MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD (NCT04563741), a randomized na study. The primary outcome is Weight (Pounds) Change From Baseline to 6 Months Post-baseline.

2. Clinical Question

3. Trial Design

This was a randomized, single-masked, parallel-group behavioral study. Participants were allocated to MOVE!+UP or MOVE!, with usual care in both arms. The registry records an enrollment of 174 and a completed status. The listed phase is NA. The sponsor is the VA Office of Research and Development. The study start is recorded as 2020-10-01 and the primary completion date as 2025-03-26.

Random allocation is intended, in general, to make treatment groups comparable with respect to both measured and unmeasured factors at assignment. A parallel design means each participant is assigned to one of the two approaches, rather than receiving both in sequence. Single masking indicates that the registry identifies masking but does not specify in this record which parties were masked. Details about the allocation sequence, concealment, and masking procedures are not reported in the registry record.

The control arm received usual care enhanced with MOVE!, while the experimental arm received usual care enhanced with MOVE!+UP. The study therefore addresses the incremental comparison between these programs in the population under study. It does not directly compare either program with no weight-management support.

Weight change at six months was the primary outcome. The registry also posts weight change at twelve months and PTSD symptom severity at six and twelve months. It lists 18 outcome measures and 18 analyses, while three secondary outcomes are described in the posted results. The registry record does not report the original sample-size justification, detailed eligibility criteria, a prespecified statistical analysis plan, or the full protocol. Those omissions limit how much can be concluded about design decisions beyond the features explicitly listed.

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: We randomized 174 enrolled participants to MOVE! (control) or MOVE!+UP (intervention) in a 1:1 ratio within each recruitment cohort, using a permuted block design, with varying block sizes (2 or 4). People doing data collection and analysis remained masked until after 12-month data collection.

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 (Pounds) Change From Baseline to 6 Months Post-baseline, measured over baseline and 6 months post-baseline.

The primary endpoint measures change in body weight, in pounds, between baseline and six months after baseline. The registry describes the measure as a mean with standard deviation and states that the primary aim is to test whether participants receiving MOVE!+UP have greater six-month weight loss than controls. A negative change represents a lower weight at follow-up than at baseline in the posted arm summaries.

Weight is a continuous outcome: it can take a range of values rather than representing a yes-or-no event. Comparing mean changes gives a summary of the average change in each group, while the between-group mean difference focuses on how far apart those averages are. The endpoint is relevant to the program’s stated weight-management purpose, and the six-month time point is the registry’s designated primary assessment. It does not by itself describe each participant’s individual change or the distribution of changes within an arm.

The arm-level summaries show mean changes of -7.8 pounds for MOVE! and -8.9 pounds for MOVE!+UP. The reported primary analysis uses a linear mixed effects regression model and reports a mean difference in final values. The registry record does not provide the model specification or explain how the baseline measurement and repeated observations were handled. Accordingly, the posted group summaries and the reported model result should be kept distinct when interpreting the endpoint.

7. Results Posted in the Registry

• Experimental Condition: MOVE!+UP: mean -8.90 versus -7.80 on control; difference -1.10 (95% CI -5.56 to 3.36), standardized effect d = -0.08; z-test p = 0.629.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Weight (Pounds) Change From Baseline to 12 Months Post-baseline

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Experimental Condition: MOVE!+UP: mean -8.80 versus -8.00 on control; difference -0.80 (95% CI -6.39 to 4.79), standardized effect d = -0.05; z-test p = 0.779.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Experimental Condition: MOVE!+UP and the control. The interval gives the range of effects that remain compatible with the data.

PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 6 Months Post-baseline

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Experimental Condition: MOVE!+UP: mean -7.90 versus -7.60 on control; difference -0.30 (95% CI -3.99 to 3.39), standardized effect d = -0.03; z-test p = 0.873.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Experimental Condition: MOVE!+UP and the control. The interval gives the range of effects that remain compatible with the data.

PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 12 Months Post-baseline

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Experimental Condition: MOVE!+UP: mean -7.40 versus -9.60 on control; difference 2.20 (95% CI -2.26 to 6.66), standardized effect d = 0.16; z-test p = 0.333.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Experimental Condition: MOVE!+UP and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes cover weight at twelve months and PTSD symptom severity at six and twelve months. Across these outcomes, the arm summaries show average changes from baseline, while the between-group comparisons remain uncertain. The posted comparisons do not show a clear separation between the programs across the secondary measures. This broad pattern is consistent with the primary result’s lack of a precise between-group distinction, rather than providing a separate, strong signal of added benefit in a particular secondary domain.

The secondary outcomes help describe whether the observed pattern is confined to the primary six-month weight assessment or appears across other follow-up measures. They also extend the picture to PTSD symptom severity, which is relevant to the program’s stated aims. The different outcomes measure different aspects of change and have different follow-up times; they should not be combined into a single conclusion without a prespecified method for doing so.

Secondary findings generally carry less inferential weight than the primary outcome. Multiple outcomes create more opportunities for chance findings, especially when each is assessed separately. The registry record does not report whether the secondary analyses were adjusted for multiplicity or designated as confirmatory versus exploratory. The posted p-values are unadjusted recalculations, while the sponsor’s model results are presented separately; readers should not treat a pattern of nominal results as if it were a single prespecified test.

These results are useful for context and follow-up, but they do not overturn the primary comparison. Nor does the absence of a clear secondary separation prove that the groups had identical outcomes. The intervals and the missing multiplicity information call for caution: these outcomes can inform further study and interpretation of the trial, but they do not provide definitive evidence on their own.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Weight (Pounds) Change From Baseline to 12 Months Post-baseline
• PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 6 Months Post-baseline
• PTSD Symptom Severity on the PTSD Checklist for DSM-5 Change From Baseline to 12 Months Post-baseline

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous, and the registry presents it as a mean change with standard deviation. A mean summarizes the central level of the observations; a standard deviation describes how spread out individual values are around that mean. The spread is relevant because participants can have quite different changes even when the group average is similar. Group means therefore offer a compact summary, not a full account of individual responses.

What does the reported model estimate?

The registry reports a linear mixed effects regression model for the primary comparison, with the parameter described as a mean difference in final values. In general, linear models estimate relationships in a continuous outcome, while mixed effects models can account for correlated observations, such as repeated measurements from the same participant, when their structure is specified. The registry record does not give the model formula, covariates, covariance structure, or other implementation details. It is therefore not possible to determine from this record exactly how the model used baseline values or repeated measurements.

The reported estimate, -1.52, is the model-based comparison as posted. It should be distinguished from the simple recalculation using arm-level summary statistics. That recalculation estimates an unadjusted mean difference from the posted means and standard deviations, and does not reproduce a regression model that may incorporate additional information. Since the registry’s reported analysis is the trial’s own analysis, it is the main inferential result to foreground; the recalculation is useful as a transparent, simple cross-check rather than a substitute.

How should confidence intervals be understood?

A confidence interval communicates uncertainty around an estimated effect. In general, a narrower interval indicates greater precision, while a wider interval indicates less precision. The reported primary 95% confidence interval runs from -5.93 to 2.89. Because this interval includes no difference and extends in both directions, the estimate does not pin down the direction or size of the between-group effect. The interval is not a guarantee that the true effect lies within its limits, and it does not describe the range of individual participants’ weight changes.

The recalculated interval is based on the posted summary statistics and should be interpreted as an unadjusted calculation. It is not identical to the interval from the sponsor’s model. Differences between these quantities can arise because the analyses use different information or assumptions; the registry does not provide enough model detail to attribute the difference to a particular cause. The posted results do not mark a discrepancy, but the distinction between model-based and summary-based estimates remains important.

What does the p-value add?

In general, a p-value describes the compatibility of the observed data with a null hypothesis under a particular statistical model and its assumptions. The sponsor reports p = 0.50 for the primary comparison. This value should be considered alongside the estimate and confidence interval, rather than used alone as a decision rule. A p-value does not say how likely the result is to replicate, the probability that one approach is better, or the size of a treatment effect. It also cannot establish that two approaches have the same effect.

The recalculation’s unadjusted p-value is 0.629. It is based on posted summaries and should not be read as the trial’s model-based p-value. The registry does not report whether the sponsor’s primary analysis used a one- or two-sided test, how it treated missing observations, or whether any additional model diagnostics were applied. The planned sample-size illustration separately states a two-sided significance level of 0.05; that planning assumption should not be taken as confirmation of every detail of the trial’s own analysis procedure.

Why do analysis details matter?

Statistical estimates depend on the analysis population, the observations included, and the way the model handles repeated measurements and incomplete data. The registry record does not report the primary analysis population definition, the number included in the model, a missing-data method, or sensitivity analyses. These are not minor details: they help readers judge whether the reported estimate follows the assigned groups and whether conclusions are robust to incomplete follow-up or modeling choices.

Randomization supports a fair comparison in general, but it does not remove uncertainty from finite samples or automatically resolve missing-data concerns. Nor does a registry entry with outcome summaries fully replace a protocol or statistical analysis plan. Readers can interpret the reported model result and its uncertainty, while recognizing that some methodological details needed for a fuller audit are not reported in the registry record.

11. Confidence Intervals and Precision

The primary sponsor-reported estimate is a mean difference of -1.52, with a 95% confidence interval from -5.93 to 2.89. The interval includes no difference and extends to estimates in either direction. This means that the point estimate alone gives a more definite impression than the interval supports. The data do not identify a single precise between-group effect.

Precision concerns how tightly an estimate is determined by the data and analysis. It is different from whether an estimate is statistically significant, and it is also different from the spread of individual measurements. The arm standard deviations describe variability among participant outcomes; the confidence interval describes uncertainty about the estimated group contrast. Both matter, but they answer different questions.

The interval from the recalculation based on arm summaries is -5.561 to 3.361. This is an unadjusted recalculation and does not replace the sponsor’s reported model-based interval. The two intervals have a similar substantive message: they include no difference and leave uncertainty about the size and direction of the contrast. The registry record does not report a clinically important difference threshold, so the intervals cannot be classified against such a threshold from the information.

A confidence interval should not be read as a range covering most participants’ outcomes or as proof that every value inside it is equally plausible. It summarizes uncertainty under the analysis assumptions. Since the model details and analysis population are not reported in the registry record, readers should also keep those limits in mind when assessing precision. The posted interval is informative, but it cannot resolve all uncertainty about the treatment comparison.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size table and curve are planning illustrations based on the observed effect, not a reconstruction of the trial’s original design. For these continuous outcomes, the figures are participants per arm. The assumptions listed for the illustration are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; each row uses the stated fraction of the observed effect as the effect to detect. The original trial’s sample-size assumptions and justification are not reported in the registry record.

The 80% power column shows the illustrative number of participants per arm under those assumptions for a design with an 80% chance of detecting the specified effect, if that effect is the true effect and the assumptions hold. The 90% power column gives the analogous planning figure for a design with a 90% chance. Higher target power generally requires a larger planned sample for the same effect and assumptions. These are prospective planning concepts, not properties observed after a trial has finished.

The rows use planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. A smaller effect is harder to distinguish from random variation, so the illustration requires more participants per arm as the target effect becomes smaller. The table is a sensitivity illustration: its estimates change with the chosen effect size and assumptions. It should not be treated as a claim about the sample size that MOVE!+UP needed or about the rationale used when the study was designed.

These figures are not observed power. Observed power calculated after seeing the results would add little information beyond the estimate and its uncertainty. For interpretation of the completed trial, the reported effect and confidence interval are more informative. The curve provides a visual version of the same planning relationship; it does not add a separate estimate of the trial’s outcome.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -1.100; pooled standard deviation σ = 13.749.
2. n = 2 × (1.96 + 0.842)² × 13.749² / -1.100² = 2,452.6, rounded up to 2,453 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -1.1                      # observed difference in means
sigma <- 13.7493964514002                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4563741)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 2,453 (80% power), 3,284 (90% power)
 75% of observed effect: n per arm = 4,361 (80% power), 5,837 (90% power)
 50% of observed effect: n per arm = 9,811 (80% power), 13,134 (90% power)
power.t.test: 2453.5 
Simulated power at n = 2,453 per arm: 0.802 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry’s primary result is the sponsor-reported linear mixed effects regression analysis: mean difference -1.52, 95% confidence interval -5.93 to 2.89, and p = 0.50. This is the trial’s own reported inferential analysis and should be treated as the main result. It compares the arms using the stated model, although the registry record does not give enough detail to reconstruct that model fully.

The simple recalculation from posted arm summaries gives a mean difference of -1.1, an interval from -5.561 to 3.361, and an unadjusted p-value of 0.629. It is not the same analysis as the sponsor’s regression model. It uses only the posted summary values and does not account for model features that are not available in those summaries. Its role is to provide a transparent, unadjusted reference alongside the reported analysis.

The estimates are not numerically identical, but both point to substantial uncertainty and intervals that include no difference. The registry does not mark a discrepancy between the sponsor analysis and the recalculation. Even so, interpretation should prioritize the trial’s reported model result rather than selecting whichever estimate appears preferable. The summary-based calculation is best understood as a cross-check, not as evidence that the reported analysis is incorrect or that the two approaches are interchangeable.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists 18 outcome measures and 18 analyses, and the posted results include a primary endpoint and three secondary outcomes. When many outcomes or comparisons are examined, the chance of at least one apparently notable result arising by chance can increase. In general, multiplicity procedures address this issue by adjusting the interpretation or error rate across a defined family of tests. The registry record does not report whether such procedures were planned or used for the outcomes in this study.

The primary endpoint is identified as primary, which gives it a distinct role in interpretation. Secondary outcomes can provide supportive or exploratory information, but their status and multiplicity handling matter when interpreting p-values. The registry does not report a hierarchy among secondary outcomes, a multiplicity adjustment, or a statistical analysis plan specifying which comparisons were confirmatory. The secondary recalculations are unadjusted, and should not be treated as a collection of independent confirmatory tests.

Missing-data handling is another important issue for longitudinal outcomes. The registry reports different numbers of participants in the outcome summaries at different follow-up assessments, but does not explain why those counts differ, how missing observations were handled in the model, or whether sensitivity analyses were performed. It would be inappropriate to infer a particular reason for the differences from the posted counts alone. The primary analysis population and the treatment of participants after randomization are also not reported in the registry record.

Randomization defines the assigned groups, but the analysis population and incomplete outcome data can affect how closely the analyzed comparison reflects that assignment. In general, an intention-to-treat analysis retains participants in their randomized groups regardless of adherence, while other analysis populations may use different criteria. The registry does not state which population was used here, so the reported analysis should not be labeled intention-to-treat or per-protocol on the basis of this record.

These omissions do not invalidate the reported results, but they limit independent assessment of robustness and multiplicity. A protocol, analysis plan, or fuller results report could clarify these details; they are not reported in the registry record.

16. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pacreatitis (2.4%), syncope (1.2%), diabetes (1.2%), lymphoma (1.2%), blood clot (1.1%).

The registry reports serious adverse events for 5 participants at risk of 89 in the MOVE! group and 5 participants at risk of 85 in the MOVE!+UP group. It reports other adverse events for 60 participants at risk of 89 in MOVE! and 60 participants at risk of 85 in MOVE!+UP. Deaths are reported as 2 in MOVE! and 0 in MOVE!+UP. These are the posted event counts and risk-set figures; they should be read as registry safety summaries, not as evidence that an event was caused by a particular program.

The registry’s listed top serious-event terms include Pacreatitis at 2.4%, Syncope at 1.2%, Diabetes at 1.2%, Lymphoma at 1.2%, Blood Clot at 1.1%, and Stroke (death) at 1.1%. These terms and percentages are reproduced as recorded. The record does not provide enough detail to interpret event timing, relatedness, recurrence, or the basis of the listed percentages.

The safety risk-set counts differ from the outcome-summary counts and the enrollment figure. The registry does not explain this difference in the information, so it should not be reconciled by assumption. A between-arm comparison of these counts alone would also omit context about event definitions and participant follow-up. The posted figures describe what the registry reports; they do not establish comparative safety or causality.

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

The result answers a focused question: whether the registry’s reported comparison shows a difference in six-month weight outcome between MOVE!+UP and MOVE! In this randomized study. The sponsor’s estimate is uncertain, and its confidence interval includes no difference. The arm averages show decreases from baseline in both groups, but the randomized between-group contrast does not establish that MOVE!+UP produced greater weight loss than MOVE!.

This is not proof that the programs have the same effect. A finding that does not distinguish the groups can arise when the true difference is small, when the estimate is imprecise, or for other reasons. The record does not report an equivalence or noninferiority design or margin. Therefore, equivalence cannot be concluded from a nonsignificant comparison. The interval is more informative than a simple label of positive or negative: it shows that multiple effect sizes remain compatible with the reported model.

The result also does not establish that either program is effective compared with receiving no program. Both groups received an active weight-management approach as an addition to usual care. The comparison is between MOVE!+UP and MOVE!, not between intervention and no intervention. Within-arm change is not a substitute for this randomized contrast because changes over time can reflect factors other than the difference between assigned programs.

The endpoint is weight change at a specified follow-up. It does not alone establish effects on other health outcomes, quality of life, implementation, or long-term outcomes beyond those posted. The secondary symptom and weight results provide additional context, but they also have uncertainty and are subject to the limitations of multiple outcomes and incomplete reporting. The safety figures likewise describe reported events but do not identify causation.

More broadly, the registry entry is not a complete account of every design and analysis decision. Eligibility details, the original sample-size justification, model specification, missing-data methods, and multiplicity procedures are not reported in the registry record. Those gaps limit the scope of conclusions that can be drawn from this page. The most defensible interpretation remains specific: the reported analysis does not demonstrate a clear six-month weight difference between the two active approaches, and the estimate is not precise enough to establish that the approaches are equivalent.

18. Why This Trial Matters Statistically

This trial is statistically informative because its central question is an active-comparator question. The analysis must distinguish changes within each arm from the difference between arms. Both groups can show average change from baseline while the randomized contrast remains uncertain. Keeping those quantities separate prevents a common interpretive mistake: treating improvement within an arm as evidence that one program outperformed the other.

The record also illustrates why an effect estimate and its interval matter alongside a p-value. The primary estimate is close to no difference relative to its uncertainty, and the interval allows effects in either direction. A single significance label would hide that range. The results do not establish equivalence, but neither do they establish a clear difference; the uncertainty is central to the statistical reading.

Another lesson is the distinction between a trial’s reported model analysis and an unadjusted calculation from summary data. The recalculation is useful for transparency and as a broad cross-check, but it does not reproduce the regression model. The registry’s report of a linear mixed effects model makes the reported estimate the relevant trial analysis, while the limited model details constrain independent verification.

The sample-size illustration also demonstrates how planning depends on the effect a future study is designed to detect. Smaller target effects require larger illustrative samples under the listed assumptions. This does not turn the illustration into evidence about the completed trial’s design or its probability of success. The trial’s original sample-size rationale is not reported in the registry record.

Finally, the multiplicity, missing-data, and analysis-population details matter for a study with multiple outcomes and follow-up times. Their absence does not erase the posted findings, but it limits how confidently readers can assess robustness. Statistical interpretation involves both what the estimates show and what the record does not make available.

19. 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 registry record leaves several trial-specific details unavailable. Eligibility criteria are not reported in the information, so the degree to which participants represent all Veterans with PTSD and overweight or obesity cannot be assessed from this entry alone. The record also does not describe the recruitment setting, participant characteristics, or the extent to which the programs were delivered as intended. Those details would be useful for understanding how broadly the findings may apply.

The posted primary analysis is identified as a linear mixed effects regression model, but its specification is not reported. The record does not state which covariates were included, how baseline values and repeated observations were handled, or how incomplete data were treated. The analysis population is likewise not specified. Because the posted outcome counts vary across assessments, the absence of an explanation for those counts limits assessment of follow-up and missingness; no particular cause can be inferred from the counts alone.

The registry does not report the original sample-size justification, planned effect, or detailed analysis plan. This limits assessment of whether the study was designed around a clinically meaningful target and which secondary analyses were intended as confirmatory. The posted sample-size figures are planning illustrations based on observed effects, not the trial’s own design calculations.

The study compares two active approaches, which is appropriate for the stated incremental question but does not estimate effects against no weight-management program. The primary endpoint is limited to weight change at six months, and the registry also posts selected outcomes at twelve months. The record does not provide longer-term outcomes in the results. Single masking is listed, but which parties were masked and how masking was implemented are not reported.

Finally, safety counts are posted without enough context to assess event relatedness, timing, or the basis of the risk sets. Multiplicity adjustment for the many listed outcomes is not reported. These limitations are reporting gaps in the registry record and should be distinguished from evidence that the methods were or were not handled appropriately.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD — NCT04563741.
• Registry record last updated 2026-05-06; status last verified 2026-05.
• Results first posted 2026-05-06.
• 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.

23. Record Summary

NCT04563741, MOVE!+UP: Testing a Tailored Weight Management Program for Veterans With PTSD, is a completed, randomized, single-masked, parallel-group behavioral study sponsored by the VA Office of Research and Development. The registry records enrollment of 174, a phase of NA, start date 2020-10-01, and primary completion date 2025-03-26.

The primary outcome is weight change from baseline to six months, comparing usual care enhanced with MOVE!+UP against usual care enhanced with MOVE!. The reported linear mixed effects analysis estimates a mean difference of -1.52, with a 95% confidence interval from -5.93 to 2.89 and p = 0.50. The interval includes no difference and leaves uncertainty about the size and direction of the comparison.

The record also posts weight and PTSD symptom outcomes at later assessments, alongside adverse-event summaries. Important details—including the original sample-size rationale, model specification, missing-data approach, analysis population, and multiplicity handling—are not reported in the registry record.