Helping HAND: Healing Anorexia Nervosa Digitally: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Helping HAND: Healing Anorexia Nervosa Digitally (NCT05499676), a randomized na study. The primary outcome is Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Eating Disorder Psychopathology, as Assessed by the Eating Disorder Examination-Questionnaire..

2. Clinical Question

3. Trial Design

NCT05499676, titled “Helping HAND: Healing Anorexia Nervosa Digitally,” is a randomized, parallel-group trial sponsored by Washington University School of Medicine. The registry lists the study as completed, with an enrollment of 90. Its start date is 2022-12-01, and its primary completion date is 2025-03-01. The phase is listed as NA, and masking is listed as none.

The study compared three approaches in the post-acute period: a mobile coached intervention, the mobile coached intervention plus social networking, and treatment as usual. The mobile intervention arms offered access to the app for 6 consecutive months. The social networking arm also included Facebook. Participants in the app conditions could access other usual care options and were encouraged to follow their discharge plans. The usual-care group was encouraged to follow its discharge plan and seek follow-up or referral information as needed.

The registry describes the project as developing and pilot testing a coached mobile app, including a social networking component, for people with anorexia nervosa after acute treatment. The design can therefore be read as an evaluation of app-based support options against usual care in this setting, rather than as a comparison of an app with no access to care.

The registry lists the primary outcome as EDE-Q Global score, assessed at baseline, 6 weeks, 6 months, and 9 months. It also lists secondary outcomes concerning reported eating behaviors, body mass index, depression measured by the Patient Health Questionnaire, and clinical impairment measured by the Clinical Impairment Assessment. The record lists 7 outcome measures and 23 analyses, but does not report the primary outcome estimates or a complete statistical analysis plan.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Differences in the analysis population reflect incomplete assessment and measure completion over time. Analyses were conducted using all available data for each measure at each time point.

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 Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Eating Disorder Psychopathology, as Assessed by the Eating Disorder Examination-Questionnaire., measured over baseline, 6 weeks, 6 months, and 9 months.

The primary endpoint is eating disorder psychopathology measured with the Eating Disorder Examination-Questionnaire (EDE-Q). The registry describes the EDE-Q as a 28-item measure derived from a diagnostic interview and identifies it as the standard measure of eating disorder psychopathology. The main outcome variable is its Global score, an overall measure of eating disorder psychopathology.

The score ranges from 0 to 6, with higher scores indicating greater eating disorder psychopathology. This makes the endpoint a continuous measure: it can describe variation in scores rather than only whether a participant meets a threshold or experiences a particular event. The registry says results are expressed as a mean and standard deviation.

Repeated assessments were planned at baseline, 6 weeks, 6 months, and 9 months. In general, repeated measurements can describe how a measure changes over time and whether patterns differ between study groups. The registry record does not report the primary outcome estimates, so the size, direction, and precision of any group differences in EDE-Q Global score cannot be described from this record.

The EDE-Q is used to quantify the psychological outcome named in the trial’s primary question. It is not, on its own, a complete account of participants’ health, experience, or care. The other listed outcomes address additional domains, but their results are also not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies this as a randomized, parallel-group trial with no masking. Random allocation is intended, in general, to make study groups comparable at the point of assignment, on average. It does not guarantee that every measured or unmeasured characteristic will be balanced in a particular trial. A parallel-group design assigns participants to a group and compares outcomes across groups rather than having each participant receive every study condition. The registry does not report further details about the randomization procedure or allocation concealment.

What does the primary measure represent?

The primary outcome is the mean EDE-Q Global score, a continuous measure with possible scores from 0 to 6. A mean describes the average score among the observations included in an analysis; the standard deviation describes variability among those scores. These summaries answer different questions: the mean locates the group average, while the standard deviation describes how dispersed individual scores are around that average. Neither summary alone shows the range of participants’ experiences.

For a comparison between groups, an estimated difference in means would describe the separation between their average scores on the scale. A confidence interval, if reported, would express the uncertainty around that estimate under the analysis assumptions. A narrow interval indicates greater precision than a wide interval, but neither an interval nor a p-value establishes whether a difference matters clinically. The registry record does not report an estimate or confidence interval for the primary outcome.

Why are there repeated assessments?

Assessments were scheduled at baseline, 6 weeks, 6 months, and 9 months. In general, repeated outcome measurements can describe change over time and allow investigators to compare the course of scores across groups. The interpretation depends on the chosen analysis: for example, an analysis could focus on change from baseline, a comparison at a particular follow-up, or differences in the pattern over time. The registry record does not state which approach was used for the primary analysis, nor does it provide the outcome estimates at the assessment times.

Because the intervention access period was 6 consecutive months, the 9-month assessment is a later measurement than the stated app access period. That schedule allows a later outcome to be assessed, but the record does not establish what participants did after app access ended or how later care was handled. The record also does not report whether follow-up assessments were completed at similar rates across the groups.

How should incomplete observations be understood?

The registry states that analysis populations differed because assessment and measure completion were incomplete over time. It also says analyses used all available data for each measure at each time point. In general, an available-data approach uses observed measurements without requiring every participant to have completed every measure at every assessment. This can make the contributing sample differ from one time point or outcome to another.

Missing observations matter because the participants with observed measurements may differ from those without them. The consequences depend on why data are missing and on the assumptions used in the analysis. The registry record does not describe a missing-data method, sensitivity analysis, or the counts available for each primary outcome assessment. It therefore does not support a judgment about whether missingness altered the estimated group comparisons.

What does the planning illustration mean?

The record describes a sample-size planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. This is a planning exercise, not evidence of the trial’s original sample-size justification. The record explicitly distinguishes the illustration from the trial’s own design, and does not report a protocol-based sample-size rationale.

In general, sample-size planning asks how many participants would be needed under specified assumptions to detect an effect with a chosen power and significance level. A planning result is conditional on those assumptions. When based on an effect observed in the same study, it should not be mistaken for a prospective design justification or for observed power. No planning counts are described in the registry information, so no such counts can be interpreted.

The record’s illustration assumes equal allocation between two arms, although the trial has three groups. It should therefore be understood as a hypothetical two-arm planning comparison, not as a description of the actual three-group allocation. The registry does not identify the exact comparison used for each planning calculation in the narrative.

Why can count outcomes require different methods?

Some secondary outcomes concern numbers of participants with reported eating behaviors. In general, count outcomes can vary more than a simple statistical model expects, a feature called over-dispersion. When over-dispersion is present, methods that allow for extra variability can produce more appropriate uncertainty estimates than a model that assumes a tighter distribution. This is a general statistical point, not a claim about the analysis used in this trial: the registry record does not report the model used for that secondary outcome.

The registry lists 23 analyses and 7 outcome measures. Multiple outcomes, time points, and comparisons create opportunities for multiple statistical tests. In general, multiplicity procedures can control the chance of false-positive findings across a defined family of tests, but the appropriate approach depends on which outcomes and contrasts were designated as confirmatory. The registry record does not report a multiplicity procedure, a prespecified testing hierarchy, or enough detail to identify such a family.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 7 outcome measures and 23 analyses, with a primary outcome assessed at baseline, 6 weeks, 6 months, and 9 months and several secondary outcomes. When a study makes multiple comparisons or tests multiple outcomes, the chance of at least one apparently unusual result can increase. In general, multiplicity methods address this issue by defining a family of tests and adjusting interpretation or statistical thresholds. The registry record does not report whether any adjustment was used, how tests were grouped, or which analyses were designated as confirmatory.

The listed secondary outcomes cover reported eating behaviors, body mass index, depression measured by the Patient Health Questionnaire, and clinical impairment measured by the Clinical Impairment Assessment. Their inclusion does not by itself establish how they were prioritized or interpreted relative to the EDE-Q primary outcome. The registry record does not give a detailed statistical analysis plan or results for these secondary outcomes.

For the primary outcome, the registry says analysis populations differed because assessment and measure completion were incomplete over time. Analyses used all available data for each measure at each time point. This description indicates that the data contributing to estimates could vary across assessments and measures. It does not specify the number of observations in each analysis or the assumptions used to handle missing measurements.

In general, missing-data assumptions matter because observed participants may differ from those whose measurements are unavailable. A complete-case analysis, an available-data analysis, and a model that uses incomplete repeated measurements can rely on different assumptions and use the data differently. The record does not identify which particular model or sensitivity analysis was used for the primary outcome. Accordingly, the effect of incomplete assessment on the estimated results cannot be evaluated from the registry record.

The record’s description of available data is useful for understanding why analysis populations may change, but it is not a substitute for per-time-point participant counts, a missing-data analysis plan, or reported estimates with uncertainty.

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 serious adverse event terms

Serious events with the highest arm-level rate: participant death while enrolled (3.3%).

The registry reports serious adverse event counts for each group, with 30 participants at risk in each. Treatment as usual had 0 serious adverse events; Mobile Coached Intervention had 0; and Mobile Coached Intervention Plus Social Networking had 1. The listed serious event term is “Participant death while enrolled,” reported as 3.3% for that term. The registry reports 1 death in the social networking group and 0 in each of the other groups.

These are descriptive counts in the registry record. They do not establish why an event occurred, whether it was related to an intervention, or whether the groups differ in underlying risk. A count of 0 in a group does not establish that an event could not occur; it means none was recorded in that group in the posted safety data. The record does not provide further detail about the circumstances or attribution of the reported death.

The registry also reports 0 other adverse events in each group. Safety counts should be read separately from the primary EDE-Q outcome: they address reported adverse events, not changes in eating disorder psychopathology. The record does not provide enough information to make causal interpretations of the serious event counts.

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

The registry record describes a randomized pilot trial of mobile support options for people with anorexia nervosa after acute treatment. Its primary question concerns EDE-Q Global score, with assessments scheduled at baseline, 6 weeks, 6 months, and 9 months. It also specifies three study groups and lists secondary outcomes spanning eating behaviors, body mass index, depression, and clinical impairment.

What the record does not establish is the result of the primary comparison. No group outcome estimates, changes in EDE-Q Global score, confidence intervals, or p-values are reported. Therefore, the record cannot support a statement about the direction or size of any difference between mobile support and usual care, the precision of an estimate, or whether the app-plus-social-networking condition differed from the app condition alone.

Even if outcome estimates were available, statistical evidence would need to be interpreted in context. An estimate describes the observed contrast under the analysis used; its confidence interval describes uncertainty, and a p-value addresses compatibility with a specified null model. Neither statistical significance nor its absence alone determines the practical importance of a difference. Those interpretations also depend on measurement, missing data, analysis choices, and the relevance of the study population and care setting.

The pilot designation and the registry’s description of development and testing place the work in an early evaluation context. The record does not report a protocol-based sample-size justification, detailed analysis plan, or primary results. The posted safety counts are limited to the events listed and do not establish causation. They should not be used to infer broader safety or effectiveness conclusions.

In short, the registry supports a description of what was studied and how the primary outcome was intended to be measured, but not a conclusion about the intervention’s effects. The outcome results are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it evaluates more than a simple app-versus-usual-care contrast. The three groups distinguish mobile coached support, mobile coached support combined with social networking, and treatment as usual. In principle, separate comparisons can address the app-based approach relative to usual care and the potential additional contribution of the social networking component. Those comparisons require clear specification and interpretation, and the registry does not report their outcome estimates.

The study also follows a continuous primary measure at several times, including assessments during and after the stated 6-month access period. Repeated measurements can give a richer picture than a single endpoint, but they also raise questions about which time point or pattern is primary, how within-participant measurements are modeled, and how incomplete follow-up is handled. The record says analyses used available data at each time point and that analysis populations varied, but does not give further modeling detail.

The registry lists 7 outcome measures and 23 analyses. That breadth makes prespecification and multiplicity important for distinguishing planned primary evidence from exploratory comparisons. The record does not report a multiplicity strategy or a full analysis plan, so the intended inferential hierarchy cannot be evaluated from the posted information.

Finally, the registry describes the study as a development and pilot-testing project. Such work can be relevant for evaluating the feasibility of a digitally delivered approach and informing later study design, but this record does not report feasibility results or primary outcome effects. Its statistical contribution, as posted, is therefore chiefly the specification of a multi-group, repeated-measure question and the identification of information needed to interpret results when they are reported.

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 registry record does not report the primary outcome results. Without group means, estimated changes, between-group contrasts, confidence intervals, or p-values, the direction, magnitude, and precision of the primary finding cannot be assessed. Results for the listed secondary outcomes are also not reported in the record.

The registry says that analysis populations differed because assessment and measure completion were incomplete over time, and that analyses used all available data for each measure at each time point. It does not provide the number of participants contributing to each outcome at each assessment, the reasons measurements were missing, or the method used to address missing data. This limits assessment of how incomplete follow-up may affect comparisons.

The record lists multiple outcomes and analyses but does not report a complete statistical analysis plan or a multiplicity procedure. It also does not explain which time point or contrast was treated as the principal inferential comparison. These omissions make it difficult to distinguish confirmatory analyses from other analyses using the registry information alone.

The three-group design includes both an app-only support condition and an app-plus-social-networking condition, alongside treatment as usual. This creates more than one potentially relevant contrast, but the record does not report estimates for those contrasts. The sample-size planning description is explicitly an illustration based on an observed effect and two-arm assumptions, not the trial’s own design justification; the protocol’s sample-size rationale is not reported in the registry record.

Finally, the posted safety information provides event counts but not details about circumstances or attribution. Those counts should not be interpreted as establishing a cause or a comparative risk.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Helping HAND: Healing Anorexia Nervosa Digitally — NCT05499676.
• Registry record last updated 2026-05-05; status last verified 2026-05.
• Results first posted 2026-05-05.
• 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

NCT05499676, “Helping HAND: Healing Anorexia Nervosa Digitally,” is a completed randomized, parallel-group trial sponsored by Washington University School of Medicine. The registry lists an enrollment of 90, no masking, and phase NA. The study began on 2022-12-01, with primary completion on 2025-03-01.

The trial compared a mobile coached intervention, the mobile intervention plus a Facebook social networking component, and treatment as usual. The primary outcome was EDE-Q Global score, scheduled for assessment at baseline, 6 weeks, 6 months, and 9 months. Secondary outcomes included eating behaviors, body mass index, depression, and clinical impairment.

The registry reports one serious adverse event, a participant death while enrolled, in the mobile intervention plus social networking group, and none in the other groups. Primary and secondary outcome results are not reported in the registry record.