Eating Mindfully to Prevent Weight Regain: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Eating Mindfully to Prevent Weight Regain (NCT04847843), a randomized na study. The primary outcome is Changes in Body Weight.

2. Clinical Question

3. Trial Design

The registry lists a randomized, double-masked, parallel-group behavioral study. The interventions were MORE and a control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program; each is described as an 8-week intervention. The study is marked completed. Its listed start date is 2021-06-16, and its primary completion date is 2023-05-08. The phase is listed as NA, and the sponsor is the University of Utah.

The registry gives enrollment as 48. That enrollment figure is not the same as the number of observations in the posted primary outcome summaries: the MORE summary lists n = 11, and the control summary lists n = 9. The reason for this difference is not reported in the registry record. The record does not describe whether these outcome counts reflect missing follow-up measurements, exclusions, a particular analysis population, or another reason, so none should be assumed.

The primary outcome is titled Changes in Body Weight and is measured in kilograms. The registry identifies the statistic as a mean with standard deviation and gives the timeframe as baseline and 6 month follow up. Its description refers to body weight measured using a calibrated digital scale and defines the outcome as follow-up weight minus baseline weight. It also says that measurements were taken at three time points, while naming baseline and 6 month follow up. The specific timing of any additional measurement is not reported in the registry record.

The record lists five secondary outcomes: Ways of Savoring Checklist, dietary restraint, dietary disinhibition, interoceptive awareness, and hedonic hunger. It lists six outcome measures and five analyses. The descriptions, results, and analysis details for those secondary measures are not included in the record. The planned sample-size justification, randomization procedure, masking procedures, and other protocol 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.

Before assignment: Seven participants were withdrawn before assignment: 2 ineligible, 2 scheduling conflicts, 1 COVID exposure, 1 family tragedy, 1 unknown reason.

Overall Study

Reasons for not completing this period:

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 Changes in Body Weight, measured over Baseline and 6 month follow up.

The primary endpoint is change in body weight, expressed in kilograms, from baseline to 6 month follow up. The registry says weight was measured with a calibrated digital scale. It defines change as follow-up weight minus baseline weight, so a lower value represents greater weight loss. Under that definition, a positive mean change represents an average increase in weight over the interval, while a negative mean change represents an average decrease. This direction matters when interpreting the group summaries: the sign is not interchangeable with a measure defined as baseline minus follow-up.

Body weight is a continuous measure. Reporting its mean describes the average change in each group, while the standard deviation describes how spread out individual changes are around that group mean. These summaries do not by themselves show the adjusted between-group contrast from the regression analysis. Nor do they describe the uncertainty around that contrast; a confidence interval for the regression result is not reported in the registry record.

Using a defined weight-change endpoint allows the trial to compare average change across its randomized groups over the stated follow-up period. The record does not explain the rationale for choosing this endpoint, identify a clinically meaningful difference, or give further detail on how the endpoint was selected. It also contains an ambiguity about measurement timing: its timeframe names baseline and 6 month follow up, whereas the description refers to three time points but names only those two. The timing of any additional measurement is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the mean describe?

For a continuous outcome, the mean is the arithmetic average of the measured values in a group. Here, the values are changes in body weight, defined as follow-up weight minus baseline weight. The MORE group mean is 2.45 kilograms, and the control group mean is -3.78 kilograms. Because the endpoint is defined in that direction, lower values correspond to greater weight loss. A mean condenses the group data into a central summary; it does not show every participant's change or the shape of the distribution.

The standard deviation describes the spread of individual measurements around the group mean. The posted standard deviations are 1.02 for MORE and 1.2 for control. In general, a larger standard deviation indicates more variation around the mean, though the meaning of a spread measure depends on the distribution and data context. A standard deviation is not a confidence interval for the mean, and it does not quantify uncertainty in a between-group effect.

What does the regression test add?

The registry identifies linear regression as the method for the reported group comparison. In general, linear regression models a continuous outcome in relation to explanatory variables. In a randomized two-group setting, a model can estimate a group contrast, potentially with additional terms if specified. The registry record does not report the model equation, covariates, coding choices, assumptions checks, or the coefficient from the fitted model. It is therefore not possible to describe the reported regression as adjusted or unadjusted, or to infer which further modeling choices were used.

The reported p value is <0.001. A p value summarizes the compatibility of the data with a null hypothesis under a statistical model and its assumptions. It does not state the probability that the null hypothesis is true, does not measure the size of the group contrast, and does not establish practical importance. The record does not report the exact test statistic, degrees of freedom, or the precise null hypothesis, so interpretation should remain at the level of the reported regression p value.

Why is an estimate with a confidence interval useful?

An effect estimate would express the modeled difference between groups on the outcome scale. A confidence interval would convey the uncertainty around that estimate. In general, a confidence interval gives a range of values compatible with the data and the method at its stated confidence level; it is not a guarantee that the true value lies within that particular interval. The registry does not report a regression estimate or confidence interval for this comparison. The means alone cannot reproduce the reported model result, and no recalculated two-group estimate is available for this continuous endpoint.

That missing information matters because statistical significance and precision answer different questions. The reported p value addresses compatibility with a null model under the test assumptions. An estimate and interval would show the direction and scale of the modeled contrast and the range of uncertainty. Without them, the p value cannot tell readers whether the contrast is small or large on the kilogram scale, nor how tightly it was estimated.

What can a recalculation establish?

A simple unadjusted recalculation, when estimable, uses posted group summaries to produce a comparison without incorporating the sponsor's regression model. Such a calculation can serve as a check on the descriptive data, but it is not a substitute for the sponsor's planned analysis and may differ if the sponsor used covariates or other modeling choices. In this record, the two-arm continuous comparison is marked as not estimable because values are missing. Accordingly, there is no recalculated estimate or interval to interpret, and none should be inferred from the means.

How should the planning illustration be understood?

The record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. Such calculations are hypothetical planning exercises: they describe sample sizes under assumptions about a future study, rather than the actual performance of this completed trial. They are not observed power and do not show the probability that this trial detected an effect. The registry does not report the original design's sample-size justification or planning assumptions, so the illustration should not be mistaken for the trial's own design rationale.

In general, planning estimates depend on assumptions about the target effect, variability, allocation, and testing approach. Changing assumptions can change the estimated sample size. A planning calculation based on the observed result is especially distinct from a prospective design justification, because it uses an effect observed after data collection rather than an independently specified target. The record does not report the values for every planning row in the registry record, so no specific planning count can be stated.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Mindfulness Orientated Recovery Enhancement (MORE)", "Control Intervention")
n   <- c(11, 9)
m   <- c(2.45, -3.78)
sp  <- c(1.02, 1.2)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Mindfulness Orientated Recovery Enhancement (MORE)  11  2.450  1.020  1.765  3.135
CARM  Control Intervention  9  -3.780  1.200  -4.702  -2.858

11. Analyses Reported by the Sponsor

The registry reports the sponsor's primary comparison as linear regression, classified as a superiority analysis, with p < 0.001. It does not report the regression coefficient, confidence interval, covariate details, or additional model specifications. The posted means and standard deviations are descriptive summaries, not the sponsor's modeled effect estimate. Because the two-arm continuous comparison is marked as not estimable for recalculation, no independent unadjusted estimate is available to compare with the sponsor's analysis.

The record does not indicate a discrepancy between a recalculation and the sponsor's result. That does not resolve the interpretation limits created by the absent estimate and confidence interval: the size and precision of the modeled contrast remain unclear from the registry record. The p value reports the outcome of the sponsor's statistical test, but it cannot be used to reconstruct a coefficient or interval.

The group summaries should be interpreted using the endpoint's stated direction: follow-up weight minus baseline weight, with lower values indicating greater weight loss. The sponsor's test and the descriptive means answer related but not identical questions. The regression test is inferential, while the means describe the group averages. Without further model details, the record does not support a more specific reconciliation between them.

12. Multiplicity, Missing Data and Analysis Populations

The registry lists five secondary outcomes: Ways of Savoring Checklist, dietary restraint, dietary disinhibition, interoceptive awareness, and hedonic hunger. It also lists six outcome measures and five analyses. These counts alone do not establish which analyses correspond to which outcomes, which outcomes were prespecified as confirmatory, or whether the reported analyses represent all analyses conducted.

When several outcomes or statistical tests are considered, the chance of at least one small p value can increase. Statistical approaches to multiplicity can address that issue, but the registry record does not report whether a multiplicity procedure was used, how the primary and secondary outcomes were prioritized, or whether the primary result was tested within a broader family of hypotheses. The reported p value should therefore be read as recorded, without assuming an adjustment or assuming that none was used.

Missing-data handling is also not reported in the registry record. The posted primary outcome summaries list n = 11 for MORE and n = 9 for control, whereas enrollment is 48. The record does not explain this difference or state how missing follow-up measurements, if any, were handled. It does not report imputation, sensitivity analyses, or the assumptions used for any missing-data method. These methods cannot be inferred from the outcome counts.

The analysis population is not identified in the registry record. It does not state whether the primary analysis followed an intention-to-treat approach, included participants according to treatment received, or used another population definition. The randomization label describes the design, but it does not on its own establish how participants were handled in the analysis. Without the analysis-population definition and a missing-data account, the relation between the enrolled sample and the outcome summaries is uncertain. These omissions limit assessment of how robust the reported comparison is to missing outcomes and analytic choices.

13. 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.

The registry's adverse-event figures list zero participants affected by serious adverse events in the MORE group, with 19 at risk, and zero in the control group, with 22 at risk. It also lists zero participants affected by other adverse events in each group, with the same respective at-risk counts. Deaths are listed as zero in both groups. These are the registry's recorded figures; they do not provide detail about event type, timing, severity grading, or how adverse events were collected.

The safety at-risk counts differ from the primary outcome summary counts. The registry does not explain the relationship between these sets of counts, and they should not be treated as interchangeable denominators. In general, an observed count of zero does not establish that the underlying risk is zero. The amount of information available depends in part on the number at risk, the duration of observation, and the completeness of reporting. The record does not provide enough detail to assess those factors fully.

No serious adverse-event terms are listed among the top terms. The posted safety figures should therefore be read narrowly as reported counts of participants affected, not as a comprehensive account of safety or as evidence about outcomes beyond the recorded categories.

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

The posted data describe a randomized comparison of an 8-week mindfulness-based behavioral intervention with an 8-week behavioral control intervention, focused on preventing weight regain in weight-reduced adults. The primary outcome was change in body weight at 6 month follow up. The group means were 2.45 kilograms for MORE and -3.78 kilograms for control, with the endpoint defined as follow-up minus baseline and lower values indicating greater weight loss. The registry also reports a linear-regression p value of <0.001.

These results do not, on their own, provide a complete estimate of the between-group effect. The regression coefficient and confidence interval are not reported, and the available information does not permit a recalculated contrast. The p value does not show the magnitude of the modeled difference or its precision. The descriptive means indicate the group averages in the posted summaries, but they should not be substituted for the regression estimate.

The record does not report why the primary outcome counts are smaller than the enrollment figure, how missing outcomes were handled, or which analysis population was used. It also does not report multiplicity procedures, detailed model specifications, or a clinically meaningful threshold for weight change. These gaps constrain conclusions about the analysis and the extent to which its result depends on analytic choices.

The registry's zero recorded affected counts for serious and other adverse events and zero deaths are limited to the categories and at-risk counts reported. They do not establish that no unrecorded events occurred or characterize safety beyond the recorded information. The registry record also does not provide detail on adherence, intervention exposure, or the timing of any additional body-weight measurement mentioned in the outcome description.

Accordingly, the record supports a cautious statistical description: a small reported regression p value accompanies group summaries in the stated direction, but the modeled effect size and its uncertainty are unavailable. The trial record does not establish how broadly its results apply, and it does not supply enough methodological detail to settle questions about missing data, analysis populations, or multiplicity.

15. Why This Trial Matters Statistically

This trial is statistically informative because its registry record juxtaposes descriptive group summaries with an inferential result while omitting the regression estimate and confidence interval. That combination illustrates why a p value alone is an incomplete account of a treatment comparison. The p value conveys information about a test under its assumptions; the estimate and interval would communicate the scale and uncertainty of the modeled group contrast. Without those, the reported significance cannot be translated into a precise kilogram difference.

The endpoint definition also matters. Change is calculated as follow-up weight minus baseline weight, and lower values indicate greater weight loss. Reading the signs in the opposite direction would reverse the descriptive interpretation. Clear definition of the measurement direction is therefore essential when comparing group summaries, especially when one mean is positive and the other is negative.

The enrollment figure and posted outcome counts are not aligned, and the record does not explain why. This makes transparent reporting of analysis populations and missing-data procedures important for understanding who contributed to the result and how incomplete outcomes were treated. The lack of reported multiplicity information also illustrates why a list of secondary outcomes and analyses is not enough to assess how a primary p value fits within the full testing strategy.

Finally, the record distinguishes a completed trial's observed results from planning illustrations based on an observed effect. Planning calculations are conditional on assumptions and should not be read as observed power or as the original design rationale. Taken together, these features underscore the value of reporting estimates, uncertainty, analysis details, and participant flow alongside p values and outcome summaries.

16. 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 trial-specific details needed for a fuller statistical assessment are not reported in the registry record. The primary outcome summaries include n = 11 for MORE and n = 9 for control, while enrollment is 48; the reason for the difference is not stated. The analysis population, number of participants with available follow-up data, handling of missing outcomes, and any sensitivity analyses are not reported. Those omissions prevent a clear account of how the posted summaries relate to the enrolled sample.

The sponsor's regression result is reported only as a method label and p < 0.001. The coefficient, confidence interval, model specification, covariates, assumptions checks, and test details are not reported. The means and standard deviations cannot fill in those missing model results, and the registry marks the unadjusted two-group recalculation as not estimable. The magnitude and precision of the modeled comparison therefore remain unknown from this record.

The record lists secondary outcomes and analyses but does not describe the analysis plan, outcome hierarchy, or multiplicity handling. It does not state which analyses were prespecified or how the primary outcome was distinguished from other tests. The original sample-size justification is also not reported; the described planning illustration is based on the observed effect and is not the trial's own design rationale.

There is a timing ambiguity in the primary outcome description: it identifies baseline and 6 month follow up, but also says body weight was measured at three time points without naming the additional time point. The record does not provide further detail about measurement procedures beyond use of a calibrated digital scale. It also does not report adherence, intervention exposure, or detailed eligibility and participant characteristics. These limitations restrict assessment of the analysis, the endpoint's timing, and the context in which the results were obtained.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: Eating Mindfully to Prevent Weight Regain — NCT04847843.
• Registry record last updated 2025-11-25; status last verified 2025-11.
• Results first posted 2025-11-25.
• 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.

20. Record Summary

NCT04847843 is a completed, randomized, double-masked, parallel-group behavioral study sponsored by the University of Utah. It compares an 8-week Mindfulness Orientated Recovery Enhancement intervention adapted for preventing weight regain with an 8-week control intervention based on the Diabetes Prevention Program's Prevent T2 for Life program. Registry enrollment is 48. The study is listed as starting on 2021-06-16, with primary completion on 2023-05-08.

The primary outcome is change in body weight in kilograms, defined as follow-up minus baseline, with lower values indicating greater weight loss. At 6 month follow up, the posted summaries are 2.45 with standard deviation 1.02 for MORE and -3.78 with standard deviation 1.2 for control. The registry reports a linear-regression comparison with p < 0.001, but does not report its coefficient or confidence interval. The primary outcome counts, missing-data handling, analysis population, and multiplicity approach are not explained in the registry record.