MOBILE Intervention in College Students With Elevated Blood Pressure: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for MOBILE Intervention in College Students With Elevated Blood Pressure (NCT05956925), a randomized na study. The primary outcome is BP Level.

2. Clinical Question

The study asks whether MOBILE can be implemented with college students who have elevated blood pressure and whether it can collect self-measured blood pressure over the intervention period. The intervention combines daily measurement with a motivation rating and tailored text messages. The control description includes an educational session and planned follow-up assessments. The record does not give enough analyzed outcome information to determine how blood pressure changed in either group or whether the groups differed.

The brief summary describes a formative phase to refine intervention messages and a later trial intended to evaluate feasibility. It refers to planned recruitment of 42 students, including 8-10 students in formative work and 32 in the feasibility aim. The registry lists enrollment as 29. The record does not explain how these figures relate to one another or identify the number included in any outcome analysis.

3. Trial Design

The registry describes a randomized, parallel-group study with no masking. It lists the study as completed and gives the dates 2020-12-03 for study start and 2021-06-30 for primary completion. The condition listed is hypertension. The sponsor is the University of Nevada, Las Vegas.

The intervention group was asked to measure blood pressure daily, report a motivation level, and communicate with a research assistant to receive the appropriate text-message prompt. The intervention description frames the messages as tailored behavioral-change prompts. The control description says participants had an educational session and that blood pressure, sodium intake assessed with the ASA24 Dietary Assessment Tool, and pre-test hypertension knowledge were obtained. It also describes a follow-up meeting scheduled four weeks later. The record does not fully describe the control activities at follow-up.

The study summary distinguishes a formative development aim from a feasibility aim. In the formative phase, investigators planned to refine tailored messages and a self-administered motivation scale. The next aim was to evaluate implementation feasibility in college students with elevated blood pressure. The summary describes a 4-week, two-armed trial. These plans provide context for the study, but they do not establish how many participants completed each phase or were included in a specific analysis.

The registry enrollment is 29, while the brief summary describes planned recruitment of 42 and an aim involving 32 students. Those figures are not reconciled in the record. Randomization is stated, but the method used to generate or conceal the allocation is not reported in the registry record. The record also does not report masking, beyond stating that the study was unmasked, in greater detail, or describe any stratification or blocking procedures.

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: Participants who had HTN stage II (SBP \>140 mm Hg or DBP \>90 mm Hg) during screening and enrollment, but did not provide a health care provider note were not assigned to a group.

Overall Study

Analysis population for the primary outcome, as defined in the registry: College students between ages 18-29

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 BP Level, measured over Average value from 28 days.

The primary outcome is blood pressure level, measured in millimeters of mercury. It covers systolic and diastolic blood pressure, with the timeframe described as an average value from 28 days. The record identifies college students between ages 18-29 as the outcome population. It says that participants in the intervention group took their blood pressure using a Withings Wireless BP cuff.

Blood pressure is a continuous measure, and reporting a mean and standard deviation describes its location and variability in a group. The systolic and diastolic values represent separate components of the recorded blood pressure, so an interpretation should not treat them as a single interchangeable measurement. The registry does not provide the group means, standard deviations, or an estimated contrast between groups.

As a general statistical rationale, repeated measurements can describe blood pressure over a period rather than relying on a single reading. An average over the stated timeframe may summarize the readings collected, but interpretation depends on what readings were available and how the average was formed. The registry record does not report the precise averaging rule, adherence to daily measurement, or how missing readings were handled. It also does not clarify how the primary outcome was compared between groups. These omissions prevent a detailed assessment of the endpoint calculation.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Random allocation is intended, in general, to make treatment groups comparable on average with respect to both measured and unmeasured characteristics. It does not guarantee that groups will be identical, especially in a pilot study. The record labels the study randomized and parallel, meaning participants were assigned to groups that were followed as separate arms rather than crossing over between interventions. It does not describe how the random sequence was generated, how assignments were concealed before enrollment, or whether any balancing procedure was used. Those details are not reported in the registry record.

What does an unmasked design mean?

The registry states that masking was absent. In general, masking means keeping participants, study personnel, or outcome assessors unaware of assigned intervention when feasible. When participants know their assignment, behavior and reporting can be influenced by that knowledge. That possibility is relevant to a study where participants measure blood pressure and interact with an intervention team. The record does not describe who, if anyone, was involved in outcome assessment without knowledge of assignment, or whether any steps were taken to reduce measurement or reporting bias.

How should a mean and standard deviation be read?

For a continuous outcome, the mean describes the group’s average measurement. The standard deviation describes how spread out individual measurements are around that average. These answer different questions: the mean describes location, while the standard deviation describes variability among measurements. A standard deviation is not the same as the uncertainty around the mean or around a between-group contrast. Confidence intervals are a general way to express the range of effect estimates compatible with the data and model assumptions. No means, standard deviations, or confidence intervals for blood pressure are reported in the registry record.

Why does the analysis need to define its comparison?

A study can describe measurements within each group, or it can estimate a contrast between groups. Those are not interchangeable summaries. A within-group change describes how a group’s measurement differs across time, while a between-group comparison addresses how the groups differ under the chosen analysis. The registry record identifies blood pressure as the primary outcome but does not state the analysis model, contrast, or baseline adjustment. It is therefore not possible to say which statistical comparison was used or how it accounted for repeated readings.

What is the role of the planning assumptions?

The record describes a planning illustration based on an observed effect. It specifies a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect set as a stated fraction of the observed effect. In general, a sample-size calculation estimates the amount of information needed to detect a specified effect under stated assumptions. It is a planning exercise, not a result from the trial and not observed power. The record does not provide the numerical outputs of that illustration or report the trial’s own design justification. It also does not report a formal power analysis used to plan this pilot.

Why can over-dispersion matter?

As a general statistical concept, over-dispersion occurs when the observed variability is greater than a model assumes. If a model understates variability, standard errors may be too small and uncertainty may appear narrower than warranted. Appropriate methods depend on the outcome distribution and study design. The registry identifies the primary outcome as a continuous mean with standard deviation, but does not report a fitted model or describe an over-dispersion assessment. There is no basis in the record to say that over-dispersion was present or that a particular adjustment was used.

What information is needed to assess repeated readings?

The primary timeframe is described as an average value from 28 days, and intervention participants were asked to take blood pressure daily. Repeated measures from the same participant are generally related rather than independent. An analysis that uses all repeated readings may need to account for this within-person dependence; an analysis of participant-level averages would address the data differently. The registry does not say whether the analysis used every reading, participant-level averages, or another summary. It does not state how readings taken less often than requested, invalid measurements, or participant-level missingness were handled.

In general, statistical interpretation should consider the estimate, its uncertainty, the outcome definition, the analysis population, and the assumptions of the method. Here, the record does not report an outcome estimate or statistical analysis, so those aspects cannot be evaluated. The randomized design describes the intended allocation structure; it does not fill in the missing analysis details or establish a result by itself.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists sodium intake and hypertension knowledge as secondary outcomes, alongside the primary blood pressure outcome. It also lists three outcome measures, but does not report results or analyses for them. The record does not describe a prespecified hierarchy among outcomes, a multiplicity adjustment, or how any secondary-outcome findings would be interpreted alongside the primary outcome. These items are not reported in the registry record.

As a general statistical issue, testing multiple outcomes or multiple contrasts can increase the chance of obtaining at least one apparently unusual result even when no true effect exists. Strategies such as defining one primary comparison in advance or adjusting for multiple tests can address that issue, but the record does not identify an approach used in this study. No multiplicity procedure should be inferred from the outcome listing alone.

The record does not describe missing-data frequency, reasons for missingness, imputation, or sensitivity analyses. Daily self-measurement creates the possibility that some scheduled readings may not be available; whether that occurred is not reported. The exact handling of incomplete blood pressure series and incomplete secondary-outcome assessments is also not reported in the registry record.

The analysis population is not specified. The record does not state whether analyses followed randomized assignment, included only participants with complete measurements, or used another rule. It does not give the number analyzed for any outcome. These details matter because an analysis based on a selected subset can differ from one that preserves the randomized groups, and because missingness can affect both precision and interpretation. No analysis-population definition or missing-data method can be attributed to the study from this record.

11. 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 adverse-event information lists a serious-event risk group of 14 for Control and 15 for MOBILE Intervention Group. Serious events affecting participants are recorded as 0 in both groups, and deaths are recorded as 0 in both groups. The other-event fields also list risk groups of 14 and 15, with affected counts of 0 in both arms. No serious-event terms are listed.

These figures describe what is entered in the registry record; they do not establish that every possible adverse event was actively assessed or reported. The record does not explain the event-collection procedures, the observation period for these fields, or whether events were independently reviewed. The risk counts shown for safety should not be assumed to define the analysis population for blood pressure outcomes.

A zero recorded count means that no events are listed in that category for the corresponding group in the registry. It should not be read as proof that an intervention has no safety risk. The study is described as a pilot, and the record does not provide further details that would permit broader safety conclusions.

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

The record documents a randomized parallel-group pilot of a mobile health intervention for college students with elevated blood pressure. MOBILE involved daily self-measurement, a reported motivation level, and tailored text messages. Blood pressure was identified as the primary outcome, with systolic and diastolic measurements averaged over a 28-day timeframe. The record also describes sodium intake and hypertension knowledge as secondary outcomes.

Those design details explain what investigators intended to study; they do not show what happened to participants’ measurements. No group-level outcome values, estimated treatment contrasts, confidence intervals, or p-values are reported. The record therefore cannot establish the direction or magnitude of a blood pressure difference, how uncertain an estimate might be, or whether a statistical test supported a particular conclusion. It also does not report the feasibility findings described in the study aims.

In general, a pilot study can help assess whether recruitment, measurement, and intervention procedures can be carried out and can inform later research. Feasibility evidence is distinct from a definitive estimate of a clinical effect. In this case, the registry does not provide the numerical feasibility or outcome results needed to assess either. The fact that the study is marked completed is a status description, not an outcome finding.

The record should not be used to claim that MOBILE changed blood pressure, that the groups were equivalent, or that any benefit or harm was demonstrated. It also does not provide enough information to assess adherence, missing readings, or the statistical analysis. The defensible interpretation is limited to the study’s design and stated outcome definitions, with outcome results and analysis details not reported in the registry record.

13. Why This Trial Matters Statistically

This study is statistically interesting because it combines a randomized comparison with a behavioral intervention that relies on repeated self-measurement and participant engagement. Such a design raises practical questions about whether participants can make measurements consistently, communicate with the study team, and receive tailored prompts as intended. Those questions are central to interpreting a feasibility study, but the registry record does not report their results.

The primary outcome also illustrates why measurement and analysis details matter. An average across 28 days can summarize repeated readings, but interpretation depends on how readings were collected, which readings were included, and how participant-level differences were handled. The record identifies the intended timeframe and measurement device but does not report the averaging rule or statistical model. Without outcome estimates and those methods, a reader cannot assess either the size or precision of a blood pressure comparison.

The distinction between planned recruitment and registry enrollment is another useful point for reading trial records. The brief summary describes planned recruitment of 42, including a formative phase and a feasibility aim, while registry enrollment is 29. The record does not reconcile these figures. This makes it important to distinguish proposed study plans from the enrollment figure recorded for the completed study rather than assuming the same participant count applies to each phase or analysis.

Finally, a completed status and a randomized design do not by themselves supply evidence about an outcome. Statistical interpretation depends on reported data, analysis populations, methods, and uncertainty. Here, the registry’s descriptions support understanding of the study question and planned measures, while the absence of posted analyses sharply limits what can be concluded.

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 main limitation for interpreting this trial record is that outcome results and analyses are not reported. There are no blood pressure summaries or between-group estimates, and no results for sodium intake or hypertension knowledge. This prevents assessment of effect direction, magnitude, or precision and means that the stated feasibility aims cannot be evaluated from the registry record.

The record’s enrollment figures are not reconciled. It lists enrollment as 29, while the brief summary describes intended recruitment of 42, with 8-10 students in formative work and 32 in the feasibility aim. The record does not explain whether the figures refer to different study phases or how many participants were randomized, completed follow-up, or contributed to each outcome. No group totals beyond the safety risk counts should be inferred from these figures.

Some intervention and control descriptions are incomplete. The control description refers to an educational session and assessments, but its follow-up wording is truncated. The primary outcome description specifies measurement by intervention participants, while the control description also refers to blood pressure collection. The record does not clarify whether measurement procedures were the same in both groups.

Other important analysis details are not reported in the registry record: the randomization procedure, the exact blood pressure averaging rule, handling of repeated and missing measurements, analysis population, statistical model, and multiplicity approach. The record also does not give a sample-size justification for the trial or numerical outputs for the planning illustration. These limitations concern what can be learned from the registry record and should not be mistaken for evidence that a particular procedure was or was not performed outside the information recorded there.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: MOBILE Intervention in College Students With Elevated Blood Pressure — NCT05956925.
• Registry record last updated 2024-08-19; status last verified 2024-03.
• Results first posted 2024-08-19.
• 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.

18. Record Summary

NCT05956925 is a completed randomized, parallel-group pilot study sponsored by the University of Nevada, Las Vegas. The registry lists no masking, enrollment of 29, a start date of 2020-12-03, and primary completion on 2021-06-30. The study concerns college students with elevated blood pressure.

The MOBILE intervention involved daily blood pressure measurement, a motivation rating, and tailored text messages. The primary outcome was systolic and diastolic blood pressure, described as an average over 28 days. Sodium intake and hypertension knowledge were listed as secondary outcomes.

The brief summary describes formative development and a feasibility aim, with planned recruitment figures that are not reconciled with registry enrollment. No outcome analyses or results are reported. The record therefore describes the study’s design and intended measures but does not support conclusions about comparative blood pressure outcomes or feasibility findings.