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 Together Overcoming Diabetes (NCT04734015), a randomized na study. The primary outcome is Change in Adult Participant Fasting HbA1c.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04734015 |
| Phase | NA |
| Condition | Type 2 Diabetes |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 162 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johns Hopkins Bloomberg School of Public Health |
| Results posted | Yes |
2. Clinical Question
The trial asks whether the Together Overcoming Diabetes (TOD) curriculum, delivered to adult-youth family dyads, is associated with changes in adult participants’ fasting HbA1c over follow-up compared with a waitlist group. The registry record identifies this as a randomized, parallel-group trial involving American Indian adult caregivers diagnosed with type 2 diabetes and youth aged 10-16 years at enrollment across 5 Ojibwe tribal communities.
Population
Adult caregivers with type 2 diabetes and their youth family members, aged 10-16 years at enrollment. Adult participants with data collected are the stated population for the primary endpoint.
Intervention
The family-based, culturally centered TOD curriculum: 14 lessons delivered in participants’ homes by local Family Health Coaches over a 6-month period.
Comparator
A waitlist control group that did not initially receive the intervention and was scheduled to begin it in 2 years.
Primary question
How does adult fasting HbA1c change across the scheduled assessments in the randomized groups? The registry record names the outcome and assessment times, but does not report the comparative outcome estimates.
The trial also planned to assess cholesterol, adult blood pressure, biometric measures, and psychosocial and behavioral outcomes in adults and youth. Secondary outcomes include changes in adult and youth BMI measures and depression and depressive symptoms. These additional measures provide context about the broader assessment program, but the primary question specified in the record is adult fasting HbA1c change.
3. Trial Design
The registry record describes Together Overcoming Diabetes as a completed randomized, double-masked, parallel-group behavioral trial. Enrollment is listed as 162. The arm descriptions specify 81 family dyads assigned to the TOD curriculum and 81 assigned to waitlist control. A family dyad consists of an adult caregiver and a youth participant. Random assignment is intended to make the groups comparable on average at the point of assignment, although it cannot ensure that every characteristic is balanced.
Group A began the intervention immediately. Group B did not initially receive it and was scheduled to begin in 2 years. The curriculum consists of 14 lessons delivered in the participant’s home by local Family Health Coaches over 6 months. The registry describes assessments at baseline, 3, 6, 12, 18, and 24 months in both groups. Measures include HbA1c, cholesterol, adult blood pressure, biometric measures, and psychosocial and behavioral outcomes for adults and youth.
The design is parallel because participants were assigned to one of two groups rather than cycling through both conditions. The waitlist arrangement also means that the comparison concerns immediate access to the curriculum versus delayed access, rather than intervention versus a group that would never receive it. The exact masking procedures, including who was masked and how masking was maintained for a home-delivered behavioral program, are not reported in the registry record.
The registry lists the study as completed, with a total enrollment of 162. Its stated primary completion date is 2025-04-30. Completion status describes the trial’s registry status; it does not establish that results for every scheduled outcome or assessment have been posted.
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: A total of 162 participants (81 adults and 81 youth) were enrolled and randomized after completing the Baseline assessment. 82 participants (41 adults and 41 youth) were assigned to the Intervention group to immediately receive the TOD curriculum while 80 participants (40 adults and 40 youth) were assigned to the Waitlist group and received the intervention after completion of assessment visits (baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).
Overall Study
| Stage | Together Overcoming Diabetes (TOD) Curriculum | Waitlist Control |
|---|---|---|
| STARTED | 82 | 80 |
| Adult Caregivers | 41 | 40 |
| Youth | 41 | 40 |
| COMPLETED | 82 | 80 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Adult participants with data collected
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: Adult Caregivers and Youth
| Characteristic | Unit | Together Overcoming Diabetes (TOD) Curriculum | Waitlist Control | Total |
|---|---|---|---|---|
| Participants analysed | 82 | 80 | 162 | |
| Age, Continuous: Adults | Years | 50.28 (SD 11.83) | 48.71 (SD 12.22) | 49.50 (SD 11.97) |
| Age, Continuous: Youth | Years | 13.2 (SD 1.7) | 13.1 (SD 2.1) | 13.2 (SD 2.0) |
| Sex/Gender, Customized: Youth gender – Boy | Participants | 17 | 21 | 38 |
| Sex/Gender, Customized: Youth gender – Girl | Participants | 22 | 18 | 40 |
| Sex/Gender, Customized: Youth gender – Different identity | Participants | 2 | 0 | 2 |
| Sex: Female, Male: Female | Participants | 31 | 32 | 63 |
| Sex: Female, Male: Male | Participants | 10 | 8 | 18 |
| Race (NIH/OMB): Adults – American Indian or Alaska Native | Participants | 41 | 40 | 81 |
| Race (NIH/OMB): Adults – Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Adults – Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Adults – Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Adults – White | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Adults – More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Adults – Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Youth – American Indian or Alaska Native | Participants | 41 | 40 | 81 |
| Race (NIH/OMB): Youth – Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Youth – Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Youth – Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Youth – White | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Youth – More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Youth – Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Adult participant Fasting HbA1c | Percentage Glycated Hemoglobin | 7.67 (SD 1.90) | 8.20 (SD 2.07) | 7.93 (SD 1.99) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Adult Participant Fasting HbA1c, measured over Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percentage Glycated Hemoglobin |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in adult participant fasting HbA1c, expressed as percentage glycated hemoglobin. HbA1c is a laboratory measure related to average blood glucose over the preceding period. In general, it is used in diabetes research because it provides a measure that is less dependent on a single momentary glucose reading. That general rationale does not establish what the trial found.
The registry specifies a mean and standard deviation for the outcome and identifies adult participants with data collected as the endpoint population. Assessments are scheduled at Day 0 and Month 3, Month 6, Month 12, Month 18, and Month 24. Thus, the outcome is longitudinal: it concerns changes across repeated assessment times, not just a single follow-up value. The registry record does not report the actual means, standard deviations, changes, or a between-group estimate for these time points.
Change in HbA1c is relevant to the intervention’s diabetes-management focus, but interpreting a change requires knowing how it was calculated and compared. For example, an analysis might compare group trajectories or changes from baseline, but the analysis selected for this trial is not reported in the registry record. The endpoint description alone therefore identifies what was measured and when, not the magnitude or precision of any treatment contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical limitation is that the registry record identifies the primary outcome but does not report its numerical results. There is no posted HbA1c mean, change estimate, between-group contrast, confidence interval, or p-value in the record. Consequently, the effect’s direction, magnitude, and precision cannot be characterized from these details. The completed status and scheduled assessments do not substitute for outcome estimates.
The outcome is measured repeatedly, at baseline and through Month 24. In general, repeated measurements can describe how a measure evolves over time and can distinguish a group difference at one visit from a difference in trajectories. Those are different statistical questions. Without the reported analysis and estimates, it is not possible to know which comparison was used, whether the groups’ patterns differed, or how much uncertainty surrounds any contrast.
The registry’s enrollment and arm descriptions establish the planned scale and structure of the trial: enrollment is 162, and the arm descriptions specify 81 family dyads in each group. They do not establish how many participants contributed data at each assessment, whether all randomized dyads were included in the primary analysis, or how missing measurements were handled. The primary endpoint population is described as adults with data collected, but an explicit analysis population is not reported in the registry record.
Safety counts are reported separately for adults and youth. The TOD adult group lists 41 at risk for serious adverse events and 1 affected; the corresponding youth group lists 41 at risk and 0 affected. The waitlist adult and youth groups each list 40 at risk and 0 affected. The registry also lists 1 death in the TOD adult group and none in the other groups. These descriptive counts do not establish whether an event was caused by the intervention, and the record does not state whether the death and serious event were the same or separate occurrence.
Any interpretation should therefore separate what is known about design and measurement from what is not available about outcomes. The record supports describing the intervention, comparator, scheduled endpoint, and posted safety counts. It does not support a conclusion about the size or statistical certainty of the primary HbA1c contrast.
9. Statistical Methods Explained
The registry identifies a randomized, double-masked, parallel-group design and a continuous primary outcome reported as a mean with standard deviation. It does not report the statistical analysis used for the primary endpoint. The explanations below describe general statistical ideas relevant to this design; they should not be read as a description of methods that the investigators necessarily used.
What randomization contributes
In general, random assignment is used to reduce systematic differences between groups at the time of allocation. It makes treatment assignment independent of measured and unmeasured participant characteristics in expectation, but chance imbalances can still occur in a particular trial. A randomized design therefore supports a comparative interpretation when the analysis preserves the assigned groups and when outcomes are measured and handled appropriately. The registry record does not provide baseline comparisons or details of the primary analysis population.
The trial assigns adult-youth dyads, so observations within a dyad may be related. In general, related measurements should not automatically be treated as statistically independent. The adult HbA1c endpoint is measured on adults, while youth outcomes include different measures. The registry record does not describe whether or how any within-family relationship was addressed analytically.
Means, standard deviations, and contrasts
A mean describes the average value of a continuous measurement in a specified group and population. A standard deviation describes the spread of individual measurements around that group’s mean. It is not the same as a standard error or a confidence interval: the latter describe uncertainty in an estimate rather than the dispersion of individual observations. The registry identifies mean and standard deviation as the summary type for the primary endpoint, but gives no outcome values.
A between-group contrast would express how the outcome differed between the randomized groups under a specified definition, such as a difference at a visit or a difference in change from baseline. The interpretation depends on the exact contrast, the time point or trajectory being considered, and the analysis population. None of those primary-analysis details is reported in the registry record. It would therefore be inappropriate to infer a contrast from the endpoint name alone.
Repeated measurements over time
The scheduled assessments span baseline through Month 24. In general, repeated measurements can be analyzed using methods that account for correlation among measurements from the same participant. Such methods may estimate group differences over time while using information from more than one visit. Other approaches may analyze a selected visit or a change from baseline. These strategies answer related but not identical questions and can make different assumptions about missing observations and the pattern of change.
The registry lists the assessment schedule but does not report whether the primary analysis used a repeated-measures model, a baseline-adjusted comparison, a visit-specific test, or another approach. It also does not report the model’s covariates, assumptions, handling of departures from assumptions, or the planned primary time point. These details matter for reproducing an analysis and for understanding exactly what an estimate would represent.
Uncertainty and statistical evidence
In general, a confidence interval gives a range of values compatible with the data and the statistical model at a stated confidence level. Its width reflects precision: wider intervals indicate less precision, while narrower intervals indicate more precision under that model. A p-value summarizes how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the model assumptions were true. Neither quantity establishes whether an effect is important in practice, and neither can be interpreted without the estimate and analysis context.
No confidence interval, p-value, or primary effect estimate is reported in the registry record. There is therefore no basis for describing statistical significance, precision, or the direction of the primary outcome. General explanations of these concepts cannot fill that gap.
Planning and observed evidence
Sample-size planning asks how much information a study may need to detect an effect under stated assumptions. A planning illustration based on an observed effect is not a report of what the trial was designed to detect, and it is not observed power. The registry record does not report the trial’s own sample-size justification or enough primary-outcome results to interpret a numerical planning illustration. Any sample-size figure should be read only according to its stated assumptions, not as evidence that the trial’s primary finding is certain or clinically important.
More generally, over-dispersion means that observed variation is greater than a model assumes. If a model underestimates variation, its standard errors may be too small and its confidence intervals too narrow. That concept is relevant only if the outcome and analysis support such a concern; the registry record does not report a model or diagnostic results establishing over-dispersion in this trial.
10. Multiplicity, Missing Data and Analysis Populations
The trial assesses multiple outcomes in adults and youth and schedules repeated assessments from baseline through Month 24. When several outcomes, time points, or statistical contrasts are examined, the chance of obtaining at least one apparently notable result can increase. In general, multiplicity procedures can address this issue by defining a primary comparison in advance, adjusting inference across multiple tests, or clearly distinguishing confirmatory analyses from exploratory ones.
The registry identifies adult fasting HbA1c change as the primary outcome and lists secondary outcomes concerning BMI measures and depression and depressive symptoms in adults and youth. However, the multiplicity strategy, any hierarchy among outcomes, and any correction across time points or contrasts are not reported in the registry record. The precise primary comparison is also not reported. Without those details, the scope of any confirmatory claim cannot be established.
The registry specifies participants with data collected as the primary endpoint population, but does not describe the primary analysis population or how missing measurements were handled. With repeated assessments, participants may have measurements at some visits and not others. In general, different approaches to incomplete data rely on different assumptions; the assumptions and sensitivity analyses matter because missingness can affect both the estimate and its uncertainty.
The record does not report reasons for missing outcome data, completion by visit, imputation methods, sensitivity analyses, or whether analyses followed randomized assignment. It also does not report a prespecified statistical analysis plan. These omissions do not establish that such procedures were absent; they mean they are not reported in the registry record. Interpretation of any posted estimate would require those details, especially when considering results across multiple outcomes and assessment times.
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 |
|---|---|---|---|
| Together Overcoming Diabetes (TOD) Curriculum - ADULTS | 1 | 41 | 2.4% |
| Together Overcoming Diabetes (TOD) Curriculum - YOUTH | 0 | 41 | 0.0% |
| Waitlist Control - ADULTS | 0 | 40 | 0.0% |
| Waitlist Control - YOUTH | 0 | 40 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Together Overcoming Diabetes (TOD) Curriculum - ADULTS | 1 of 41 |
| Together Overcoming Diabetes (TOD) Curriculum - YOUTH | 0 of 41 |
| Waitlist Control - ADULTS | 0 of 40 |
| Waitlist Control - YOUTH | 0 of 40 |
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 |
|---|---|
| Together Overcoming Diabetes (TOD) Curriculum - ADULTS | 0 of 41 |
| Together Overcoming Diabetes (TOD) Curriculum - YOUTH | 0 of 41 |
| Waitlist Control - ADULTS | 0 of 40 |
| Waitlist Control - YOUTH | 0 of 40 |
Most frequent serious adverse event terms
| Event term | Organ system | Together Overcoming Diabetes (TOD) Curriculum - ADULTS | Together Overcoming Diabetes (TOD) Curriculum - YOUTH | Waitlist Control - ADULTS | Waitlist Control - YOUTH |
|---|---|---|---|---|---|
| Participant became ineligible due to progression of memory loss | General disorders | 1 of 41 | 0 of 41 | 0 of 40 | 0 of 40 |
Serious events with the highest arm-level rate: participant became ineligible due to progression of memory loss (2.4%).
The registry reports serious adverse event counts separately for adult and youth participants in each group. For the TOD curriculum, 41 adults were listed at risk, with 1 affected, and 41 youth were listed at risk, with 0 affected. For waitlist control, 40 adults and 40 youth were listed at risk, with 0 affected in each group. The record also lists 1 death in the TOD adult group and 0 in each of the other groups.
These are descriptive counts, not a comparison adjusted for follow-up time or participant characteristics. The record does not identify the serious event’s nature in the group counts, give event timing, or establish whether the death and the serious event refer to the same person or separate occurrences. It also does not state the cause of death or attribute any event to the intervention. A count recorded in a trial arm should not by itself be interpreted as evidence of causation.
The registry lists “Participant became ineligible due to progression of memory loss” among top serious event terms, with 2.4%. The relationship between that term and the arm-level serious-event counts is not specified in the record. Further detail about event definitions, collection windows, relatedness assessments, and the basis of the percentage is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record describes a trial designed to compare immediate participation in a family-based diabetes curriculum with waitlist assignment, using adult fasting HbA1c change as the primary outcome. It also describes a culturally centered, home-delivered program involving adult caregivers and youth in Ojibwe communities. These design details define the question and context; they are not evidence of the intervention’s effect.
The record identifies the endpoint, measurement scale, population, and assessment schedule, but does not report numerical primary outcome results. It therefore does not show the size or direction of any HbA1c difference, its confidence interval, or its statistical significance. It is not possible to determine from the posted information whether the groups had similar or different outcomes or how precisely any estimated contrast was measured.
Likewise, a completed trial status does not mean that all outcome analyses are available in the registry record. The enrollment count and assigned group descriptions do not tell readers how many adults contributed outcome data at each visit. Without reported outcome completeness and analysis details, the meaning of any future estimate would depend on how the investigators defined the comparison and handled missing data.
The safety counts show the events recorded by group in the registry, including 1 serious event affected and 1 death listed for the TOD adult group, with zero listed in the other groups. These counts are not sufficient to determine causation, comparative risk, or whether the serious event and death were the same occurrence. Additional event details are not reported.
Accordingly, the record supports a description of the trial’s design and measures, but not a conclusion about the intervention’s effect on HbA1c or other outcomes. Statistical conclusions require estimates, uncertainty, and analysis details, none of which can be replaced by the fact that the study was randomized or completed.
13. Why This Trial Matters Statistically
Several features make the statistical framing important. The intervention is delivered to family dyads, while the primary endpoint is measured in adults and additional outcomes involve youth. This means that the research question spans related participants and distinct types of outcomes. In general, careful definitions of the unit of assignment, unit of measurement, and analysis population help readers understand what a comparison represents.
The waitlist design also creates a time-based contrast: one group begins the curriculum immediately, while the other is scheduled to begin in 2 years. Assessments continue through Month 24. The timing of any primary comparison therefore matters. A contrast at an earlier visit may address a different period of access than a comparison at the end of scheduled follow-up. The exact primary analysis time point is not reported in the registry record.
The 14-lesson curriculum is delivered in participants’ homes by local Family Health Coaches over 6 months. In general, a behavioral program’s delivery and participation may vary across participants, so analysis plans and reporting can help distinguish assignment to the program from engagement with its components. The registry record does not report adherence or implementation measures for the primary endpoint analysis.
Finally, the registry specifies an outcome that is repeatedly measured and clinically relevant to diabetes research, but does not report its numerical results. This distinction is central to statistical interpretation: a well-defined question and an appropriate design do not by themselves reveal an effect. Estimates and uncertainty are needed to assess what the observed data support. The absence of these results in the registry record limits what can be concluded while leaving the trial’s population, intervention, comparator, and scheduled endpoint clearly described.
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 results is that the registry record does not report the primary endpoint estimates or other numerical efficacy results. No adult HbA1c means, changes, between-group contrasts, confidence intervals, or p-values are available in the record. The registry’s completed status does not resolve this lack of posted outcome information.
The record describes assessment at baseline and Month 3, Month 6, Month 12, Month 18, and Month 24, but does not state which time point or contrast defines the primary analysis. It also does not report the statistical model, covariates, analysis population, handling of missing data, or multiplicity strategy. Those omissions limit reproducibility and prevent assessment of how robust a reported comparison would be to analysis choices.
The registry identifies adult participants with data collected as the primary outcome population, but does not provide visit-specific completion or explain how data availability affected inclusion. The total enrollment and arm descriptions do not establish how many participants contributed complete or partial outcome data. Reasons for missingness and sensitivity analyses are not reported in the registry record.
For safety, the posted counts do not include event timing, causes, relatedness assessments, or enough detail to determine whether the listed death and serious event overlap. The event-reporting period and the relationship of the listed serious-event term to the group counts are not reported.
Finally, the registry identifies participation across 5 Ojibwe tribal communities and a culturally centered intervention, but the information does not provide community-specific outcome estimates or details needed to assess variation in delivery. These are limits on interpretation of the posted record, not evidence that the trial did not collect additional information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Together Overcoming Diabetes — NCT04734015.
- Registry record last updated 2026-06-16; status last verified 2026-06.
- Results first posted 2026-06-16.
- 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
Together Overcoming Diabetes is a completed randomized, double-masked, parallel-group behavioral trial with enrollment listed as 162. The registry describes American Indian adult caregivers with type 2 diabetes and youth aged 10-16 years at enrollment across 5 Ojibwe tribal communities. Arm descriptions specify 81 family dyads assigned to the TOD curriculum and 81 to waitlist control.
The intervention consists of 14 home-delivered lessons over 6 months. Assessments are scheduled at baseline and Month 3, Month 6, Month 12, Month 18, and Month 24. The primary outcome is change in adult fasting HbA1c, reported as a mean with standard deviation. Numerical primary outcome results and the primary statistical analysis are not reported in the registry record.
Serious adverse event counts are listed separately for adults and youth; the TOD adult group also lists 1 death. The record does not establish causation or clarify whether the serious event and death overlap.