This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Helping Educate and Advance Learning Through Healthy Bite-Sized Eating Strategies (NCT06082830), a randomized na study. The primary outcome is Diet Quality.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06082830 |
| Phase | NA |
| Condition | Adolescent Obesity, Adolescent Overweight, Diet, Healthy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Children's Hospital of Philadelphia |
| Results posted | Yes |
2. Clinical Question
The registry record frames the study around feasibility and preliminary effectiveness: whether a digital diet-quality intervention can be used with adolescents with overweight or obesity, and whether diet quality and meal-timing traits improve. It describes a comparison between an intervention group and a control group, with outcomes assessed using dietary recalls, a urine biomarker, and continuous glucose monitoring. However, a primary outcome comparison is not reported in the registry record, so the posted information does not establish what changes were observed or how precisely they were estimated.
Population
Adolescents aged 14-17 years with overweight or obesity. The primary outcome data were collected for adolescents only, not caregivers.
Intervention
A behavioral mobile health intervention with personalized goals, meal timing, nutrition skills, the home food environment, and engagement strategies. Its stated duration was four weeks.
Comparator
The control arm received no intervention materials.
Primary question
Can the digital intervention be implemented, and is there preliminary evidence of change in diet quality? The primary outcome was change in overall Healthy Eating Index (HEI) 2020 score, but a group comparison is not reported in the registry record.
3. Trial Design
This was a randomized, parallel-group behavioral trial sponsored by Children's Hospital of Philadelphia. The registry lists the study as completed, with enrollment of 15. The study start date is 2024-10-01 and the primary completion date is 2025-06-14. The phase is listed as NA. Masking is listed as none, so the record does not describe a masked comparison.
The control arm received no intervention materials. The intervention arm was described as a four-week program with five components: personalized goal, meal timing, nutrition skills, home food environment, and engagement strategies. The registry description of how text messages would be designed and delivered is incomplete; the specific number, design, and content of messages are not reported in the registry record.
Participants were to complete three-day 24-hour dietary recalls, collect urine samples, and wear a continuous glucose monitor, sleep tracker, and physical activity tracker. The registry describes comparisons of diet quality and meal-timing traits using dietary recalls, a urine biomarker, and continuous glucose monitoring. The primary outcome timeframe is listed as 6 weeks, while the intervention duration is four weeks. The registry record does not explain the timing or relationship between these stated periods.
The listed secondary outcomes are urinary concentrations of sodium and potassium. Randomization details, including the sequence-generation procedure and allocation concealment, are not reported in the registry record. The record also does not report a sample-size justification or enough outcome information to assess the balance of the randomized groups.
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: There were 15 parents who consented for their child's participation and children who assented for their own participation and completed a baseline visit, 1 dyad was ineligible based on the child's baseline nutrition assessment. There were 14 adolescent-caregiver dyads (14 adolescents, 14 caregivers) who were eligible for randomization after the baseline period.
Overall Study
| Stage | Control | Intervention | Not Randomized |
|---|---|---|---|
| STARTED | 7 | 7 | 1 |
| COMPLETED | 7 | 7 | 0 |
| NOT COMPLETED | 0 | 0 | 1 |
Reasons for not completing this period:
| Reason | Control | Intervention | Not Randomized |
|---|---|---|---|
| Ineligible After Baseline Diet Assessment | 0 | 0 | 1 |
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.
Only the first 6 of 7 groups are shown.
| Characteristic | Unit | Control (Adolescent) | Control (Caregiver) | Intervention (Adolescent) | Intervention (Caregiver) | Not Randomized (Adolescent) | Not Randomized (Caregiver) |
|---|---|---|---|---|---|---|---|
| Participants analysed | 7 | 7 | 7 | 7 | 1 | 1 | |
| Age, Continuous | Years | — | 45.57 (SD 8.23) | — | 43.71 (SD 5.79) | — | 54 |
| Age, Customized: 14 years | Participants | 4 | 0 | 3 | 0 | 0 | 0 |
| Age, Customized: 15 years | Participants | 1 | 0 | 1 | 0 | 1 | 0 |
| Age, Customized: 16 years | Participants | 1 | 0 | 2 | 0 | 0 | 0 |
| Age, Customized: 17 years | Participants | 1 | 0 | 1 | 0 | 0 | 0 |
| Sex/Gender, Customized: Female | Participants | 4 | 6 | 5 | 6 | 1 | 1 |
| Sex/Gender, Customized: Male | Participants | 3 | 1 | 2 | 1 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 2 | 1 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 4 | 7 | 2 | 5 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 3 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 1 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 | 6 | 7 | 7 | 1 | 1 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Diet Quality, measured over 6 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in overall Healthy Eating Index (HEI) 2020 score. The HEI-2020 ranges from 0-100; a greater score indicates greater adherence to the 2020 - 2025 Dietary Guidelines for Americans and better diet quality. The registry describes deriving scores from dietary data collected through three 24-hour dietary recalls at baseline and follow-up and processed using Nutrient Data System for Research software.
HEI-2020 is used in this study to represent overall diet quality as a continuous measure. A change score can describe whether a participant's measured diet quality differs between baseline and follow-up. In a randomized comparison, the difference in change between groups would address whether the observed pattern differed between those assigned to the intervention and those assigned to control. That interpretation depends on the analysis and the completeness and quality of the recall data.
The endpoint is specified as a mean with standard deviation, and its timeframe is listed as 6 weeks. The registry record does not report group means, change estimates, standard deviations, confidence intervals, or a statistical test for this endpoint. It also notes that the primary outcome has several categories or time points and is not reduced to one comparison. Consequently, the registry information does not permit a numerical estimate of the intervention-control contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the main outcome of interest as change in HEI-2020 score and describes a randomized comparison, but it does not report a primary outcome comparison. There are no posted group-level outcome values, estimated changes, confidence intervals, or p-values in the record described for this analysis. The size and direction of any observed difference, and the precision of such a difference, are therefore not reported in the registry record.
The record also states that the primary outcome has several categories or time points and is not reduced to one comparison. This matters because a reader cannot treat the trial as having one clearly reported estimate of diet-quality change. The registry does not explain which comparisons were made, how they were selected, or whether any analysis adjusted for baseline score or other factors. Those details are not reported in the registry record.
The study is described as addressing feasibility and preliminary effectiveness. Feasibility and effectiveness are distinct questions: implementation can be assessed through measures such as participation or completion, while effectiveness concerns outcome differences between groups. The registry summary describes the trial's aims and participant procedures, but feasibility results, adherence measures, and outcome results are not reported in the registry record. No conclusion about whether the intervention was feasible or whether diet quality changed can be drawn from the design description alone.
The stated enrollment is 15. The adverse-event entries list 7 participants at risk in each arm, but the record does not explain how these counts relate to enrollment or to the populations used for efficacy analyses. The record lists three outcome measures and three analyses, but does not report the analysis methods or outcome estimates needed to interpret those analyses. It is therefore not possible to judge whether data were missing, whether all randomized participants contributed outcome data, or whether the estimates are stable.
General statistical interpretation: an estimate describes the magnitude and direction of a group contrast, while a confidence interval describes the range of values compatible with the data and the assumptions of the analysis. Without an estimate and interval, precision cannot be assessed. A p-value alone, even if available, would not describe the size or practical importance of a difference. In this case, the relevant results are not reported in the registry record, so the evidence cannot be characterized as showing either a clear difference or no difference.
9. Statistical Methods Explained
The registry identifies the primary outcome as a continuous measure summarized by a mean and standard deviation. General explanation: a mean describes the average observed score in a group, while a standard deviation describes how spread out individual scores are around that group average. Neither quantity alone gives the intervention-control contrast. For a randomized trial, interpretation generally depends on comparing outcomes or changes between groups, with uncertainty around that contrast. The group summaries and comparison estimate are not reported in the registry record.
What a change score represents
The endpoint is change in HEI-2020 score from baseline to follow-up. General explanation: a change score is calculated by comparing a participant's later measurement with that participant's earlier measurement. Group-level change can then be compared across randomized groups. This can account for each participant's starting value in describing change, but the exact analysis method matters. The registry record does not report whether the analysis used change scores, follow-up scores adjusted for baseline, or another approach.
Dietary recalls are the stated source for the HEI-2020 calculation. The registry says that three 24-hour dietary recalls are collected at baseline and follow-up and processed using Nutrient Data System for Research software. General explanation: dietary recalls depend on reported intake and may vary from day to day, so repeated measurements can help characterize usual intake more fully than a single recall. The registry does not report recall completion, quality checks, scoring details beyond the stated method, or the amount of missing dietary data.
Randomization and masking
The trial is listed as randomized, with a parallel model and no masking. General explanation: random assignment is intended to make the groups comparable on average at the time of assignment, while a parallel design follows separate groups under their assigned conditions. Randomization does not ensure that every measured characteristic is balanced in a small trial, and it does not eliminate the need to describe who was analyzed. The sequence-generation procedure, allocation concealment, baseline group characteristics, and analysis populations are not reported in the registry record.
Masking is listed as none. General explanation: when participants or study staff know which group a participant is in, expectations and behaviors can influence participation, reporting, or measurement. This may be relevant to self-reported dietary recalls and engagement with a digital intervention. The registry record does not describe whether outcome assessors or analysts were masked, so those details are not reported in the registry record.
Precision and statistical significance
General explanation: a confidence interval expresses uncertainty around an estimated effect under the model's assumptions. A narrower interval indicates greater precision than a wider interval, but precision depends on the amount and variability of usable data as well as the analysis. The primary outcome estimate and its confidence interval are not reported in the registry record. The registry also does not report a p-value or a statistical testing procedure for the primary endpoint.
The record includes a planning-illustration description based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect and that non-time-to-event illustrations express participants per arm. These are planning illustrations, not observed power and not a description of the trial's original design justification. The registry record does not report the trial's own sample-size justification or the numerical planning results.
Over-dispersion and outcome distributions
General explanation: over-dispersion occurs when observed variation is greater than a statistical model expects. It can make standard errors too small if the model does not account for the extra variation, leading to intervals that are too narrow and tests that appear more decisive than they should. This concept can be relevant to count or event outcomes, but the primary endpoint is a continuous HEI-2020 score. The registry record does not report a model diagnostic or an over-dispersion assessment.
The urine outcomes are listed as urinary concentrations of sodium and potassium, and the brief summary also describes a novel urine biomarker and continuous glucose monitoring. The registry record does not provide outcome values, distributional summaries, or analytical methods for these measures. No claim about their statistical behavior or relationship to the primary endpoint can therefore be made.
Planning versus observed evidence
General explanation: sample-size planning asks how much information a future study might need under specified assumptions; it does not report what the trial observed. Planning illustrations based on an observed effect can be especially sensitive to the estimated effect in a small study. They should not be interpreted as proof that the study had adequate power or that an effect is real. The actual primary outcome comparison, its uncertainty, and the analysis plan are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry notes that the primary outcome has several categories or time points and is not reduced to one comparison. It lists three outcome measures and three analyses, but does not specify how the multiple outcomes, time points, or comparisons were handled. A multiplicity adjustment, hierarchy of outcomes, or prespecified strategy for selecting comparisons is not reported in the registry record.
General explanation: when several outcomes or comparisons are tested, the chance of at least one apparently notable result can increase if each is assessed separately. A prespecified testing strategy or adjustment can help control that risk, but the appropriate approach depends on the research questions and analysis plan. Without details of the planned and conducted analyses, the registry information does not establish how multiplicity affects interpretation.
Missing-data handling is also not reported in the registry record. The record does not state how incomplete dietary recalls, missing follow-up scores, or unavailable urine or device measurements were handled. It does not describe whether analyses used all randomized participants, only participants with observed measurements, or another population. The analysis populations and reasons for missing data are not reported in the registry record.
General explanation: missing outcome data can reduce precision and can bias a comparison if missingness is related to group assignment or participants' likely outcomes. The direction and extent of any such effect depend on why data are missing and on the analytic assumptions used. Without participant-flow information and a missing-data method, readers cannot evaluate this issue for the trial.
The registry's planning-illustration assumptions do not substitute for a prespecified statistical analysis plan. The trial's sample-size justification, interim analyses, multiplicity strategy, and missing-data procedures are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Control | 0 | 7 | 0.0% |
| Intervention | 0 | 7 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Control | 0 of 7 |
| Intervention | 0 of 7 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Control | 0 of 7 |
| Intervention | 0 of 7 |
The adverse-event entries list 7 participants at risk in the Control group and 7 in the Intervention group. Each group has 0 serious adverse events, 0 other adverse events, and 0 deaths recorded. These are the event counts presented in the registry record; they do not describe the primary diet-quality outcome.
General explanation: a zero count in a registry entry means that no events of that type are listed for the stated group and reporting period. It does not establish that the underlying risk is absent. Interpretation depends on how events were defined, collected, and monitored, and on the number of participants with safety information and the duration of observation. The adverse-event definitions, monitoring procedures, and reporting period are not reported in the registry record.
The record lists enrollment of 15, while the adverse-event entries list 7 participants at risk in each arm. The relationship between those counts is not explained in the registry record, so the safety entries should not be treated as a complete account of the number enrolled or analyzed. They also do not establish that every participant completed follow-up or had safety data collected. No further safety conclusion can be drawn from the posted counts alone.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized trial designed to examine feasibility and preliminary effectiveness of a mobile health intervention for adolescents with overweight or obesity. It specifies a primary outcome, change in HEI-2020 score, and lists additional measurement approaches involving dietary recalls, urine samples, continuous glucose monitoring, sleep tracking, and physical activity tracking.
What the record does not report is the primary outcome comparison. There are no group-level HEI-2020 results, estimated changes, confidence intervals, or p-values in the information available for this analysis. The registry therefore does not show the direction, size, or precision of a difference between the intervention and control groups. It also does not report feasibility findings, such as intervention engagement or completion, so those aims cannot be evaluated from the record.
The recorded enrollment is 15, and the study is listed as completed. These design and status details do not, on their own, show that the planned outcomes were measured for all participants or that the study had sufficient precision to distinguish a meaningful difference from random variation. The analysis populations, missing-data handling, and original sample-size justification are not reported in the registry record.
General explanation: absence of a reported comparison is not evidence that groups had identical outcomes, nor is it evidence that the intervention changed outcomes. A result requires an estimate and information about its uncertainty, interpreted in light of the analysis plan and data completeness. Since these outcome results are not reported in the registry record, no conclusion about benefit, lack of benefit, or clinical importance follows from the design description or the zero adverse-event counts.
The stated endpoint is a measure of diet quality, not a direct measure of health outcomes. Any broader interpretation would require outcome data and a suitable analysis, neither of which is reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically interesting because it combines a randomized comparison with several kinds of measurement in a small study focused on feasibility and preliminary effectiveness. The stated enrollment is 15. In a study of this scale, the amount of information available for estimating group differences can be limited, especially when outcomes require repeated recalls, urine collection, or wearable-device measurements. The registry record does not report how many participants contributed data to each outcome, so the precision of any estimate cannot be assessed.
The primary endpoint also depends on dietary data collected at baseline and follow-up and converted into HEI-2020 scores. General explanation: a continuous score can preserve information about variation across participants, but the resulting estimate remains dependent on measurement quality, data completeness, and the analysis method. Repeated dietary recalls and other measurement sources may broaden assessment, but their presence in the protocol description is not itself evidence of complete or reliable data.
The record's aims distinguish feasibility from preliminary effectiveness. That distinction is important: a study may be informative about whether procedures can be carried out even when its outcome estimates are too imprecise to settle an effectiveness question. Here, the registry record does not report feasibility results or a primary outcome estimate, limiting both kinds of interpretation.
The study also illustrates why the analysis plan matters. The primary outcome is described as involving several categories or time points, while a single comparison is not reported. Without a clear account of which contrast was intended, how repeated measures were analyzed, and how missing data and multiple comparisons were handled, readers cannot connect the planned question to a specific statistical result. Those details are not reported in the registry record.
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.
A central limitation of the registry record for statistical interpretation is that it does not report a primary outcome comparison. Group values, changes, effect estimates, uncertainty intervals, and tests are not reported in the registry record. The record itself indicates that the primary outcome has several categories or time points and is not reduced to one comparison, leaving the target contrast unclear.
The stated enrollment is 15, but the registry does not describe participant flow or the number contributing data to each outcome. Adverse-event entries list 7 participants at risk per group, and the relationship between those entries and enrollment is not explained. The record does not report adherence to the intervention, completion of the dietary recalls, or completeness of urine and device measurements.
The intervention description is partial. It names five components and states a four-week duration, but the specific number, design, and content of text messages are not reported in the registry record. The record does not report the randomization procedure, allocation concealment, baseline group characteristics, or whether outcome assessors or analysts were masked.
The primary outcome timeframe is listed as 6 weeks, while intervention duration is four weeks; their relationship is not explained. Analysis methods, the original sample-size justification, handling of missing data, multiplicity procedures, and analysis populations are not reported in the registry record. These omissions limit assessment of bias, precision, and whether the reported analyses address the stated research questions.
The study is unmasked, and dietary recalls rely on reported intake. General explanation: participant awareness and self-report can influence measurement, though the extent cannot be determined from the registry description. These limitations do not establish that the results are biased; they identify uncertainties that would need fuller methods and outcome reporting to evaluate.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Helping Educate and Advance Learning Through Healthy Bite-Sized Eating Strategies — NCT06082830.
- Registry record last updated 2026-10-27; status last verified 2026-10.
- Results first posted 2026-10-27.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT06082830 is a completed randomized, parallel-group behavioral trial sponsored by Children's Hospital of Philadelphia, with enrollment of 15 and no masking listed. It studied a mobile health intervention for adolescents aged 14-17 years with overweight or obesity. The intervention included personalized goals, meal timing, nutrition skills, the home food environment, and engagement strategies; the control group received no intervention materials.
The primary outcome was change in HEI-2020 score, with a listed timeframe of 6 weeks. Secondary outcomes were urinary concentrations of sodium and potassium. Participants were to complete dietary recalls, collect urine samples, and wear glucose, sleep, and activity trackers. The registry record does not report the primary outcome comparison, analysis populations, missing-data methods, multiplicity procedures, or the trial's sample-size justification. It lists 0 serious adverse events, 0 other adverse events, and 0 deaths in each group, with 7 participants at risk per group.