Everyday Activity Supports You (EASY) Pilot Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Everyday Activity Supports You (EASY) Pilot Study (NCT01842061), a randomized na study. The primary outcome is Feasibility of Study Recruitment and Retention.

2. Clinical Question

The central statistical question is therefore about feasibility rather than a definitive estimate of physical-activity benefit. A pilot can inform whether recruitment, retention, intervention delivery, and measurement procedures appear workable enough to consider in future research. The record also describes planned economic and process evaluations intended to guide a larger study and scaled-up implementation. Results for those evaluations are not reported in the registry record. The available information does not establish a recruitment target or a threshold for judging feasibility, so the posted counts cannot be compared with a stated success criterion.

3. Trial Design

The EASY Pilot Study is recorded as a randomized, parallel-group trial with single masking. It is marked completed and has an enrollment of 25. The registry lists the study start as 2013-05 and primary completion as 2013-12. The study description calls it a 6-month feasibility study. Its phase is listed as not applicable.

Participants were assigned to the Active Living Program or the Education group. The intervention was a self-management program focused on reducing sedentary behaviour and increasing physical activity. The control group was offered monthly drop-in sessions about general health and well-being that were unrelated to physical activity. The registry does not report additional details about the randomization procedure, allocation concealment, or who was masked. Those design details are not reported in the registry record.

The primary registered outcome is the number of participants recruited and finishing the 6-month study with a final assessment. The registry displays values of 12 for Active Living Program and 8 for Education. These are presented as participant counts, not as an estimate of an intervention effect. The record separately describes mean daily step count by accelerometry at 6 months as the primary health outcome of secondary interest. Other listed secondary outcomes concern sedentary time, physical activity, body composition, and active transportation.

The study’s stated purpose was to assess feasibility and acceptability, with health, economic, and process evaluations intended to inform future research. A protocol, recruitment target, sample-size justification, detailed analysis plan, and feasibility thresholds are not reported in the registry record. The design should therefore be read as a pilot framework, not as evidence that the trial was sized or planned to provide a precise comparative estimate of a health outcome.

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

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 Feasibility of Study Recruitment and Retention, measured over 6 months.

The registered primary endpoint is a count: the number of study participants recruited and finishing the 6-month study, including completion of the final assessment. The registry displays a value of 12 for the Active Living Program and 8 for Education. These values describe participant counts for the endpoint; the record does not provide a statistical comparison or confidence interval for them.

Feasibility outcomes are used in pilot studies to describe whether key study processes can be carried out and to inform the design of future research. Recruitment and completion are relevant because a larger study depends on enrolling participants and obtaining follow-up assessments. To judge such counts against a prespecified feasibility standard, however, readers would need the target, threshold, and definitions used by the investigators. Those details are not reported in the registry record.

The endpoint is distinct from the physical-activity measure described in the study summary. Mean daily step count measured by accelerometry at 6 months is identified as a secondary health outcome, even though the summary calls it the primary health outcome. The registry’s primary outcome listing instead concerns recruitment and completion. Results for step count are not reported in the registry record. This distinction matters: a participant-count endpoint can describe study completion, but it does not itself quantify changes in steps, sedentary time, or other health measures.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record describes a randomized, parallel-group feasibility study and lists recruitment and completion as the primary outcome. It posts participant counts by group but no comparative analysis. The statistical interpretation is therefore mainly descriptive. The registry does not report an analysis plan, a model for the primary outcome, or a method for handling incomplete observations.

What does a count endpoint describe?

A count records how many participants meet a stated condition. For this study, the condition is recruitment and completion of the 6-month study with a final assessment. A count can be useful for describing feasibility, but interpretation depends on its denominator and on a benchmark set before the study. For example, readers need to know the number eligible, the number approached, the number enrolled, and how completion was defined to understand recruitment and retention fully. Those details and any prespecified thresholds are not reported in the registry record.

General statistical explanation: counts alone do not express uncertainty or establish whether groups differ. An inferential comparison would require a defined estimand, a clear analysis population, and an appropriate method for the form of the outcome and study design. A confidence interval would communicate the range of values compatible with the data under the chosen method. No such interval or comparative estimate is posted for this endpoint.

Why is there no comparative estimate?

The record indicates that values needed for a two-arm comparison of the binary endpoint are missing or not estimable. It lists no analyses. This means a recalculated unadjusted comparison cannot be formed from the posted endpoint information. No effect estimate, standard error, confidence interval, or p-value should be inferred from the arm counts. The registry’s available counts remain descriptive.

General statistical explanation: a binary outcome classifies each participant according to whether an event or condition occurred. A valid comparison generally needs the number with the event and the relevant denominator in each group, together with a clear event definition and analysis population. Although the registry identifies a participant-count endpoint and displays group values, it does not supply the information needed for the indicated two-arm binary comparison. The missing comparison is a limitation of the posted results, not evidence that the groups were equivalent.

What does randomization contribute?

Random assignment is intended to create groups that can be compared without allocating participants according to their expected outcomes. In general, randomization supports causal interpretation when allocation is implemented as planned and outcomes are collected and analyzed appropriately. It does not by itself guarantee balance in a small pilot, remove bias from missing outcomes, or replace reporting of the analysis. The record says the study was randomized but does not describe the sequence-generation or concealment procedures, nor does it post a comparative result.

The parallel design means participants were assigned to one of the two intervention groups rather than described as crossing between them. Single masking is listed, but the masked role or roles are not reported in the registry record. These missing details limit assessment of the safeguards against bias.

How should planning calculations be read?

The registry’s planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such calculations are planning aids for a hypothetical future study, not an analysis of the trial’s observed evidence and not observed power. The effect to detect is described as a stated fraction of the observed effect. Because the record does not post an estimable two-group effect for the primary endpoint, no specific planning result can be interpreted as a reliable estimate of the effect seen in this study.

General statistical explanation: planning calculations depend on assumptions about the outcome, target effect, variability, allocation, and analysis. Changing those assumptions changes the required sample size. Pilot estimates can be particularly uncertain, so a calculation based on an observed pilot effect should be treated as an illustration rather than a guarantee that a future study will achieve a particular precision. The registry does not report its own sample-size justification or the assumptions used in the original trial design.

The study also has multiple outcomes: recruitment and completion, step count, sedentary time, physical activity, body composition, and active transportation are described in the record. The statistical plan for prioritizing or analyzing these outcomes is not reported in the registry record. Accordingly, there is no basis for determining how the investigators planned to address multiple comparisons or distinguish confirmatory findings from exploratory ones.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Active Living Program", "Education")
n      <- c(12, 8)
events <- c(12, 8)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Active Living Program  12  12  100.0  73.5  100.0  75.8  100.0  75.3  99.8
ARM  Education  8  8  100.0  63.1  100.0  67.6  100.0  66.4  99.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists recruitment and completion as the primary outcome and identifies several secondary outcomes, including sedentary time, physical activity, body composition, and active transportation. The study summary also identifies mean daily step count by accelerometry at 6 months as a secondary health outcome. Although five outcome measures are recorded, the analysis details and numerical results for these outcomes are not reported in the registry record.

When a study evaluates multiple outcomes, the chance of obtaining at least one apparently unusual result can depend on how many comparisons are made and how they are interpreted. General statistical explanation: researchers may prespecify a hierarchy of outcomes, adjust inference for multiple testing, or treat secondary analyses as exploratory. The registry does not report whether any such approach was planned or used. No multiplicity adjustment or outcome hierarchy should be assumed.

Missing-data methods are not reported in the registry record. The available information does not specify how missing final assessments were handled, whether participants were analyzed according to randomized group, or whether any imputation or sensitivity analysis was used. The record also does not describe an intention-to-treat, per-protocol, or other analysis population. These details matter because incomplete follow-up can affect both feasibility estimates and comparisons of health outcomes.

The group counts displayed for the primary endpoint do not resolve these uncertainties. The record does not provide participant flow, reasons for non-completion, or denominators for all outcome analyses. It also does not give a prespecified feasibility threshold against which recruitment and completion could be judged. Thus the posted counts cannot establish whether the study met its intended feasibility criteria, and the absence of secondary results prevents assessment of the broader outcome set.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists serious adverse events for groups of 13 participants in Active Living Program and 12 in Education, with zero affected in each group. Other adverse events are also listed with those group counts at risk and zero affected. Deaths are recorded as zero for both groups. No serious adverse-event terms are listed.

These values describe the safety information posted for the study. They do not provide a comparison with uncertainty estimates, and the registry does not report event definitions, collection procedures, severity classifications beyond the serious-versus-other categories, or the period covered by the figures. The record also does not explain the relationship between the safety groups at risk and the primary outcome counts.

General statistical explanation: observing zero events in a study does not establish that the underlying risk is zero. The amount of information depends on the number observed, the follow-up period, and how events were sought and defined. The posted figures should therefore be read narrowly as no affected participants recorded in these categories in the registry results, not as a guarantee of safety or evidence that one group is safer than the other.

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

The registry record establishes that the EASY Pilot Study was a completed randomized feasibility study comparing the Active Living Program with an Education condition. It describes an intended 6-month program for women aged 55–70 years and lists recruitment and completion as the primary outcome. The posted participant-count values are 12 for Active Living Program and 8 for Education. The record also lists zero serious adverse events, zero other adverse events, and zero deaths in each group’s safety information.

These data do not show how the intervention affected daily steps, sedentary time, body composition, active transportation, or other health measures. The registry identifies these outcomes but does not report their numerical results. It also does not provide a comparative estimate or uncertainty interval for the primary endpoint. The counts cannot by themselves establish that one group had better feasibility, because denominators, participant flow, and prespecified benchmarks are not reported.

The study’s stated goals included assessing feasibility and acceptability and informing a future larger study. The posted record does not report the acceptability results, process evaluation, economic evaluation, or investigators’ conclusions about whether a larger study is warranted. Nor does it provide enough detail to determine how missing assessments or multiple outcomes were handled.

General statistical explanation: absence of a posted estimate is not the same as an estimate of no effect. It means that the registry record does not contain the information needed to quantify an effect or its precision. Likewise, zero recorded events in the safety categories does not prove the absence of risk. The defensible interpretation is limited to the descriptive information and study aims documented in the record.

14. Why This Trial Matters Statistically

This trial is statistically informative as a feasibility study because it places recruitment and completion at the center of its registered primary outcome. For pilot research, the ability to recruit participants and obtain final assessments can shape whether a larger trial is practical. The study also includes a behavioral intervention and an education comparison, making it relevant to the planning of research on sedentary behaviour and physical activity in women aged 55–70 years.

The registry record illustrates why the outcome definition and reporting context matter. A participant count is meaningful only alongside its denominator, the participant pathway, and the criteria for successful feasibility. Here, the record describes the intended endpoint and displays group counts, but does not report recruitment targets, completion criteria, or participant flow. It also lacks a comparative analysis. That combination constrains what can be concluded from the numbers.

The study description distinguishes feasibility from health-effect assessment: it names step count as a secondary health outcome while registering recruitment and completion as the primary outcome. That distinction can help readers avoid treating a pilot’s descriptive process measures as evidence about clinical or behavioral effects. Results from the secondary outcomes, and from planned economic and process evaluations, are not reported in the registry record.

More broadly, a completed pilot can support future planning only when its estimates and methods are reported with enough detail to assess uncertainty and applicability. The record does not include the original sample-size justification, analysis plan, missing-data methods, or a reported comparative effect for the primary outcome. Its statistical contribution is therefore chiefly the documentation of trial aims, design, and limited outcome counts, rather than a quantitative estimate of intervention effect.

15. 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 study constrain interpretation of the registry record. First, the trial is described as a feasibility study, and the primary endpoint concerns recruitment and completion rather than a health effect. The record does not state a target for recruitment or a threshold for acceptable completion, so the posted counts cannot be evaluated against a prespecified feasibility criterion.

Second, the record lists enrollment of 25 and group values of 12 and 8 for the primary endpoint but does not explain participant flow or the relationship among these counts. The number randomized, the number completing assessment in each group, and reasons for any missing outcomes are not reported in the registry record. This prevents a clear assessment of retention and of the denominators relevant to outcome interpretation.

Third, no comparative analysis is posted for the primary outcome, and the record indicates that a two-arm comparison for the binary endpoint could not be estimated from the available values. Results for step count and the other secondary outcomes are also not reported. The intended economic and process evaluations are described, but their findings are not reported in the registry record.

Finally, details needed to assess design and analysis quality are absent. Randomization is stated, but the sequence-generation and concealment methods are not reported. Single masking is listed without identifying who was masked. The analysis plan, multiplicity approach, missing-data procedures, analysis populations, and original sample-size justification are not reported in the registry record. The available safety figures also lack event definitions and collection details. These limitations make the record useful for describing the study’s stated design and posted counts, but insufficient for a full appraisal of its comparative results.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Everyday Activity Supports You (EASY) Pilot Study — NCT01842061.
• Registry record last updated 2021-10-14; status last verified 2021-09.
• Results first posted 2021-10-14.
• 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.

19. Record Summary

The Everyday Activity Supports You (EASY) Pilot Study is recorded as a completed, randomized, parallel-group, single-masked feasibility study with enrollment of 25. It compared the Active Living Program, a self-management program intended to reduce sedentary behaviour and increase activity, with Education sessions about general health and well-being unrelated to physical activity. The study was intended for women aged 55–70 years and was described as lasting 6 months.

The registered primary outcome is the number of participants recruited and finishing the study with a final assessment. The record displays values of 12 for Active Living Program and 8 for Education, but no comparative estimate is posted. Mean daily step count at 6 months and other behavioral and body-composition outcomes are described, while their numerical results are not reported in the registry record. Safety figures list zero serious adverse events, zero other adverse events, and zero deaths in each group. The record does not report the analysis plan, missing-data methods, feasibility thresholds, or original sample-size justification.