Incentive-based and Media Literacy Informed Approaches to Improve Vaping Cessation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Incentive-based and Media Literacy Informed Approaches to Improve Vaping Cessation (NCT05586308), a randomized na study. The primary outcome is Engagement_remote checkin_3.

2. Clinical Question

The primary endpoint is a measure of participation in a remote check-in, rather than a direct measure of abstinence. The study also lists biochemically verified and self-reported vaping abstinence as secondary outcomes. These address different questions: submitting a sample indicates completion of a check-in, whereas abstinence outcomes concern vaping behavior. The registry record does not report participant-level results or enough detail to establish how the secondary outcomes were analyzed.

3. Trial Design

This completed pilot study is registered as randomized, double-masked, and parallel-group. It enrolled 40 participants and lists the study phase as NA. The sponsor is the University of Nebraska. The record lists a start date of 2023-12-07 and a primary completion date of 2024-11-01. These registry entries describe the trial’s administrative design and timeline; they do not establish the exact dates on which participants were recruited or followed.

The active control received evidence-based text-messaging support. The media literacy group received e-learning lessons in addition to that support. The financial incentive group received incentives and the same support. The combined group received lessons, incentives, and text-messaging support. Thus, the planned contrasts could address the added contribution of the different program elements, although the registry record does not report the allocation counts or the results of those contrasts.

Randomization is intended to reduce systematic differences between groups at assignment, on average. It does not guarantee that every group has identical characteristics, particularly in a pilot study. Double masking indicates that the registry classifies the study as masked, but who was masked, how masking was maintained, and whether participants could infer their assignment from the interventions are not reported in the registry record. The randomization procedure, allocation concealment, planned follow-up schedule beyond the stated endpoint timeframe, and analysis population are also not reported in the registry record.

The stated primary endpoint concerns engagement at the 3-month remote check-in. The record describes it as the proportion of participants who submitted a remote saliva cotinine sample. Enrollment and completion status alone do not show how many participants submitted samples or whether submission differed among groups. Those outcome counts and group-specific denominators 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

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 Engagement_remote checkin_3, measured over 3 months.

The primary endpoint is engagement at remote check-in 3: the number of participants who submitted a remote saliva cotinine sample, described in the registry record as a proportion of participants. The stated timeframe is 3 months. This endpoint captures completion of a study procedure, not whether a participant stopped vaping. Sample submission may be relevant to whether a remote assessment process is workable, while abstinence is a distinct behavioral outcome.

For a proportion, the numerator is the participants who submitted a sample and the denominator is the participants considered eligible for that check-in under the analysis definition. Clear reporting of both is important: the same number of submitted samples can imply different proportions under different denominators. The registry record does not report the numerator, denominator, or denominator rule for this endpoint. It therefore does not allow a numerical assessment of submission rates or a comparison of precision among groups.

Engagement is useful in a feasibility-focused pilot because intervention delivery and outcome collection depend on participants taking part in study activities. However, sample submission is not itself evidence of abstinence. The registry record separately lists biochemically verified vaping abstinence and self-reported vaping abstinence as secondary outcomes. Their numerical results and detailed definitions are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Several statistical ideas help clarify what the primary endpoint could show, even though the registry record does not report its numerical results. The trial is randomized and parallel-group: participants are assigned to one study group and the groups are followed under their respective intervention conditions. In general, randomization supports comparisons by reducing systematic differences in baseline characteristics. It cannot guarantee balance in a pilot study, and it does not remove uncertainty due to limited outcome information. The registry record does not describe the randomization sequence, concealment procedures, or group allocation counts.

How should a submission proportion be read?

For a binary endpoint, each participant contributes an outcome such as sample submitted or sample not submitted, according to the endpoint definition. A group proportion is the number meeting the endpoint divided by the relevant denominator. Interpreting it requires knowing who was included in that denominator, whether participants missing the check-in were counted as not submitting, and how other unavailable outcomes were handled. Those rules and the observed counts are not reported in the registry record.

In general, a proportion is an estimate rather than a complete description of an underlying rate. Its precision depends in part on the amount of information contributing to it. A confidence interval communicates that uncertainty; it is not a guarantee that the true value lies within the interval. Comparisons between groups also have uncertainty, so an estimated difference should be read alongside its interval and the analysis definition. Neither group-specific proportions nor comparison estimates and intervals for this endpoint are reported in the registry record.

What would a between-group comparison mean?

A randomized comparison can estimate the difference associated with assignment to one program rather than another, under the analysis assumptions and population definition. Here, the control group receives text-messaging support, while the other groups add media literacy lessons, financial incentives, or both. A comparison of the combined group with a single-component group would address a different contrast from a comparison of an incentive-related group with a group without incentives. The exact statistical contrasts and estimates are not reported in the registry record.

In general, a regression model may be used to compare binary outcomes, but the choice of model, covariates, and effect measure matters. A risk difference describes an absolute difference between proportions; a relative measure describes a proportional comparison. These are not interchangeable. The registry record does not report the model, adjustment variables, effect measure, test statistic, or p-value for the primary endpoint. No model should be inferred from the outcome’s binary classification alone.

Why is missingness important?

For a remote sample-submission endpoint, a participant without a recorded submission might have missed the check-in, been unable to provide a sample, or had an unrecorded result. These possibilities are not equivalent for all analyses. In general, complete-case analysis uses participants with observed outcomes, whereas other approaches make different assumptions about missing outcomes. The missing-data definition and handling method are not reported in the registry record. Without them, the meaning of a denominator or comparison cannot be fully assessed.

Missingness also matters for abstinence outcomes. Biochemical verification and self-report are different measurement approaches, each requiring an explicit outcome definition and handling rule for unavailable assessments. The registry lists both as secondary outcomes, but their definitions, observed results, and missing-data methods are not reported in the registry record.

What do the planning assumptions say?

The registry record describes sample-size illustrations as planning calculations based on a stated fraction of the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It specifies that non-time-to-event illustrations are expressed as participants per arm; time-to-event illustrations would be expressed as total events. These are planning assumptions, not a report of the trial’s statistical design or a measure of observed power. The record does not report a sample-size justification, the trial’s own power calculation, or numerical illustration results. The underlying observed effect and its estimate are not reported in the registry record.

General sample-size calculations depend on assumptions about the effect to detect, variability, significance threshold, and allocation. Changing these assumptions changes the resulting planning estimate. A retrospective calculation based on an observed effect would not establish what the study could reliably detect before it began. Sample-size illustrations should therefore not be interpreted as observed power or as evidence that a result is conclusive.

How should multiplicity be considered?

When a study evaluates several outcomes or comparisons, the chance of at least one apparently unusual result can increase if each is tested independently without a plan for multiplicity. In general, prespecified primary outcomes and contrasts help readers distinguish the main question from exploratory analyses. The registry lists 4 outcome measures and 1 analysis, but does not report a multiplicity adjustment, a hierarchy among all outcomes, or a complete statistical analysis plan. The endpoint record also indicates that its multiple categories or time points were not reduced to one comparison. The analysis strategy for those categories or time points is not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 4 outcome measures and 1 analysis. The primary endpoint concerns submission of a remote saliva cotinine sample at the 3-month check-in. Biochemically verified vaping abstinence and self-reported vaping abstinence are listed as secondary outcomes. The endpoint entry indicates that it has several categories or time points and was not reduced to one comparison. Which categories or time points were analyzed, and how they relate to the single listed analysis, are not reported in the registry record.

When a study considers multiple endpoints, time points, or pairwise contrasts, multiplicity can affect interpretation. In general, testing many hypotheses without adjustment increases the chance of at least one result appearing statistically notable by chance. A prespecified hierarchy, correction procedure, or clear distinction between confirmatory and exploratory analyses can help readers understand the evidence. The multiplicity strategy, prespecified contrasts, and statistical analysis plan are not reported in the registry record.

The record does not give outcome numerators, denominators, or missing-data methods. For the engagement endpoint, those details are needed to understand how non-submission and unavailable observations were treated. For abstinence outcomes, the definitions and missing-data rules are also not reported in the registry record. The analysis population—such as whether analysis followed randomized assignment regardless of intervention participation—is not reported in the registry record.

These omissions constrain interpretation: neither the completeness of outcome follow-up nor the impact of missing observations can be assessed from the registry information. They also prevent a reader from determining whether the reported analysis, if any, followed a prespecified plan.

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

The study’s stated purpose was to assess feasibility and compare preliminary effects of vaping cessation programs combining text-messaging support with media literacy education, financial incentives, or both. The primary engagement outcome focuses on whether participants submitted a remote saliva cotinine sample at the 3-month check-in. This can speak to participation in a remote assessment process if the relevant counts and denominators are reported.

The registry record does not report those counts, proportions, or group comparisons. It therefore does not show which group had higher sample submission, how large any difference was, or how precisely it was estimated. Enrollment of 40 and the completed status do not supply that missing outcome information. The record also does not report numerical results for the listed abstinence outcomes.

Even if submission differed between groups, that result would concern engagement with the check-in, not necessarily cessation. Conversely, the absence of numerical abstinence results in the registry record cannot establish whether abstinence differed. The proposed hypotheses should be read as the questions the study set out to examine, not as conclusions.

In general, findings from a pilot study are most informative when interpreted with attention to feasibility, outcome completeness, effect estimates, and uncertainty. A pilot estimate can be imprecise, and a planning calculation based on an observed effect is not a substitute for an observed treatment comparison or a measure of observed power. The registry record does not report numerical sample-size illustrations or an observed effect estimate.

The adverse-event fields record zero serious events, zero other events, and zero deaths in each listed group. These registry entries do not establish that adverse events were absent under all circumstances, because details of ascertainment and reporting are not reported in the registry record. Overall, the registry information describes the design and intended questions, but does not support a conclusion about the size, direction, or certainty of intervention effects.

12. Why This Trial Matters Statistically

This trial brings together several components that pose distinct statistical questions. Text-messaging support is common to all groups, while media literacy lessons and financial incentives vary. The design can therefore be used to examine engagement in relation to added program components, but interpretation depends on clearly defined contrasts. The registry record does not report the exact comparative analysis or its numerical results.

The primary endpoint also highlights the distinction between intervention engagement and a clinical or behavioral outcome. Submitting a remote saliva sample reflects completion of an assessment step. It does not, by itself, establish abstinence. Separating this endpoint from the listed biochemical and self-reported abstinence outcomes is important when deciding what a result would mean.

Statistically, a feasibility-focused pilot can identify practical issues in delivering interventions and collecting follow-up outcomes. To judge such issues, readers need participant flow, group-specific denominators, submission counts, and missing-data information. Those details are not reported in the registry record. Without them, neither engagement rates nor their precision can be evaluated.

The study also illustrates why hypotheses and results must be distinguished. The registry describes expected relationships involving the combined intervention, abstinence, and incentive-related engagement. Those statements identify research questions; they are not evidence that the expected patterns occurred. The absence of numerical outcome findings in the registry record leaves those questions unresolved.

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 important details unavailable for assessing how the trial was conducted and analyzed. Although it classifies the study as randomized and double-masked, the randomization method, allocation concealment, identity of masked parties, and practical masking procedures are not reported in the registry record. Participant characteristics, eligibility criteria, recruitment setting, group allocation counts, and participant flow are also not reported in the registry record.

The primary endpoint is described as the proportion submitting a remote saliva cotinine sample at the 3-month check-in, but its observed counts and denominators are not reported. The rule for handling participants who did not submit a sample is not reported in the registry record. This limits assessment of engagement and makes it impossible to evaluate whether missing outcomes could alter a comparison. The registry record also does not report numerical results or detailed definitions for the abstinence outcomes.

Methods needed to assess the comparisons—including the statistical model, effect measure, adjustment variables, confidence intervals, p-values, and prespecified contrasts—are not reported in the registry record. Nor are the analysis population, multiplicity strategy, or full analysis plan. The presence of a single listed analysis does not resolve these omissions, particularly because the endpoint entry notes multiple categories or time points.

Finally, the registry describes a pilot with enrollment of 40, but does not report a trial-specific sample-size justification. Any planning illustration based on an observed effect should not be mistaken for a prospective design calculation or observed power. Adverse-event fields list zero events and deaths, but event-collection procedures and completeness are not reported in the registry record.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Incentive-based and Media Literacy Informed Approaches to Improve Vaping Cessation — NCT05586308.
• Registry record last updated 2026-01-29; status last verified 2025-01.
• Results first posted 2026-01-29.
• 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.

17. Record Summary

The registry describes a completed randomized, double-masked, parallel-group pilot study of approaches to vaping cessation among young adults. Enrollment was 40; the sponsor was the University of Nebraska. The listed start date is 2023-12-07, the primary completion date is 2024-11-01, and the phase is recorded as NA.

The active control received evidence-based text-messaging support. The other groups added media literacy lessons, financial incentives, or both. The primary endpoint was engagement, defined by submission of a remote saliva cotinine sample at the 3-month check-in. Biochemically verified and self-reported vaping abstinence were listed as secondary outcomes.

The registry information describes the study design and hypotheses, but does not report numerical outcome findings, group-specific denominators, or comparative estimates. Statistical analysis details, missing-data methods, and participant characteristics are not reported in the registry record.