My Baby My Move A Community Wellness Intervention: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for My Baby My Move A Community Wellness Intervention (NCT04294095), a randomized na study. The primary outcome is Weight.

2. Clinical Question

3. Trial Design

The registry describes My Baby My Move A Community Wellness Intervention as a randomized, parallel-group study with no masking. The listed phase is NA. The study status is completed, and the recorded enrollment is 68. The record gives a start date of 2020-09-01 and a primary completion date of 2022-01-01. The University of Colorado, Denver is listed as sponsor.

The study compared My Baby My Move+ with a control condition. The brief summary describes the intervention as peer-led and intended to support prenatal physical activity, mood, and sleep quality. It describes a planned 12-week program and says participants in the intervention group would receive electronic information about weight management and prenatal physical activity during the first four weeks. The control description lists electronic prenatal materials, including topics such as preparation for birth, birthing options, and responsive parenting. Both arm descriptions stop before all later activities are specified, so the full delivery schedule is not reported in the registry record.

The summary describes recruitment of up to 100 pregnant women, with 50 planned for each group, and frames the work as a test of feasibility and sustainability to inform a future, larger randomized trial. The completed record, however, lists enrollment of 68. For the primary weight result, posted group sizes are 25 in the intervention group and 24 in the control group. Those figures describe participants contributing to that measure; the reasons for the difference between the planned enrollment, the recorded enrollment, and the outcome-specific group counts are not reported in the registry record.

Random allocation supports a comparison between groups, but the record does not report the allocation sequence method or concealment procedures. With no masking listed, participants or study personnel may have known group assignment, but the extent of any masking for outcome collection or analysis is not reported in the registry record. The trial’s own original sample-size justification and detailed statistical plan 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.

Before assignment: 68 participants were consented - 18 dropped out prior to randomization due to physician request, no longer interested A total of 50 participants were randomized of which 49 completed all assessments.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Average Weight of pregnant women for intervention versus control at 12 weeks post-baseline

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, measured over 12 week post-baseline.

The primary endpoint is average weight, measured in pounds, at 12 weeks post-baseline. The registry describes it as the average weight of pregnant women in the intervention group compared with the control group at that time. Weight is a continuous measure, so the posted summaries use a mean and standard deviation for each group.

A mean gives a concise description of the group’s measured weight, while the standard deviation describes how spread out individual measurements are around that mean. Comparing group averages offers a way to describe how the endpoint differed between randomized groups at the specified follow-up. The measure is not itself the same as gestational weight gain: a single follow-up weight does not show how much weight each participant gained from baseline unless baseline and change data are also reported. The registry record does not post baseline weight summaries or an analysis of change from baseline.

The endpoint was selected in a study concerned with excessive gestational weight gain, but its interpretation is limited to the posted measurement and timeframe. The record does not report a threshold for excessive gain, a weight-gain classification, or longer-term weight outcomes. The 12-week endpoint therefore describes average weight at follow-up, rather than establishing whether participants met a guideline or whether a difference persisted beyond the measured period.

7. Results Posted in the Registry

• Intervention: mean 162.90 versus 162.30 on control; difference 0.60 (95% CI -18.47 to 19.67), standardized effect d = 0.02; z-test p = 0.951.

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.

Depression

• 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:
  • Intervention: mean 8.10 versus 6.30 on control; difference 1.80 (95% CI -0.95 to 4.55), standardized effect d = 0.36; z-test p = 0.200.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention and the control. The interval gives the range of effects that remain compatible with the data.

Anxiety

• 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:
  • Intervention: mean 4.70 versus 3.70 on control; difference 1.00 (95% CI -0.77 to 2.77), standardized effect d = 0.32; z-test p = 0.267.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention and the control. The interval gives the range of effects that remain compatible with the data.

Physical Activity

• 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:
  • Intervention: mean 48.00 versus 35.90 on control; difference 12.10 (95% CI 4.23 to 19.97), standardized effect d = 0.85; z-test p = 0.003.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Intervention than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Across the posted secondary endpoints, the pattern is not uniform. The comparison for physical activity has a positive intervention-minus-control estimate and an interval that excludes zero. The depression and anxiety comparisons have positive estimates, but their intervals include zero. These results point in different degrees of statistical separation, rather than presenting a consistent pattern across all secondary measures.

The secondary outcomes relate to the primary question because the intervention was intended to address prenatal wellness behaviors and mood as well as excessive gestational weight gain. They may therefore help describe whether the intervention’s targeted domains differed between groups at follow-up. They do not substitute for the primary weight endpoint, and they do not establish a pathway from changes in behavior or mood to weight. The record does not report mediation analyses or a combined outcome across these domains.

The secondary results are unadjusted comparisons. When several outcomes are examined, the chance of at least one apparently unusual result can increase, even if none reflects a reproducible group difference. A multiplicity adjustment or prespecified hierarchy can address this issue, but neither is reported in the registry record. The physical-activity finding should therefore be regarded as exploratory in the context of the full set of outcomes rather than as a standalone confirmation.

The registry lists depression, anxiety, and physical activity as secondary outcomes, and reports no analyses in the reported-analysis listings. The numeric comparisons are recalculated from the posted group summaries, not documented sponsor analyses. The record does not provide outcome instrument names, scale direction, clinically meaningful thresholds, or a prespecified analysis plan for these measures. Without that context, the magnitude and practical significance of the differences cannot be established from the posted means alone.

Overall, the secondary data suggest a stronger statistical signal for physical activity than for depression or anxiety, while uncertainty and multiplicity remain relevant. This broad pattern adds context to the short-term weight result but does not resolve its imprecision or support broader conclusions about longer-term health outcomes.

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

• Depression
• Anxiety
• Physical Activity

9. Statistical Interpretation

10. Statistical Methods Explained

The primary result is a comparison of means for a continuous outcome. The registry posts the number of participants, mean weight, and standard deviation in each group. The difference between the intervention and control means is reported as an unadjusted recalculation from those summaries; the registry record lists no reported analysis for the primary outcome.

What does a mean difference represent?

A mean difference expresses the separation between two group averages in the outcome’s original units. Here, that unit is pounds. A positive estimate means the intervention-group mean is higher than the control-group mean; a negative estimate means it is lower. The estimate describes the groups as posted. Without an adjusted model or change-from-baseline analysis, it does not account for other variables or the participants’ starting values.

The group standard deviations describe variation among participant measurements within each group. They are not standard errors and do not directly show how precisely the group mean has been estimated. Standard errors quantify sampling uncertainty in an estimate, while standard deviations characterize individual variation. The posted comparison also includes standard errors for each group mean, but the record does not report a complete analysis model or an analysis population definition.

How should the interval be read?

A confidence interval gives a range of values compatible with the data under the procedure used to construct it. In general, a narrower interval indicates greater precision, while a wider interval indicates more uncertainty. The reported interval for the weight mean difference extends from -18.47 to 19.67 pounds. Because it crosses zero, the data do not clearly distinguish a positive group difference from a negative one at the interval’s stated level. The confidence level and detailed interval-construction method are not reported in the registry record, so no coverage level should be inferred from the posted endpoints alone.

An interval should be considered alongside the point estimate rather than as a separate verdict. The point estimate is 0.6 pounds, but plausible values represented by the interval cover a broad range around it. Thus, the small observed separation does not guarantee that the true group difference is small. Conversely, the interval does not establish that a large difference occurred; it expresses uncertainty about the estimate.

What does the p-value contribute?

The unadjusted p-value for the primary comparison is 0.951. In general, a p-value describes how unusual data at least as discrepant as those observed would be under a specified null model. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of a difference. Its interpretation depends on the model and analysis procedure. Because the registry record does not post a sponsor-reported primary analysis or detailed model specification, the displayed p-value belongs to the unadjusted recalculation rather than a fully documented trial analysis.

A large p-value does not prove that two groups are identical. A finding of no clear statistical separation can occur when the true difference is small, when the data are variable, or when precision is limited. The confidence interval is useful for seeing this uncertainty in the outcome’s units. In this trial, the interval’s breadth is an important part of the result, not merely an accessory to the p-value.

Why do allocation and masking matter?

Random allocation is intended to make the groups comparable, on average, with respect to measured and unmeasured factors at the time of assignment. It does not guarantee exact balance in a small study. The registry identifies the design as randomized and parallel, but the sequence-generation and concealment details are not reported in the registry record. Masking is listed as none. Knowledge of assignment can sometimes affect behavior, intervention delivery, or measurement, although the record does not establish whether any such influence occurred. It also does not say whether outcome assessors or analysts were masked.

General statistical principle: randomization supports a between-group comparison, but the credibility of an estimate also depends on implementation, outcome measurement, missing data, and the analysis plan. Those details are incomplete in this record. They should not be filled in by assuming a conventional protocol.

Why does variation matter?

General statistical principle: greater variability makes group means harder to estimate precisely when sample size is fixed. The weight standard deviations are large relative to the observed mean separation, and the interval is correspondingly broad. This helps explain why a near-zero point estimate can coexist with substantial uncertainty. The standard deviations describe the observed groups; they are not evidence by themselves that the treatment caused or did not cause the variation.

All comparisons should also be understood as unadjusted. The record does not report covariate adjustment, a repeated-measures model, imputation, or another method for handling missing endpoint data. No statistical plan, interim analysis, or analysis-population definition is reported in the registry record. These omissions limit what can be inferred about the intended estimand and the robustness of the posted results.

11. Confidence Intervals and Precision

The primary mean-difference estimate is 0.6 pounds, with an interval from -18.47 to 19.67 pounds. The interval includes zero, so it is compatible with no group difference, as well as with weight being higher in either group. Its width indicates that the estimate is imprecise relative to the small observed separation between the group means.

A confidence interval is a range generated by a statistical procedure to represent uncertainty in an estimate. In general, if the same procedure were repeated across comparable studies, intervals would vary because each study’s data vary. The interval is not a list of outcomes for individual participants, nor does it mean that every value within it is equally likely. The confidence level and construction method for the posted interval are not reported in the registry record.

The posted standard deviations, 29.9 pounds in the intervention group and 37.6 pounds in the control group, describe substantial spread in participant weights. The outcome-specific group sizes are 25 and 24. With those group counts and the observed spread, the group means remain uncertain; the interval communicates that uncertainty in pounds. The primary p-value of 0.951 is consistent with the interval including zero, but it does not make the interval narrow or establish that the groups are equivalent.

Precision is distinct from whether a result is important. The endpoint is average weight at 12 weeks post-baseline, and the record gives no clinically meaningful difference threshold, equivalence margin, or decision threshold. Therefore, the interval can be described statistically, but its implications for clinical importance cannot be classified using a threshold absent from the registry record. The results also cannot be extended to baseline-to-follow-up weight change or later outcomes that were not posted.

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 illustrations translate observed effects into planning examples. For these continuous outcomes, the counts are participants per arm, not total events. Each row represents planning for a stated fraction of the observed effect, and the 80% and 90% power columns show the estimated participants per arm for detecting that effect under the listed assumptions. The figures are planning illustrations and are not the trial’s observed power.

The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. For example, the rows describe planning for 100%, 75%, or 50% of the observed effect; they do not establish which effect size is clinically important. The original trial’s own sample-size justification and design assumptions are not reported in the registry record.

In general, 80% power means that a study designed under those assumptions would have an 80% chance of detecting the specified effect if that effect were truly present, using the specified testing procedure. The 90% column represents a higher planned chance of detection under the same assumptions. Neither column is a guarantee that a future study will produce a statistically significant result, because actual results depend on the data and whether the assumptions hold.

Smaller effects are harder to distinguish from random variation and therefore require more participants. The illustrations accordingly show larger participant requirements when planning for a smaller fraction of the observed effect. These estimates use the observed effect as their starting point, which is uncertain in a small study; they should not be treated as a definitive design recommendation or as evidence that the trial was adequately powered for its original aims.

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 = 0.600; pooled standard deviation σ = 33.887.
2. n = 2 × (1.96 + 0.842)² × 33.887² / 0.600² = 50,073.9, rounded up to 50,074 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 <- 0.599999999999994                      # observed difference in means
sigma <- 33.8873980216961                     # 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(4294095)
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 = 50,074 (80% power), 67,035 (90% power)
 75% of observed effect: n per arm = 89,021 (80% power), 119,173 (90% power)
 50% of observed effect: n per arm = 200,296 (80% power), 268,140 (90% power)
power.t.test: 50074.9 
Simulated power at n = 50,074 per arm: 0.805 (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. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures in total: the primary weight measure and three secondary outcomes, depression, anxiety, and physical activity. Examining multiple outcomes creates a multiplicity issue. General statistical principle: as more hypotheses are tested, the likelihood of at least one apparently notable result can rise even when the underlying effects are absent. A prespecified testing sequence, adjustment procedure, or clear distinction between confirmatory and exploratory outcomes can help readers interpret a collection of results.

No multiplicity strategy is reported in the registry record. The posted comparisons are unadjusted, so their p-values should not be read as if they necessarily account for the family of outcomes. The physical-activity comparison is a notable unadjusted result, but its evidential weight is less secure when viewed among multiple outcomes without a documented plan. This does not imply that the finding is false; it means the registry record does not establish how the result was selected or how the overall testing burden was handled.

Missing-data methods are also not reported. The primary outcome summaries include 25 participants in the intervention group and 24 in the control group, while the registry records total enrollment of 68. The number of participants with each secondary outcome is also posted, but reasons for unavailable measurements and the methods used to handle missing observations are not described. It is therefore unclear whether missingness could have affected the group summaries or comparisons.

The record does not define an intention-to-treat, per-protocol, or other analysis population, and it does not report imputation, sensitivity analyses, or a missing-data model. These details matter because estimates can depend on which randomized participants are included and how missing outcomes are treated. No interim analysis, stopping rule, prespecified statistical analysis plan, or detailed outcome model is reported in the registry record. These omissions limit the ability to assess whether analyses followed a plan established before the results were known.

15. 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 1% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: miscarriage (4.0%).

The adverse-event figures are grouped by intervention and control. In the intervention group, 25 participants were listed as at risk for serious adverse events, and 1 was affected. In the control group, 24 were listed as at risk, and 0 were affected. The record lists no other adverse events in either group and no deaths in either group. The most frequent serious-event term is miscarriage, listed as 4.0%.

These figures describe what was posted for the study groups; they do not establish that an event was caused by the intervention or by control participation. The registry record does not provide event narratives, timing, severity beyond the serious-event classification, relatedness assessments, or a detailed definition of the safety population. The percentage for miscarriage is reported as 4.0%; its denominator and calculation details are not explained alongside the term.

Small group counts make safety comparisons descriptive. A count of zero in a group does not establish that the underlying risk is zero, and a count in one group does not by itself establish a between-group safety difference. No formal statistical safety comparison is reported in the registry record. The posted figures should be read as event counts and the listed term, with substantial limits on causal interpretation.

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

The primary result describes average weight at one follow-up point. The intervention-group mean was 162.9 pounds and the control-group mean was 162.3 pounds, with an unadjusted mean difference of 0.6 pounds. The interval from -18.47 to 19.67 pounds conveys substantial uncertainty around that estimate. These data do not identify a clear direction or precise size for a group difference in follow-up weight.

The result does not show whether participants gained more or less weight during pregnancy, because the registry record does not post baseline weight or a change-from-baseline analysis. It also does not classify participants according to excessive gestational weight gain or an Institute of Medicine guideline. The study’s summary describes excessive gestational weight gain as a motivating concern, but the posted primary endpoint is average weight at 12 weeks post-baseline.

The primary comparison cannot establish equivalence between the groups. Equivalence requires a prespecified acceptable range for differences and an analysis designed to test whether the interval lies within that range. Neither an equivalence margin nor a non-inferiority margin is reported in the registry record. A large p-value is not proof of no effect, and a small difference in group means is not proof that all meaningful differences have been ruled out.

Similarly, the secondary comparisons do not establish that changes in mood or physical activity caused, or would cause, differences in weight. The record does not report mediation analyses, long-term follow-up results, or child outcomes. The intervention was framed as a feasibility and sustainability effort intended to inform a future larger randomized trial, but findings on feasibility and sustainability are not posted in the results summarized by this record.

Accordingly, the posted evidence supports a narrow descriptive statement about the observed short-term group averages and their uncertainty. It does not support medical advice, a conclusion about individual participants, or a broad claim about effectiveness. Further interpretation would require fuller information on study conduct, missing data, analysis methods, and outcomes beyond the single follow-up measure.

17. Why This Trial Matters Statistically

This study illustrates a common statistical challenge in early-stage randomized research: the main estimate can be close to zero while remaining too imprecise to rule out a range of differences. The 0.6-pound mean difference is straightforward to state, but the interval from -18.47 to 19.67 pounds is essential context. Reporting the point estimate alone would conceal how uncertain the comparison is.

The study summary describes the project as an effort to examine feasibility and sustainability and to inform a future larger randomized trial. That context matters when interpreting the posted outcome data. A trial framed to prepare for later research may address a different purpose from a definitive evaluation of an intervention’s effects. Still, the registry record does not post specific feasibility outcomes, sustainability results, or a protocol-based sample-size justification, so the extent to which those aims were achieved cannot be assessed from the listed results.

The record also demonstrates why endpoint definitions matter. Average weight at 12 weeks post-baseline is not interchangeable with weight gain during pregnancy or excessive gestational weight gain. Matching the interpretation to the measured endpoint avoids claiming more than the data describe.

Finally, multiple outcomes and incomplete analysis details affect the strength of inference. The secondary findings may be useful for generating questions, but no multiplicity plan or reported analysis set is available in the registry record. The study therefore offers descriptive estimates and planning illustrations, while also showing why larger, well-specified studies need clear outcome definitions, analysis plans, and reporting of missing data.

18. 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 record constrain interpretation. The primary endpoint is a follow-up average rather than a reported change from baseline. No baseline weight summary, change score, or adjusted comparison is posted, so starting group values and weight trajectories cannot be evaluated from the reported endpoint alone. The endpoint also does not report the proportion meeting a definition of excessive gestational weight gain.

The registered enrollment is 68, while the summary describes a plan to recruit up to 100 participants. The primary outcome counts are 25 in the intervention group and 24 in the control group. Reasons for the difference between the enrollment figure and outcome-specific counts are not reported in the registry record. There is no description of missing outcomes, participant flow, or the population used for each analysis.

Descriptions of both study arms are incomplete: each ends before the activities after the initial materials are fully detailed. The randomization sequence and concealment procedures are not reported, and masking is listed as none. The record does not clarify whether outcome assessors or analysts were masked. These limits prevent a detailed assessment of implementation and potential sources of bias.

The comparison statistics are unadjusted recalculations from posted group summaries, and no sponsor-reported analyses are listed. The registry record does not report the original sample-size justification, analysis plan, outcome instrument details for the secondary measures, multiplicity handling, missing-data methods, or interim analyses. The planning illustrations are based on observed effects and do not replace a design justification tied to a prespecified, clinically meaningful effect.

Finally, the reported follow-up is short-term, and no longer-term maternal or child outcomes are posted. The record’s stated feasibility and sustainability aims are not accompanied by corresponding results in the posted outcome summaries. These limitations narrow the conclusions to descriptive short-term findings.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: My Baby My Move A Community Wellness Intervention — NCT04294095.
• Registry record last updated 2023-03-21; status last verified 2023-03.
• Results first posted 2023-03-21.
• 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.

22. Record Summary

NCT04294095 is a completed randomized, parallel-group study of My Baby My Move A Community Wellness Intervention, sponsored by the University of Colorado, Denver. The registry lists enrollment of 68, no masking, and a primary outcome of average weight in pounds at 12 weeks post-baseline. The posted primary group means are 162.9 pounds for the intervention group and 162.3 pounds for the control group.

The unadjusted mean difference recalculated from the group summaries is 0.6 pounds, with an interval from -18.47 to 19.67 pounds and an unadjusted p-value of 0.951. The interval is broad and includes zero. Depression, anxiety, and physical activity are listed as secondary outcomes; the comparisons are unadjusted and no reported analyses are listed. The record does not report the trial’s original sample-size justification, detailed statistical plan, or methods for missing data and multiplicity.