is 2015-09. The phase is recorded as NA. The study is marked as having no masking, so the registry does not describe it as a blinded trial.
Participants were assigned to structured physical-activity education or standard physical-activity education. The structured program is described as education and behavior counseling from a qualified Exercise Specialist, identified in the intervention record as a Registered Kinesiologist. Its arm description also includes access to a community health and fitness centre, exercise instruction, and ongoing support and motivation. The comparator arm is described as receiving the standard approach from a Certified Diabetes Educator.
The arm descriptions state that 50 subjects would receive each approach, whereas the registry’s enrollment field records 5. The posted primary-outcome groups have reported counts of 2 for standard education and 3 for structured education. These record entries describe different aspects of the trial and do not explain the difference between planned arm descriptions and recorded enrollment. The reason is not reported in the registry record.
The primary endpoint is mean change in hemoglobin A1c at baseline and 12 months. The stated study aims also encompass blood pressure, lipids, body mass index, waist circumference, and adherence to exercise recommendations. The registry lists two secondary outcomes concerning adherence to aerobic and resistance exercise recommendations. Further details about the allocation procedure, concealment, follow-up schedule beyond the primary endpoint timeframe, and implementation of the program 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 | Standard PA Education for People With T2DM (From a CDE) | Structured PA Education Program for People With T2DM |
|---|---|---|
| STARTED | 2 | 3 |
| COMPLETED | 2 | 3 |
| NOT COMPLETED | 0 | 0 |
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 | Standard PA Education for People With T2DM (From a CDE) | Structured PA Education Program for People With T2DM | Total |
|---|---|---|---|---|
| Participants analysed | 2 | 3 | 5 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 3 | 5 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 1 | 2 | 3 |
| Sex: Female, Male: Male | Participants | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Change in Hemoglobin A1c (HbA1c) Levels, measured over Baseline and 12 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | mmol/mol |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is mean change in hemoglobin A1c (HbA1c) levels, reported in mmol/mol, with the timeframe recorded as baseline and 12 months. Hemoglobin A1c reflects glucose attached to hemoglobin over time and is used in diabetes research as a measure of longer-term glycemic status. In a trial, measuring change over a stated follow-up period can describe how this measure differs from its baseline value in each group.
The registry reports the endpoint as a mean and identifies its dispersion as a full range. The posted mean change is 0.001 in the standard physical-activity education group and -0.007 in the structured physical-activity education group. The record does not explain the sign convention for change, such as the order in which follow-up and baseline values were subtracted. That detail matters when assigning a direction to a positive or negative change, so the signs should be read as recorded rather than given a clinical interpretation.
A group mean is a summary of the observed values, not a measure of how variable each individual’s response was, and a range is not a confidence interval. The registry does not post a between-group estimate, confidence interval, or statistical test for this endpoint. It also does not state how missing measurements, if any, were handled. The recorded endpoint therefore identifies the outcome of interest and gives arm-level summaries, but it does not fully describe the uncertainty in a comparative treatment effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary-outcome record gives a mean change of 0.001 for standard physical-activity education and -0.007 for structured physical-activity education. The corresponding outcome-group counts are 2 and 3. These are descriptive summaries from the posted record. The positive and negative signs indicate that the recorded means lie on opposite sides of zero, but the registry does not specify the subtraction convention used to calculate change. They should not be translated into a claim that one group improved more without that definition and a direct comparison.
The record identifies the outcome dispersion as a full range. A range describes the span of observed values; it does not quantify uncertainty in the group mean in the same way as a confidence interval. The registry’s posted arm summaries do not include a confidence interval for a difference between groups, a standard error for that difference, or a p-value. No comparative analysis for the primary outcome is listed. Thus, the posted results do not establish whether the groups differed beyond what could reasonably be expected from sampling variability.
The very small recorded outcome-group counts mean that the arm-level summaries should be treated cautiously. With so few recorded observations, individual values can strongly influence a mean, and the data provide limited information about the range of possible results in a broader population. This is a general statistical limitation of small samples, not evidence about what happened to any participant. The registry does not report a sample-size justification or a precision target for the primary comparison.
The arm descriptions mention 50 subjects in each group, while the enrollment field records 5 and the primary-outcome counts are 2 and 3. The record does not explain this difference. It is therefore important to keep the intended descriptions separate from the recorded enrollment and outcome counts rather than infer that all planned participants were enrolled or analyzed. Reasons for the outcome counts and any exclusions or losses to follow-up are not reported in the registry record.
The record includes other study interests, including blood pressure, lipids, body mass index, waist circumference, and adherence outcomes, but it does not post analysis results for those measures in the registry record for this interpretation. The registry lists 12 outcome measures and identifies two secondary adherence outcomes. No analysis entries are listed. Without reported estimates and methods for the other measures, their findings cannot be characterized.
The result is best read as an incomplete descriptive record of a pilot study’s primary endpoint. It documents the direction and magnitude of each arm’s posted mean as recorded, but does not supply enough comparative statistical information to establish an effect or its precision. The registry record also does not report a prespecified analysis plan, handling of missing data, or analysis population. Those omissions limit how far the summaries can be interpreted.
9. Statistical Methods Explained
Randomized parallel-group design
Randomization is intended to make assignment independent of participants’ measured and unmeasured characteristics, on average, so that a comparison between assigned groups can support a causal interpretation when the trial is sufficiently well conducted and analyzed. In a parallel-group design, participants remain in their assigned group while outcomes are followed. Randomization does not guarantee that groups will be balanced in a small study, and it does not remove uncertainty from a small number of observations. The registry says allocation was randomized, but the sequence-generation procedure and allocation concealment are not reported in the registry record.
The record lists no masking. When participants and intervention staff know which education approach is being delivered, expectations and behavior may differ between groups. This is a general consideration for behavior-based interventions. Whether outcome assessors or data analysts were masked is not reported in the registry record.
What does a mean change describe?
A mean change summarizes the average change recorded among participants with data, according to the study’s definition of change. It can be useful for describing the central tendency of an outcome, but it does not show how many participants changed in a particular direction, whether the values cluster near the mean, or how uncertain the mean is. Those questions require additional summaries or an analysis that accounts for sampling variability.
The registry identifies the primary endpoint as a mean and its dispersion as a full range. The range reports the observed span, while a confidence interval would describe uncertainty around an estimate under a statistical model. These quantities answer different questions. The range should not be read as a confidence interval, and the record does not post a confidence interval for the difference between groups.
How should the group results be compared?
A trial’s comparative question is generally addressed by estimating the difference between groups and reporting its uncertainty. A confidence interval gives a set of values compatible with the data and the assumptions of the analysis; it communicates precision as well as the direction and scale of an estimated effect. A statistical test can address compatibility with a specified null hypothesis, but a p-value alone does not measure clinical importance or prove that a treatment effect is present or absent.
No comparative estimate, confidence interval, or p-value for the primary endpoint is listed in the registry record. The posted means therefore do not supply the full statistical comparison. The difference between the means must not be calculated from the arm summaries for this interpretation. A reader should not infer statistical significance from the signs or apparent separation of the reported values.
What is the role of sample-size planning?
Sample-size planning asks how many participants would be needed for a future study to target a chosen effect size and level of statistical precision or power under stated assumptions. A planning illustration is not a result from the current trial, and it is not observed power. The registry’s planning description says its illustrations use the observed effect, a stated fraction of that effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also distinguishes participant-per-arm planning from total-event planning for time-to-event outcomes.
These assumptions describe a calculation framework; they do not establish that the trial itself was designed using that framework. The registry does not report the trial’s own sample-size justification. In particular, no conclusion should be drawn about the adequacy of the design from a planning illustration based on an observed result. Observed effects from small studies can be unstable, so using them as planning inputs can produce estimates that vary substantially if the study were repeated.
Why can over-dispersion matter?
For count outcomes, a statistical model may assume a particular relationship between the mean and variability. Over-dispersion occurs when observed variability is greater than that assumed by a model. If it is ignored, estimated uncertainty can be too small, making intervals too narrow and tests too optimistic. This is a general statistical concept; the primary endpoint in this registry is a continuous mean-change outcome, and the record does not report a count-outcome analysis or identify over-dispersion as an issue.
More generally, analysis choices should follow the outcome type and trial design. For continuous measurements such as hemoglobin A1c, a full analysis would explain the model or estimator, adjustment for baseline values if used, assumptions about the outcome distribution, and the handling of missing observations. Those details are not reported in the registry record, so no particular method should be assumed.
The record lists zero analysis entries. It therefore does not identify an analysis population, covariate-adjusted model, or strategy for multiplicity. Statistical methods describe general principles and do not imply that any specific procedure was used in this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 12 outcome measures, including the primary hemoglobin A1c outcome and two secondary outcomes concerning adherence to aerobic and resistance exercise recommendations. The study description also names blood pressure, lipids, body mass index, and waist circumference among the measures of interest. When a study examines several outcomes, the chance of a false-positive finding can increase if each is tested separately without accounting for the multiplicity of tests. This is a general statistical concern, not a claim that a false-positive result occurred in this trial.
A multiplicity strategy could specify which endpoint is primary, how secondary comparisons will be interpreted, or whether adjustments will be used. The registry record does not report such a strategy. It lists 0 analyses, so no posted analysis results or testing hierarchy are available to assess. The result summaries considered for the primary endpoint do not include a p-value or comparative confidence interval.
Missing-data methods can also affect interpretation. The record gives outcome-group counts of 2 and 3 and enrollment of 5, but does not explain whether any measurements were missing, why the counts differ from the arm descriptions, or how missing values were handled. The analysis population—such as all randomized participants or only those with measured outcomes—is not reported in the registry record. No imputation method, sensitivity analysis, or follow-up completeness information is reported.
These omissions matter because estimates based only on participants with recorded outcomes can be affected if outcome availability is related to health, assignment, or response. That is a general possibility, not evidence that such a pattern occurred. The registry record does not provide enough information to assess it or to determine how robust the posted summaries are to missing data.
11. What the Result Does, and Does Not, Mean
The posted result gives an arm-specific mean change in hemoglobin A1c: 0.001 for standard education and -0.007 for structured education. It is a descriptive summary of the participants represented in the registry’s outcome groups. The recorded outcome is relevant to the study’s stated question about changes in hemoglobin A1c over the baseline-to-12-month timeframe.
The result does not, on its own, show that the education approaches caused different outcomes. A randomized design can support a comparison, but interpretation requires a clearly defined comparative estimate and its uncertainty, as well as information about the conduct and analysis of the trial. The registry record does not post a between-group estimate, confidence interval, or statistical test for the primary endpoint. It also does not specify the change sign convention, so the direction of change cannot be assigned a clinical meaning from the signs alone.
The posted group counts are 2 and 3, while the record’s enrollment field is 5 and the arm descriptions state 50 subjects for each approach. The registry does not explain these entries. The small outcome-group counts limit the precision and generalizability of the summaries, but the record does not provide enough information to quantify that uncertainty for the group comparison.
The study is identified as a pilot, and the registry describes interests beyond the primary endpoint, including adherence and other clinical measures. The available record does not report results for those other measures. Nor does it provide evidence about longer-term outcomes beyond the stated primary timeframe, or about how well the structured program could be implemented in other settings.
Accordingly, the result documents what was posted for the primary endpoint but does not establish a treatment effect, its clinical importance, or the reliability of a comparative conclusion. It should be interpreted as a limited descriptive record rather than a definitive estimate.
12. Why This Trial Matters Statistically
This trial is statistically notable because it connects a randomized design with a very small recorded outcome sample and a behavioral intervention. Randomization is valuable for reducing systematic differences between groups, but it cannot make a small set of observations precise. In a small pilot, group means can be particularly sensitive to individual observations, and estimates may vary substantially across repetitions of a study.
The registry’s entries also illustrate why a planned arm description, enrollment field, and analyzed outcome counts should not be treated as interchangeable. The arm descriptions state 50 subjects per approach, the enrollment field records 5, and the primary-outcome groups report counts of 2 and 3. Because the record does not explain the differences, readers cannot determine from these entries alone how recruitment, follow-up, or analysis proceeded.
The primary endpoint is named and its timeframe and unit are recorded, which helps identify what the trial intended to measure. However, a mean for each group is not a complete comparative analysis. A between-group estimate with an uncertainty interval, together with a transparent account of analysis and missing observations, would be needed to assess the magnitude and precision of the comparison.
The study also names several other clinical measures and adherence outcomes. Considering multiple outcomes makes it important to distinguish a primary question from secondary or exploratory questions and to describe how results will be interpreted. That statistical plan is not reported in the registry record. With no analysis entries listed, the posted record offers a useful example of how incomplete reporting constrains interpretation even when the broad study question and primary outcome are clear.
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. The most apparent is the difference between the arm descriptions, which state that 50 subjects would receive each approach, and the enrollment field, which records 5. The primary-outcome groups report 2 and 3 participants. No explanation is reported in the registry record, so it is not possible to identify whether these entries reflect a change in recruitment plans, incomplete follow-up, exclusions, or another reason.
The primary endpoint is described as mean change from baseline to 12 months, but the record does not define the sign convention or provide a detailed measurement and analysis procedure. It identifies the dispersion as a full range, but does not provide a comparative confidence interval or a statistical test in the available outcome information. The arm-level summaries therefore do not establish the precision of a between-group result.
Additional design and conduct details are not reported in the registry record. These include the randomization procedure, concealment of assignments, whether outcome assessors were masked, the analysis population, adherence to the assigned education approach, and the extent and reasons for missing data. The study is marked as having no masking, but the record does not specify whether masking was used for any particular role.
The registry lists outcomes beyond hemoglobin A1c, but analysis results for those measures are not available in the record. A multiplicity plan and the trial’s own sample-size justification are also not reported. These limits restrict assessment of completeness, risk of selective emphasis, and the strength of any comparative interpretation. They do not show that any specific bias occurred; they identify information that is unavailable from the registry record.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus — NCT02093702.
- Registry record last updated 2016-10-06; status last verified 2016-08.
- Results first posted 2016-10-06.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
17. Record Summary
NCT02093702 is a completed, randomized, parallel-group pilot study of structured versus standard physical-activity education for patients with type 2 diabetes mellitus. It is sponsored by Royal Victoria Hospital, Canada, and is recorded as having no masking. The registry lists a start date of 2014-04 and primary completion date of 2015-09.
The primary endpoint is mean change in hemoglobin A1c from baseline to 12 months, in mmol/mol. The posted means are 0.001 for standard education and -0.007 for structured education. The outcome-group counts are 2 and 3, respectively. The registry also lists 12 outcome measures and two secondary adherence outcomes, but no analysis entries.
The record does not report a comparative estimate or uncertainty interval for the primary outcome, explain the different enrollment and arm-description entries, or describe missing-data handling and the analysis population. The posted values therefore support a descriptive account of the registered outcome summaries, not a definitive comparative conclusion.