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 Using Mobile Technology to Improve Self-Regulation (NCT03774433), a na na study. The primary outcome is Rate of Binge Eating Episodes [Binge Eating Sample Only].
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03774433 |
| Phase | NA |
| Condition | Self-regulation, Binge Eating, Smoking |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 114 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Dartmouth-Hitchcock Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
The study description covers smokers and overweight or obese people with binge eating disorder. It describes intended samples of 50 smokers and 50 people in the binge-eating sample; the registry lists enrollment as 114. The primary endpoint applies only to the binge-eating sample. For that endpoint, the recorded population is participants who completed >10% of EMA assessments, specified as at least 12. How many participants met that criterion is not reported in the registry record.
Intervention
All participants were invited to use Laddr, a mobile behavioral assessment and intervention platform. The study description says the platform offers self-regulation assessment and behavior-change tools and that its content can be modified. The registry classifies Laddr as behavioral. Details such as the precise content each participant received, how often participants used the platform, and the extent of use are not reported in the registry record.
Comparator
There is no randomized control group described. The trial is recorded as a single-group study, and allocation is listed as not applicable. The registry says all participants were invited to use Laddr; it does not describe a separate untreated or alternative-treatment group. Consequently, the record does not support a like-for-like comparison between Laddr and a control condition.
Primary question
For the binge-eating sample, the primary endpoint concerns the mean number of self-reported binge-eating episodes per week across a 28-day period. A reported episode requires both self-reported overeating and loss of control. The registry describes weekly measurement but does not report the weekly means, standard deviations, or an analysis estimating change over time. The clinical question is therefore clear as a measurement objective, but the posted record does not provide numerical results to establish the observed pattern.
3. Trial Design
The registry describes a completed, single-group behavioral study of Laddr, a mobile platform intended to support self-regulation assessment and behavior change. The study title concerns using mobile technology to improve self-regulation. Its brief description says the investigators aimed to evaluate whether engaging behavioral targets was associated with desired changes in medical regimen adherence during 4-week interventions and in health behavior. The specified behaviors were smoking among smokers and binge eating among people in the binge-eating sample.
The planned populations in the brief description are smokers and overweight or obese people with binge eating disorder, with a stated sample of 50 for each. The registry lists enrollment as 114. The primary endpoint addressed in this analysis is limited to the binge-eating sample, rather than both populations. The record also identifies smoking and self-regulation as conditions, but it does not give numerical results for smoking behavior or adherence in the information available for interpretation.
All participants were invited to use Laddr. The registry records allocation as not applicable, masking as none, and the model as single group. It therefore does not describe random assignment, blinded assessment, or a separate control arm. Participants’ outcomes are not set against a randomized comparator in this design. The registry says that the study builds on NCT03352713 and describes this as the fourth and final phase of a broader effort to identify putative mechanisms of behavior change. Further details of the earlier phase or the relationship between phase activities are not reported in the registry record.
The study is recorded as completed. The listed start date is 2019-02-27 and the listed primary completion date is 2020-06-29. The record gives no protocol-level explanation for the enrollment target, no detailed schedule of intervention delivery, and no account of changes made during implementation. Those design details 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
| Stage | Laddr |
|---|---|
| STARTED | 114 |
| COMPLETED | 100 |
| NOT COMPLETED | 14 |
Reasons for not completing this period:
| Reason | Laddr |
|---|---|
| Participants who completed less than 12 EMAs are not included in the final analysis | 14 |
Analysis population for the primary outcome, as defined in the registry: Participants included completed \>10% (at least 12) EMAs.
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: Total number of consented participants.
| Characteristic | Unit | Laddr |
|---|---|---|
| Participants analysed | 114 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 114 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 33.83 (18 to 50) |
| Sex: Female, Male: Female | Participants | 65 |
| Sex: Female, Male: Male | Participants | 49 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 9 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 105 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 7 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 14 |
| Race (NIH/OMB): White | Participants | 83 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 9 |
| Region of Enrollment: United States | Participants | 114 |
6. Primary Endpoint
The registry lists the primary outcome as Rate of Binge Eating Episodes [Binge Eating Sample Only], measured over 28 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | binge eating episodes |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the rate of binge-eating episodes in the binge-eating sample, expressed as a mean number of episodes. The measurement period is 28 days, with the registry describing assessments four times daily: morning, early afternoon, late afternoon or evening, and night. Participants report whether they overate since the last prompt and whether they lost control over their eating. Overeating is scored as yes or no; loss of control uses a scale from 1 to 5, with scores of 4 or 5 treated as loss of control. An episode is defined by the combination of overeating and loss of control.
The record says assessments are averaged within each week to calculate episodes per week, with separate summaries intended for Week 1, Week 2, Week 3, and Week 4. The stated summary measures are the mean and standard deviation. This endpoint is used to describe the target behavior over the intervention period in the binge-eating sample. Repeated weekly summaries can show the pattern of the measured behavior across the 28-day period, but without a comparison group they do not, by themselves, separate changes associated with Laddr from changes that might have occurred for other reasons.
The endpoint definition and measurement schedule are described, but the weekly numerical means and standard deviations are not reported in the registry record. Nor is a numerical estimate of change, with uncertainty, reported there. The record’s population note specifies participants who completed >10% of EMAs, at least 12. How that criterion was applied to the reported endpoint, and how incomplete weekly data were handled, are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a behavioral intervention and describes a repeated measure of binge-eating episodes. It does not provide the numerical results for that primary endpoint. Although the outcome description specifies weekly means and standard deviations across four weeks, those values are not reported in the registry record. The record also lists zero analyses. As a result, the size, direction, and precision of any change in binge-eating episodes cannot be assessed from the recorded information.
A mean would describe the average number of episodes per week among the participants contributing data to that summary. A standard deviation would describe the spread of individual observations around that mean. Neither quantity is an estimate of how much the outcome changed because of Laddr. To assess change, an analysis would need to define a contrast, such as change over time, and report an estimate with an appropriate measure of uncertainty. Such an analysis is not reported in the registry record.
The study is single group, with all participants invited to use Laddr and no randomized comparator described. Even if weekly values were available, a change from one week to another would be a within-study pattern, not a direct estimate of the difference between receiving Laddr and receiving an alternative or no intervention. General statistical interpretation: without a concurrent comparison group, observed changes can reflect influences other than the intervention, including natural fluctuation, time trends, measurement effects, or other changes occurring during follow-up. The registry record does not establish how much any such influences affected the measured behavior.
The endpoint is based on repeated self-report. Its definition combines reports of overeating and loss of control, and the record describes prompts several times daily. Repeated assessment can capture behavior at multiple points during the day, but the resulting summaries depend on participants responding to prompts and on the endpoint’s operational definition. The registry specifies a threshold for loss of control and an EMA completion criterion, but does not report response rates, the number of participants contributing to each weekly summary, or sensitivity analyses using alternative definitions.
The record does not provide confidence intervals, p-values, or model estimates for the primary endpoint. Statistical significance and precision therefore cannot be evaluated. A confidence interval, in general, expresses the range of values compatible with an estimate under a specified statistical procedure; it would help show whether an estimate is precise or uncertain. No such interval is reported for the primary outcome. The absence of these results is not evidence that the outcome did or did not change. It means the registry record, as described, does not permit a numerical conclusion about the endpoint.
The registry lists 114 as enrollment, while the primary endpoint applies only to the binge-eating sample and its population note identifies an EMA completion threshold. These registry entries do not establish how many people contributed to each outcome summary. The registry record does not report the endpoint-specific analyzed sample size, the distribution of missing assessments, or whether all enrolled participants were included in any analysis. Those omissions further limit interpretation of both the average outcome and its precision.
9. Statistical Methods Explained
General: A continuous outcome is measured on a numerical scale, and its mean describes the average value among the observations included in the calculation. The primary endpoint is defined as a mean number of binge-eating episodes per week. The standard deviation describes how dispersed the observations are around that mean. It is not the same as the standard error: the standard deviation describes variation in the observed data, while the standard error describes uncertainty in an estimated mean under a statistical model. The registry names the mean and standard deviation as the intended summaries, but does not report their numerical values.
What does the endpoint definition capture?
The endpoint uses repeated self-reports about eating since the previous prompt. An episode is defined by both overeating and loss of control. The registry specifies a yes-or-no overeating item and a loss-of-control scale, with scores of 4 or 5 counted as loss of control. This operational definition makes clear which responses contribute to the endpoint. It does not show how often episodes occurred, because the weekly values are not reported in the registry record.
Assessments are described as occurring four times daily across a 28-day period. Weekly averages are intended to characterize the behavior over time. General: Repeated measurements can provide a more detailed view of a changing behavior than a single measurement, but measurements from the same participant are usually related to one another. An analysis of repeated measures should account for that dependence if it estimates a time trend or compares weeks. The particular statistical model, if any, is not reported in the registry record; the analysis count is zero.
How should a mean and standard deviation be read?
General: A mean is sensitive to the values included in its calculation, including unusually high observations. A standard deviation provides context about the spread of those values, but it is not a direct measure of the precision of the mean. A confidence interval or standard error is generally used to express uncertainty about an estimated mean or contrast. The registry description names standard deviations but does not report confidence intervals, standard errors, or a model-based estimate for the primary endpoint. Thus, the intended descriptive summaries cannot be used to judge precision without the numerical results and the number of observations contributing to them.
The registry’s population note says participants included for the endpoint completed >10% of EMAs, specified as at least 12. This is a threshold for assessment completion, but it does not fully describe the analysis population. The record does not say whether the threshold was applied once across the measurement period or separately by week, how partial data were summarized, or how participants below the threshold were handled. Those decisions matter because a summary based on observed assessments can differ from one based on a method that accounts for missing observations.
Why does the single-group design matter?
General: In a single-group study, changes over time are assessed within the group receiving or being invited to use the intervention. A within-group change does not provide the same evidence as a comparison of outcomes between randomized groups. Other influences may coincide with the study period, and the design cannot directly balance those influences against a control condition through random allocation. Here, the registry records a single-group model, allocation as not applicable, and no masking. All participants were invited to use Laddr. No control arm or randomized treatment contrast is described.
Consequently, an analysis of weekly measurements could describe the pattern of reported episodes, but a causal interpretation would require assumptions beyond the descriptive pattern. The registry record does not report a causal analysis, adjustment strategy, or comparison with an external or historical control. The intervention’s intended purpose and the observed outcome, if numerical results were available, would need to be kept distinct: an intervention may be designed to change behavior, while an outcome summary only describes what was measured among participants.
What do planning assumptions mean?
General: A sample-size calculation is a planning exercise based on a target effect and statistical assumptions; it is not a measure of what the completed study achieved. The planning assumptions described for the associated illustration include 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 an observed effect. These are planning assumptions, not a description of the registered single-group design. The registry record does not report the trial’s own sample-size justification or a design based on equal allocation between two arms.
Planning sample sizes should not be described as observed power. Observed power is not a substitute for an estimate and its uncertainty after data collection. The registry record does not provide the numerical primary-outcome results needed to interpret the effect used in such a planning illustration, and no planning sample-size values are reported in the registry record. Any such calculation should be read as hypothetical planning information, not as evidence that the study was adequately powered or that the endpoint changed.
General: Over-dispersion occurs when data vary more than a model’s assumed distribution allows. For episode counts, a model that assumes a particular mean-to-variance relationship may fit poorly if the observed spread is larger. A suitable analysis may need to account for over-dispersion and within-person dependence in repeated counts. Whether an analysis assessed these features, which distribution or model was considered, and how model fit was evaluated are not reported in the registry record. No model estimates or diagnostic results are reported.
More broadly, a complete statistical report for this endpoint would ordinarily make clear the target estimand, the data included, the method for repeated measurements, the handling of incomplete observations, and the uncertainty around the main estimate. These items determine what a result means and to whom it applies. The registry gives a measure definition and an inclusion threshold, but the corresponding analysis details and numerical results are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures, but only the binge-eating episode endpoint is described in detail in the information available for interpretation. The other outcome measure’s definition and results are not reported in the registry record. The record lists zero analyses, and does not describe a statistical testing plan, a hierarchy of outcomes, or a procedure for addressing multiplicity. It is therefore not possible to determine whether multiple outcomes or repeated weekly measurements were treated as confirmatory, exploratory, or purely descriptive.
General: Multiplicity arises when several hypotheses or outcomes are examined. Without a prespecified plan, repeated tests can increase the chance of finding an apparently unusual result by chance. A multiplicity adjustment or a clear hierarchy can help define how evidence should be interpreted. The registry record does not report whether any such approach was planned or used. Since no primary-outcome p-values or analyses are reported, there is no basis for reconstructing a testing strategy from the posted results.
The population note for the primary endpoint specifies participants who completed >10% of EMA assessments, at least 12. The record does not report the number meeting this criterion or the number included in each weekly summary. It also does not describe how missing EMA prompts, incomplete weeks, or participants below the completion threshold were handled. Imputation, complete-case analysis, and other missing-data methods are not reported in the registry record.
Likewise, the registry does not identify an intention-to-treat population, a per-protocol population, or another analysis population by name. The endpoint-specific completion criterion provides some information about inclusion, but it does not explain whether the analysis followed that criterion consistently or how deviations were addressed. These gaps limit assessment of selection effects and the extent to which the reported endpoint, if available, would represent the study population.
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 |
|---|---|---|---|
| Laddr | 1 | 114 | 0.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Laddr | 0 of 114 |
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 |
|---|---|
| Laddr | 1 of 114 |
Most frequent serious adverse event terms
| Event term | Organ system | Laddr |
|---|---|---|
| Facial Fractures | Injury, poisoning and procedural complications | 1 of 114 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Laddr |
|---|---|---|
| Deep Vein Thrombosis | Blood and lymphatic system disorders | 1 of 114 |
Serious events with the highest arm-level rate: facial fractures (0.9%).
The registry’s adverse-event record lists the Laddr group with 114 participants at risk for serious adverse events and 1 affected; it also lists 114 at risk for other adverse events and 1 affected. The deaths entry is 0. The listed top serious term is Facial Fractures, with 0.9% shown for that term. These are the safety figures recorded in the registry.
Those entries should be read as registry counts, not as proof of a causal relationship with Laddr. The record does not describe an independent assessment of whether an event was caused by the intervention, nor does it provide timing, clinical detail, or an event-level narrative. It is also not reported in the registry record whether the serious and other event entries refer to the same person or to separate people. The top-term entry does not establish when the event occurred or its relationship to platform use.
General: Adverse-event summaries depend on how events are defined, collected, and classified, and on the period over which participants are monitored. A recorded event count alone does not establish comparative safety, particularly when the study has no described control arm. The registry does not report a comparative safety analysis, exposure-adjusted rates, or detailed follow-up duration for these entries. Accordingly, the figures describe what the record lists; they do not establish that Laddr caused an event or that no unlisted events occurred.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a completed, single-group study in which participants were invited to use Laddr, a mobile behavioral assessment and intervention platform. It also defines a primary outcome for the binge-eating sample: mean self-reported binge-eating episodes per week over 28 days, based on a specified combination of overeating and loss of control. These details identify the intervention and the intended behavioral measure.
The record does not report the primary endpoint’s weekly means or standard deviations, a numerical change estimate, confidence intervals, p-values, or an analysis model. Therefore, the posted information does not show whether the measured behavior increased, decreased, or remained similar over the intervention period. It also does not show how precise any estimated pattern would be. This absence of numerical results should not be interpreted as evidence of either benefit or no benefit.
The design also limits what could be concluded from a within-group pattern. Because the record describes one group and no randomized comparator, a temporal change would not by itself estimate what would have happened without Laddr. The record does not provide a comparative effect or a causal estimate. It is therefore not possible to attribute a change in behavior to the intervention from the information reported.
The enrollment entry of 114 does not identify how many participants contributed to the binge-eating endpoint. The endpoint population note applies an EMA completion threshold, but the number meeting it and the handling of incomplete assessments are not reported. This makes it impossible to determine the precision or representativeness of any endpoint summary from the record.
The safety entries list one serious adverse event, one other adverse event, and zero deaths, alongside the listed serious term Facial Fractures. These are registry-recorded figures and do not establish causation or comparative safety. In sum, the record provides useful design and measurement descriptions, but it does not provide the numerical outcome analyses needed to judge the observed behavioral pattern or its uncertainty.
13. Why This Trial Matters Statistically
This study is statistically notable for trying to measure a behavior repeatedly in everyday settings using a mobile platform. The endpoint description specifies prompts across the day and a weekly summary across a 28-day period. Such measurement aims to capture behavior at multiple moments rather than relying on a single retrospective assessment. The operational definition also makes explicit how overeating and loss of control combine to form the target event.
At the same time, repeated measurement introduces analytical questions. Responses from one participant are not necessarily independent, and incomplete prompts can affect the number and timing of observations. A useful statistical account would explain how these repeated and potentially incomplete observations were summarized and modeled. The registry record states an EMA completion threshold, but the analyzed sample size, missing-data handling, and model are not reported.
The study also illustrates the distinction between a descriptive behavioral trajectory and an intervention effect. Weekly summaries could describe how reported episodes vary during a four-week period. Without a comparison group, those summaries would not isolate the intervention’s contribution from other changes over time. This distinction is important when translating a within-group pattern into a claim about efficacy.
Finally, the registry record makes clear that the primary endpoint is restricted to the binge-eating sample, while the broader study description also includes smokers and smoking behavior. Separating populations and outcome definitions is necessary to avoid treating a heterogeneous study as though it had one common endpoint. However, the numerical outcome results and analysis details needed to assess the findings are not reported in the registry record. The statistical importance of the study’s measurement approach is therefore clearer than the evidence for any particular outcome pattern.
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 available record is that it describes the primary endpoint without reporting its numerical results. Weekly means and standard deviations are specified as intended summaries, but no values, change estimates, uncertainty intervals, or model results are reported in the registry record. The registered analysis count is zero. As a result, the endpoint’s direction, magnitude, and precision cannot be evaluated.
The single-group design lacks a randomized comparator in the registry description. All participants were invited to use Laddr, and allocation is listed as not applicable. This means that even a documented change over time would not, on its own, distinguish intervention-related change from other time-varying influences. Masking is listed as none, and no blinded outcome assessment is described.
The primary outcome relies on EMA self-report and an operational definition requiring overeating and loss of control. The registry specifies the questions and threshold but does not report adherence to prompts, measurement reliability, or whether alternative definitions were examined. The endpoint population is described using an EMA completion criterion of >10%, at least 12, yet the number meeting the criterion and the treatment of missing assessments are not reported.
The record lists enrollment as 114 and describes intended samples of 50 for each of two populations, but does not report endpoint-specific analysis counts. It also does not provide a detailed statistical plan, sample-size justification, or the methods used to handle repeated measurements. The brief summary mentions medical regimen adherence, smoking, and binge eating, while the primary endpoint covers binge eating only; numerical results for the other behaviors are not reported in the registry record. These limitations restrict both the substantive interpretation and the assessment of statistical precision.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Using Mobile Technology to Improve Self-Regulation — NCT03774433.
- Registry record last updated 2021-08-24; status last verified 2021-07.
- Results first posted 2021-08-24.
- 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.
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18. Record Summary
The registry identifies NCT03774433 as a completed, single-group behavioral study of Laddr, a mobile technology platform intended to support self-regulation and behavior change. The study description includes smokers and overweight or obese people with binge eating disorder. The primary endpoint discussed in the record applies only to the binge-eating sample and measures mean self-reported episodes per week across 28 days.
The endpoint definition, assessment schedule, and EMA completion criterion are described. Enrollment is listed as 114. The record does not report numerical primary-outcome summaries or analyses, and lists zero analyses. It does not describe a randomized comparator or a statistical method for the repeated measurements. Safety entries list one serious adverse event, one other adverse event, and zero deaths; the listed top serious term is Facial Fractures. These entries do not establish causation. Overall, the record documents the study’s measurement and design, but does not report the results needed to quantify the primary behavioral outcome or its uncertainty.