This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Modifying Physical Activity and Sedentary Time in Filipino Faith Leaders (NCT03439852), a randomized na study. The primary outcome is Minutes Per Week of Hi/Light Intensity Physical Activity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03439852 |
| Phase | NA |
| Condition | Physical Activity and Sedentary Behavior, Healthy Aging |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Hawaii |
| Results posted | Yes |
2. Clinical Question
Population
At-risk older Filipino adults who were lay leaders in Filipino Catholic clubs in Hawaii. The registry record states that the primary-outcome analyses involved randomized participants who had both baseline and 12-week follow-up assessments. Further details about the analyzed population are not reported in the registry record.
Intervention
A 12-week program intended to increase light-to-moderate physical activity and reduce sedentary time. It included group discussions during 3 monthly club meetings and 12 weekly telephone counseling calls from nursing students.
Comparator
A delayed-treatment/healthy-aging condition. During the initial 12 weeks, participants received healthy-aging information and 12 telephone calls using a contact-matched protocol.
Primary question
How did minutes per week of high/light intensity physical activity, measured at baseline and after 12 weeks, compare across the randomized groups? The registry record does not report a single primary-outcome comparison or its estimate.
The study focused on a behavioral program for older Filipino community leaders, rather than a medication or procedure. Its planned activities addressed both movement and sitting: the intervention aimed to encourage light-to-moderate activity and to reduce or interrupt sedentary time. The primary measure was self-reported activity minutes per week, assessed with the Community Health Activities Model Program for Seniors survey.
The clinical question is therefore about change or group differences in reported activity over the intervention period, not about a clinical event or a measure of disease progression. The registry record identifies the measurement time points but does not report the actual group values, an estimated contrast, or its uncertainty. It also does not report a detailed clinical rationale for choosing this outcome as primary. Without an outcome estimate, the direction and size of any difference between groups cannot be described.
3. Trial Design
The study is listed as a randomized, double-masked, parallel-design trial with an enrollment of 35. Its status is completed. The registry record lists the start date as 2018-03-11 and the primary completion date as 2020-01-22. The phase is recorded as NA. The sponsor is the University of Hawaii.
The intervention was behavioral. The active condition combined group cohesion activities with personalized telephone counseling, with a stated goal of increasing light-to-moderate physical activity and reducing sedentary time. The brief summary describes 3 group discussions during monthly club meetings and 12 weekly calls. The calls were intended to help participants address barriers to increasing activity and decreasing or breaking up sitting time.
The comparator was labeled delayed treatment/healthy aging. During the initial 12 weeks, it involved healthy-aging materials and telephone contact to assess symptom ratings. The registry description indicates that delayed treatment followed the initial period, but the details of what participants received afterward are not fully reported in the registry record.
The primary outcome was assessed at baseline and after 12 weeks. The listed analysis population consisted of randomized participants with both assessments, regardless of reported activity or sedentary time during calls or the number of condition-specific calls received. The remainder of that population description is incomplete, and further eligibility or analysis details are not reported in the registry record.
Although the record identifies randomization and masking, it does not report the allocation method, how masking was maintained, or who was masked. It also does not report the statistical analysis plan, the intended sample-size justification, or whether interim analyses were planned. These omissions limit how specifically the design and analysis can be appraised from the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: If the participants' self reported height/weight (i.e, BMI) (collected anonymously to determine eligibility prior to signing a consent form) was below our BMI cutpoint, but their measured height and weight exceeded our BMI cutpoint (measured after consent form signed), participants were excluded from study before condition-specific information was provided.
Baseline to 12 Weeks
| Stage | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging |
|---|---|---|
| STARTED | 12 | 23 |
| COMPLETED | 8 | 16 |
| NOT COMPLETED | 4 | 7 |
Reasons for not completing this period:
| Reason | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging |
|---|---|---|
| Failed complete 12 wk survey | 4 | 7 |
12weeks to 24weeks
| Stage | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging |
|---|---|---|
| STARTED | 8 | 16 |
| COMPLETED | 6 | 16 |
| NOT COMPLETED | 2 | 0 |
Reasons for not completing this period:
| Reason | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging |
|---|---|---|
| failed complete 12 or 24 wk surveys | 2 | 0 |
24 Weeks to 36 Weeks Follow up
| Stage | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging |
|---|---|---|
| STARTED | 6 | 16 |
| COMPLETED | 5 | 16 |
| NOT COMPLETED | 1 | 0 |
Reasons for not completing this period:
| Reason | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging |
|---|---|---|
| failed to complete 36 wk survey | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Analyses were performed on randomized participants who provided both a baseline and 12-week (follow-up) assessment (survey), regardless of the level of physical activity/sedentary time they reported during a phone call, the number of condition-specific telephone calls they received, or the number of LMPA/ST condition group cohesion sessions they attended. Four participants in LMPA/ST condition and 7 participants in DT/HG condition did not provide a 12-week assessment.
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: Adults recruited from community-based Catholic Churches
| Characteristic | Unit | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging | Total |
|---|---|---|---|---|
| Participants analysed | 12 | 23 | 35 | |
| Age, Continuous | years | 65.5 (SD 6.6) | 63.8 (SD 6.1) | 64.4 (SD 6.2) |
| Sex: Female, Male: Female | Participants | 10 | 18 | 28 |
| Sex: Female, Male: Male | Participants | 2 | 5 | 7 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 12 | 22 | 34 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 12 | 23 | 35 |
| Minutes per week physical activity | minutes per week | 180 (SD 207) | 171 (SD 175) | 174 (SD 183) |
| Minutes/week of High-Light physical activity | minutes per week | 445 (SD 274) | 335 (SD 300) | 370 (SD 293) |
| Breaks per hour at baseline | breaks per hour | 2.5 (SD 1.7) | 1.1 (SD 1.0) | 1.8 (SD 1.3) |
| Sitting time hours per day | hours per day | 5.4 (SD 4.9) | 6.3 (SD 6.3) | 5.8 (SD 5.6) |
| Breaks per hour in sitting time at work | breaks per hour | 2.6 (SD 1.8) | 1.5 (SD 1.5) | 2.05 (SD 1.65) |
6. Primary Endpoint
The registry lists the primary outcome as Minutes Per Week of Hi/Light Intensity Physical Activity, measured over Measured at Baseline and after 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | minutes per week |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is minutes per week of high/light intensity physical activity. It is a continuous measure summarized as a mean, with standard deviation listed as the dispersion measure. The registry record states that it was measured at baseline and after 12 weeks.
Participants completed the Community Health Activities Model Program for Seniors survey. They reported how often they performed specific activities and selected a time range describing the amount of time spent on each activity. The endpoint was defined as the sum of minutes spent in activities with metabolic equivalents >2 and <3. This definition places the measure on the light-intensity activity range specified in the record.
A weekly activity-minutes measure is useful for describing the amount of activity participants report over a period of time. Repeated measurement at baseline and follow-up can support a comparison of activity levels over the intervention period. General statistical interpretation: a mean describes the group’s average reported activity, while a standard deviation describes how varied individual observations are around that average. Neither measure alone establishes a difference between randomized groups.
The reason this measure was selected as primary, and whether any validation or measurement-error adjustment was planned, are not reported in the registry record. The registry record also does not report the endpoint values or a group comparison, so the observed amount of activity and the precision of a contrast cannot be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized behavioral trial and a primary measure of weekly high/light intensity activity, but it does not report a single primary-outcome comparison. The record notes that the primary outcome has several categories or time points and was not reduced to one comparison. It lists 7 outcome measures and 7 analyses, but does not provide outcome estimates, standard deviations, confidence intervals, or p-values for interpreting the primary outcome.
As a result, the direction and magnitude of any between-group difference in activity are not reported in the registry record. It is not possible to determine from the record whether the groups had similar or different activity levels at follow-up, how much their values changed from baseline, or how uncertain any estimated difference might be. No conclusion about the effect of the program should be drawn from the design description alone.
General statistical interpretation: an estimated group difference describes the size and direction of a contrast, while a confidence interval describes the range of values compatible with the data and the analysis assumptions. A p-value addresses compatibility with a specified null hypothesis under an analysis model; it does not measure the size or practical importance of an effect. Since these statistics are not reported for a single primary-outcome comparison, neither the magnitude nor the precision of such a contrast can be evaluated.
The registry record’s description of the analysis population is relevant: it refers to randomized participants who completed both baseline and 12-week surveys, regardless of reported activity or call exposure. This is a restriction to participants with both measurements, rather than an explicitly reported analysis of all randomized participants. The number contributing primary-outcome data in each group and the handling of missing assessments are not reported in the registry record.
The record describes a planning illustration based on a fraction of an observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. The corresponding sample-size values are not reported in the registry record. Such planning figures are not observed power and do not replace an outcome estimate or its uncertainty. The stated description also does not establish that these assumptions were the trial’s original design assumptions.
Overall, the posted information supports a description of the trial’s population, intervention, comparator, measurement, and some safety counts. It does not support a quantitative conclusion about the primary physical-activity outcome. That distinction is important: absence of a reported comparison is not evidence that groups were equal, nor is it evidence of a difference.
9. Statistical Methods Explained
What does a mean and standard deviation describe?
The primary outcome is continuous: it records minutes per week, rather than assigning participants to a small set of categories. The registry record names the mean as the summary measure and the standard deviation as the measure of dispersion. General statistical explanation: the mean represents the average value in a group, while the standard deviation describes the spread of participant values around that average. A similar mean can occur in groups with different amounts of individual variation, so the mean alone does not convey how consistent participants’ reports were.
The registry record does not report the mean or standard deviation for either randomized group. It also does not report a contrast between the groups. Accordingly, the listed summary approach can be explained, but its numerical results cannot be interpreted.
What would a confidence interval add?
General statistical explanation: a confidence interval expresses uncertainty around an estimate, such as a difference in average minutes per week. A relatively narrow interval indicates greater precision than a wide interval, given the same analysis framework. The interval’s position also helps readers assess which effect sizes are compatible with the observed data. A confidence interval does not guarantee that the true value lies within the interval, and it does not by itself establish clinical importance.
A confidence interval for the primary comparison is not reported in the registry record. The sample size and design description alone cannot supply that missing precision information.
Why does allocation matter?
General statistical explanation: random allocation is intended to create groups that are comparable, on average, with respect to both measured and unmeasured characteristics at the time of assignment. It does not guarantee that the groups will be identical, particularly in a small study. Baseline descriptions and an analysis that respects the randomized comparison help readers understand how the groups were treated analytically. The registry record identifies the trial as randomized, but allocation procedures and baseline outcome values are not reported in the registry record.
What can masking tell readers?
The design is labeled double-masked. Masking can help limit some forms of bias when participants, study staff, or outcome assessors do not know assignments. However, the record does not identify which people were masked or explain how masking was maintained. Because the intervention involved group meetings and counseling calls, the practical masking procedures would be relevant to evaluating the study, but further details are not reported in the registry record.
How should the planning illustration be read?
The registry record describes a planning illustration based on the observed effect, a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. It states that the effect to detect is a specified fraction of the observed effect. The resulting sample-size figures are not reported in the registry record.
General statistical explanation: a planning calculation estimates the sample size that would be needed under stated assumptions. It depends on choices such as the target effect, variability, significance level, and desired power. A calculation based on an observed effect is particularly dependent on that effect estimate, which may be uncertain. Planning values should not be interpreted as observed power or as proof that the completed study could detect a particular effect. The record does not report the trial’s original sample-size justification or its assumptions, so the planning illustration should be kept distinct from the original design rationale.
Why can over-dispersion matter?
General statistical explanation: over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model understates variability, standard errors may be too small and confidence intervals may be too narrow. This issue can arise in several kinds of data, but the registry record does not identify an over-dispersion problem or report a model for the primary endpoint. It should not be assumed that over-dispersion occurred in this trial.
Likewise, the registry record does not report whether the primary comparison used an unadjusted or adjusted model, how repeated measurements were handled, or whether any distributional assumptions were checked. Those analytical details are not reported in the registry record and cannot be inferred from the outcome’s continuous scale or the stated summary measure.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 7 outcome measures and 7 analyses. The primary outcome is measured at baseline and after 12 weeks, and the record states that it has several categories or time points and was not reduced to one comparison. It does not identify a single estimate that can be treated as the primary between-group result.
General statistical explanation: when several outcomes, time points, or comparisons are tested, the chance of obtaining at least one apparently notable result can increase. A prespecified hierarchy or multiplicity adjustment can help control the interpretation of a family of tests. Whether such procedures were planned or used is not reported in the registry record. The number of listed outcomes alone does not establish which analyses were confirmatory, exploratory, or adjusted.
The registry record describes the primary-outcome population as randomized participants with both baseline and 12-week follow-up survey assessments. It states that inclusion did not depend on the level of activity or sedentary time reported during a phone call or on the number of condition-specific calls received. The rest of the population description is incomplete. The number of participants with both assessments in each group, reasons for missing follow-up, and methods for handling missing data are not reported in the registry record.
General statistical explanation: restricting an analysis to participants with observed measurements can yield a biased comparison if availability of follow-up data is related to outcome values or group assignment. Other methods may use additional information to address missingness, but their validity depends on assumptions. The registry record does not report whether any such methods were used. It also does not report whether analyses followed an intention-to-treat approach or whether sensitivity analyses examined alternative missing-data assumptions.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Light to Moderate Physical Activity/Sedentary Time | 0 | 12 | 0.0% |
| Delayed Treatment/Healthy Aging | 1 | 23 | 4.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Light to Moderate Physical Activity/Sedentary Time | 0 of 12 |
| Delayed Treatment/Healthy Aging | 0 of 23 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Light to Moderate Physical Activity/Sedentary Time | 0 of 12 |
| Delayed Treatment/Healthy Aging | 0 of 23 |
Most frequent serious adverse event terms
| Event term | Organ system | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging |
|---|---|---|---|
| Serious adverse event - hospitalization | Surgical and medical procedures | 0 of 12 | 1 of 23 |
Serious events with the highest arm-level rate: serious adverse event - hospitalization (4.3%).
The serious adverse event counts are reported separately by randomized group. In the light-to-moderate physical activity/sedentary-time group, 12 participants were at risk and 0 had a serious adverse event. In the delayed-treatment/healthy-aging group, 23 participants were at risk and 1 had a serious adverse event. The record reports 0 deaths in each group.
For other adverse events, the record lists 0 affected participants among 12 at risk in the intervention group and 0 among 23 at risk in the delayed-treatment group. It also lists “Serious adverse event - hospitalization” as the top serious adverse event term, with 4.3%. That term and percentage should be read as the registry’s reported event listing; further detail about the event is not reported in the registry record.
These are counts from a small completed trial and describe events recorded in the registry. They do not establish whether an event was caused by an intervention, nor do they provide a precise estimate of comparative safety. General statistical explanation: sparse event counts can leave substantial uncertainty about underlying event rates, and an absence of recorded events in a group does not prove that the true risk is zero. The registry record does not report additional details about event timing, seriousness criteria, relatedness, or follow-up duration for safety reporting.
12. What the Result Does, and Does Not, Mean
The record describes a trial designed to assess whether a group-based and telephone-supported program could influence activity and sedentary behavior among older Filipino lay leaders in Hawaii. It identifies a randomized, double-masked, parallel design, a 12-week intervention period, and a self-reported physical-activity endpoint. These details establish what the study set out to examine, not what the study found.
The primary endpoint was minutes per week of high/light intensity physical activity, defined using activity reports from the CHAMPS survey. However, a single primary-outcome comparison and its numerical estimate are not reported in the registry record. The record also does not report the group means, standard deviations, confidence interval, or p-value needed to characterize the result. Consequently, the direction, size, and precision of a primary difference cannot be stated.
The record lists 7 outcome measures and 7 analyses, but does not provide enough information to distinguish all planned comparisons or to evaluate multiplicity procedures. The analyzed population is described as randomized participants with baseline and follow-up assessments, but the number with complete measurements and the approach to missing data are not reported. These gaps matter because they affect how representative and precise an outcome comparison would be.
The safety record includes 0 serious adverse events among 12 at risk in the intervention group and 1 among 23 at risk in the delayed-treatment group, with 0 deaths in both groups. These counts describe reported events; they do not by themselves establish a causal safety difference.
General statistical interpretation: a trial’s design, outcome definition, and event counts can be informative even when the treatment-effect estimate is unavailable. They cannot substitute for a reported estimate with uncertainty. The registry record therefore supports a description of the research question and methods, but not a conclusion about whether the program changed physical activity or sedentary time.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it links a behavioral intervention to a continuous, self-reported outcome measured at baseline and follow-up. Readers must distinguish the research plan from the results: randomization and a clearly described endpoint indicate how a comparison was intended to be made, but do not reveal the size or precision of that comparison.
The study also illustrates why an analysis population needs to be described carefully. The record refers to randomized participants who posted both baseline and 12-week assessments, while the number with complete data and the handling of missing assessments are not reported. General statistical explanation: conclusions based on participants with observed follow-up can be affected if missingness is related to participants’ outcomes or assignment. The analysis population and missing-data approach are therefore part of interpreting, not merely documenting, a result.
Multiplicity is another important issue. The registry lists 7 outcomes and 7 analyses and notes several categories or time points for the primary endpoint. Without a single reported comparison or details of any multiplicity procedure, readers cannot identify the inferential status of individual findings. A collection of analyses should not be treated as one definitive test without understanding how they were planned and interpreted.
Finally, the sample-size description is explicitly framed as a planning illustration based on the observed effect. Such an illustration depends on assumptions and should not be confused with the trial’s original sample-size justification or with observed power. Because its numerical values and the original design rationale are not reported in the registry record, it cannot resolve questions about precision or adequacy.
The central statistical lesson is that a transparent endpoint and trial design are necessary but not sufficient for interpreting an intervention effect. A reported estimate, its uncertainty, analysis population, and treatment of missing data are also needed.
14. 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 record does not provide a single primary-outcome comparison, despite identifying the primary measure and its assessment times. It therefore lacks the numerical information needed to describe the observed group values, effect estimate, or precision. The record’s note that the primary outcome includes several categories or time points explains why it was not reduced to one comparison, but does not indicate which comparison should guide interpretation.
The primary measure relies on participant reports of activity frequency and duration using the CHAMPS survey. Self-report can be affected by recall and reporting differences; whether and how such measurement error affected this study is not reported in the registry record. The endpoint definition uses the sum of minutes for activities with metabolic equivalents >2 and <3, but further detail about scoring decisions is not reported.
The record describes the analysis population as participants with both baseline and follow-up assessments. It does not report the number with complete data in each group, reasons for missing follow-up, or methods used to address missing data. The remainder of the population description is incomplete. This limits assessment of how closely the analyzed population represents all randomized participants.
Details of randomization and masking are also limited: the allocation procedure, the people masked, and the methods used to maintain masking are not reported in the registry record. The statistical model, adjustment strategy, multiplicity handling, interim analyses, and original sample-size justification are likewise not reported. These limitations concern what can be assessed from the registry record and should not be mistaken for evidence that a particular procedure was or was not used.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Modifying Physical Activity and Sedentary Time in Filipino Faith Leaders — NCT03439852.
- Registry record last updated 2023-06-18; status last verified 2023-05.
- Results first posted 2023-06-18.
- 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.
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18. Record Summary
The registry record describes a completed randomized, double-masked, parallel behavioral trial sponsored by the University of Hawaii, with enrollment of 35. The study began on 2018-03-11 and reached primary completion on 2020-01-22. It examined a 12-week program intended to increase light-to-moderate physical activity and reduce sedentary time among older Filipino lay leaders in Catholic clubs in Hawaii.
The primary outcome was minutes per week of high/light intensity physical activity, measured with the CHAMPS survey at baseline and after 12 weeks. The comparator was a delayed-treatment/healthy-aging condition. The record lists 7 outcome measures and 7 analyses but does not report a single primary-outcome comparison or its estimate. Safety listings report 0 serious adverse events among 12 at risk in the intervention group and 1 among 23 at risk in the comparator group, with 0 deaths in either group. Further analysis and missing-data details are not reported in the registry record.