Promoting Healthy Lifestyle Behaviors: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Promoting Healthy Lifestyle Behaviors (NCT05675020), a na na study. The primary outcome is Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions..

2. Clinical Question

This is a within-group change question: it compares measurements taken from participants before and after the educational session. It is not a direct comparison between the intervention and an untreated or alternative-treatment group. Accordingly, any observed change would describe the participants’ measured responses over the assessment period, rather than isolate the effect of the session from other influences.

The registry’s summary names nutrition, physical activity, screen time, and sleep as lifestyle topics. The primary endpoint is framed around correct answers to survey questions, not a clinical health outcome. The specific questions, scoring rules, and results are not reported in the registry record.

3. Trial Design

The registry classifies the study as a single-group, one-group pretest-posttest project. Participants and their parent or legal guardian were to receive a family-based educational intervention: a 45-minute presentation delivered via Zoom. The summary says participants could choose between 2-3 presentation dates and times. Assessments were planned before the program and after one month, using a REDCap survey for the adolescent and parent or legal guardian.

The record lists enrollment as 86, while the study summary describes a project for 30 adolescents and the primary endpoint description says the project included nine parent-adolescent dyads. These figures appear in different parts of the registry record and are not reconciled there. The number contributing to each endpoint or assessment is not reported in the registry record.

The study is marked completed. Its recorded start date is 2022-10-07, and its primary completion date is 2023-01-13. The intervention is classified as behavioral. Allocation is listed as NA, masking as none, and the model as single group. There is no like-for-like control arm in the design as described.

The record identifies Florida State University as the sponsor. It does not report a phase beyond NA. A formal protocol, eligibility details beyond the examples in the summary, the timing of any additional assessments, and the statistical analysis plan are not reported in the registry record. The summary says the survey used an adapted version of the 2021 National Youth Risk Behavior S…, but the description is truncated, so further instrument details cannot be established from the registry record.

In a one-group pretest-posttest design, the same participants are intended to contribute measurements at different times. That structure can describe change over time, but without a separate comparison group it cannot by itself distinguish intervention-associated change from changes due to other circumstances, repeated measurement, or selective follow-up.

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

Analysis population for the primary outcome, as defined in the registry: This project included nine parent-adolescent dyads. Examples of eligible diagnosed mental health conditions include major depressive disorder (MDD), generalized anxiety disorder (GAD), attention-deficit disorder (ADD)/ attention deficit hyperactivity disorder (ADHD), and bipolar disorder (BPD). Participants' exclusion criteria include children under 12 years old or older than 18 years old. Non-legal guardians were unable to participate in the project.

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.

Population: Participants (dyads) who completed the pre-survey

6. Primary Endpoint

The registry lists the primary outcome as Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions., measured over One Month.

The listed primary endpoint is the percent of participants with correct responses to healthy lifestyle behavior knowledge survey questions. The questionnaire was to be administered before the 45-minute online educational session and again one month afterward. The registry says the same questionnaire was used at both assessments.

This endpoint focuses on knowledge as measured by survey responses. Correctness is treated as a binary response at the question level: a response is either classified as correct or not. Expressing results as a percentage of participants with a correct response can make performance on a question easier to interpret than a raw count, particularly when the number assessed differs between time points. The record does not describe the scoring rules, the questions included, or whether a participant-level overall score was also calculated.

Knowledge is a relevant intermediate outcome for an educational program because the program’s stated aims include increasing knowledge about healthy lifestyle behaviors. However, a correct survey response is not itself evidence that a behavior changed. The summary separately mentions an aim to evaluate healthy lifestyle behaviors, including nutrition, physical activity, screen time, and sleep. The primary endpoint listed in the record is about knowledge-question responses, and the details and results for behavior measures are not reported in the registry record.

The endpoint description gives its unit as a percentage of participants, while the parameter is listed as NUMBER. That wording leaves some ambiguity about the exact reported measure. No endpoint values, estimates of change, confidence intervals, or statistical test results are reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a pretest-posttest comparison estimate?

In a one-group pretest-posttest design, outcomes are measured in the same group at an earlier and a later time. The comparison describes how the measured outcome differs across those assessments. Because participants are not compared with a separate control group, the change does not automatically estimate what would have happened without the intervention. General considerations include secular changes, repeated-testing effects, and changes in which participants contribute data at follow-up.

The registry describes assessments before the educational session and one month afterward. It does not report the statistical method used to compare them. In particular, it does not state whether the analysis used paired participant-level data, a question-level approach, or another method. The appropriate method depends on the outcome definition, the dependence between measurements, and the amount and pattern of missing data.

How should a percentage of correct responses be understood?

The endpoint is described as the percentage of participants with correct responses to healthy lifestyle knowledge survey questions. A percentage expresses the frequency of a defined response relative to the people assessed for that response. Its interpretation depends on knowing the denominator: for example, whether every participant answered each question and how incomplete questionnaires were handled. Those details are not reported in the registry record.

A confidence interval, as a general statistical concept, describes a range of values compatible with the observed data under a specified statistical model and procedure. It communicates uncertainty as well as an estimate. A narrow interval generally indicates greater precision than a wide interval, while neither width nor interval location alone establishes causality. No confidence interval or endpoint estimate is reported in the registry record.

Because the same questionnaire was intended for before and after assessment, observations may be linked within participants. General statistical methods for paired data account for that relationship rather than treating both assessments as independent groups. Whether the reported analysis accounted for pairing is not reported in the registry record.

What can a statistical test tell the reader?

In general, a statistical test evaluates how compatible the observed data are with a specified null model, given assumptions about the data and analysis. A p-value is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of a change. Interpreting a test requires the estimate, its uncertainty, the analysis population, and the design context. No p-value, test statistic, or named test is reported in the registry record.

For a binary response such as correct versus not correct, possible analyses can compare response proportions. When responses are paired, the analysis may need to use the within-person pattern of changes. If multiple survey questions are tested, the number of questions and the analysis plan matter for interpretation. The record does not report the detailed analysis method or whether separate question-level tests were performed.

What do planning illustrations mean?

Sample-size calculations are planning tools, not descriptions of observed results. The registry’s stated planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as fractions of the observed effect. The stated convention is participants per arm for most outcomes, while time-to-event calculations use total events.

Those assumptions describe a two-arm planning framework, whereas this study is classified as single group and has no like-for-like control comparison. The registry does not report that these assumptions were the study’s original design plan or that the illustration was used to justify enrollment. Any planning illustration should not be read as observed power or as evidence that the study had adequate precision. No calculation results are reported in the registry record.

What statistical plan is available?

The statistical analysis plan, the sample-size justification, any interim analyses, and the method used for the primary endpoint are not reported in the registry record. The record lists one analysis, but it does not describe its model, covariates, handling of repeated measurements, or approach to uncertainty. Without those details and without outcome estimates, the planned statistical interpretation cannot be reconstructed.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies healthy lifestyle knowledge as the primary endpoint and describes additional aims concerning healthy lifestyle behaviors. It does not report a multiplicity strategy, such as a prespecified hierarchy of outcomes or an adjustment for testing multiple questions or outcomes. Whether multiplicity was relevant to the analysis actually performed is not reported in the registry record.

Multiple questions can produce multiple estimates and tests. As a general statistical matter, interpreting many tests without a prespecified plan can make isolated findings harder to distinguish from chance variation. The number of questions analyzed, the number of comparisons, and any correction or prioritization strategy are not reported in the registry record.

The record does not describe how incomplete questionnaires, missed one-month assessments, or other missing observations were handled. It also does not state whether participants were analyzed according to an intention-to-treat principle, only when they completed both assessments, or under another analysis population definition. The number contributing data at each time point is not reported in the registry record.

These omissions matter because complete-case results can represent a different group from the one originally enrolled if follow-up is incomplete. General methods for missing data rely on assumptions about why values are missing; no particular assumption or imputation method can be attributed to this study based on the record. The different study-size descriptions—enrollment of 86, a summary describing 30 adolescents, and an endpoint description of nine parent-adolescent dyads—add uncertainty about the analysis population. The relationship among those descriptions is not reported in the registry record.

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

The registry describes a family-based educational session and a plan to compare healthy lifestyle knowledge survey responses before the session and one month afterward. This establishes the intended clinical and statistical question, but the registry record does not report numerical outcome results. It therefore does not establish whether correct responses changed or how precisely any change was estimated.

Even if a before-and-after difference were available, it would describe change in a single group. Without a control group, the design cannot separate an effect of the educational session from other influences on responses over time. The pretest may itself affect later responses, and changes in follow-up participation can affect who is represented in the comparison. These are general limitations of interpreting an uncontrolled pretest-posttest study.

The primary measure is knowledge-question performance. It is not the same as demonstrated changes in nutrition, physical activity, screen time, or sleep. The registry summary names those behaviors as areas of interest, but detailed behavior results are not reported in the registry record. Nor does the listed endpoint measure mental health outcomes or establish clinical benefit.

The record’s different descriptions of study size and the absence of endpoint values, uncertainty estimates, analysis details, and missing-data information limit interpretation further. The listed zero counts in the adverse-event categories do not establish that no events occurred, because the record does not provide a detailed safety assessment. The narrowest supported conclusion is that the registry describes a completed single-group educational project with a planned one-month knowledge assessment, while its results and key analysis details are not reported in the registry record.

12. Why This Trial Matters Statistically

This study illustrates why the design and the outcome definition matter as much as the topic of an intervention. An educational program may aim to influence both knowledge and behavior, but those are distinct outcomes. The primary endpoint concerns correct survey responses, while the summary also describes behavioral aims. Keeping those measures separate prevents knowledge performance from being mistaken for evidence of behavior change.

The one-group pretest-posttest structure is useful for describing within-group patterns over time. Statistically, however, it does not provide the same causal contrast as a controlled comparison. Readers need to distinguish a temporal change from an intervention effect, and to consider repeated measurement and follow-up participation when interpreting any estimated change.

Clear reporting of the analysis population is also essential. The registry gives enrollment as 86, describes a project for 30 adolescents, and says the primary endpoint included nine parent-adolescent dyads. Without an explanation of how those figures relate, readers cannot readily determine the denominator behind a result or how completely the intended group was assessed.

Finally, effect estimates and uncertainty are necessary for evaluating what the data can support. A percentage alone would not show the precision of the estimate, and a test result alone would not communicate the size or practical meaning of a change. The registry record does not report endpoint results or their uncertainty, so this study’s statistical findings cannot be evaluated from the available record.

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 most immediate limitation for interpretation is that the registry record does not report the primary endpoint results. There are no pre-intervention or post-intervention percentages, estimated changes, confidence intervals, or test results. Consequently, neither the direction nor precision of change can be assessed.

The record contains unreconciled descriptions of study size: enrollment is listed as 86, the summary describes a project for 30 adolescents, and the primary endpoint description says nine parent-adolescent dyads were included. It does not identify the number analyzed at each assessment or explain the relationship among those descriptions. This leaves the endpoint denominator and follow-up coverage unclear.

The study has no separate control group according to its single-group design description. A pretest-posttest comparison can document change over time but cannot by itself attribute that change to the intervention. The registry also does not report detailed eligibility criteria, the full questionnaire, scoring rules, or how the behavioral outcomes named in the summary were measured.

Important analysis details are absent: the statistical test or model, handling of paired measurements, missing-data methods, analysis populations, multiplicity strategy, and sample-size justification are not reported in the registry record. The summary’s description of the survey instrument is truncated. The adverse-event entries are not a detailed safety account, and their zero counts should not be interpreted as proof that no events occurred.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Promoting Healthy Lifestyle Behaviors — NCT05675020.
• Registry record last updated 2024-11-15; status last verified 2024-11.
• Results first posted 2024-10-15.
• 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, single-group educational study sponsored by Florida State University. Adolescents aged 12-17 years with mental health conditions and their parent or legal guardian were to receive a 45-minute Zoom presentation promoting healthy lifestyle knowledge and behaviors. The planned assessment used the same questionnaire before the session and one month afterward.

The primary endpoint concerns the percentage of participants with correct responses to healthy lifestyle behavior knowledge questions. The design has no separate control group. The registry lists enrollment as 86, while its summary describes a project for 30 adolescents and its endpoint description says nine parent-adolescent dyads were included; the record does not reconcile these figures.

No primary outcome estimates, uncertainty measures, or detailed statistical methods are reported in the registry record. Thus, the record describes the intervention and intended assessment, but does not allow the direction or precision of an outcome change to be evaluated.