The STEP 4Life Trial: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The STEP 4Life Trial (NCT05069155), a randomized na study. The primary outcome is Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period..

2. Clinical Question

This is a question about physical activity as measured by a wearable, not a direct test of whether participants developed Alzheimer's disease or another dementia. The registry describes prevention or delay of Alzheimer's disease and related dementias as the broader motivation, but the primary endpoint is change in steps. The reported group difference therefore speaks to the recorded activity measure over the specified periods. It does not by itself establish effects on cognition, function, dementia incidence, or long-term health. The record identifies random allocation, but it does not report further details about how allocation was implemented or how the at-risk population was defined. Those details would help readers judge how the study population and comparison correspond to the broader clinical question.

3. Trial Design

The registry identifies STEP 4Life as a randomized, triple-masked, parallel-group behavioral study, with phase recorded as not applicable. Its status is completed. The listed enrollment is 240. The registry dates the study start to 2021-11-01 and primary completion to 2022-11-21. These are registry-level design and status details; they do not describe how many participants contributed outcome data at each assessment.

The two groups were Control and Gamification. Participants in both groups received a wearable device, described as a Fitbit or similar device. The gamification group entered a game using behavioral economics concepts to address barriers to behavior change during a 12-week intervention period. The control description specifies no other intervention during the intervention or follow-up periods, while also mentioning completion of study milestones such as cognition and function assessments. Further details of the control activities are not reported in the registry record.

The primary outcome timeframe is baseline to the end of the 12-week intervention period, described as weeks 1–12. A secondary outcome addresses change in mean daily step counts during a 6-week follow-up period, described as weeks 13–18. Fitbit Inspire is named as the device for measuring the outcomes. The record lists one behavioral intervention and four outcome measures, but only one secondary outcome is posted with results.

Triple masking is the registry's design label; which roles were masked and how masking was maintained are not reported in the registry record. The record also does not report the randomization procedure, allocation concealment, the protocol's original sample-size justification, or details of recruitment and retention. These omissions limit assessment of design implementation. The posted outcome groups contain fewer observations than the registry's enrollment figure, but the reasons for that difference are not reported in the registry record. It would be inappropriate to infer whether it reflects missing measurements, exclusions, withdrawals, or another process.

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: 240 participants were officially consented and enrolled per study design protocol. Out of 240, 137 are deemed ineligible due to high baseline (\>7500 steps) during the 2-week run-in or did not complete all recruitment steps before the study closed for enrollment. Out of 103 randomized, 9 from the intervention arm dropped before starting the study.

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.

Population: 94 participants were started in the study, but 4 participants dropped out. 90 participants completed the entire study.

6. Primary Endpoint

The registry lists the primary outcome as Change in Mean Daily Steps From the Baseline Period to the End of the 12 Week Intervention Period., measured over Baseline to 12 week intervention period (Weeks 1 - 12).

The primary endpoint is the change in mean daily steps from the baseline period to the end of the 12-week intervention period. It is a continuous measure collected by a Fitbit Inspire device. The registry reports the outcome in steps and specifies the mean and standard deviation as the summary measures. The posted group values are 735.0 for Control and 2422.0 for Gamification, with a mean difference of 1687.0 steps for Gamification relative to Control.

Daily step counts provide a wearable-based measure of recorded activity. Using change from baseline focuses the comparison on how the measured group averages shifted over the intervention period, rather than only comparing endpoint levels. A mean summarizes the average change, although individual participants may have changes that differ substantially from that average. The reported standard deviations indicate variation in the observed group values; they are not confidence intervals for the mean difference.

This endpoint is useful for assessing whether the behavioral program was associated with a difference in the targeted activity measure over the stated period. It is not a direct measure of the development or prevention of Alzheimer's disease or related dementias. Nor does a difference in steps alone describe whether changes were maintained beyond the reported follow-up, how the activity pattern varied day to day, or what happened to cognition and function. Those questions require outcomes and analyses that are not reported in the posted results.

7. Results Posted in the Registry

• Gamification: mean 2,422 versus 735.00 on control; difference 1,687 (95% CI 1,124 to 2,250), standardized effect d = 1.22; z-test p = <0.001.

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 Mean Daily Step Counts During the 6 Week Follow-up Period After the End of the Intervention Period Tracked by Fitbit Inspire Device.

• 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:
  • Gamification: mean 1,983 versus 705.00 on control; difference 1,278 (95% CI 590.42 to 1,966), standardized effect d = 0.74; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Gamification than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted secondary outcome concerns mean daily step-count change during the 6-week follow-up period after the intervention. Its numerical comparison follows the same direction as the primary endpoint: the Gamification group has the higher reported mean change. The uncertainty interval for that comparison also lies above no difference. This pattern indicates that the between-group contrast in step counts was not limited to the primary intervention-period measure in the posted summaries.

The secondary result relates to the primary result by assessing the same broad activity target over a later timeframe. It may help readers consider whether the direction of the observed group contrast continued during follow-up. It does not establish that an intervention effect persisted beyond the reported period, or that the pattern would continue longer. Nor does it answer whether changes in steps correspond to changes in cognition, function, or dementia risk.

Secondary results generally carry less weight than a prespecified primary outcome because they may be one of several outcomes or timeframes considered. Testing multiple outcomes increases the chance that at least one comparison will look unusual by chance. Here, the p-value is unadjusted, and the registry does not report a multiplicity procedure or a hierarchy specifying how secondary outcomes were to be interpreted. The registry lists four outcome measures, while one secondary outcome is posted with results; a complete accounting of other outcomes and their status is not reported in the registry record.

The record lists no reported analyses, so it is unclear whether this secondary comparison was prespecified in the analysis plan, how repeated measurements were handled, or whether covariate adjustment was intended. It should be viewed as supporting descriptive context rather than as a separate definitive test. Agreement in direction can be informative, but it does not remove concerns about missing data, analysis choices, or multiple testing. The strongest interpretation remains tied to the specified primary endpoint and its reported precision.

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

• Change in Mean Daily Step Counts During the 6 Week Follow-up Period After the End of the Intervention Period Tracked by Fitbit Inspire Device.

9. Statistical Interpretation

10. Statistical Methods Explained

The primary result compares a mean change in a continuous outcome between two randomized groups. A continuous outcome can take a range of numerical values, such as the number of steps recorded as a change over the assessment period. The mean is the arithmetic average within a group. It provides a compact description of the group's central level, but it does not imply that every participant had a change near that average.

What does the mean difference represent?

The reported mean difference is the Gamification group mean minus the Control group mean for the stated change outcome. A positive estimate means the Gamification group had a higher average change in recorded steps. The registry comparison reports an estimate of 1687.0 steps. Its interpretation depends on the outcome definition and comparison groups; it is not a percentage change, a rate, or an individual-level effect. No additional computation is needed to read the reported estimate.

The standard deviation describes how spread out participant-level outcome values are around a group's mean. The reported standard deviations are 1306.0 in Control and 1460.0 in Gamification. A larger standard deviation means greater variation in the observed values, not greater uncertainty in the mean difference by itself. Uncertainty in a group mean also depends on how many observations contribute and on the distribution and measurement of the outcome.

What does the confidence interval add?

A confidence interval gives a range of values compatible with the data and the method used to calculate it, under the assumptions of that method. The primary 95% confidence interval extends from 1124.0 to 2250.0 steps for the mean difference. It communicates precision in a way that a point estimate alone cannot. The interval does not mean that 95% of individuals had changes in that range, nor does it guarantee that the true value is inside the particular interval. Its coverage interpretation applies across repeated use of the stated method under its assumptions.

The registry also reports an unadjusted p-value of <0.001 for the primary comparison. A p-value measures how incompatible the observed data are with a specified null model of no group difference, assuming that model and the analysis assumptions hold. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of the difference. Because the value is unadjusted, it does not account for the possibility of testing multiple outcomes or comparisons.

Why can variation matter?

When continuous outcomes vary more than a simple model expects, standard errors and confidence intervals from that model may be too optimistic. This is the general issue of over-dispersion: observed variability is greater than the model allows. Methods that account for extra variation can produce more realistic uncertainty. The record summarizes the outcome with means and standard deviations and gives standard errors for each group, but it does not report a separate model diagnostic or an analysis addressing over-dispersion. The observed standard deviations alone do not establish that over-dispersion occurred.

The posted comparison is described as a mean difference, and the registry has no reported analyses. Consequently, the comparison should not be taken as evidence of adjustment for baseline characteristics, repeated measurements, or other factors. The comparison's confidence interval and p-value are presented as unadjusted. How the registry calculated them and whether the sponsor used additional prespecified methods are not reported in the registry record. A detailed statistical analysis plan is not reported in the registry record.

How does randomization relate to the analysis?

Random allocation is intended to create groups that are comparable on average before intervention, including on factors that may not have been measured. It supports a between-group comparison, but it does not guarantee identical groups or eliminate the need for appropriate analysis. The record labels the trial randomized, yet the sequence-generation method, concealment process, and analysis population are not reported in the registry record. The available group summaries therefore support a basic descriptive comparison, while details needed to assess the full randomized-trial analysis remain unavailable.

Missing outcome data can affect both the mean and the uncertainty, especially if availability of wearable measurements is related to activity or group assignment. The record does not report the amount or pattern of missing step data, imputation methods, or sensitivity analyses. Without this information, it is not possible to determine how the posted means would compare with estimates under alternative assumptions about missingness. This is a limitation of interpretation, not proof that missing data biased the result.

The planning illustrations use a normal approximation and equal allocation, as stated in the planning assumptions. They use fractions of the observed effect and a two-sided significance level of 0.05. Such calculations address what sample size might be needed under those assumptions; they do not recover the trial's original design rationale. The original assumptions, including the effect size used in planning the trial, are not reported in the registry record.

11. Confidence Intervals and Precision

The primary mean difference is 1687.0 steps, with a 95% confidence interval from 1124.0 to 2250.0. The interval represents uncertainty around the group-average contrast, not the range of individual outcomes. All values in the interval are positive, so the interval does not include a zero difference under the reported calculation. The estimate is therefore more informative than a direction-only statement: it indicates both the estimated scale of the average difference and a range reflecting sampling uncertainty.

The interval is not especially narrow relative to the point estimate, so appreciable uncertainty remains about the precise size of the mean difference. Its lower and upper limits do not say that the effect must be at one of those endpoints, or that values outside the interval are impossible. They describe precision under the calculation and its assumptions. The registry does not report a detailed analysis plan or diagnostics that would allow a full assessment of those assumptions.

The group standard deviations, 1306.0 for Control and 1460.0 for Gamification, show that participant-level changes were dispersed around the averages. Such dispersion is distinct from uncertainty in the estimated group difference. The reported group standard errors are 184.7 and 220.1, respectively; they describe precision of the separate group means, not a substitute for the confidence interval for the contrast.

The interval also needs to be interpreted in context. It concerns measured mean daily steps over the primary timeframe, not the probability of preventing dementia or the size of a change in cognition or function. The confidence interval does not account for unreported aspects such as missing-data handling or multiplicity. It conveys statistical precision for the stated comparison, while other uncertainties about design, measurement, and analysis remain.

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 illustrations report participants per arm for 80% power and participants per arm for 90% power. They do not give total event counts: the endpoint is continuous, and these figures are participants per arm. The planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is specified as a stated fraction of the observed effect. The trial's original design assumptions and sample-size justification are not reported in the registry record.

Power is the probability that a planned analysis will detect an effect of the chosen size at the chosen significance level, under the calculation's assumptions. The 80% power column gives the estimated participants per arm for an 80% chance of detecting the selected effect; the 90% column gives the corresponding planning figure for a 90% chance. For example, the rows describe planning for 100%, 75%, and 50% of the observed effect. Smaller effects are harder to distinguish from random variation, so they require more participants per arm under the same assumptions.

The illustrations are based on the observed effect, not the trial's documented original target. They are hypothetical planning exercises and are not observed power. Observed power is not a useful way to summarize the evidence after results are known; the confidence interval gives a more direct account of uncertainty in the estimated difference. The figures also rely on simplifying assumptions, including equal allocation, and may not match the trial's actual design, data completeness, analysis method, or participant flow.

The primary and follow-up outcomes have separate planning illustrations because their estimated effects and variability differ. These calculations do not show that a future study would reproduce the observed effect. A prudent design would need to select an effect of substantive interest and justify assumptions independently of the observed result. The registry record does not report such a prospective justification.

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 = 1687.000; pooled standard deviation σ = 1380.119.
2. n = 2 × (1.96 + 0.842)² × 1380.119² / 1687.000² = 10.5, rounded up to 11 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 <- 1687                      # observed difference in means
sigma <- 1380.11878820818                     # 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(5069155)
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 = 11 (80% power), 15 (90% power)
 75% of observed effect: n per arm = 19 (80% power), 26 (90% power)
 50% of observed effect: n per arm = 43 (80% power), 57 (90% power)
power.t.test: 11.6 
Simulated power at n = 11 per arm: 0.780 (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

Multiplicity arises when a study evaluates more than one outcome, time point, comparison, or analysis. If each is tested without accounting for the others, the chance of at least one apparently notable result arising by chance can increase. The registry lists four outcome measures and reports one secondary outcome in addition to the primary endpoint. The reported p-values are unadjusted. A multiplicity strategy, such as a prespecified hierarchy or adjustment procedure, is not reported in the registry record.

This absence does not show that no such plan existed outside the registry, but the posted record does not allow readers to verify one. The secondary comparison should therefore be interpreted more cautiously than a single prespecified primary analysis. The number of analyses reported in the registry is zero, and no reported analyses are listed. The statistical methods underlying the posted comparisons, including whether they were planned before outcome data were examined, are not reported in the registry record.

Missing data are another important issue for wearable outcomes. A device-based step count may be unavailable for some periods or participants, but the registry does not describe the completeness of device wear, rules for valid measurement days, or how missing observations were handled. The reasons that the outcome group counts differ are not reported in the registry record. It is also not reported whether the analysis used all randomized participants, only those with available measurements, or another population. These details affect the interpretation of group means and uncertainty.

The record does not report imputation, sensitivity analyses, or an assessment of whether missingness differed between groups. Without such information, readers cannot determine whether the results would be robust to alternative assumptions about missing outcomes. This uncertainty should not be mistaken for evidence that the estimates are biased; it means the relevant checks cannot be assessed from the registry record.

Finally, the record does not report the original statistical analysis plan, prespecified covariates, or interim analyses. Those omissions limit evaluation of whether the posted comparisons match the planned analysis and whether the reported inferences reflect all relevant outcomes and decisions.

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.

Most frequent non-serious adverse event terms

The registry reports serious adverse events for both groups as zero among the participants at risk: 50 in Control and 44 in Gamification. It reports other adverse events as two in Control and two in Gamification, with those same group-specific numbers at risk. Deaths are reported as zero in both groups. No serious adverse event terms are listed.

These figures describe the adverse-event counts recorded in the registry; they do not establish that no events occurred outside the reporting definitions or observation process. The record does not provide event descriptions for the other adverse events, severity details, relatedness assessments, or timing. It also does not describe how adverse events were collected or how long safety surveillance continued for each participant.

Because the trial concerns a behavioral program and wearable monitoring, these counts should be read as registry safety reporting, not as a complete characterization of risk. The event counts are small, and the record does not provide an analysis comparing safety outcomes. The figures do not support a broad conclusion about safety in other populations or settings. They simply report the events and denominators recorded for these groups.

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

The posted primary result is a positive average difference in change in recorded daily steps between the randomized groups, with the Gamification group having the higher mean. The confidence interval indicates that the estimate is not highly precise, although its reported range lies above no difference. The secondary step-count comparison follows the same direction during the stated follow-up period. Together, these results describe a pattern in the activity measure collected by wearable devices.

That pattern should not be translated into a claim that gamification prevents or delays Alzheimer's disease or related dementias. The trial's stated motivation concerns those conditions, but the primary endpoint is daily steps. The posted results do not report dementia diagnoses, disease progression, or a primary cognitive or functional outcome. A step-count difference is not itself evidence of a change in those clinical outcomes. No conclusion about an individual's health or treatment choice follows from these group summaries.

The randomized design is relevant because it supports a comparison between groups, but important details needed to judge execution and analysis are not reported in the registry record. These include the allocation procedure, the analysis population, missing-data methods, and the original statistical plan. Outcome counts are lower than the registry enrollment figure, but the reasons are not reported. The uncertainty from these omissions is separate from the confidence interval's sampling uncertainty.

The record describes the objective as testing feasibility of behavioral economic interventions, including gamification with social incentives, targeting daily steps. The posted outcome summaries speak to the step-count comparison, but they do not report a formal feasibility analysis, such as recruitment, adherence, device wear, or acceptability measures. Those aspects are not reported in the registry record. Consequently, the available results provide a limited view of the broader stated objective.

The most defensible reading is narrow: the recorded average step-count changes were higher in the gamification group for the reported intervention and follow-up comparisons. The estimates have statistical uncertainty, and the registry does not resolve important questions about missing measurements, multiplicity, or analysis choices. The findings should be interpreted as evidence about this measured outcome in this trial, not as proof of a clinical effect or a guarantee of a similar result in other populations.

17. Why This Trial Matters Statistically

This trial illustrates why an endpoint's relationship to the clinical objective matters. The stated motivation is prevention or delay of Alzheimer's disease and related dementias, while the primary measure is change in mean daily steps. The step-count outcome is a measurable behavioral target, but it is not equivalent to a clinical disease outcome. Statistical interpretation must keep the observed measure distinct from the broader rationale for studying it.

The results also show why estimates and intervals are more informative than a significance label alone. The reported mean difference describes the scale and direction of the group contrast, while the confidence interval communicates uncertainty about its size. The unadjusted p-value addresses compatibility with a null comparison under assumptions; it does not describe clinical importance, participant-level variation, or the probability that the intervention is effective.

Wearable measures create additional statistical questions about data completeness and measurement rules. The registry does not report device-wear criteria or missing-data handling, so readers cannot assess how those choices influenced the outcome summaries. Transparent reporting of these details is particularly important when the endpoint depends on ongoing device recording.

Finally, the record contains a planning illustration based on the observed effect, but not the original sample-size rationale. Separating prospective planning assumptions from post-result illustrations helps prevent an observed estimate from being treated as a guaranteed future effect. The registry's randomized design and posted summaries are informative, while fuller reporting of analysis populations, multiplicity, missing data, and planned methods would make the statistical evidence easier to assess.

18. Limitations

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

Several limitations specific to this trial constrain interpretation. The primary outcome is a wearable-recorded step-count change, not a measure of Alzheimer's disease, dementia, cognition, or function. Although the registry frames the intervention around prevention or delay of Alzheimer's disease and related dementias, the posted results do not establish an effect on those conditions.

The registry lists enrollment as 240, while the primary outcome summaries report 50.0 observations in Control and 44.0 in Gamification. Why the numbers contributing to the outcome differ from the enrollment figure is not reported in the registry record. There is no reported participant-flow account, explanation of missing Fitbit data, definition of valid measurement, or description of the analysis population. The degree to which available measurements represent all randomized participants therefore cannot be assessed.

The posted comparison is unadjusted, and the registry lists no reported analyses. The original statistical analysis plan, any planned covariates, and the method used to calculate the comparison are not reported in the registry record. The record also does not report a multiplicity adjustment despite listing multiple outcome measures. These limitations make the primary result more straightforward to interpret than the secondary result, but they still leave uncertainty about the analysis process.

The trial is described as triple-masked, but the roles masked and the masking procedures are not reported. The randomization method and allocation concealment are likewise not reported. The control arm description is truncated, and details beyond the stated wearable device and absence of other interventions are not available. The registry does not report whether participants adhered to the game or the extent of device use.

Finally, the record lists a feasibility objective but does not post detailed feasibility outcomes. The observed step-count comparisons do not answer questions about acceptability, implementation, or longer-term maintenance beyond the stated follow-up timeframe. These are reporting limitations, not evidence that the unreported procedures or outcomes were unfavorable.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: The STEP 4Life Trial — NCT05069155.
• Registry record last updated 2023-11-28; status last verified 2023-11.
• Results first posted 2023-11-28.
• 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

The STEP 4Life Trial is listed as a completed randomized, triple-masked, parallel-group behavioral study sponsored by the University of Pennsylvania. The registry lists enrollment of 240 and dates from 2021-11-01 to primary completion on 2022-11-21. Its stated objective was to test gamification with social incentives to target daily steps in older adults at risk for Alzheimer's disease and related dementias.

The primary endpoint measured change in mean daily steps from baseline to the end of the 12-week intervention period using a Fitbit Inspire device. The posted mean difference favored the Gamification group, with a 95% confidence interval from 1124.0 to 2250.0 steps and an unadjusted p-value of <0.001. The secondary follow-up step-count comparison had the same general direction.

The record does not report the original sample-size rationale, a detailed analysis plan, the analysis population, missing-data methods, or a multiplicity procedure. The results describe step-count outcomes; they do not establish effects on Alzheimer's disease or related dementias.