The Mobile Lifestyle Intervention for Food and Exercise Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Mobile Lifestyle Intervention for Food and Exercise Study (NCT05176847), a randomized na study. The primary outcome is Change in Body Weight.

2. Clinical Question

The primary contrast is between two active digital interventions. That distinction matters: the result addresses whether adding social gaming and competition to mLIFE was associated with a different weight change, not whether mLIFE itself differed from usual care or from receiving no intervention. The registry describes a diverse cohort as an aim, but it does not report subgroup-specific outcomes in the posted results.

3. Trial Design

The registry describes a randomized, double-masked, parallel-group study. It is marked completed, with enrollment of 243. The record lists a start date of 2022-03-01 and a primary completion date of 2024-07-12. The posted arm counts are 121 for the Gamified mLIFE App Group and 122 for the Standard mLIFE App group.

Both groups received an mLIFE app intervention. The gamified group had social gaming and healthy competition features; the standard group received the same intervention without features that facilitated gaming or competition. Other behavioral intervention entries include podcasts and tips of the day, self-regulation features, and social-support features. The registry does not give a detailed account of how each component was delivered over time, how participants used the app, or how adherence was assessed.

The primary outcome was analyzed using repeated measures, and the registry says the intent-to-treat analysis included all participants. The reported primary comparison is identified as a mixed models analysis of mean difference in final values. The registry does not report the full model specification, including its covariates, covariance structure, or handling of departures from model assumptions.

The study description identifies a planned aim involving 240 adults with overweight or obesity and at least 3 type 2 diabetes risk factors. The enrolled number is 243, while the posted primary-arm counts are 121 and 122. The original sample-size justification, planned attrition allowance, randomization procedure details, allocation concealment method, and exact masking procedures are not reported in the registry record. No phase is applicable in the record.

Alongside change in body weight, the registry lists change in energy intake and change in weekly moderate to vigorous physical activity as secondary outcomes, each assessed at 12 months. The stated objective about social support is not accompanied by a posted social-support outcome result.

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: Eligible and interested participants were offered a choice of orientation session times. During the session, the study coordinator provided a comprehensive overview of the study, addressed participant questions, and obtained informed consent. Participants were guided in establishing Fitbit accounts, synchronizing physical activity and weight trackers, and completing baseline assessments. Those who successfully completed baseline procedures were subsequently randomized.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent-to-treat (ITT) analysis was conducted; primary and secondary outcomes were addressed using repeated measure. All participants were included in the analysis.

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 Change in Body Weight, measured over 12 months.

The primary endpoint is change in body weight at 12 months, measured as follow-up weight minus baseline weight and expressed in kilograms. Because of this direction convention, negative changes indicate weight loss, while positive changes indicate weight gain. The endpoint summarizes how weight changed over the follow-up interval; it does not, by itself, explain why an individual’s weight changed.

A continuous endpoint retains information about the size and direction of change rather than reducing each participant’s experience to a yes-or-no category. Comparing group means can therefore describe whether the groups had different average changes. The registry reports least-squares means and standard errors for each group, with a mixed-model comparison of mean difference in final values. A least-squares mean is a model-based estimate of a group average; its interpretation depends on the fitted model. The full model specification is not reported in the registry record.

Weight is relevant to the study’s stated purpose of examining sustained weight loss, and the 12-month assessment corresponds to the primary aim described in the record. However, a group-average change does not show the full distribution of individual responses, and it does not establish that every participant changed in the same direction. The registry record does not provide individual-level results or a separate measure of how many participants achieved a particular amount of weight change.

The endpoint is one part of the study’s broader behavioral question. The two posted secondary endpoints concern energy intake and weekly moderate to vigorous physical activity. Those measures may describe other aspects of behavior, but they do not replace the primary body-weight comparison or establish the pathway behind any observed weight change.

7. Results Posted in the Registry

• Gamified mLIFE App Group: mean -5.30 versus -3.49 on control; difference -1.81 (95% CI -3.70 to 0.08), standardized effect d = -0.24; z-test p = 0.060.

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 Energy Intake

• 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 errors.
• Result:
  • Gamified mLIFE App Group: mean -347.73 versus -257.42 on control; difference -90.31 (95% CI -345.44 to 164.82), standardized effect d = -0.09; z-test p = 0.488.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Gamified mLIFE App Group and the control. The interval gives the range of effects that remain compatible with the data.

Change in Weekly Moderate to Vigorous Physical Activity (MVPA)

• 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 errors.
• Result:
  • Gamified mLIFE App Group: mean -4.66 versus -3.50 on control; difference -1.16 (95% CI -68.21 to 65.89), standardized effect d = -0.00; z-test p = 0.973.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Gamified mLIFE App Group and the control. The interval gives the range of effects that remain compatible with the data.

The two posted secondary outcomes concern change in energy intake and change in weekly moderate to vigorous physical activity at 12 months. At the broad level, both comparisons are uncertain: neither recalculated interval rules out zero difference. Their estimates therefore do not provide clear evidence of a between-group distinction in these measures. The detailed endpoint estimates and intervals should be read on their own scales and not treated as interchangeable with the body-weight result.

This general pattern is consistent with the primary result in one important statistical respect: the posted estimates do not establish a clear difference between the app groups. It does not mean that the outcomes are identical, nor does it show that changes in energy intake or activity explain the weight estimates. Establishing relationships among these measures would require analyses of their joint patterns and the timing of changes, which are not reported in the registry record.

The study description also states an aim to examine differences in social-support provision and receipt, but results for that aim are not reported in the registry record. The absence of a posted result cannot be interpreted as evidence that the groups did or did not differ on social support.

Secondary results generally carry less weight than the primary result when they are not accompanied by a reported multiplicity strategy. Testing several outcomes creates more opportunities for apparently notable findings to occur by chance. The registry does not report an adjustment for multiple comparisons or a hierarchy for interpreting secondary outcomes. Accordingly, these outcomes are best treated as additional descriptive evidence rather than as independent confirmation of the primary result. Their interpretation should also account for uncertainty, the model and measurement details not reported in the record, and the fact that the study’s stated primary question centered on body-weight change.

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

• Change in Energy Intake
• Change in Weekly Moderate to Vigorous Physical Activity (MVPA)

9. Statistical Interpretation

10. Statistical Methods Explained

The registry’s primary result comes from a mixed models analysis of mean difference in final values. The primary outcome is continuous: it is measured in kilograms and summarized by a group mean. A model-based comparison estimates the difference between the groups while using the repeated-measures approach described in the record. The record says primary and secondary outcomes were addressed using repeated measures, but the model details needed to understand precisely how repeated observations were represented are not reported in the registry record.

What the mean difference represents

The mean difference compares the group-level changes, with the gamified group contrasted against the standard-app group. The estimated difference is -1.81 Kg. Given the outcome definition, a negative contrast points toward a greater average reduction in body weight in the gamified group. The contrast is an average, not a statement that every participant experienced that amount of change. It also does not identify which app component, if any, accounts for the difference.

The group estimates are least-squares means, which are model-based averages. These can differ from simple arithmetic averages when a model adjusts or accounts for other features of the data. The registry does not list the model covariates or other specifications, so the posted least-squares means should be understood as reported model estimates rather than independently reconstructed raw means.

What a standard error describes

The registry reports standard errors alongside the group least-squares means: 0.64 for the gamified group and 0.72 for the standard group. A standard error describes the statistical uncertainty around an estimated mean, not the spread of individual participants’ measurements. In general, smaller standard errors indicate more precise estimates, while larger standard errors indicate more uncertainty. They should not be read as ranges containing a fixed proportion of individual observations.

The recalculation uses posted summary statistics to form an unadjusted comparison. Its pooled standard deviation is approximate, and the recalculated interval and p-value do not reproduce every feature of a repeated-measures mixed model. The method is useful as a simple check on the scale and uncertainty of the posted contrast, but the sponsor’s reported model analysis remains the relevant result when the calculations differ. In this record, the reported and recalculated estimates are close, although their intervals and p-values are not identical.

How to understand the confidence interval

A confidence interval gives a range of values compatible with the estimate under the statistical model and its assumptions. In general, a 95% confidence procedure would include the true value in 95% of repeated samples if the model assumptions and procedure were appropriate. It is not a statement that there is a 95% probability that this particular interval contains the true difference. The reported 95% interval extends from -3.71 to 0.09 Kg. Since it crosses zero, it includes both a possible difference favoring a greater mean reduction in the gamified group and values that do not indicate a greater reduction in that group.

What the p-value adds

The reported p-value is 0.09. In general, a p-value measures how unusual data at least as incompatible with a specified no-difference model would be, assuming that model and the analysis assumptions hold. It is not the probability that the no-difference model is true, and it does not measure the size or practical importance of an effect. The recalculated unadjusted p-value is 0.06 and comes from a different, simpler calculation. Neither value should be interpreted without the estimated difference and its interval.

Why the analysis population matters

The record says an intent-to-treat analysis was conducted and all participants were included. In general, an intent-to-treat approach seeks to analyze participants in the groups to which they were assigned, preserving the comparison created by randomization. The record does not provide participant flow, the amount or pattern of missing outcome data, or details of how the mixed model handled missing observations. Those omissions limit assessment of how complete the analysis was and how sensitive it might be to missing-data assumptions.

Randomization supports a fair group comparison in principle, but it does not remove uncertainty from a finite study or address every concern about implementation and follow-up. Double masking is recorded, yet the roles that were masked and the procedures used to maintain masking are not reported. The registry also does not report checks of model assumptions, prespecified covariates, or sensitivity analyses. These details would help readers judge how robust the modeled estimate is.

11. Confidence Intervals and Precision

The registry reports a 95% confidence interval for the primary mean difference from -3.71 to 0.09 Kg. The point estimate is -1.81 Kg. The interval gives a sense of precision: it is not concentrated on one exact value, and it crosses zero. Values within the interval include a difference favoring a larger mean reduction in the gamified group, values close to no difference, and a small positive value. Thus, the estimate does not pin down the direction of the true group difference with high precision.

The recalculated interval from the posted summary statistics is -3.698 to 0.078 Kg. This unadjusted interval also crosses zero. Its endpoints differ slightly from the registry’s reported model-based interval, which is expected when a simple calculation from summaries is not the same procedure as the mixed-model analysis. The registry’s reported analysis should be used to describe the sponsor’s primary result; the recalculation is a supplementary approximation, not a replacement for the fitted model.

In general, an interval’s width reflects both the variability in the data and the amount of information available, together with the analysis method. A more precise estimate would have a narrower interval, while a less precise estimate would have a wider one. The posted interval allows a range of effects rather than identifying one exact treatment contrast. It cannot be used to infer the range of changes experienced by individual participants, which would require information about individual-level variability and outcome distributions.

The registry does not report a prespecified clinically meaningful difference for body weight. Therefore, the interval cannot be classified against a registry-defined threshold for importance. Precision and clinical importance are distinct: an estimate can be precise but small, or uncertain while including effects of differing magnitudes. The posted results support describing the estimate and its uncertainty, not a definitive conclusion about practical importance.

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. They are illustrations based on the observed effect, not the study’s original design calculation. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each row considers an effect to detect equal to the stated fraction of the observed effect. The original design assumptions and sample-size justification are not reported in the registry record.

The 80% power column describes the number of participants per arm that the planning calculation estimates would be needed for an 80% chance of detecting the specified effect under those assumptions, if that effect were the true one. The 90% power column gives the corresponding planning number for a 90% chance. These are prospective planning concepts; they do not describe the probability that this completed study found a true effect.

For the primary outcome, the planning illustrations use the observed contrast and smaller fractions of that contrast. The entries for 100% of the observed effect are 271 participants per arm for 80% power and 362 participants per arm for 90% power. Planning for 75% of the observed effect gives 481 participants per arm for 80% power and 644 participants per arm for 90% power. Planning for 50% gives 1,082 participants per arm for 80% power and 1,448 participants per arm for 90% power. The same display reports separate figures for the secondary outcomes.

Smaller effects are harder to distinguish from random variation, so planning for a smaller effect requires more participants under the same assumptions. These figures are not observed power: they are planning illustrations derived from the observed effect and do not measure the probability that the completed trial detected an effect.

13. How the Sample Size Is Derived

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

Formula

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

Worked calculation for this trial

1. Observed difference Δ = -1.810; pooled standard deviation σ = 7.512.
2. n = 2 × (1.96 + 0.842)² × 7.512² / -1.810² = 270.4, rounded up to 271 participants per arm for 80% power.

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

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -1.81                      # observed difference in means
sigma <- 7.51209613767973                     # 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(5176847)
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 = 271 (80% power), 362 (90% power)
 75% of observed effect: n per arm = 481 (80% power), 644 (90% power)
 50% of observed effect: n per arm = 1,082 (80% power), 1,448 (90% power)
power.t.test: 271.4 
Simulated power at n = 271 per arm: 0.802 (20000 replicates)

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

14. Analyses Reported by the Sponsor

The registry’s reported primary analysis is a mixed models analysis of mean difference in final values. It estimates a difference of -1.81 Kg, with a 95% confidence interval from -3.71 to 0.09 and p = 0.09. This is the sponsor’s reported model-based result and is the appropriate result to cite when describing the analysis recorded for the trial.

The recalculation from the posted summary statistics also gives a mean difference of -1.81 Kg, but its unadjusted confidence interval is -3.698 to 0.078 and its p-value is 0.06. This calculation does not use the full mixed-model analysis; it is an approximate, unadjusted check based on the posted group summaries. Small differences in interval limits and p-values can arise because the methods and assumptions differ.

The record does not provide enough detail about the mixed model to reproduce the sponsor’s result independently. The recalculated values should therefore not be presented as a correction to the reported analysis. Both sets of results indicate uncertainty around the estimated group difference, and both intervals include zero. The sponsor’s own analysis takes precedence if a discrepancy is present; the registry record does not flag a discrepancy in this case.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies change in body weight as the primary outcome and lists change in energy intake and change in weekly moderate to vigorous physical activity as secondary outcomes. The study description also includes a social-support aim, but corresponding results are not reported in the registry record. The record does not state whether a formal hierarchy was used to test the outcomes or whether any multiplicity adjustment was planned or applied.

Multiplicity matters because interpreting several statistical tests separately can make at least one result appear notable by chance more often than interpreting a single prespecified test. In general, methods that account for multiple comparisons change how evidence across a group of tests is assessed. Without a reported strategy, the secondary p-values should be regarded as unadjusted and exploratory in context, rather than as a set of confirmatory tests. The primary outcome remains the clearest focus of the stated trial question, but the registry does not provide a complete statistical analysis plan with which to assess prespecification.

The record says the analysis was intent-to-treat and included all participants. It also says primary and secondary outcomes were addressed using repeated measures. However, participant flow, the number with outcome data at each assessment, missingness patterns, and the method used to handle missing observations are not reported in the registry record. The mixed-model result may use available repeated measurements, but the record does not specify its missing-data assumptions. It is therefore not possible to judge from the registry alone whether missingness could have affected the comparison or how sensitive the findings are to alternative assumptions.

Further details that are not reported include the full model specification, covariates, covariance structure, assumption checks, sensitivity analyses, and any interim analyses. The analysis population description does not, on its own, reveal how deviations from the planned intervention or incomplete follow-up were handled. These omissions do not invalidate the posted result, but they limit independent appraisal of robustness and of how closely the analysis followed a prespecified plan.

16. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: neck injury due to fall (0.8%).

The registry reports one serious adverse event among 121 participants in the Gamified mLIFE App Group and none among 122 participants in the Standard mLIFE App group. The serious event term listed is neck injury due to fall, reported as 0.8%. No other adverse events are reported in either group, and no deaths are listed.

These counts describe events recorded in the registry; they do not establish that the app or its gaming features caused the serious event. A single event in one group and none in the other provide limited information about comparative safety, particularly for uncommon events. The registry record does not provide a detailed narrative, timing, severity grading beyond the serious classification, or an assessment of relatedness for the event.

Zero reported non-serious events should be read as zero recorded in the posted results, not proof that no symptoms or other events occurred. The record’s counts are useful for understanding what was reported, but they are not a comprehensive estimate of the risk of all possible harms. No medical conclusion about individual participants follows from these group-level registry entries.

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

The posted primary estimate describes average body-weight change in two groups receiving different versions of the mLIFE app. The gamified group’s mean change was -5.3 Kg, and the standard group’s was -3.49 Kg. The reported between-group estimate was -1.81 Kg, with an interval that includes zero. The result therefore supports a description of the observed estimates, while leaving meaningful uncertainty about the size and direction of the true difference.

The estimate is not proof that the gamified app is superior, and it is not proof that the two app versions have identical effects. A confidence interval that crosses zero is compatible with no difference as well as with some differences in either direction. The trial’s reported p-value and interval should be interpreted together; neither supplies certainty on its own. The posted results do not establish whether any possible difference would be important to participants, because a clinically meaningful threshold is not reported in the registry record.

Both groups received an app-based intervention. The trial therefore does not answer whether an app intervention is better than no intervention, nor does it compare the app with another form of care. It focuses on adding social gaming and competition to the standard mLIFE intervention. The group-level results also do not show how individual participants responded or which participants might have experienced larger or smaller changes.

The secondary outcomes do not establish a clear difference between groups, and the stated social-support aim has no posted result. The record also does not provide detailed data on engagement, adherence, missing outcomes, or subgroups. As a result, it cannot show whether use of particular app features mediated weight change, whether effects varied by participant characteristics, or whether results apply beyond the population described in the study.

These are statistical interpretations of the registry results, not medical advice. They indicate what the posted estimates can and cannot establish without converting an uncertain group comparison into a claim about individual benefit or harm.

18. Why This Trial Matters Statistically

This trial is statistically informative because it compares two active versions of the same digital intervention. That design focuses the question on the added social-gaming and competition features, rather than mixing their potential contribution with the broader effect of receiving an app. The distinction helps define what the estimated group contrast can address.

The primary result also illustrates why estimates should be read alongside uncertainty. The point estimate suggests a difference in average weight change, but the confidence interval includes zero. A point estimate alone can give a misleading impression of certainty; an interval makes visible the range of values compatible with the analysis. The recalculation from summary statistics offers a useful comparison, while also showing why an approximate unadjusted calculation should not be mistaken for the sponsor’s mixed-model analysis.

The study’s repeated-measures and intent-to-treat descriptions matter because they indicate an effort to use measurements over time and retain the randomized group comparison. Yet incomplete reporting of model details, missingness, and multiplicity constrains how fully those methods can be evaluated. Statistical interpretation depends not only on a result but also on how the result was estimated and how uncertainty and multiple outcomes were handled.

Finally, the planning illustrations connect observed effect sizes to future design choices without turning the completed trial’s result into a measure of power. They show that smaller target effects require larger planned samples under the stated assumptions. The registry does not report the original design justification, so those illustrations cannot explain why this study enrolled its observed number of participants. Taken together, the record is a useful example of distinguishing a reported model result, a summary-statistic recalculation, secondary evidence, and planning assumptions.

19. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry does not report the full statistical analysis plan, the mixed model’s covariates or covariance structure, or the assumptions used to handle missing observations. Although the record states that all participants were included in an intent-to-treat analysis, participant flow and outcome completeness at each assessment are not described. This limits evaluation of how follow-up and missing data may have influenced the estimates.

The original sample-size justification is not reported. The planning illustrations are based on the observed effects under stated assumptions and cannot establish what effect the trial was originally designed to detect. The record also does not report whether interim analyses were planned or performed, or whether any formal multiplicity adjustment was used for the primary and secondary outcomes.

The posted results give group-level summaries, but do not provide individual-level distributions, subgroup estimates, or results for the stated social-support aim. The registry does not report measures of app engagement or adherence, so the estimates cannot be linked to how frequently participants used specific features. It also does not give enough detail to assess the fidelity of delivery or the exact role of each behavioral component.

Masking is recorded as double, but the record does not state who was masked or how masking was maintained. The description identifies an intended population with overweight or obesity and at least 3 type 2 diabetes risk factors, but the posted results do not provide subgroup-specific information or evidence about generalizability to populations beyond those described. These are limitations of what can be assessed from the registry record; they do not by themselves demonstrate that the trial was conducted improperly.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: The Mobile Lifestyle Intervention for Food and Exercise Study — NCT05176847.
• Registry record last updated 2026-01-15; status last verified 2026-01.
• Results first posted 2026-01-15.
• 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.

23. Record Summary

The registry describes a completed, randomized, double-masked, parallel-group study of the mLIFE app, with enrollment of 243. It compared a gamified version of the app with a standard version. The primary endpoint was change in body weight at 12 months, defined as follow-up minus baseline.

The reported mixed-model estimate for the primary comparison was -1.81 Kg, with a 95% confidence interval from -3.71 to 0.09 and p = 0.09. The interval includes zero, indicating uncertainty about the between-group difference. Recalculation from the posted summaries gives a similar estimate but uses a simpler, unadjusted method.

Energy intake and weekly moderate to vigorous physical activity were also posted as secondary outcomes. A result for the study’s stated social-support aim is not reported in the registry record. The record lists one serious adverse event in the gamified group, no other adverse events, and no deaths. Further details about the analysis plan, missing data, multiplicity, and original sample-size justification are not reported.