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 "GameDay Ready": Evaluating a Behavioral Weight Management Program for Black Men Living in the Rural South (NCT05530980), a na na study. The primary outcome is Study Interest.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05530980 |
| Phase | NA |
| Condition | Obesity, Physical Inactivity, Diet, Healthy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 7 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of South Carolina |
| Results posted | Yes |
2. Clinical Question
Population
Black men living in the rural South were the intended population. The official title describes obese African American men, and the study lists obesity, physical inactivity, and healthy diet among its conditions. Detailed eligibility criteria and the characteristics of enrolled participants are not reported in the registry record.
Intervention
The intervention was the GameDay Ready Program, a 12-week, football-themed behavioral weight management program. Its stated elements include physical activity, attention to sedentary time and dietary habits, education, self-monitoring, personalized goals, and group-based competition. The program was adapted for Black men living in the rural South.
Comparator
There was no separate control group. The registry describes a single-group study, with allocation listed as not applicable. The intervention group therefore cannot be compared with a concurrent untreated or alternative-treatment group in this record.
Primary question
The primary outcome concerns the number of people expressing interest in the study, measured up to week one. The study’s stated objective is to test feasibility and acceptability of the adapted program. The numerical result for study interest is not reported in the registry record.
The central statistical question is therefore about whether the record documents recruitment interest and feasibility-related observations, rather than whether the program changes weight relative to a control. Weight, body mass index, waist circumference, blood pressure, physical activity, dietary intake, and social or environmental support appear among the secondary outcomes. Their presence indicates areas of interest, but outcome names alone do not establish that a change occurred. Numerical results for those outcomes are not reported in the registry record.
3. Trial Design
The study is registered as a completed, single-group behavioral intervention study, with enrollment of 7. Allocation is listed as not applicable and masking as none. The phase is listed as not applicable. These characteristics describe an intervention study without a randomized allocation or a concurrent comparison arm. Accordingly, the record does not support a randomized between-group estimate of the program’s effect.
The study is titled “GameDay Ready”: Evaluating a Behavioral Weight Management Program for Black Men Living in the Rural South. Its official title describes development of a lifestyle intervention to reduce body weight for obese African American men living in the rural South. The stated primary objective is to test feasibility and acceptability of a 12-week intervention adapted for Black men in that setting.
The intervention combines a football-themed curriculum with physical activity and behavior-change components. The registry description mentions gradual increases in activity, reductions in sedentary time, improvements in dietary habits, self-monitoring, personalized goals, male-specific health concerns, and group competition. It also describes facilitator and peer concordance to the extent possible and a limited educational component. The record does not provide enough detail to infer how consistently each component was delivered or received.
The study start date is 2022-08-19, the primary completion date is 2023-04-01, and the status is completed. These registry dates do not, by themselves, establish the timing of each participant’s follow-up or the completeness of outcome collection. Recruitment procedures, the setting’s precise location, and further operational 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 | GameDay Ready Intervention |
|---|---|
| STARTED | 7 |
| COMPLETED | 4 |
| NOT COMPLETED | 3 |
Analysis population for the primary outcome, as defined in the registry: Overall number of participants analyzed represents number of participants screened for study interest prior to enrollment.
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 | GameDay Ready Intervention |
|---|---|---|
| Participants analysed | 7 | |
| Age, Continuous | years | 36 (SD 8) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 7 |
| 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 | 7 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Study Interest, measured over Up to week 1.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Number of people |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is the number of people expressing interest in the study, with a timeframe of up to week one. The registry describes the analyzed population for this measure as people screened for study interest prior to enrollment. This is a count-oriented recruitment measure, not a measure of weight change or another health outcome. Its placement as the primary outcome aligns with the stated objective of assessing feasibility and acceptability: evidence about whether people express interest can inform understanding of recruitment and engagement.
However, the registry record does not report the numerical result for study interest. Enrollment of 7 is reported, but enrollment is not interchangeable with the number who expressed interest or were screened. It would be inappropriate to treat the enrollment figure as the endpoint result or to infer a recruitment rate from it. The number screened, the number expressing interest, and the relationship between those counts are not reported in the registry record.
In general, a feasibility outcome can help describe whether a study approach appears workable in its intended context. It does not, on its own, establish a treatment effect. In this case, the primary outcome is specifically about interest in study participation, so it cannot directly quantify changes in body weight, physical activity, diet, or other health measures. The registry lists several such measures as secondary outcomes, but their numerical findings are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a small, single-group feasibility study rather than a controlled efficacy comparison. Enrollment was 7, and the intervention was designed for Black men living in the rural South. The stated purpose was to assess feasibility and acceptability of an adapted behavioral weight management program. These design features set the limits on what can be concluded: without a separate comparison group, observed changes cannot be separated from other influences using a randomized contrast.
The primary outcome is the number of people expressing interest in the study up to week one. Although the registry describes the outcome and its intended population, it does not report the numerical result. Consequently, the posted record does not establish how many people expressed interest, how many were screened, or what proportion of those screened proceeded to enrollment. The enrollment figure cannot substitute for these missing outcome details.
Weight and other health-related measures are listed as secondary outcomes, including body mass index, waist circumference, blood pressure, moderate-to-vigorous physical activity, dietary intake, and measures of social and environmental support. These outcome labels tell readers what the study planned to examine, but no numerical results for them are reported in the registry record. Without the results, there is no basis for describing the direction, magnitude, or precision of any changes.
There are no analyses reported in the registry record. Thus there are no reported effect estimates, confidence intervals, or significance tests to interpret. In general, an effect estimate describes the size and direction of an observed contrast, while a confidence interval communicates the uncertainty around that estimate. In this single-group design, a within-group change could describe what happened over time among participants, but it would not provide the same causal evidence as a comparison with a concurrent control group. No such change estimates are reported.
The record reports no serious adverse events, other adverse events, or deaths among the intervention group’s 7 participants at risk. These are descriptive counts in a small group, not a precise estimate of event risk. Zero recorded events does not establish that an intervention is free from risk, nor does it indicate how well adverse events were actively sought or recorded. Details about safety surveillance are not reported in the registry record.
Overall, the available information describes the study’s purpose, intervention, design, and outcome definitions. It does not provide outcome values that would allow a statistical assessment of feasibility results or changes in health measures. Interpretations should therefore remain focused on what was registered rather than assuming results from the study title, intervention rationale, or completed status.
9. Statistical Methods Explained
The registry characterizes the study as a single-group intervention and lists no allocation or masking. This is a descriptive design feature with important implications for statistical interpretation. A controlled trial can compare outcomes between groups that received different assigned conditions. A single-group study has no concurrent arm to provide that contrast. If change over time is measured, that change can be described, but potential influences such as natural variation, concurrent behavior changes, or measurement effects cannot be ruled out by a randomized comparison in this design.
What does a single-group design estimate?
In general, a single-group analysis may describe outcomes within the participants who took part, such as a measurement at follow-up compared with an earlier measurement. That description is not equivalent to estimating what would have happened to the same participants without the intervention. A comparison group helps address that question, although the strength of the comparison also depends on how groups are formed and analyzed. The registry lists no control group or randomized allocation for this study, and no outcome analyses are reported.
How should the primary count outcome be read?
The primary measure is a count of people expressing interest in the study, with a timeframe of up to week one. A count describes the number of events or people meeting a stated definition. Interpretation depends on having the observed count and a clear account of who was eligible to be counted. The record describes the relevant population as people screened for study interest before enrollment, but does not report the numerical count or the total screened. Therefore, the outcome cannot be translated into a recruitment proportion or compared with a target using the record’s reported results.
Enrollment of 7 is a separate registry fact. It should not be used as the numerator or denominator for the interest outcome unless the record explicitly identifies it that way, which it does not. The count of people expressing interest, the screening flow, and the criteria used to classify interest are not reported in the registry record. These omissions prevent a fuller assessment of recruitment feasibility from the primary outcome.
What do the listed secondary outcomes establish?
The registry lists changes in weight, body mass index, waist circumference, blood pressure, and moderate-to-vigorous physical activity, alongside dietary intake and social or environmental support measures. These are outcome domains, not results. A change outcome generally requires measurements at more than one time or a clearly defined comparison. To interpret such an outcome, readers would need the observed values, the analysis population, the method for handling repeated measurements, and an estimate of uncertainty. Those numerical findings and analysis details are not reported in the registry record.
In general, a confidence interval gives a range of values compatible with the data under the analysis assumptions and conveys precision. A narrow interval indicates greater precision than a wide interval, but precision is not the same as freedom from bias. A p-value, when reported, addresses compatibility between data and a specified null model; it does not state the probability that a treatment works. No confidence intervals or p-values are reported in the registry record, so neither precision nor statistical evidence for an outcome can be assessed from the listed outcome names.
What is the role of the planning assumptions?
The record describes sample-size calculations as planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also states that the effect to detect is a stated fraction of the observed effect, and distinguishes participant counts per arm from total events for time-to-event calculations. These are planning assumptions, not a description of the actual single-group study design. They should not be read as evidence that this study randomized participants between two arms or that a particular sample size was justified in its protocol.
In general, a sample-size calculation asks what amount of information might be needed to detect a specified effect under stated assumptions. When based on an observed effect, such calculations are sensitive to uncertainty in that effect and are best understood as illustrations for future planning. They are not observed power, and they do not establish that an analysis was adequately powered. No specific planning values or protocol sample-size justification are reported in the registry record.
Why does over-dispersion matter for counts?
In general, count outcomes may vary more than a simple statistical model assumes. Over-dispersion means that the observed variability exceeds the model’s expected variability. If present and not accounted for, standard errors can be too small and confidence intervals too narrow, making results appear more precise than they are. Whether over-dispersion is relevant depends on the outcome distribution and the analysis. The registry record does not report a count analysis or enough outcome data to assess this issue for study interest.
Statistical methods must be interpreted alongside the design and the data actually reported. Here, the registry provides the study structure and outcome definitions, but no analyses and no numerical results for the primary or secondary outcomes. General statistical concepts can clarify what such analyses would mean, but they cannot supply the missing estimates or determine whether any intervention-related change occurred.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcome domains and reports 20 outcome measures. It reports 0 analyses. The presence of multiple outcomes raises a general multiplicity consideration: when many hypotheses are tested, the chance of obtaining at least one apparently unusual result can increase if each is assessed separately without an appropriate strategy. A prespecified hierarchy, adjustment method, or clear distinction between confirmatory and exploratory outcomes can help readers understand how to interpret a collection of tests. Such a statistical strategy is not reported in the registry record.
Because no analyses or numerical outcome results are reported, there are no reported estimates or tests to evaluate for multiplicity. The listed outcomes should therefore be treated as registered areas of measurement, not as evidence of positive, negative, or statistically significant findings. A multiplicity adjustment should not be inferred from the fact that several outcomes are listed.
Missing-data methods are not reported in the registry record. The record does not describe the amount or pattern of missing outcome data, whether all enrolled participants contributed measurements at each time, or how missing observations were handled. In general, missing-data methods matter because conclusions may depend on why values are absent and on assumptions made about those unobserved values.
The analysis populations are also not reported in the registry record. The primary outcome description refers to people screened for study interest before enrollment, but does not provide a numerical screening flow or define an analysis set for the intervention outcomes. It is therefore not possible to determine which participants were included in any outcome analysis or whether analyses followed a prespecified population definition.
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 |
|---|---|---|---|
| GameDay Ready Intervention | 0 | 7 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| GameDay Ready Intervention | 0 of 7 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| GameDay Ready Intervention | 0 of 7 |
The registry reports 0 serious adverse events among the 7 participants at risk in the GameDay Ready intervention group. It also reports 0 other adverse events among the 7 participants at risk and 0 deaths. These are the adverse-event counts recorded for this group; the registry lists no serious adverse-event terms.
These figures are descriptive. With a small group, a zero count does not show that the true risk is zero, and it cannot establish that no event could occur in a larger or different population. The counts also do not describe how events were defined, how actively they were monitored, or how long participants were followed for safety. Those details are not reported in the registry record.
There is no control group in this single-group study, so the adverse-event counts cannot be used to compare safety between intervention and control conditions. The absence of reported events should be read narrowly as a registry report of zero events in the stated group, not as a general conclusion about safety.
12. What the Result Does, and Does Not, Mean
The record establishes that GameDay Ready was studied as a behavioral weight management intervention intended for Black men living in the rural South. The program was football-themed and included physical activity and dietary behavior components. Its stated purpose was to test feasibility and acceptability, and the registry classifies the study as completed with a single group and enrollment of 7.
The primary outcome concerns interest in participating, rather than weight loss or another clinical endpoint. The registry gives the outcome definition and timeframe but does not report its numerical value. The number enrolled cannot be treated as the number who expressed interest or as a recruitment rate. As a result, the available record does not quantify the primary feasibility outcome.
Likewise, listed secondary measures do not show whether weight, body mass index, waist circumference, blood pressure, physical activity, diet, or support changed. Numerical results and analyses for these measures are not reported in the registry record. The design also lacks a concurrent comparison group, so even reported within-group changes would not, by themselves, identify the program as their cause.
The record does report zero serious adverse events, zero other adverse events, and zero deaths in the intervention group among the 7 participants at risk. That limited description is not proof of no risk, especially without further information about monitoring and follow-up.
In general, feasibility evidence can help guide the design of later research, while evidence about comparative effects requires suitable outcome data and a design that supports the intended comparison. This record describes a relevant intervention and its study structure, but the unreported outcome results prevent conclusions about how feasible or acceptable the program was in practice or whether participants experienced changes in the listed health measures.
13. Why This Trial Matters Statistically
This study is statistically notable for the distinction between a program’s clinical ambition and the question its primary outcome actually measures. The title and intervention concern behavioral weight management, but the primary outcome is the number of people expressing interest in the study. That outcome can speak to recruitment interest when its count and screening context are reported; it does not directly quantify weight change or establish an intervention effect.
The single-group design also makes the study’s intended feasibility focus important. Without a concurrent control group, a later analysis of change among participants would remain a description of change over time rather than a randomized estimate of the program’s effect. Recognizing that distinction prevents a small developmental study from being interpreted as a controlled efficacy trial.
The intervention is adapted for Black men living in the rural South and incorporates football-themed content, physical activity, dietary behavior, and group elements. Such features make the study’s context and implementation questions relevant to the interpretation of feasibility research. However, the registry record does not report numerical findings that would establish whether participants engaged with the intervention or whether its components were delivered as intended.
Statistically, the record also illustrates why registered outcome definitions and reported results serve different purposes. An outcome list signals what researchers planned to measure; estimates and uncertainty are needed to evaluate what the data show. Here, 20 outcome measures are reported, but 0 analyses are reported. As a result, readers can identify the intended scope of measurement but cannot assess effect size, precision, or the consistency of findings across outcomes.
The study can be understood as a completed feasibility-oriented investigation with limited reported outcome information, rather than as evidence for or against a clinical effect. That distinction is central to responsible interpretation of early-stage intervention research.
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 most consequential limitation for interpreting outcomes is the absence of numerical results in the registry record. The primary measure is defined, but its value is not reported; numerical findings for the listed secondary outcomes are also not reported. Without outcome estimates, the direction and magnitude of any observed changes cannot be assessed.
Enrollment was 7, and the study had a single group with no randomized allocation or concurrent comparator. This limits what can be inferred about intervention effects and how representative the findings might be beyond the participants who enrolled. The record does not report detailed participant characteristics, eligibility criteria, or the number screened, so the recruitment context and reach cannot be fully evaluated.
The intervention description identifies several components, but the record does not report measures of adherence, attendance, implementation fidelity, or participant acceptability results. Although feasibility and acceptability are stated aims, the primary outcome of study interest alone would not cover every aspect of those aims even if its numerical result were available.
Analysis methods, analysis populations, missing-data procedures, and approaches to multiplicity are not reported in the registry record. These omissions leave uncertainty about how the planned outcomes would have been summarized and how incomplete observations or multiple outcomes would be handled. Follow-up details for the listed measures are also not reported beyond the primary outcome timeframe.
The safety counts are limited to the recorded group and do not include enough monitoring detail to characterize how events were collected. Collectively, these limitations mean the record documents the study’s design and aims more clearly than it documents its results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: "GameDay Ready": Evaluating a Behavioral Weight Management Program for Black Men Living in the Rural South — NCT05530980.
- Registry record last updated 2024-02-02; status last verified 2024-01.
- Results first posted 2024-02-02.
- 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
NCT05530980 is a completed, single-group study of the GameDay Ready behavioral weight management program for Black men living in the rural South. The intervention is described as a 12-week, football-themed program. Enrollment was 7; allocation was listed as not applicable, and masking as none. The recorded study dates are 2022-08-19 to primary completion on 2023-04-01.
The stated objective was to test feasibility and acceptability. The primary outcome was the number of people expressing interest in the study up to week one, with the relevant population described as people screened before enrollment. Its numerical result is not reported in the registry record. The registry lists 20 outcome measures and 0 analyses. Numerical findings for the listed secondary outcomes are not reported.
The record reports 0 serious adverse events, 0 other adverse events, and 0 deaths among the intervention group’s 7 participants at risk. These counts describe the recorded group and do not establish a general safety conclusion or a comparative treatment effect.