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 Research Intervention to Support Healthy Eating and Exercise (NCT04353258), a randomized na study. The primary outcome is Weight.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04353258 |
| Phase | NA |
| Condition | Obesity |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 195 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Connecticut |
| Results posted | Yes |
2. Clinical Question
Population
Adults from economically disadvantaged backgrounds with obesity. The registry record describes the intended population but does not report detailed eligibility criteria or the characteristics of participants who enrolled.
Intervention
A 12-month behavioral weight-loss intervention delivered primarily via mobile phone, with behavioral economics components. The registry calls this the Behavioral Economics intervention, or BE mHealth.
Comparator
A 12-month behavioral weight-loss intervention delivered primarily via mobile phone without the stated behavioral economics components. The registry calls this the Standard mHealth intervention, or mHealth.
Primary question
The study’s primary aim was to test the efficacy of the behavioral economics intervention for weight loss in adults from economically disadvantaged backgrounds. The registered primary outcome was weight change measured over follow-up. The record does not report the observed weight changes or an estimate of the difference between groups.
The comparison concerns the added behavioral economics components within mobile-delivered weight-loss interventions. It is not a comparison of mobile delivery with no intervention: both groups were assigned a mobile-phone-based program. The clinical question is whether the intervention groups differed in weight change over the registered assessment period. The record identifies that question, but it does not provide results with which to judge the size, direction, or precision of any difference.
3. Trial Design
The registry describes a randomized, single-masked, parallel-group study. Participants were allocated to BE mHealth or standard mHealth. The record does not specify who was masked, so the masking designation cannot be interpreted more narrowly. The interventions were behavioral, and the study concerned obesity.
The registry lists enrollment as 195 and study status as completed. The study start date is 2021-09-07, and the primary completion date is 2024-12-17. These dates describe the registered study timeline; they do not establish when all follow-up or analysis activities occurred.
Both interventions were planned as 12-month weight-loss programs delivered primarily via mobile phone. BE mHealth included behavioral economics components, while the standard mHealth description does not state that it included those components. The record does not give further detail about intervention content, adherence, delivery frequency, or whether participants received other support.
Weight was scheduled for assessment at baseline, 2 month, 6 month, 12 month, and 18 months. Thus, the registered outcome schedule includes follow-up beyond the stated 12-month intervention period. The registry notes that attrition occurred over time, with more participants lost to follow-up as time passed. It does not report the number assessed at each occasion or the reasons for missing follow-up measurements.
The allocation method beyond the label “randomized,” concealment procedures, and any stratification factors are not reported in the registry record. Nor does the record describe a detailed statistical analysis plan. Without those details, the registered design can be described, but its implementation and the planned analysis cannot be fully assessed.
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 | Behavioral Economics Intervention (BE mHealth) | Standard mHealth Intervention (mHealth) |
|---|---|---|
| STARTED | 97 | 98 |
| COMPLETED | 83 | 85 |
| NOT COMPLETED | 14 | 13 |
Analysis population for the primary outcome, as defined in the registry: There was attrition over time during this longitudinal study, such that more participants were lost to follow-up over time.
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.
| Characteristic | Unit | Behavioral Economics Intervention (BE mHealth) | Standard mHealth Intervention (mHealth) | Total |
|---|---|---|---|---|
| Participants analysed | 97 | 98 | 195 | |
| Age, Continuous | years | 37.6 (SD 12.8) | 42.0 (SD 16.9) | 39.7 (SD 15.1) |
| Sex/Gender, Customized: Gender – Female | Participants | 84 | 84 | 168 |
| Sex/Gender, Customized: Gender – Male | Participants | 13 | 13 | 26 |
| Sex/Gender, Customized: Gender – Non-binary | Participants | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 71 | 77 | 148 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 25 | 21 | 46 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): Asian | Participants | 7 | 3 | 10 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 33 | 37 | 70 |
| Race (NIH/OMB): White | Participants | 36 | 47 | 83 |
| Race (NIH/OMB): More than one race | Participants | 10 | 6 | 16 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 8 | 4 | 12 |
| Body Mass Index (BMI; kg/m2) | kg/m2 | 35.7 (SD 7.1) | 34.7 (SD 6.5) | 35.2 (SD 6.8) |
6. Primary Endpoint
The registry lists the primary outcome as Weight, measured over Baseline, 2 month, 6 month, 12 month, 18 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | kg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is weight, expressed in kilograms. The registry describes weight change measured on a digital scale to the nearest 0.1-kilogram and gives a schedule of baseline, 2 month, 6 month, 12 month, and 18 months. The endpoint is a continuous measure, and the registry identifies the summary parameter as a mean with standard deviation as the dispersion measure.
Weight is used to represent the outcome targeted by the study: weight loss. Repeated measurements can describe how weight changes during and after the intervention period, rather than relying on a single measurement. Baseline measurement provides a reference for describing subsequent change. The 18-month assessment extends beyond the stated 12-month intervention, although the registry does not explain the intended interpretation of that later assessment.
As general statistical context, a mean describes the average measurement in a group, while a standard deviation describes how spread out individual measurements are around that average. A group mean alone does not show how much participants varied. A comparison of change between groups would be needed to address the study’s comparative question, and its precision would ordinarily be assessed with an uncertainty estimate such as a confidence interval.
The registry record does not report mean weights, mean changes, a between-group estimate, or a confidence interval. It therefore identifies what was to be measured, but does not establish the observed weight outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registered objective is a comparison of weight loss between BE mHealth and standard mHealth among adults from economically disadvantaged backgrounds. The registry identifies random allocation and a longitudinal weight outcome, but it does not report outcome estimates or analyses. Consequently, the record does not establish the direction or magnitude of the observed difference in weight change, nor how precisely that difference was estimated.
No primary-outcome analysis is listed in the record. A numerical effect estimate, confidence interval, and significance test are not reported in the registry record. This means that readers cannot use this record to judge whether the groups had similar or different observed weight changes, or whether any estimated difference was compatible with a range of clinically relevant effects. Absence of results in the record should not be mistaken for evidence of no effect.
The registered assessment schedule covers baseline, 2 month, 6 month, 12 month, and 18 months. A longitudinal outcome can be presented in several ways, including change from baseline at a selected follow-up, group means at each occasion, or a model that uses repeated measurements. Those approaches answer related but not identical questions. The statistical analysis used, the primary time point for an efficacy comparison, and whether the analysis accounted for repeated observations are not reported in the registry record.
The record explicitly notes that attrition increased over time. This matters because weight outcomes are unavailable for participants who do not attend follow-up unless measurements are otherwise obtained. If loss to follow-up is related to weight, treatment experience, or other factors, the observed measurements may not represent all randomized participants. The record does not report follow-up counts, reasons for missing measurements, or how missing data were handled, so the potential effect of attrition on the result cannot be assessed.
Randomization is intended, in general, to make treatment groups comparable at the start of a trial. It does not by itself ensure that later outcome data are complete, that intervention delivery is consistent, or that a particular analysis is unbiased. No baseline comparison, adherence information, or analysis population is reported. These omissions limit interpretation of the conduct and results, independently of the fact that the primary outcome results themselves are absent.
Safety information is recorded separately from the primary weight outcome. The record lists serious and other adverse-event figures for each group and reports no deaths in either group. These figures do not supply an efficacy result and should not be treated as a substitute for the missing weight analysis. Further detail about event definitions, timing, and statistical comparisons is not reported.
The record also describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. These are described as planning illustrations rather than the trial’s own design justification. The illustration values and the underlying observed effect are not reported in the registry record. Such planning figures would not constitute observed power or evidence about the trial’s outcome.
9. Statistical Methods Explained
The registry identifies the study as randomized, with two parallel intervention groups and a continuous primary outcome. It does not report a detailed statistical analysis plan. The explanations below describe general statistical concepts relevant to this design; they are not claims about analyses performed in this trial.
What does randomization contribute?
In general, random allocation is used to reduce systematic differences between groups at the start of a trial. If allocation is implemented as intended, differences in outcomes can be interpreted as comparisons between assigned interventions with less concern that participants selected their own group. Randomization does not guarantee that every measured or unmeasured characteristic will be identical between groups, especially in a finite study. It also does not resolve missing outcome data or establish that participants followed the assigned program.
The registry does not describe the sequence-generation procedure, concealment of allocation, or any stratification. These details help readers assess how allocation was carried out. The record’s “single-masked” designation also does not name the masked party. Without that information, the practical implications of masking cannot be determined.
What does a mean and standard deviation describe?
For a continuous outcome such as weight, a mean gives a measure of the group’s average, while a standard deviation describes variation among measurements. They answer different questions: the mean concerns the central level, and the standard deviation concerns spread. Neither quantity alone gives the uncertainty around a comparison between groups. A confidence interval for a treatment contrast would ordinarily help show the range of effects reasonably compatible with the data under the analysis assumptions. No such estimate is reported in the registry record.
Weight was scheduled repeatedly, so observations from the same participant are related rather than independent. As general statistical context, an analysis of repeated measurements should account for that within-participant relationship. A model can use measurements from more than one occasion, but its interpretation depends on the model structure, the outcome being estimated, and the assumptions used. The registry does not report whether a repeated-measures model was used, which follow-up occasion was primary for inference, or how the correlation among measurements was handled.
Why does the chosen contrast matter?
A difference in mean weight at a particular follow-up is not identical to a difference in mean change from baseline. A repeated-measures model may estimate an overall group pattern or a group contrast at a specified occasion. These quantities can answer different questions, and their interpretation depends on the analysis plan. The record describes weight change and its measurement schedule, but the specific estimand and analysis contrast are not reported.
In general, a p-value assesses how compatible observed data are with a specified null model, conditional on assumptions. It is not the probability that an intervention is effective, and it does not measure the size or practical importance of an effect. A confidence interval communicates uncertainty about an estimate and is usually more informative when interpreted alongside the estimated effect. The registry does not report a p-value, confidence interval, or effect estimate for the primary outcome.
How can attrition affect inference?
Missing follow-up measurements reduce the information available for a longitudinal outcome. The registry states that more participants were lost to follow-up over time. In general, complete-case analysis uses only participants with the required observed measurements, while other approaches may use available measurements under explicit assumptions about the missingness process. Different approaches can lead to different results when assumptions differ. No missing-data method or assumption is reported in the registry record, and the changing follow-up counts are not available.
Over-dispersion is a concept most relevant to outcomes whose variability is greater than a chosen model expects, often count data. It can make standard errors too small if ignored. The registered primary endpoint is continuous weight, so a count-outcome over-dispersion model cannot be assumed to apply. More generally, the distribution and residual assumptions of any continuous-outcome model should be assessed; the registry does not report such diagnostics or the model used.
What do the planning assumptions mean?
The registry describes a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. General sample-size planning asks how much information would be needed to detect an assumed effect under specified statistical assumptions. The answer depends on the assumed effect and variability, among other factors.
The registry characterizes these figures as planning illustrations, not as the trial’s own design. Their values and the effect on which they were based are not reported in the registry record. Planning calculations must not be interpreted as observed power, a trial result, or proof that a study was adequately sized. The record also does not report a sample-size justification for the trial itself.
What can be concluded from the available methods information?
The design and endpoint allow the intended comparison to be described, but not reproduced or fully evaluated. The analysis population, handling of repeated measurements, missing-data strategy, multiplicity approach, and inferential results are not reported in the registry record. Without those details and the outcome estimates, the statistical evidence for the primary question cannot be assessed from this record.
10. Multiplicity, Missing Data and Analysis Populations
The weight outcome was scheduled at baseline, 2 month, 6 month, 12 month, and 18 months. Assessing treatment differences at multiple follow-up occasions can raise a multiplicity question: the more comparisons considered, the greater the chance of finding an apparently notable result by chance if each is interpreted separately. As general statistical context, trials may identify one primary time point, adjust for multiple comparisons, or use a model with a prespecified overall contrast. The registry record does not report a multiplicity plan or identify a primary follow-up comparison.
The record describes attrition over time, with more participants lost to follow-up as time passed. It does not report the number with measurements at each occasion, reasons for missingness, or the method used to handle missing outcomes. This prevents assessment of whether the reported analysis, if any, included all randomized participants or relied on a subset with observed data. The analysis population and any sensitivity analyses are not reported in the registry record.
These omissions matter because conclusions can depend on which outcomes and time points are emphasized and on how incomplete follow-up is handled. No claim about multiplicity adjustment, imputation, or a particular analysis population can be made from the registry information. The absence of these details is not evidence that a method was or was not used; it means that the method is 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 |
|---|---|---|---|
| Behavioral Economics Intervention (BE mHealth) | 3 | 97 | 3.1% |
| Standard mHealth Intervention (mHealth) | 6 | 98 | 6.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Behavioral Economics Intervention (BE mHealth) | 0 of 97 |
| Standard mHealth Intervention (mHealth) | 0 of 98 |
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 |
|---|---|
| Behavioral Economics Intervention (BE mHealth) | 7 of 97 |
| Standard mHealth Intervention (mHealth) | 5 of 98 |
Most frequent serious adverse event terms
| Event term | Organ system | Behavioral Economics Intervention (BE mHealth) | Standard mHealth Intervention (mHealth) |
|---|---|---|---|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | 2 of 97 | 0 of 98 |
| Hospitalization | Nervous system disorders | 1 of 97 | 1 of 98 |
| Hospitalization | Cardiac disorders | 0 of 97 | 2 of 98 |
| Hospitalization | Gastrointestinal disorders | 0 of 97 | 2 of 98 |
| Hospitalization | Musculoskeletal and connective tissue disorders | 0 of 97 | 1 of 98 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Behavioral Economics Intervention (BE mHealth) | Standard mHealth Intervention (mHealth) |
|---|---|---|---|
| COVID - long/severe | Respiratory, thoracic and mediastinal disorders | 2 of 97 | 2 of 98 |
| Break/Bad Sprain | Musculoskeletal and connective tissue disorders | 1 of 97 | 3 of 98 |
| Gall Bladder | Gastrointestinal disorders | 2 of 97 | 0 of 98 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 1 of 97 | 0 of 98 |
| Back issues | Musculoskeletal and connective tissue disorders | 1 of 97 | 0 of 98 |
Serious events with the highest arm-level rate: hospitalization (2.1%).
The registry lists serious adverse-event figures for BE mHealth as 97 at risk and 3 affected, and for standard mHealth as 98 at risk and 6 affected. For other adverse events, it lists 97 at risk and 7 affected in BE mHealth, and 98 at risk and 5 affected in standard mHealth. Deaths are listed as 0 in each group. The most frequently listed serious-event term is Hospitalization, with 2.1% shown.
These figures are descriptive registry entries. They do not establish that an intervention caused an event, and they do not provide an adjusted comparison between groups. The record does not explain event definitions, ascertainment procedures, timing, or whether the figures refer to participants with events or event episodes beyond the labels reported. The percentage for Hospitalization is presented without further denominator detail in the record, so it should not be reinterpreted as a new rate or comparison.
Serious adverse events are distinct from the primary weight outcome. The listed counts do not resolve the efficacy question, and the absence of a death entry does not characterize all possible safety outcomes. No formal safety analysis or statistical comparison is reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized comparison was registered between two mobile-delivered weight-loss interventions for adults from economically disadvantaged backgrounds with obesity. One intervention included behavioral economics components; the comparator was a standard mobile weight-loss intervention. Weight was the primary outcome, with repeated assessments planned through 18 months.
The record does not report the observed weight measurements, group changes, between-group effect estimate, confidence interval, or primary-outcome analysis. Therefore, it cannot show whether the groups differed, in which direction any difference lay, or how precisely it was estimated. A completed study status does not itself provide evidence about the outcome. Equally, the lack of results in this record is not evidence that the interventions had the same result.
Even if a numerical comparison were available, interpretation would depend on its size and uncertainty, the time point and contrast analyzed, and how missing measurements were handled. A statistical test alone would not establish the practical importance of an effect. Those considerations are general principles; the specific result and analysis needed to apply them are not reported in the registry record.
The adverse-event entries offer limited descriptive safety information, including serious and other events and deaths, but do not provide a causal or adjusted safety comparison. The registry also does not report the detailed methods needed to evaluate multiplicity, adherence, or analysis populations. Accordingly, the appropriate reading is narrow: the record describes the research question, design, outcome schedule, and some safety counts, but does not provide the efficacy results needed to answer the primary question.
13. Why This Trial Matters Statistically
This trial’s statistical question is a comparative one: whether adding behavioral economics components to a mobile-delivered weight-loss intervention is associated with a different weight trajectory than a standard mobile intervention. Randomization is relevant because it is intended to support a fair comparison between assigned groups. Repeated weight measurements are also statistically important because they can describe change over time rather than relying on one follow-up measurement.
The record highlights two issues that matter when interpreting longitudinal clinical outcomes. First, the outcome was assessed at several occasions, so a clear primary contrast and a multiplicity strategy help readers understand which comparison supports the main conclusion. Second, the record notes increasing attrition over time. Missing follow-up can affect both the precision and validity of an estimate, depending on why measurements are unavailable and how the analysis addresses them.
Those design features make the study relevant for teaching how a protocol question, endpoint schedule, and analysis plan fit together. Yet the registry entry does not report the primary outcome analysis or its results. It also does not report the handling of repeated measurements, missing data, or multiplicity. The statistical importance of the trial therefore lies in the structure of the question and the information needed to interpret it, not in a result that this record does not contain.
Careful interpretation distinguishes trial completion from evidence about an intervention and distinguishes a planning illustration from a finding. The registry describes planning assumptions, but does not provide the underlying observed effect or illustration values. Those assumptions cannot substitute for an estimate of weight change or its uncertainty. Without those results, the comparative efficacy question remains unanswered by 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.
The central limitation for interpretation is that the registry record does not report primary-outcome results or analyses. There is no reported estimate of weight change by group, between-group contrast, or uncertainty interval. It is therefore not possible to characterize the observed efficacy result from this record.
The record notes increasing attrition over time but does not give follow-up counts at each assessment, reasons for loss to follow-up, or the approach to missing measurements. This limits assessment of whether missingness could have influenced the outcome comparison. The record also does not identify the analysis population or describe adherence to either intervention.
Several design and analysis details are absent: who was masked, how random allocation was generated or concealed, the prespecified primary comparison, any method for accounting for repeated weight measurements, and any approach to multiple time-point comparisons. These details are not reported in the registry record and should not be inferred from the registered design labels.
The registered outcome description indicates measurement on a digital scale to the nearest 0.1-kilogram, but the record does not provide information about measurement procedures beyond that description. It does not report the distribution of participant characteristics, intervention engagement, or reasons for nonattendance. The safety entries likewise lack details about event definitions and ascertainment. These limitations restrict evaluation of trial conduct and interpretation; they do not establish that a particular problem occurred.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Research Intervention to Support Healthy Eating and Exercise — NCT04353258.
- Registry record last updated 2026-01-09; status last verified 2025-07.
- Results first posted 2026-01-09.
- 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
NCT04353258, titled “Research Intervention to Support Healthy Eating and Exercise,” is a completed randomized, single-masked, parallel-group study sponsored by the University of Connecticut. Its stated aim was to test a behavioral economics intervention for weight loss in adults from economically disadvantaged backgrounds. The registered comparison was BE mHealth versus standard mHealth; both were 12-month interventions delivered primarily via mobile phone.
The primary outcome was weight change measured on a digital scale, with assessments planned at baseline, 2 month, 6 month, 12 month, and 18 months. The record notes increasing attrition over time. It lists adverse-event figures for both groups and deaths as 0 in each group.
The registry record does not report the primary weight results, effect estimates, confidence intervals, or analyses. It also does not report the methods used for missing data, repeated measurements, or multiplicity. The study status and registered design describe the trial, but the efficacy question cannot be answered from the reported outcome information.