Lifestyle Enhancement for ADHD Program: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Lifestyle Enhancement for ADHD Program (NCT03690674), a na na study. The primary outcome is Moderate to Vigorous Physical Activity (MVPA).

2. Clinical Question

3. Trial Design

The Lifestyle Enhancement for ADHD Program is a completed, single-group behavioral study sponsored by Seattle Children's Hospital. The registry lists ADHD as the condition, enrollment as 35, phase as not applicable, and allocation as not applicable. Masking is listed as none. Its stated purpose was to investigate whether a modified behavioral management training program could increase physical activity in children with ADHD.

The study began on 2018-11-15, with primary completion on 2019-12-09. The record identifies the program as the intervention and explicitly states that there was no comparison or control arm. Accordingly, the main design described is a within-group assessment over time rather than a randomized comparison between treatment groups. A change from baseline, if reported, would describe participants' measurements during the program; without a control group, it would not by itself separate program-related change from other explanations for change.

The primary outcome was moderate to vigorous physical activity, assessed at baseline before week 1 of the treatment group and again at week 9. Children wore accelerometers for this measurement. The record also lists secondary measures covering task performance, executive function, impairment, parenting, health behaviors, and sleep habits. Although the registry identifies 14 outcome measures, it lists 0 analyses. Outcome values and analysis results 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.

Before assignment: 70 participants consisting of 35 dyads (caregver+child) were initially enrolled in the study. 2 dyads withdrew from the study before the group treatment sessions began.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Only child participants wore the accelerometer. Number analyzed at post reflects participants who withdrew from study and/or did not complete this measurement.

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: Baseline Population Description is based on the number of parents that began treatment group. 35 were initially enrolled (provided consent), but 2 withdrew before treatment groups began.

6. Primary Endpoint

The registry lists the primary outcome as Moderate to Vigorous Physical Activity (MVPA), measured over Baseline (measured prior to week 1 of Treatment Group) and week 9.

The primary endpoint is moderate to vigorous physical activity (MVPA), expressed as moderate-vigorous minutes per day. It was measured with an accelerometer worn by child participants at baseline, before week 1 of the treatment group, and at week 9. An accelerometer provides a device-based measure of movement rather than relying only on a participant's or caregiver's recollection. The endpoint therefore addresses the study's stated question about whether physical activity could increase during participation in the program.

The registry specifies that only children wore the accelerometer. It also notes that the number analyzed at post reflects participants who withdrew from the study and/or did not complete this measurement. That detail matters because the number with a week 9 measurement can differ from enrollment, and the people with available measurements may not represent everyone who began the study.

The registry record does not report the baseline or week 9 MVPA values, a change estimate, or an uncertainty interval. It therefore documents what was intended to be measured and when, but does not establish the size or direction of any observed change. The choice of this endpoint fits the stated focus on physical activity; its interpretation depends on the actual measurement results and the approach used to handle incomplete follow-up.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the design estimate?

The registry describes a single-group study with measurements planned at baseline and week 9. In a general repeated-measures analysis, the central quantity might be the within-person change in MVPA between those times, or a summary of those changes across participants. Such an estimate would describe change among the people contributing the relevant measurements. The registry record does not report a change estimate or specify the exact analysis used.

A single-group change is not the same as a controlled treatment effect. A randomized or otherwise suitable comparison group can help estimate what might have occurred without the intervention. This study has no comparison or control arm, so a baseline-to-week 9 change would remain open to alternative explanations, including changes over time unrelated to the program. The registry lists allocation as not applicable and masking as none; it does not describe a blinded assessment.

How should a continuous endpoint be read?

MVPA is a continuous measure reported in minutes per day. A mean is a summary of the average measurement in a group, while a standard deviation describes the spread of individual measurements around that mean. These summaries answer different questions: the mean locates the group average, and the standard deviation conveys how much measurements vary. The record specifies mean and standard deviation as the endpoint's summary format, but does not report their values at either assessment.

In general, an effect estimate should be read together with its uncertainty. A confidence interval indicates the range of effects reasonably compatible with the observed data and the statistical model. It helps readers assess precision, rather than only whether a test crosses a significance threshold. No estimate, confidence interval, or significance test for MVPA is reported in the registry record, so there is no numerical result to interpret.

Why can over-dispersion matter?

Over-dispersion is a general concern for count outcomes when their variability exceeds what a simple statistical model expects. A model that does not account for this extra variability can understate uncertainty and make evidence appear more precise than it is. The primary endpoint in this study is a continuous mean measure, not a count of events; the registry does not identify a count-model analysis for it. This concept therefore does not establish anything about the endpoint results. It illustrates why a statistical method should match the outcome's scale and distribution.

What do the planning assumptions mean?

The record describes sample-size assumptions for a planning illustration: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a stated fraction of the observed effect. It says that non-time-to-event planning values are participants per arm, while time-to-event values are total events. These are planning assumptions, not a description of this study's design. The Lifestyle Enhancement for ADHD Program is a single-group study with no two-arm allocation in the registry record.

Any sample-size illustration based on an observed effect is not observed power and does not establish the adequacy of this study's enrollment. The registry record does not report a trial-specific sample-size justification or an observed MVPA effect for such an illustration to use. The planning assumptions should therefore not be mistaken for evidence about the program's effect, the study's statistical power, or the precision of its findings.

What analyses are available?

The registry lists 14 outcome measures and 0 analyses. That distinction matters: an outcome's presence in a registry is not evidence that numerical results or statistical comparisons were posted for it. The record names secondary measures including the Stop Signal Reaction Time task, Digit Span task, Finger Windows task, executive function, impairment, parenting, health behaviors, and sleep habits. Their listed presence does not provide their results, missing-data methods, or analysis populations. Those details are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 14 outcome measures, including the primary MVPA endpoint and secondary measures involving task scores, executive function, impairment, parenting, health behaviors, and sleep habits. It lists 0 analyses, and numerical outcome results are not reported in the registry record. A multiplicity procedure, such as an adjustment for interpreting several statistical tests, is not reported in the registry record. Without posted tests and an analysis plan, it is not possible to determine whether or how the investigators addressed the risk of emphasizing a chance finding among multiple outcomes.

Missing data are a particular consideration for the week 9 accelerometer measurement. The record says the number analyzed at post reflects participants who withdrew and/or did not complete the measurement. It does not report how many contributed baseline or post measurements, why individuals lacked a post measurement, or how incomplete observations were handled analytically. Those details are not reported in the registry record. In general, simply analyzing participants with complete measurements can be misleading if completion is related to the outcome or to other participant characteristics. The registry information does not establish whether that concern affected this study.

The analysis population is also not defined beyond the endpoint description that only child participants wore accelerometers. A rule for which participants were included in each analysis is not reported in the registry record. No imputation method, sensitivity analysis, or other missing-data approach is reported in the registry record. These omissions limit assessment of how representative any potential post-treatment estimate would be, but the record contains no estimate to assess in the first place.

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.

Most frequent non-serious adverse event terms

The adverse-event record separates caregivers and children participating in the Lifestyle Enhancement for ADHD Program. For caregivers, the registry reports 0 serious adverse events among 35 at risk and 1 other adverse event among 35 at risk. For children, it reports 0 serious adverse events among 35 at risk and 2 other adverse events among 35 at risk. The record reports 0 deaths for each group.

These are event counts as recorded, not evidence that the intervention caused or prevented an event. The registry lists no serious adverse-event terms, and the individual terms or descriptions for the other adverse events are not reported in the registry record. The record also does not provide information about event timing, severity beyond the serious-versus-other classification, relatedness to the program, or follow-up duration for safety monitoring. Those details are not reported in the registry record.

Zero reported serious adverse events means that none were recorded in these group summaries; it does not establish that the risk of an event is absent. The counts should be read in the context of this single-group study and the safety information available in the registry record, without treating them as a controlled comparison or a complete account of all possible harms.

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

The registry record establishes that a completed study investigated a behavioral program intended to increase physical activity among children with ADHD. It identifies accelerometer-measured MVPA as the primary endpoint, specifies baseline and week 9 assessments, and describes that only children wore the accelerometers. These are useful details about the question and measurement strategy.

The record does not report the MVPA values or a statistical analysis of change. As a result, it does not show whether activity increased, decreased, or stayed similar during the study. It also does not provide an effect estimate or confidence interval, so the size and precision of any change cannot be assessed. The study's stated purpose must not be read as a finding.

Even if a within-group change were available, the single-group design would limit causal interpretation. Without a comparison arm, change over the study period could reflect the program, other influences, or a combination. The registry record does not allow those explanations to be separated. It also notes that post-measurement analysis reflects withdrawals and/or incomplete accelerometer measurements, while the details of missing-data handling are not reported.

The adverse-event record reports no serious adverse events or deaths for either the caregiver or child group, and reports other adverse events in both groups. These counts do not establish whether events were related to the program, and the event descriptions are not reported. Overall, the posted information supports a description of the study design and its planned measurement, not a conclusion about efficacy, causation, or the size of any benefit or harm.

13. Why This Trial Matters Statistically

This study illustrates why the design and the availability of results are both essential to statistical interpretation. The registry specifies a behavioral program, a single-group model, and repeated measurement of accelerometer-recorded MVPA. That structure makes the intended within-group question understandable: how did physical activity measurements differ between baseline and week 9 among participants with measurements?

It also illustrates a key distinction in clinical research. A change over time in one group is not a controlled estimate of what the intervention caused. Without a comparison arm, other changes occurring during the same period cannot be separated from a program effect. This is not a technical footnote; it determines the scope of the conclusion the design could support even if outcome data were available.

The record further highlights the importance of reporting numerical results and the way incomplete follow-up was handled. The post-measurement count can be affected by withdrawal and failure to complete the accelerometer assessment. Without an estimate, uncertainty interval, analysis population, or missing-data method, readers cannot evaluate the magnitude, precision, or robustness of a change.

Finally, the study lists several kinds of secondary measures, while the record lists 0 analyses. Registering measurement domains and reporting analyses are different steps. Clear results and transparent methods are needed to understand what was observed and how strongly it supports an interpretation. In this case, the available information is informative about the research question and design, but not about the primary endpoint's outcome.

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 central limitation for interpreting the study is that the registry record does not report the primary endpoint results. Baseline and week 9 MVPA values, a change estimate, and uncertainty measures are not reported. Consequently, the observed pattern and its precision cannot be assessed.

The single-group design has no comparison or control arm. Any reported change would therefore be a within-group observation rather than a direct comparison with an untreated or alternative-treatment group. The record does not describe a method that could establish what would have happened without the program.

The record notes that the number analyzed at post reflects participants who withdrew and/or did not complete the accelerometer measurement, but does not report the number with measurements at each time or the handling of missing observations. This limits assessment of potential bias from incomplete follow-up. The analysis population and statistical methods are not reported in the registry record.

Although 14 outcome measures are listed, the registry lists 0 analyses. A plan for addressing multiple outcomes is not reported. The record also provides limited detail for interpreting safety counts: serious-event terms are absent, other-event descriptions are not reported, and event relatedness and timing are not reported. These limitations mean that the record gives a partial account of design and measurement, rather than enough information to evaluate efficacy, precision, or the full safety experience.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Lifestyle Enhancement for ADHD Program — NCT03690674.
• Registry record last updated 2022-04-21; status last verified 2022-03.
• Results first posted 2022-04-21.
• 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

NCT03690674 is the completed Lifestyle Enhancement for ADHD Program, sponsored by Seattle Children's Hospital. The registry lists enrollment as 35, ADHD as the condition, a single-group model, no masking, and no comparison or control arm. Its purpose was to investigate physical activity in children using a modified behavioral management training program.

The primary endpoint was accelerometer-measured MVPA in moderate-vigorous minutes per day at baseline and week 9. The registry lists 14 outcome measures and 0 analyses. Primary and secondary outcome results are not reported in the registry record. The adverse-event record reports 0 serious adverse events and 0 deaths in both the caregiver and child groups, alongside other adverse-event counts. The missing outcome results and the lack of a control arm prevent assessment of an intervention effect from this record.