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 The University of Michigan Wellness for Liver Health Study (NCT05010070), a na phase 1, phase 2 study. The primary outcome is Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05010070 |
| Phase | Phase 1, Phase 2 |
| Condition | Nonalcoholic Fatty Liver Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Michigan |
| Results posted | Yes |
2. Clinical Question
Population
Adults with nonalcoholic fatty liver disease (NAFLD). The brief summary describes the program as adapted for adults with NAFLD. The registry record reports enrollment of 11 participants.
Intervention
A diet and lifestyle program designed to teach participants to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. The program also covered positive affect skills, including gratitude, positive reappraisal, and personal strengths, as well as mindful eating.
Comparator
There was no separate control group. The registry describes a single-group study and does not report an allocation to comparison arms. The pre-intervention measurements are not a randomized control condition.
Primary question
What change in liver fat content, measured using liver MRI-derived proton density fat fraction, was observed over 4 months among participants with outcome data? The registry identifies the measure and time frame, but does not report the observed change or its confidence interval.
3. Trial Design
The University of Michigan Wellness for Liver Health Study is registered as a phase 1 and phase 2 study sponsored by the University of Michigan. Its status is completed. The registry lists a start date of 2021-08-31 and a primary completion date of 2022-10-03. Enrollment is reported as 11.
The design is single-group, with allocation listed as not applicable and no masking. Participants received a behavioral diet and lifestyle program. The program addressed dietary practices, physical activity, sleep, positive affect skills, and mindful eating. The brief summary characterizes the study as a pilot test of an existing very-low-carbohydrate diet intervention adapted for adults with NAFLD.
This design can describe what happened among participants who received the program and had outcome data. It does not create a concurrent group receiving a different intervention or usual care. Consequently, any before-and-after change cannot be separated from other influences using a randomized between-group comparison. Changes over time could reflect the program, other events, measurement variation, or a combination of influences; the single-group design alone cannot identify their separate contributions.
The primary endpoint was change in liver fat content using liver MRI-derived proton density fat fraction, with a 4-month time frame. The registry also lists change in liver stiffness and body weight change as secondary outcomes. Although the record describes the outcome population as all participants with outcome data, it does not report how many had primary outcome data or the numerical results for these measures.
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 | Diet and Lifestyle Program |
|---|---|
| STARTED | 11 |
| COMPLETED | 9 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Diet and Lifestyle Program |
|---|---|
| Lost to Follow-up | 1 |
| Withdrawal by Subject | 1 |
Analysis population for the primary outcome, as defined in the registry: We analyzed all participants with outcome data.
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 | Diet and Lifestyle Program |
|---|---|---|
| Participants analysed | 11 | |
| Age, Continuous | years | 58.22 (SD 11.23) |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 8 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 11 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Liver Fat Content Using Liver MRI-derived Proton Density Fat Fraction, measured over 4 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of liver lobe fat |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in liver fat content measured with liver MRI-derived proton density fat fraction. The registry describes the unit as percentage of liver lobe fat, identifies the summary parameter as the mean, and gives a 4-month time frame. Measurements are described as pre- and post-intervention MRIs.
In general, MRI-derived proton density fat fraction is an imaging-based measure used to quantify fat within the liver. A change measure compares the post-intervention value with the pre-intervention value. A mean change summarizes the average change among the participants included in the analysis; it does not show whether every participant changed in the same direction or by a similar amount.
The registry specifies a 95% confidence interval as the dispersion measure. In general, a confidence interval conveys uncertainty around an estimated mean, with narrower intervals indicating greater precision under the assumptions of the analysis. The registry record does not report the mean change or its interval, so the size, direction, and precision of the primary endpoint result cannot be assessed from the recorded results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clinically relevant measurement question: whether liver fat content changed over the 4-month period among participants with outcome data. However, it does not report the numerical mean change, the 95% confidence interval, or an inferential test for this endpoint. The record lists zero analyses. Therefore, the posted information does not establish the direction or magnitude of the observed change, and it does not allow an assessment of statistical precision.
The design also matters for interpretation. This was a single-group study, not a randomized comparison. Even if a before-and-after change were available, it would describe change over time in the participating group rather than an effect isolated by comparison with a concurrent control group. Without such a comparator, changes cannot be attributed to the program alone on the basis of this design.
The record describes a mean as the primary summary and a 95% confidence interval as its dispersion measure. In general, the mean provides a measure of the group’s average change, while the interval indicates uncertainty in that estimate. An interval that is wide would indicate limited precision; a narrow interval would indicate greater precision, subject to the analysis assumptions. Neither feature can be evaluated without the actual estimate and interval. No p value or other primary outcome analysis is reported.
Enrollment was 11, but the endpoint population is described as participants with outcome data. The record does not state how many participants contributed primary endpoint data, whether all enrolled participants had both MRI measurements, or how any missing measurements were handled. Thus, the enrolled group size should not be treated as the analysis denominator for the primary endpoint.
The registry lists change in liver stiffness and body weight change as secondary outcomes, but does not report their results in the registry record for this interpretation. The completed status indicates that the study is recorded as completed; it does not supply the missing endpoint estimates. The most defensible reading is therefore descriptive: the registry defines the intervention, primary measure, and analysis population, but the posted results do not provide the primary outcome findings needed to quantify change or its uncertainty.
9. Statistical Methods Explained
What does a mean change describe?
For a continuous measure, a mean is an average across the observations included in the analysis. In this study, the primary outcome is specified as mean change in MRI-derived liver fat content from pre-intervention to post-intervention measurement. In general, a change analysis uses paired measurements: each participant’s post-intervention measurement is considered in relation to that participant’s pre-intervention measurement. The group mean then summarizes those individual changes. This is different from comparing two unrelated groups, and it depends on having the relevant measurements for the participants included.
The registry states that all participants with outcome data were analyzed. That identifies the analysis population in broad terms, but does not say how many had complete paired MRI measurements or how missing measurements were treated. The record also does not describe the exact calculation used to form the change estimate. The mean and confidence interval are specified as the intended summary, but their values are not reported.
What does a 95% confidence interval mean?
In general, a confidence interval gives a range of values compatible with an estimate under the statistical model and its assumptions. A 95% confidence interval reflects a procedure designed to capture the underlying quantity in 95% of repeated applications under those assumptions. It is not a range containing 95% of individual participants’ measurements, and it does not guarantee that the true value lies within a particular calculated interval. Its width helps communicate precision: greater width indicates more uncertainty about the estimated mean, while less width indicates greater precision. The registry record specifies a 95% confidence interval but does not report its endpoints, so precision cannot be judged.
Why does the single-group design affect inference?
In general, a before-and-after study can describe a change observed among participants over time. Without a separate comparison group, it cannot directly estimate how much of that change would have occurred without the intervention. Other changes over time, measurement variability, participant selection, and participants’ expectations can also contribute to observed differences. Random allocation to a concurrent comparison group can help address some of these concerns, but the record describes no such allocation in this study. Its design is therefore suited to a pilot description, not a randomized estimate of comparative treatment effect.
What can be said about statistical testing?
The record lists zero analyses and contains no reported primary endpoint estimate, confidence interval, or p value. No statistical test or model for the primary endpoint is described in the registry record. It would be inappropriate to infer that a test was or was not statistically significant, or to reconstruct one without the underlying data or summary results. The record also does not report a prespecified statistical analysis plan, adjustment for baseline characteristics, or handling of any departures from the intended measurement schedule.
How should planning assumptions be understood?
In general, a sample-size calculation is a planning exercise: it asks how many participants might be needed under specified assumptions about the effect to detect, variability, significance level, allocation, and analysis method. It is not a result observed in the completed study, and it is not observed power. The registry record does not report a trial-specific sample-size justification. Its planning note describes an illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect set as a stated fraction of the observed effect. Those assumptions describe a hypothetical planning exercise rather than this study’s single-group design. No planning sample-size figures are reported in the registry record for this account, and none can be inferred from the enrollment figure.
Why might over-dispersion matter in other analyses?
In general, over-dispersion occurs when observed variability is greater than a statistical model expects. It can make standard errors too small if the model does not allow for that extra variability, which can make confidence intervals too narrow and tests too optimistic. This is a general issue in some types of count or categorical data analysis; it is not a method reported for this primary continuous endpoint. The registry record does not identify an over-dispersion adjustment or any other model-based analysis for the primary outcome.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome, change in liver fat content, and two secondary outcomes: change in liver stiffness and body weight change. It also reports three outcome measures. No results or analyses are reported for these measures in the registry record, and the record does not describe a multiplicity adjustment or a hierarchy for interpreting the outcomes.
Multiplicity is a general statistical concern when several outcomes or tests are considered. The more opportunities there are to identify a result as notable, the greater the chance of a false-positive finding if tests are interpreted without accounting for their number and relationship. An analysis plan can address this by identifying a primary outcome, defining the role of secondary outcomes, and specifying any adjustment. The registry record does not report such details; it is not possible to determine whether an adjustment was planned or used.
The primary analysis population is described as all participants with outcome data. The number with available primary outcome measurements, the extent and reasons for missing data, and the method used to handle missingness are not reported in the registry record. The record does not state whether participants with incomplete MRI measurements were excluded, whether any imputation was used, or whether sensitivity analyses were conducted. These details matter because the observed participants may differ from those without outcome data.
The record also does not describe interim analyses or a statistical analysis plan. No assumptions about these procedures should be made from the completed status or the enrollment figure. Without outcome estimates and fuller analysis details, neither multiplicity handling nor the consequences of missing data can be evaluated.
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 |
|---|---|---|---|
| Diet and Lifestyle Program | 0 | 11 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Diet and Lifestyle Program | 0 of 11 |
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 |
|---|---|
| Diet and Lifestyle Program | 3 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Diet and Lifestyle Program |
|---|---|---|
| diarrhea | Gastrointestinal disorders | 1 of 11 |
| flare up of dermatitis | Skin and subcutaneous tissue disorders | 1 of 11 |
| broken foot | Musculoskeletal and connective tissue disorders | 1 of 11 |
The registry’s safety entry lists 11 participants at risk for serious adverse events and 0 affected by serious adverse events. It lists 11 at risk in the record’s other-event category and 3 affected. Deaths are reported as 0. No serious adverse event terms are listed.
These figures describe the recorded counts in this study group. They should not be interpreted as a comparison with another treatment or with an untreated group, because the study is single-group. The registry does not provide further detail about the other-event category, event types, timing, severity, or relationship to the program. The record’s counts also do not describe the likelihood of events in other populations or settings.
In general, a zero count of recorded serious events is not proof that serious events cannot occur. Safety counts from a small study can describe what was recorded among participants at risk, but they cannot rule out uncommon events or establish comparative safety. The registry record does not report additional safety analyses or detailed event narratives. The reported figures should therefore be read as a limited description of events recorded during this study, not as a broad safety conclusion.
12. What the Result Does, and Does Not, Mean
This study is recorded as a completed pilot of a diet and lifestyle program for adults with NAFLD. It defines a primary measurement—change in liver fat content using liver MRI-derived proton density fat fraction—and specifies a 4-month time frame. It also identifies liver stiffness and body weight change as secondary outcomes. Those details clarify what the study intended to assess.
The registry record does not report the numerical primary outcome result. There is no mean change or 95% confidence interval in the registry record, and no analysis is listed. The posted information therefore cannot establish whether liver fat content increased, decreased, or remained similar on average, nor how precise an estimate would be. The same limitation applies to the listed secondary outcomes: their results are not reported.
Even a reported pre- and post-intervention change in this design would not by itself show that the program caused the change. A single-group study has no concurrent control condition to help distinguish an intervention effect from other influences over time. The study can contribute pilot information about implementing and measuring a program, but its design does not provide a randomized comparison of outcomes between intervention and control groups.
The safety record lists no serious adverse events among those at risk, alongside events in the other-event category and no deaths. These are descriptive counts in the study group, not a comparative safety estimate. With the event details and broader context not reported, the counts do not settle questions about safety in other groups or settings.
In short, the record supports a description of the study’s design, intervention, planned outcome measures, and recorded safety counts. It does not provide enough outcome information to quantify the change in liver fat or draw a conclusion about the program’s effect.
13. Why This Trial Matters Statistically
This study illustrates why design and result reporting need to be read together. A clearly named endpoint and measurement schedule define what investigators intended to assess, but they do not tell readers what was observed. Here, the registry specifies MRI-derived liver fat change as the primary measure and gives a 4-month time frame, while the numerical estimate and its confidence interval are not reported. Without those results, readers cannot judge either the direction of the mean change or its precision.
The single-group design is also important. Pilot studies can be useful for testing an intervention approach and defining measurement procedures. However, a before-and-after description does not answer the same question as a randomized comparison. Keeping that distinction clear helps prevent a change over time from being interpreted as an effect attributable to the program.
The record also shows how analysis populations and missing data affect interpretation. It states that participants with outcome data were analyzed, but does not report how many contributed primary outcome data or how missing measurements were handled. Those details are necessary to understand which participants the estimate would represent and how much uncertainty missingness might introduce.
Finally, the study lists multiple outcomes but does not report outcome analyses or multiplicity procedures. A transparent statistical analysis plan and complete results would help readers distinguish the primary question from exploratory findings and understand how uncertainty was handled. The missing numerical results limit what can be learned from this record, despite its clear description of the intended primary endpoint and intervention.
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 main limitation for interpreting the registry record is the absence of numerical outcome results. The primary endpoint is described, but no mean change, confidence interval, or analysis result is reported. The secondary outcome results are not reported either. As a result, the magnitude, direction, and precision of any change cannot be evaluated.
The study is single-group, with allocation listed as not applicable and no masking. It does not include a concurrent control condition for a like-for-like comparison. Any observed change over time, if reported, would not by itself isolate the contribution of the diet and lifestyle program from other influences.
The enrollment is reported as 11, but the primary endpoint population is described as participants with outcome data. The record does not state the number with complete pre- and post-intervention MRI measurements, explain missing data, or describe sensitivity analyses. The endpoint analysis denominator and the effect of missing measurements therefore remain unclear.
The registry does not report a trial-specific sample-size justification, a detailed statistical analysis plan, or a multiplicity procedure. It also does not report interim analyses. These omissions prevent assessment of how the analysis was planned and how the several listed outcomes were intended to be interpreted. The safety information is limited to grouped counts; event details and relationships to the program are not reported. Together, these limitations mean that the record describes the study’s setup more fully than its statistical findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The University of Michigan Wellness for Liver Health Study — NCT05010070.
- Registry record last updated 2023-08-14; status last verified 2023-08.
- Results first posted 2023-08-14.
- 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 University of Michigan Wellness for Liver Health Study is a completed phase 1 and phase 2, single-group behavioral study sponsored by the University of Michigan. The registry reports enrollment of 11 and describes a diet and lifestyle program for adults with NAFLD. The program covered a very low carbohydrate, ketogenic diet, physical activity, sleep, positive affect skills, and mindful eating.
The primary outcome was change in liver fat content measured using liver MRI-derived proton density fat fraction over 4 months, summarized as a mean with a 95% confidence interval. Change in liver stiffness and body weight change were listed as secondary outcomes. The outcome population was all participants with outcome data.
The registry record does not report numerical results or analyses for the primary or secondary outcomes. Safety counts include 0 affected by serious adverse events, 3 affected in the other-event category, and 0 deaths. The design has no separate control group, which limits causal interpretation of any change over time.