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 Shift-and-persist and Cardiometabolic Markers Among Women in Puerto Rico (NCT06250738), a na na study. The primary outcome is Rates of Recruitment and Retention.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06250738 |
| Phase | NA |
| Condition | Psychological Distress, Cardiometabolic Syndrome |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 24 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Emory University |
| Results posted | Yes |
2. Clinical Question
Population
The study population was young women in Puerto Rico with elevated stress. The registry record lists an enrollment of 24 participants. It does not report further eligibility details, such as how elevated stress was defined, the participants’ age range, or the recruitment setting. Those details matter when judging how closely the study population resembles other groups of women or people experiencing stress.
Intervention
The intervention was a virtual mindfulness-based stress reduction program, alongside home exercises. Participants were asked to attend 4 weekly virtual sessions and complete daily mindfulness exercises at home. They were also asked to complete online study questionnaires. The stated purpose was to examine feasibility and acceptability, as well as changes in psychological and cardiometabolic measures. The registry record does not report how many participants attended sessions or completed the exercises.
Comparator
This was a single-group study, not a randomized comparison. The registry record lists no control group or alternative intervention. The central comparison is therefore over time within the study population, rather than between groups assigned to different conditions. Changes measured after participation cannot, by themselves, separate effects of the program from other influences that may change over time.
Primary question
The named primary outcome is rates of recruitment and retention, measured as participant counts at baseline, week 4, and week 8. The study description also asks whether the program is feasible and acceptable and what changes occur in psychological resilience, psychological distress, health behaviors, and cardiometabolic markers. Secondary outcomes include several measures of symptoms, stress, mindfulness, psychological flexibility, and shift-and-persist. Numerical results for these outcomes are not reported in the registry record.
3. Trial Design
This completed pilot enrolled 24 participants and used a single-group design. The registry record lists allocation as not applicable and masking as none. There was no randomized control arm, so the design does not support a direct comparison of outcomes between intervention and control groups. The intervention combined a virtual mindfulness-based stress reduction program with home exercises. Participants were asked to take part in 4 weekly virtual sessions, practice mindfulness at home daily, and complete online questionnaires.
The primary outcome is titled “Rates of Recruitment and Retention.” It is defined as the number of participants at the beginning of the study compared with the number at the end. The listed assessment time points are baseline, week 4, and week 8. The registry record does not give the actual participant counts at those time points or state how the recruitment and retention measures were calculated from them.
The study description identifies feasibility and acceptability as central aims. It also describes questions about changes in psychological resilience, psychological distress, health behaviors, and cardiometabolic markers. Named secondary measures include depression symptoms, anxiety symptoms, PTSD symptoms, perceived stress, shift-and-persist, mindfulness, and psychological flexibility. The registry record lists 12 outcome measures but reports no analyses. It does not provide results for the named outcomes, an analysis plan, or details of the questionnaires beyond the measure names in the outcome list.
The registry status is completed. Completion status does not itself establish that outcome data or statistical findings are available. The registry record does not report a sample-size justification, planned interim analyses, or the statistical methods used to analyze outcomes. Those omissions limit how fully the design and results can be assessed.
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 | Study Population |
|---|---|
| STARTED | 24 |
| COMPLETED | 23 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Study Population |
|---|---|
| Lost to Follow-up | 1 |
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 | Study Population |
|---|---|---|
| Participants analysed | 24 | |
| Age, Continuous | years | 25.7 (SD 3.1) |
| Sex: Female, Male: Female | Participants | 24 |
| Sex: Female, Male: Male | Participants | 0 |
| Race and Ethnicity Not Collected | Participants | — |
| Education level: High school graduate-some college | Participants | 6 |
| Education level: Undergraduate | Participants | 8 |
| Education level: Graduate | Participants | 10 |
| Employment status: Student | Participants | 11 |
| Employment status: Working full/part time | Participants | 12 |
| Employment status: Other | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Rates of Recruitment and Retention, measured over Baseline, week 4, week 8.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants, with recruitment and retention assessed at baseline, week 4, and week 8. The description frames the measure as the number at the beginning of the study compared with the number at the end. Such counts can help describe whether participants entered a study and remained through follow-up, which are practical aspects of feasibility. In a pilot, these questions can be important even when the study is not designed to estimate a treatment effect against a control group.
A count is not the same as a retention rate unless the numerator, denominator, and calculation are specified. The endpoint title uses the word “rates,” but the listed unit is participants and the parameter is a participant count. The registry record does not report a formula for recruitment or retention rates, a threshold for acceptable feasibility, or the participant counts at each assessment time. Therefore, the endpoint’s intended purpose can be described, but its numerical result and whether it met any criterion cannot be determined from the registry record.
Baseline, week 4, and week 8 allow participant numbers to be considered across the study timeline, but the registry record does not specify how missing follow-up observations were handled. Counts at these points would describe study participation; they would not establish whether mindfulness changed psychological or cardiometabolic outcomes. Those outcomes require their own reported measurements and analyses, which are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a completed pilot with 24 enrolled participants, a single-group design, and a virtual mindfulness program with home exercises. It names recruitment and retention counts as the primary outcome and lists assessment points at baseline, week 4, and week 8. These design details define the questions the study was intended to address, but they are not outcome findings. Numerical participant counts at the listed time points are not reported in the registry record.
Consequently, the posted information does not establish how many participants were recruited or retained, whether participants found the program acceptable, or whether it was feasible according to any prespecified standard. No acceptance threshold or operational definition of feasibility is reported in the registry record. The program’s stated schedule describes what participants were asked to do, not how much of the program they completed.
The study also aimed to examine changes in psychological resilience, psychological distress, health behaviors, and cardiometabolic markers. The named secondary measures cover depression, anxiety, PTSD symptoms, perceived stress, shift-and-persist, mindfulness, and psychological flexibility. However, outcome values, changes from baseline, uncertainty intervals, and statistical tests are not reported in the registry record. The registry lists 12 outcome measures and zero analyses. That means the listed information is not enough to quantify the direction, size, or precision of any change.
General statistical interpretation: in a single-group study, a before-and-after difference describes how measurements changed over time among participants with data. It does not isolate the effect of an intervention from other possible explanations, such as natural changes, concurrent events, or changes in who provides follow-up data. Without a comparison group, those explanations cannot be separated by a randomized contrast.
No confidence intervals or p-values are reported. General statistical interpretation: a confidence interval communicates uncertainty around an estimated quantity, while a p-value assesses compatibility of data with a specified statistical model and null hypothesis. Neither can be reconstructed responsibly without the relevant results and analysis details. The enrollment count alone does not show whether an outcome estimate would be precise.
The record’s status of completed indicates that the study is listed as completed, but completion is not evidence of a particular result. The defensible interpretation is limited to the study’s design, planned questions, and reported enrollment. Conclusions about feasibility, acceptability, psychological change, cardiometabolic change, or safety beyond the posted event counts are not supported by the registry information.
9. Statistical Methods Explained
What does a single-group design estimate?
This study is listed as a single-group trial with no randomized allocation and no masking. In general, a single-group design can describe measurements in participants who take part in an intervention and can track how those measurements vary over time. It does not create a concurrent comparison group that represents what would have happened without the intervention. A change after participation can therefore be described as a time-related change in the observed group, but it cannot automatically be attributed to the program.
For a randomized comparison, assignment is used to make groups comparable on average, subject to the study’s design and conduct. That design feature is absent. The registry record does not report a non-randomized comparison group either. Accordingly, comparisons between this study population and an external population would require information and assumptions that are not reported in the registry record. No such comparison is described in the posted results.
How should participant counts be understood?
The primary outcome is a participant count at baseline, week 4, and week 8, with the description comparing the beginning and end of the study. Counts can describe how many participants were present at an assessment. For recruitment, a count can reflect entry into a study; for retention, counts at later assessments can describe continued participation. These are useful feasibility indicators, but the meaning depends on definitions, denominators, and rules for determining whether a participant counts at each point.
The registry record does not report a formula for the named recruitment and retention rates, actual counts at the assessment times, or a criterion for interpreting feasibility. A count should not be recast as a percentage or a rate without the relevant definition and data. The listed unit is participants, so the primary endpoint is best described as participant counts rather than as a reported numerical rate.
What can be learned from repeated measurements?
General statistical explanation: when the same participants are assessed over time, measurements from one participant are usually related to one another. An analysis of repeated measurements should account for that within-person dependence rather than treating every measurement as if it came from a different person. The choice of method also depends on the outcome type, the number and timing of observations, the amount of missing data, and the research question.
The registry record does not report whether the secondary outcomes were analyzed as changes from baseline, as values at follow-up, or using another approach. It does not report model specifications, covariate adjustment, or handling of repeated observations. No analysis method can therefore be attributed to this study based on the registry information.
What do estimates and uncertainty communicate?
General statistical explanation: an estimated change describes the size and direction of a difference under a defined calculation. A confidence interval describes the range of values compatible with the data and statistical assumptions at a stated confidence level. Narrower intervals generally indicate greater precision, while wider intervals indicate more uncertainty. A p-value, when used, addresses compatibility with a null hypothesis under a particular model; it does not measure the size or practical importance of an effect.
None of these outcome estimates or uncertainty measures are reported in the registry record. The enrollment count of 24 does not allow them to be inferred. Nor can missing means, count distributions, or participant-level changes be reconstructed from the study description. The registry record reports zero analyses, so there are no posted statistical tests to interpret.
How do planning illustrations differ from findings?
General statistical explanation: a sample-size calculation is a planning tool based on assumptions about the design, outcome, variability, significance level, and effect of interest. It does not show that a study achieved a particular power after data collection, and a planning illustration is not an observed result. The sample-size assumptions described for this record specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect stated as a fraction of an observed effect. They are explicitly planning assumptions, not the trial’s own design.
Those assumptions do not match the listed single-group design: the trial has no two-arm allocation. The registry record does not report numerical sample-size illustrations or an observed effect estimate from which to interpret them. Such assumptions cannot be treated as the study’s protocol, a justification for enrolling 24 participants, or evidence of observed power. The registry record does not report the sample-size justification or the trial’s own statistical plan.
Why does count variability matter?
General statistical explanation: count outcomes can have different distributions depending on how frequently events occur and how variable the counts are. Some count models assume a particular relationship between the average count and its variability. Over-dispersion means that observed variability exceeds what a model assumes; if it is ignored, standard errors and uncertainty estimates may be misleading. Whether that issue applies depends on the data and model. The registry record does not report a count model, count distribution, or relevant outcome data, so no claim about over-dispersion can be made for this study.
The same caution applies to the listed cardiometabolic and psychological measures: their scales, summary statistics, and analysis choices are not reported in enough detail to assess distributional assumptions or model fit. General methods guidance can explain what those choices mean, but it cannot substitute for the missing analysis record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 12 outcome measures, including the primary participant-count outcome and secondary measures of depression, anxiety, PTSD symptoms, perceived stress, shift-and-persist, mindfulness, and psychological flexibility. The study description also identifies psychological resilience, health behaviors, and cardiometabolic markers as areas of interest. The record reports zero analyses and does not report results or a statistical analysis plan.
When a study evaluates several outcomes or makes several statistical comparisons, the chance of at least one apparently unusual finding can increase. General statistical explanation: multiplicity procedures can control that risk, or investigators can identify a small set of primary hypotheses in advance and interpret secondary analyses as exploratory. The registry record does not report a multiplicity strategy, a hierarchy among outcomes beyond the named primary outcome, or which outcomes were included in any analysis.
Missing-data methods are also not reported in the registry record. This matters because later measurements may be unavailable for some participants, and the reasons for missingness can affect interpretation. The primary outcome concerns participant counts at baseline, week 4, and week 8, but no counts or rules for incomplete follow-up are reported. For questionnaire and marker outcomes, the record does not describe how incomplete responses or missing measurements were handled.
The analysis populations are not reported in the registry record. There is no stated intention-to-treat, per-protocol, or other analysis population, and no description of exclusions from analyses. Without those details and the actual data, the extent to which analyses include all enrolled participants cannot be assessed. The absence of reported results should not be interpreted as evidence that no data were collected; it means the registry record does not give the information needed to evaluate those analyses.
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 |
|---|---|---|---|
| Study Population | 0 | 24 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Study Population | 0 of 24 |
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 |
|---|---|
| Study Population | 0 of 24 |
The serious adverse event listing identifies the study population as the group at risk. It reports 24 participants at risk, 0 affected by a serious adverse event, and 0 deaths. It also reports 24 at risk for other adverse events and 0 affected. No top serious adverse-event terms are listed.
These figures describe what is recorded in the registry, not a complete account of every possible safety outcome. A zero count in the posted record means no events are listed in that category; it does not prove that an event was impossible or that the intervention is risk-free. The registry record does not provide event definitions, the observation period for the safety counts, collection procedures, severity details beyond the serious-event category, or information about whether events were judged related to the intervention.
General statistical explanation: when an event is uncommon, a small study can provide limited precision about how often it occurs. A count of zero is therefore not equivalent to a precise estimate of zero risk. No uncertainty interval is reported for these event counts, and no further safety analysis is reported in the registry record. The figures should be read as descriptive counts for the listed study population, not as a comparative safety estimate, since this was a single-group study without a control arm.
12. What the Result Does, and Does Not, Mean
The registry record supports a description of a completed pilot that enrolled 24 young women in Puerto Rico with elevated stress. Participants were asked to attend 4 weekly virtual mindfulness sessions, practice daily at home, and complete online questionnaires. The primary question concerned recruitment and retention, with participant counts intended at baseline, week 4, and week 8. The record also names psychological and cardiometabolic outcomes as areas of interest.
It does not report the participant counts at the assessment times, results for the psychological or cardiometabolic measures, or analyses. Therefore, the posted information does not establish whether recruitment or retention met a feasibility target, whether the program was acceptable, or whether any measure changed. It also does not provide estimates of the size or precision of any outcome change. The absence of reported results is not evidence that no change occurred in either direction.
General statistical interpretation: even if within-group changes were reported, a single-group design would describe change over time among observed participants, not a randomized treatment effect. Other explanations for a change cannot be ruled out with a concurrent randomized comparison because none is listed. The registry record also does not report missing-data procedures or analysis populations, which would be important to understand who contributed to any outcome estimates.
The safety listing reports no serious adverse events, other adverse events, or deaths among the listed study population. These are descriptive registry counts, not proof that no risk exists. The study’s small enrolled group and lack of a control arm also mean these counts do not provide a comparative safety estimate.
In short, the record communicates the study’s aims, design, intervention schedule, enrollment, and listed safety counts. It does not provide the outcome evidence needed to determine what happened to recruitment, retention, acceptability, psychological measures, or cardiometabolic markers.
13. Why This Trial Matters Statistically
Feasibility pilots address whether a study approach can be carried out and whether participants engage with its procedures. That focus differs from estimating a definitive treatment effect. In this record, the stated feasibility and acceptability questions sit alongside planned assessments of psychological and cardiometabolic outcomes. Keeping those aims distinct is important: a study can be informative about participation procedures even when it cannot establish comparative effects, but the relevant feasibility results still need to be reported.
The design is statistically important because it is single-group. Without a randomized comparison, observed changes over time cannot be separated from other influences that may occur during the same period. This is especially relevant when a study’s aims include changes in symptoms, behaviors, and markers. A change score alone, if reported, would not have the same interpretation as a difference between randomized groups.
The primary endpoint also illustrates why operational definitions matter. The title refers to recruitment and retention rates, while the listed unit and parameter describe participant counts. Counts can be useful, but a reader needs actual values, denominators, timing rules, and criteria for judging feasibility to interpret them fully. These details are not reported in the registry record.
Finally, the listing of 12 outcomes makes transparency about analysis choices important. Outcome definitions, analysis populations, missing-data handling, multiplicity decisions, estimates, and uncertainty would help readers judge how much weight to place on any findings. The registry record does not report these analyses. That limits both statistical interpretation and the ability to distinguish planned questions from reported evidence.
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 study follow from the registry information. The enrollment was 24, and the design was single-group, with no randomized comparison arm. This means that any within-participant changes, if reported elsewhere, would not by themselves isolate the effect of the mindfulness program from other changes over time. The record does not report an external comparison group or methods for adjusting for potential confounding.
The target population is described as young women in Puerto Rico with elevated stress, but the registry record does not report an age range, detailed eligibility criteria, recruitment setting, or how elevated stress was defined. The extent to which the participants represent a broader population therefore cannot be assessed from the record. The registry also does not report the number of participants who completed each session, their adherence to daily home exercises, or acceptability findings.
The primary endpoint is described through participant counts at baseline, week 4, and week 8, but no actual counts or definition of the named rates are reported. No feasibility threshold is stated. The record lists 12 outcome measures and zero analyses; numerical outcome results, uncertainty estimates, and analysis methods are not reported. Missing-data procedures, analysis populations, multiplicity handling, and sample-size justification are also not reported in the registry record.
The safety listing reports zero serious adverse events, zero other adverse events, and zero deaths among 24 participants at risk. The record does not provide additional details about how events were collected, the observation period, or event relatedness. These limits mean the safety figures should be interpreted as registry counts rather than a complete comparative safety assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Shift-and-persist and Cardiometabolic Markers Among Women in Puerto Rico — NCT06250738.
- Registry record last updated 2025-06-27; status last verified 2025-06.
- Results first posted 2025-06-27.
- 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
This completed pilot studied a virtual mindfulness-based stress reduction program and home exercises among young women in Puerto Rico with elevated stress. The registry record lists 24 participants, a single-group design, no masking, and no randomized allocation. Participants were asked to attend 4 weekly virtual sessions, practice at home daily, and complete online questionnaires.
The primary outcome is recruitment and retention, expressed as participant counts at baseline, week 4, and week 8. The record also lists psychological and cardiometabolic questions and 12 outcome measures. It reports zero analyses and does not report numerical results for recruitment, retention, acceptability, or the psychological and cardiometabolic measures.
For safety, the listing reports 0 serious adverse events, 0 other adverse events, and 0 deaths among 24 participants at risk. The registry record does not report a statistical analysis plan, missing-data methods, analysis populations, or a sample-size justification. The available information therefore describes the study’s design and aims but does not establish its outcome findings.