Using MOVE! With Seriously Mentally Ill Veterans: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Using MOVE! With Seriously Mentally Ill Veterans (NCT00323193), a randomized na study. The primary outcome is Weight Measurement.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group trial with no masking. Participants were allocated to MOVE! or a control condition. In a parallel design, each participant is assigned to one group and the groups are compared over the study period. Random allocation can help balance measured and unmeasured characteristics on average, but it does not guarantee balance in a particular trial. The registry record does not describe the randomization procedure or whether allocation was concealed.

The MOVE! group was described as completing approximately 8 individual sessions with a MOVE specialist and approximately 8 group intervention sessions. The control group was offered basic diet and exercise information every month for six months. The record does not report attendance, adherence, or the amount of intervention actually received by participants, so the intended program cannot be assumed to have been delivered uniformly.

The primary outcome was weight in pounds, recorded at baseline and at six months. The listed outcome type is continuous, and the planned summary is the mean with standard deviation. The Impact of Weight on Quality of Life Survey is listed as a secondary outcome. The record reports two outcome measures and two analyses, but does not provide a full analysis plan or the results needed to interpret the outcomes.

The study is marked completed. Its start is listed as 2006-07 and its primary completion as 2010-01. The enrollment field reports 109, whereas the brief summary describes 200 veterans. This discrepancy is present in the registry record and is not reconciled there. The study phase is listed as NA. The sponsor is the US Department of Veterans Affairs.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Weight Measurement, measured over baseline and six months.

The primary endpoint is weight, measured in pounds at the baseline assessment and again at the six-month assessment. Weight is a continuous measure: it can take many possible values rather than being restricted to categories such as improved or not improved. The registry specifies that the outcome is summarized using a mean and standard deviation.

In general, a mean describes the center of a group’s measurements, while a standard deviation describes how dispersed those measurements are around the mean. Reporting both can help readers understand the group-level measurement and its variability. Because the outcome is recorded at baseline and follow-up, an analysis may consider the follow-up value, change over time, or a comparison that accounts for baseline. The registry record does not specify which approach was used for the primary analysis.

Weight is a direct measure of body mass and is relevant to a trial focused on weight management. However, the registry record does not provide a single primary comparison or a numerical result for weight. Its note indicates that the outcome has several categories or time points and was not reduced to one comparison. Consequently, the record does not establish the direction, magnitude, or precision of a primary between-group effect. The Impact of Weight on Quality of Life Survey is listed as a secondary outcome, but its result is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized parallel-group study. Randomization assigns participants to groups by chance, which is intended to reduce systematic differences between groups at the start of a trial. In general, the benefit is protection against deliberate or predictable assignment, not a guarantee that groups will be identical. Randomization details, including the sequence-generation method and allocation concealment, are not reported in the registry record. The study is listed as unmasked. This means masking is recorded as none; the record does not explain whether outcome assessors were also aware of group assignment.

What does a continuous outcome mean?

Weight in pounds is a continuous outcome, and the registry identifies the mean as its summary measure and the standard deviation as its measure of dispersion. A mean represents the average measurement within a group. A standard deviation describes how observations vary around that average. These summaries do not, by themselves, show how groups compare. To estimate a treatment contrast, an analysis must define the relevant comparison, such as a difference in follow-up measurements or a difference in change from baseline. The registry record does not report which primary comparison was used, nor does it report the numerical summaries needed to reconstruct one.

Why do baseline and follow-up measurements matter?

Baseline measurement can describe starting weight and may be used in an analysis to account for initial differences. Follow-up measurement can describe weight at six months. In general, comparing follow-up values while adjusting for baseline and comparing change from baseline are different analytical approaches. Their estimates and uncertainty can differ, particularly if baseline and follow-up measurements are related. The registry specifies measurements at baseline and six months but does not report the primary analysis method or a single contrast. No recalculation is possible from the information recorded.

How should uncertainty be assessed?

A standard error measures the estimated sampling variability of an estimate. A confidence interval uses that uncertainty to express a range of estimates compatible with the observed data and the chosen method. A p-value summarizes how unusual the data would be under a specified null hypothesis and model. These quantities answer related but distinct questions: uncertainty, compatibility with a null hypothesis, and effect magnitude should not be treated as substitutes for one another. The registry record does not report a primary estimate, confidence interval, standard error, or test result. Therefore, no numerical assessment of the weight effect’s precision or statistical compatibility is available from the record.

What do the planning assumptions represent?

The planning illustrations are described as calculations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. They are planning illustrations, not the trial’s original sample-size justification and not observed power. A planning calculation asks what sample size might be needed under stated assumptions for a future study. Its interpretation depends on the effect assumed, the outcome variability, the analysis, and other design features. The registry record does not report the protocol’s sample-size justification or a full statistical plan. The illustrations should not be read as proof that the completed trial was adequately powered or that a nonsignificant result, if one existed, would demonstrate equivalence.

Why can over-dispersion matter?

For count outcomes, over-dispersion means that variability is greater than expected under a simple model, such as a basic Poisson model. If it is ignored, standard errors can be too small and uncertainty can appear narrower than it is. This is a general statistical concern, not a description of the primary endpoint in this trial: the primary outcome is continuous weight, not a count. The registry information does not provide enough detail to assess whether any count-based analysis was used.

The record identifies two outcome measures and two analyses, but does not state the model, covariates, handling of repeated measurements, or rules for choosing among time points. It also does not report the analysis population or the approach to missing observations. Those omissions limit independent assessment of whether the reported analysis, if available elsewhere, matches the intended design.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and two analyses. Weight is identified as the primary outcome, and the Impact of Weight on Quality of Life Survey is identified as secondary. The record does not report how testing across outcomes, time points, or analyses was handled. In general, when several hypotheses are tested, the chance of at least one apparently notable result can increase unless the analysis plan addresses multiplicity. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a prespecified rule for selecting the primary time point. It is therefore not possible to determine how multiplicity was handled.

The primary outcome is described as having several categories or time points and was not reduced to one comparison. That matters because different choices of time point or summary can lead to different estimands: the precise quantity an analysis is intended to estimate. A clear prespecified estimand helps distinguish a planned comparison from a choice made after seeing the data. The registry record does not report a single primary estimand or a detailed statistical analysis plan.

Missing-data information is also absent. The record does not report how many participants contributed weight measurements at baseline and six months, the reasons measurements might be missing, or the method used to handle missing observations. In general, complete-case analyses can be biased if participants with observed data differ systematically from those without observed data. Imputation or model-based methods also rely on assumptions that should be described. The registry record does not specify an approach, so the robustness of any estimate to missingness cannot be assessed.

The record does not report whether the analysis followed assignment regardless of intervention attendance, or whether another analysis population was used. It also does not report exclusions or protocol deviations. These omissions prevent assessment of how closely an analysis preserved the randomized comparison.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event entries are recorded separately for the MOVE Group and Control Group. For serious events, each group lists 56 participants at risk and 0 affected. For other events, the MOVE Group lists 53 at risk and 0 affected, while the Control Group lists 56 at risk and 0 affected. These are the registry’s recorded counts; they should not be interpreted as a complete description of every possible safety outcome.

The at-risk counts are the denominators attached to the event entries. They are not necessarily the number enrolled or the number included in the primary weight analysis. The registry record does not explain why the at-risk count for other events differs between groups or how adverse events were collected and classified. No serious adverse-event terms are listed. Death counts are not reported in the registry record.

In general, a zero count in a trial does not establish that an event is impossible or that there is no risk. Safety interpretation also depends on how events were defined, the observation period, completeness of collection, and the amount of information available. The registry entries do not provide those details or comparative uncertainty estimates. They should therefore be read as recorded counts, not as a broad conclusion about safety.

12. What the Result Does, and Does Not, Mean

The registry record describes a randomized comparison of MOVE! with a control condition offering basic diet and exercise information. It identifies weight at baseline and six months as the primary outcome and lists a quality-of-life survey as secondary. This provides a framework for understanding what the trial was designed to compare.

It does not, however, report a single primary weight comparison or numerical results for the listed outcomes. The record therefore does not establish whether the groups differed, how large a difference might have been, or how precisely any effect was estimated. Absence of a reported result is not evidence of no effect, and it is not evidence that the interventions were equivalent. No treatment conclusion can be drawn from the information recorded.

Likewise, the adverse-event entries show zero affected participants in the listed serious and other event categories for both groups, but do not establish absence of all possible harms. Death counts are not reported in the registry record, and the event-collection methods are not described. These entries are a limited account of recorded events rather than a complete safety analysis.

The record also gives inconsistent enrollment descriptions: the enrollment field reports 109, while the brief summary describes 200 veterans. The record does not reconcile the figures. This uncertainty affects interpretation of the trial’s size and cautions against using either figure to infer how many participants contributed to a specific outcome analysis.

In general, a randomized design can support a credible group comparison when allocation, follow-up, outcome measurement, and analysis are adequately described. Here, important details about the primary analysis, missing data, and analysis population are not reported in the registry record. The appropriate conclusion is limited: the study’s design and intended measures are described, but its comparative weight result and its precision cannot be assessed from the recorded information.

13. Why This Trial Matters Statistically

This trial illustrates an important distinction between a study’s design and its interpretable result. The record identifies random allocation, two parallel groups, a behavioral intervention, a control condition, and a continuous primary outcome measured at baseline and six months. Those features describe the intended comparison. They do not substitute for an estimate of the comparison, an uncertainty interval, or a clearly defined analysis.

For continuous outcomes measured more than once, the choice of estimand matters. A follow-up comparison and a change-from-baseline comparison answer related but not identical questions. A prespecified analysis helps readers know which question was intended and reduces the risk that the reported result depends on a post hoc choice among time points or summaries. The registry record notes several categories or time points but does not reduce the primary outcome to one comparison, leaving that central statistical question unresolved.

The enrollment mismatch is another useful reminder that denominators must be interpreted in context. The registry enrollment field reports 109, while the brief summary describes 200 veterans. Without an explanation, neither figure can be confidently connected to the number included in a particular outcome analysis. Event-specific at-risk counts also should not be assumed to equal the primary outcome analysis population.

Finally, planning illustrations are not evidence of achieved power. Their assumptions may help frame a future design, but they cannot replace a reported result or an analysis plan. A clear registry report should connect the outcome definition, analysis population, missing-data approach, estimate, and uncertainty. In this record, those details are not reported, so statistical interpretation must remain bounded by the design and outcome descriptions.

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.

Several limitations specific to this trial follow from the information recorded. First, the primary endpoint is measured at baseline and six months, but the registry does not identify a single primary contrast. Its note says the outcome has several categories or time points and was not reduced to one comparison. Without a defined contrast, the intended estimand and the relevant interpretation remain unclear.

Second, the enrollment field reports 109, whereas the brief summary describes 200 veterans. The registry record does not reconcile these figures. This makes it difficult to identify the intended enrollment or relate the enrollment description to the number of participants contributing to each outcome. The at-risk counts for adverse events are reported separately and do not resolve the discrepancy.

Third, the registry record does not report group-level weight summaries, an effect estimate, confidence interval, or test result. It also does not report the quality-of-life outcome result. As a result, neither the direction nor the precision of the primary comparison can be evaluated. No conclusion about effectiveness or equivalence follows from the absence of those results.

Fourth, the record does not describe attendance or adherence to the MOVE! sessions, the exact intervention exposure, or the assessment of control-group participation. The intervention descriptions state what was offered, not what each participant received. The record also does not report how missing weight observations, protocol deviations, or the analysis population were handled.

Finally, masking is listed as none, and the registry does not explain whether outcome assessors were masked. The method for generating and concealing random allocation is also not reported. These details would help readers judge possible bias in measurement and implementation. The record’s safety entries are limited as well: event definitions and collection methods are not described, and death counts are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Using MOVE! With Seriously Mentally Ill Veterans — NCT00323193.
• Registry record last updated 2014-10-09; status last verified 2014-10.
• Results first posted 2014-10-09.
• 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.

18. Record Summary

The registry describes a completed randomized, unmasked, parallel-group trial of MOVE! versus a control condition offering basic diet and exercise information monthly for six months. The MOVE! description includes approximately 8 individual sessions and approximately 8 group sessions. The primary outcome is weight in pounds at baseline and six months; the Impact of Weight on Quality of Life Survey is listed as secondary.

The enrollment field reports 109, while the brief summary describes 200 veterans, and the discrepancy is not explained. The primary outcome was not reduced to one comparison, and numerical outcome results are not reported in the registry record. The record also does not report the primary analysis method, missing-data approach, or analysis population. Serious and other adverse-event entries list zero affected participants in both groups; death counts are not reported in the registry record. These details describe the registered study, but do not permit estimation of the comparative weight result or its precision.