Predicting Adherence to a Heart-Healthy Diet in Lean and Obese Individuals: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Predicting Adherence to a Heart-Healthy Diet in Lean and Obese Individuals (NCT01862796), a randomized na study. The primary outcome is Adherence Score.

2. Clinical Question

The study addresses whether diet adherence differs across weight groups and whether adherence in an underfeeding context differs from adherence to a weight-maintaining diet. The registry's stated objectives also include understanding factors that affect adherence and collecting information for future studies. However, the posted primary outcome is a group-level adherence score, not an analysis identifying predictors or explaining why individuals adhered differently.

The registry lists three groups: obese underfeeding, obese weight maintaining, and lean weight maintaining. This arrangement allows an observed comparison between two diets among obese participants and a separate comparison between obese underfeeding and lean weight maintenance. It does not provide a direct comparison of lean and obese participants under the same assigned diet in the posted pairwise contrasts. As a result, differences between groups cannot be attributed solely to body weight, diet assignment, or weight-loss context from these comparisons alone.

The registry reports an average adherence score for each group over six weeks. It does not report analyses of the seven component measures separately, nor does it report results for individual-level adherence predictors. Those details are not reported in the registry record. The primary statistical question that can be addressed from the posted results is therefore narrower than the broader objective: whether the observed group averages differed, and how uncertain those differences are.

3. Trial Design

The registry describes a randomized, parallel-group study with no masking. It lists an enrollment of 100 and a completed status. The study start date is 2013-05-31, and primary completion is recorded as 2018-05-22. Phase is listed as not applicable. The sponsor is the National Institute of Diabetes and Digestive and Kidney Diseases.

Participants were assigned to one of three groups in the posted results: obese underfeeding, obese weight maintaining, or lean weight maintaining. The underfeeding arm description specifies a 35% calorie-reduced diet for obese participants. The weight-maintaining arms are described as a weight-maintaining diet for obese participants and a diet matched to weight-maintaining energy needs for lean participants. The brief summary describes a six-week diet period. The registry does not report further details about how randomization was generated, how allocation was concealed, or whether assignment was stratified.

The posted primary endpoint includes 19 participants in the obese underfeeding group, 18 in the obese weight-maintaining group, and 23 in the lean weight-maintaining group. The registry's overall enrollment is 100, while the reason these arm-level endpoint counts do not account for the full enrollment is not reported in the registry record. The analysis population and the handling of participants without endpoint data are also not reported.

The trial collected information on diet adherence and listed change in weight from baseline to six weeks as a secondary outcome. The registry describes screening and assessment activities, including physical examination, medical history, blood and urine collection, body-composition scanning, and questionnaires on eating behaviors, mood, and desire to change eating patterns. Results for these assessments, apart from the posted endpoints, are not reported in the registry record. The registry does not report the original statistical analysis plan, sample-size justification, interim analyses, or details of the diet-delivery protocol beyond the arm descriptions.

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: 100 participants were assessed for eligibility, 30 were ineligible and 9 did not complete the run-in phase. Sixty-one were assigned to groups.

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 Adherence Score, measured over Average over 6 weeks.

The primary endpoint is an adherence score averaged over six weeks. The registry describes a weekly score based on seven measures of participation and adherence, with each measure scored so that a higher score indicates better adherence. The measures cover attendance, food diaries, interviewer-administered 24-hour food recalls, a computer survey, ecological momentary assessment, and arriving on time for a session. The final endpoint is the average of the six weekly scores.

The weekly score is described as the sum of the seven measurements divided by 21, the maximum score, and its range is 0 for no adherence to 1 for perfect adherence. Component scoring ranges differ: attendance is scored from 0 to 2, food diaries from 0 to 3, each listed 24-hour recall from 0 to 3, the computer survey from 0 to 3, ecological momentary assessment from 0 to 6, and on-time arrival from 0 to 1. The endpoint therefore combines several observable aspects of participation and diet monitoring rather than measuring food intake alone.

A composite score can be useful when adherence has multiple dimensions and no single measure captures the whole behavior of interest. It provides a common summary for comparing the three groups. At the same time, a group average can conceal variation among participants and differences among the score's components. The posted results do not show which components contributed most to the overall average, or whether component-level patterns varied between groups. The registry also does not report validation information for this score or a threshold defining a meaningful difference.

7. Results Posted in the Registry

• Obese Weight Maintaining (WMEN): mean 0.54 versus 0.57 on control; difference -0.03 (95% CI -0.14 to 0.08), standardized effect d = -0.17; z-test p = 0.603.
• Lean Weight Maintaining (WMEN): mean 0.59 versus 0.57 on control; difference 0.02 (95% CI -0.07 to 0.11), standardized effect d = 0.15; z-test p = 0.651.

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.

Change in Weight From Baseline to 6 Weeks

• 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:
  • Obese Weight Maintaining (WMEN): mean -1.64 versus -3.14 on control; difference 1.50 (95% CI -0.17 to 3.17), standardized effect d = 0.58; z-test p = 0.078.
  • Lean Weight Maintaining (WMEN): mean -0.54 versus -3.14 on control; difference 2.60 (95% CI 1.21 to 3.99), standardized effect d = 1.20; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Obese Weight Maintaining (WMEN) and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Lean Weight Maintaining (WMEN) than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change in weight from baseline to six weeks is the posted secondary outcome. Across its three arms, the reported means describe different weight-change patterns, while the primary endpoint describes adherence behavior. These outcomes address related but distinct questions: a dietary assignment and the observed weight change are not interchangeable with the degree to which participants followed or engaged with the diet procedures.

The secondary comparisons use the obese underfeeding group as the reference. The overall pattern can provide context for how the assigned groups differed on a measure related to the intervention, but it does not establish that weight change explains the adherence results. The registry does not report a mediation analysis, an association between individual adherence scores and weight change, or a joint model of the two endpoints. Such analyses are not reported in the registry record.

The secondary results should be interpreted more cautiously than a single prespecified primary comparison because multiple outcomes or contrasts create more opportunities for apparently notable results. The secondary p-values are unadjusted, and the registry does not report a multiplicity strategy, a hierarchy of secondary hypotheses, or which secondary analyses were prespecified. A nominal p-value therefore does not, by itself, establish a confirmatory finding.

The secondary endpoint also cannot resolve the main interpretive limits of the primary result. Weight change does not reveal which adherence components varied, whether adherence predictors differed by group, or whether the group averages represent similar individual patterns. The registry lists one secondary outcome, but details of any additional exploratory analyses are not reported. The secondary evidence is best viewed as complementary descriptive context, not as a replacement for the primary adherence comparison or as proof of a mechanism.

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

• Change in Weight From Baseline to 6 Weeks

9. Statistical Interpretation

10. Statistical Methods Explained

What does a mean difference represent?

A mean difference expresses how far apart two group averages are, with the direction determined by which group is subtracted from which. For the primary comparisons, obese underfeeding is the reference group. A negative estimate for obese weight maintenance means that its observed average score was lower than the reference average; a positive estimate for lean weight maintenance means that its observed average was higher. The magnitude is expressed on the adherence score's scale. A mean difference is a summary of group averages, not a statement about every participant.

Means are useful for continuous outcomes because they retain information about the observed scale and allow a direct comparison of average levels. They do not, by themselves, describe the full distribution. Participants within a group may have similar scores or very different scores, and the same group mean can arise from different patterns of individual values. The posted standard deviations give a measure of spread around each group mean, but individual observations and distributional plots are not reported in the registry record.

How should the standard deviation be understood?

A standard deviation describes how dispersed individual scores are around their group mean. It is not the uncertainty in the mean itself: uncertainty in a mean also depends on the number of participants contributing data. For the primary endpoint, the reported standard deviations are 0.17 for obese underfeeding, 0.18 for obese weight maintenance, and 0.1 for lean weight maintenance. The endpoint is bounded from 0 to 1, so the observed values sit on a finite scale. The registry does not report whether the score distributions were assessed for skewness, clustering near either boundary, or other features that could affect a model-based analysis.

The comparison calculations use pooled standard deviations and an unadjusted mean-difference approach. Pooling represents a common estimate of within-group variability for the two groups in a contrast. Such an approach is generally most defensible when the groups have reasonably comparable variability and the analysis assumptions are appropriate. The registry does not report a formal assumption assessment or an adjusted model. The summary data show different standard deviations across the three primary groups, but the registry does not provide enough information to determine the implications for a different model.

What does a confidence interval add?

A confidence interval expresses the uncertainty around an estimated difference using the observed data and a statistical procedure. It conveys a range of values reasonably compatible with the data under that procedure; it is not a guarantee that the true difference lies within the particular interval. The intervals for both primary contrasts include zero, so the posted summaries do not distinguish the observed differences from no difference at conventional levels using these unadjusted calculations. The widths also show that the estimates are not precise enough to rule out all differences of potential interest. The registry does not identify a threshold for clinical or behavioral importance.

What does an unadjusted p-value say?

A p-value evaluates how compatible the observed data are with a specified null model, assuming that model and the analysis conditions hold. It is not the probability that the null hypothesis is true, nor does it measure the size or importance of a difference. The posted primary p-values are unadjusted, meaning they do not account for multiple comparisons or other covariates. A value that does not fall below a conventional threshold cannot establish equality; interpretation also requires the estimate, interval, design, and quality of the data.

Random allocation can help balance measured and unmeasured characteristics on average across groups, but it does not guarantee balance in a study of this size. The registry does not report baseline comparisons or adjusted analyses for the primary endpoint. It also does not report whether all randomized participants were included according to their assigned group, or whether another analysis population was used. These omissions limit assessment of how the reported summaries relate to the randomized design.

Why can over-dispersion matter?

Over-dispersion is a general statistical concern when observed variation is greater than a model assumes. A model that understates variability can produce confidence intervals that are too narrow and p-values that are too small. Conversely, an analysis that accounts for greater variation may yield wider uncertainty. This is a general explanation, not a finding about this trial. The registry does not report a model-based diagnostic or a claim of over-dispersion. Because the endpoint is a bounded composite score, its distribution and variability are relevant to selecting and checking an analysis, but the available registry record does not document those checks.

Similarly, repeated weekly adherence measurements could in general be analyzed to account for within-participant correlation and time patterns. The posted primary result is an average over six weeks, and the registry does not report a longitudinal model or weekly results. An average can be a reasonable prespecified summary, but it cannot reveal whether group patterns changed over time. No conclusion about time trends or week-to-week variability is available from the posted primary endpoint alone.

Overall, the estimates, standard deviations, confidence intervals, and p-values provide a compact description of group-level adherence and uncertainty. They do not establish equivalence, identify causal mechanisms, or replace details of the prespecified analysis. The analysis plan, missing-data procedures, model diagnostics, and analysis populations are not reported in the registry record.

11. Confidence Intervals and Precision

The primary comparison of obese weight maintenance with obese underfeeding has an estimated mean difference of -0.03 and a 95% confidence interval from -0.143 to 0.083. The interval includes zero and spans values that would correspond to lower or higher average adherence in the weight-maintaining group. The data therefore do not pin down the direction of the difference with high precision.

For lean weight maintenance compared with obese underfeeding, the estimated mean difference is 0.02, with a 95% confidence interval from -0.067 to 0.107. This interval also includes zero and permits effects in either direction. The estimate is close to zero, but the interval is the more informative description of uncertainty: it indicates that a range of differences remains compatible with the posted data and calculation.

A confidence interval's width reflects both variability and the amount of information available. The primary endpoint groups include 19, 18, and 23 participants, respectively, and the standard deviations are 0.17, 0.18, and 0.1. The intervals should not be read as evidence that the groups are identical merely because zero is included. A claim of equivalence would require an appropriately designed analysis and a prespecified margin, neither of which is reported in the registry record.

These intervals are unadjusted recalculations from the arm-level summaries. They do not account for multiplicity, covariates, or missing-data procedures that may have been part of an analysis not included in the registry record. No clinically or behaviorally meaningful difference threshold is reported, so the importance of values within either interval cannot be judged from the registry results alone.

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 planning figures are participants per arm for the continuous-outcome comparisons, not total events. The accompanying planning illustration uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It considers effects equal to 100%, 75%, or 50% of the observed effect. The original trial's own design assumptions and sample-size justification are not reported in the registry record.

The 80% power column gives the number of participants per arm estimated to yield an 80% chance of detecting the specified effect under those planning assumptions, if that effect is the true effect and the assumptions hold. The 90% power column uses the corresponding target of a 90% chance. These are prospective design illustrations, not descriptions of the trial's achieved ability to detect an effect. This is not observed power.

Each comparison has its own planning figures because its observed mean difference and variability differ. The percentage labels refer to the fraction of that comparison's observed effect used as the assumed effect to detect. Planning for 75% or 50% of the observed effect means targeting a smaller difference than planning for the full observed effect. Smaller effects require more participants to detect under otherwise unchanged assumptions.

The figures are sensitive to the observed effect used as their starting point. An effect estimated from a small study can be uncertain, so these illustrations should not be treated as a definitive design recommendation. They also do not incorporate adjustments for missing observations, multiple comparisons, covariates, or other design features unless those are explicitly included in the stated assumptions. The registry record does not report whether such considerations informed the original study design.

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 = -0.030; pooled standard deviation σ = 0.175.
2. n = 2 × (1.96 + 0.842)² × 0.175² / -0.030² = 533.7, rounded up to 534 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 <- -0.0299999999999999                      # observed difference in means
sigma <- 0.174928556845359                     # 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(1862796)
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 = 534 (80% power), 715 (90% power)
 75% of observed effect: n per arm = 949 (80% power), 1,271 (90% power)
 50% of observed effect: n per arm = 2,135 (80% power), 2,859 (90% power)
power.t.test: 534.7 
Simulated power at n = 534 per arm: 0.795 (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 primary endpoint has two posted pairwise comparisons, each using obese underfeeding as the reference. The registry does not report whether these comparisons were prespecified as co-primary hypotheses, whether one was designated as the principal contrast, or whether a multiplicity adjustment was planned. The recalculated p-values are unadjusted. When multiple contrasts are examined, the chance of at least one apparently unusual result can increase; a prespecified testing strategy helps clarify how evidence should be judged. No such strategy is reported in the registry record.

The registry does not report the full statistical analysis plan, any interim analyses, or whether analyses were selected after examining the data. It lists no reported analyses for the primary endpoint and no reported analyses for the secondary endpoint, despite posting group summaries and recalculated comparisons. The relationship between any sponsor-conducted analysis and the posted summary calculations is not described in the registry record.

Missing-data handling is not reported. The record does not explain whether all randomized participants contributed to the endpoint, how missing weekly scores were treated when calculating an average, or whether any imputation or sensitivity analysis was used. The primary endpoint arm counts are smaller than the registry's enrollment figure, but the reason is not reported; no specific explanation for this difference can be inferred.

The analysis population is also not reported. It is unknown from the registry record whether the endpoint summaries reflect all randomized participants, participants who completed the diet period, or another defined group. Baseline adjustment, covariate selection, adherence to assigned diet, protocol deviations, and model diagnostics are not described. These omissions matter because they affect both reproducibility and the interpretation of estimates from a randomized trial.

These gaps do not invalidate the descriptive results, but they limit the ability to assess whether the displayed comparisons follow a prespecified confirmatory plan. The confidence intervals and p-values should consequently be read as unadjusted summaries of the posted arm-level data, rather than as a complete account of all planned analyses.

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 0% reporting threshold.

The registry reports zero serious adverse events and zero deaths in each of the three groups. The serious-event figures are listed for 19 participants at risk in obese underfeeding, 18 in obese weight maintenance, and 23 in lean weight maintenance. The registry also reports zero other adverse events in the corresponding groups, with the same numbers listed at risk.

These entries describe what was recorded in the registry for the participants counted at risk; they do not establish that no event of any kind occurred outside the registry's definitions or reporting period. The registry record does not provide event descriptions, severity grading beyond the serious-event category, reasons for discontinuation, or a detailed adverse-event collection procedure. No serious-event terms are listed.

Safety figures should be interpreted in the context of the reported group sizes and the study period. A zero count in a group does not establish that an event is impossible or that two diets have equivalent safety. The record does not report a formal between-group safety comparison, and these descriptive counts do not provide evidence for such a comparison on their own.

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

The posted primary results show similar group averages in the sense that the two unadjusted estimated differences are close to zero, and both confidence intervals include zero. They do not establish that adherence was identical across the groups. The intervals retain uncertainty about the direction and size of the differences, and no equivalence margin is reported.

The results concern a composite adherence score averaged over six weeks in the particular groups and diet contexts described. They do not directly answer whether lean and obese individuals would adhere differently when assigned the same diet, because the posted contrasts do not include that direct comparison. Nor do they show that weight status itself caused any observed difference, since the lean-versus-obese contrast also differs in diet context.

The registry's broader objective includes identifying factors that affect adherence. The posted primary outcome summaries do not identify individual predictors, explain the reasons for adherence, or show which component of the composite score drove the group averages. The registry does not report results for the eating behavior, mood, or motivation measures described in the study summary.

The secondary weight-change outcome gives additional information about the groups over the six-week period, but it is not a direct measure of adherence and does not demonstrate that adherence caused weight change. No individual-level association or causal pathway analysis is reported. The study also does not establish how behavior might persist after the diet period, because follow-up results are not reported in the registry record.

These results are statistical descriptions, not individual guidance. Their interpretation is bounded by the available endpoint summaries, the unadjusted nature of the posted comparisons, and the lack of reported analysis-plan and missing-data details. They do not establish effectiveness or lack of effectiveness of a diet, and they should not be extended to populations or settings not described by the record.

17. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between adherence as a behavior and weight change as a downstream outcome. A composite adherence measure can capture multiple forms of engagement, but a group mean can hide which parts of the process differ. The study illustrates why endpoint definition matters: a score that combines attendance, records, recalls, surveys, and session timing answers a broader question than any single component would.

The three-group arrangement also makes the meaning of each comparison important. Comparing the two obese groups addresses different diet assignments within the obese group, while comparing lean weight maintenance with obese underfeeding changes both the participant group and the diet context. A reader must distinguish the estimand represented by each contrast rather than treating all pairwise comparisons as interchangeable evidence about body weight or adherence.

The primary confidence intervals show why a non-significant result is not the same as proof of no difference. The intervals include zero, yet also allow differences in either direction. Reporting estimates and intervals alongside p-values makes that uncertainty visible. It also helps readers see why conclusions about equivalence require a design and analysis directed at a meaningful margin.

The registry record further demonstrates the importance of transparent reporting. Without a statistical analysis plan, population definition, missing-data approach, or multiplicity strategy, it is harder to know how the posted summaries relate to the intended confirmatory analyses. The posted recalculations remain informative descriptions, but their scope should be kept distinct from analyses that the registry does not report.

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.

The primary endpoint arm counts are 19, 18, and 23, while the registry lists enrollment of 100. The record does not explain the relationship between the enrollment figure and the endpoint counts, so the extent or causes of missing endpoint data cannot be determined from the record. Missing-data methods and the analysis population are not reported.

The registry posts only a six-week average for adherence. It does not report weekly values, component-level scores, or individual predictor analyses, despite the study's stated interest in factors that affect adherence. The composite measure therefore limits assessment of whether the groups differed in specific behaviors or whether patterns changed during the intervention.

The group structure limits separation of body-weight group and diet context. In the posted primary contrasts, the obese underfeeding group is compared with obese weight maintenance and lean weight maintenance. There is no posted direct lean-versus-obese comparison under the same diet assignment. The registry also does not report baseline characteristics or adjustment for possible imbalances.

The two primary comparisons are unadjusted recalculations, and the registry does not report a multiplicity plan, a full analysis plan, an interim-analysis plan, or model diagnostics. It also does not report an equivalence margin or a threshold for a meaningful difference in adherence. These omissions restrict claims about confirmatory inference and practical importance.

Finally, the posted primary result covers a six-week intervention period. Longer-term adherence and follow-up are not reported in the registry record. The record's brief summary is incomplete, and details beyond the listed arm descriptions are not reported. Generalizability beyond the described participants, diets, and study setting cannot be assessed from the posted results alone.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Predicting Adherence to a Heart-Healthy Diet in Lean and Obese Individuals — NCT01862796.
• Registry record last updated 2019-08-15; status last verified 2018-05-22.
• Results first posted 2019-08-15.
• 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

NCT01862796 is a completed randomized, parallel-group study with no masking and a listed enrollment of 100. It compared obese participants assigned to an underfeeding diet, obese participants assigned to weight maintenance, and lean participants assigned to weight maintenance. The primary outcome was a composite adherence score averaged over six weeks.

Mean adherence scores were 0.57, 0.54, and 0.59 across the three groups. The two unadjusted recalculated comparisons with obese underfeeding had confidence intervals that included zero. The registry also lists change in weight from baseline to six weeks as a secondary outcome and reports zero serious adverse events and zero deaths in each group.

The registry does not report the original statistical analysis plan, sample-size justification, missing-data handling, analysis population, or multiplicity strategy. The posted primary comparisons are recalculated from arm-level summaries rather than reported sponsor analyses.