Physical Health in Midlife: Influences of Adversity and Relationships Over Time: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Physical Health in Midlife: Influences of Adversity and Relationships Over Time (NCT01853332), a registered phase not stated study. The primary outcome is Hormonal Levels.

2. Clinical Question

In general, an observational study can describe patterns and associations among measured characteristics without establishing that one characteristic caused another. The stated aim includes examining experiences and relationships over time, but the record does not provide a specific causal estimand, such as the effect of a defined intervention. The clinical question is therefore best read as a set of questions about physical health and associated factors in midlife, not as a randomized test of a treatment.

3. Trial Design

The registry identifies this study as completed, with an enrollment of 210 and Beth Israel Deaconess Medical Center as sponsor. The recorded start is 2009-01 and the primary completion is 2014-05. The study is classified as kind other, rather than being described as a randomized clinical trial. Its title and summary focus on physical health in midlife and the influence of adversity, relationships, and individual characteristics over time.

Two arms are named: Cross-Sectional and Longitudinal. The Cross-Sectional description characterizes new participants and says the study targets health differences and the development of heart disease and diabetes. The Longitudinal description refers to former participants, or a partner of a former participant, from the Adolescent and Family Development Project, Young Adult Development Project, Across Generations Project, and/or Paths Over Time Project. The description of this arm is incomplete in the registry record, so its full procedures and eligibility details are not reported there.

Allocation is not stated. The registry cautions that the arms are not a like-for-like control comparison, so their labels should not be interpreted as intervention and control assignments. The record does not explain whether the same measures were collected in the same way across arms, or how participants were selected into them. Those details are important for deciding whether a difference between groups could be interpreted as a group effect rather than reflecting differing histories or recruitment.

The registry lists six outcome measures and two secondary outcomes: Body Mass Index (BMI) and Health Risk Factors. It records zero analyses. The statistical analysis plan, sample-size justification for the study’s original design, and planned handling of follow-up are not reported in the registry record. A planning illustration may use stated assumptions, but such planning is distinct from the study’s design justification and from observed results.

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.

Overall Study

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 Hormonal Levels, measured over 2.5 years.

The primary outcome is titled Hormonal Levels. Its stated unit is ng/ml, the measure type is MEAN, and the dispersion measure is Inter-Quartile Range. The stated timeframe is 2.5 years. The accompanying description places this measure within a broader assessment of clinically significant physical-health outcomes and risk factors for cardiovascular disease and type 2 diabetes mellitus.

The description names insulin and glucose, adipokines, myokines, triglycerides, HDL cholesterol, and proinflammatory markers. It also refers to establishing risk factors, identifying novel risk factors such as inflammatory markers and hormonal mediators, and determining prevalence of established cardiovascular disease and diabetes. The record does not clarify how each of these measures maps to the single primary-outcome title, nor does it report which hormonal measure was used for a particular analysis.

In general, a mean describes the average observed value, while the interquartile range describes the spread of the central portion of the observations. Reporting both can help readers understand a measure’s typical level and variability, though the mean can be influenced by unusually high or low values. The registry record reports the intended summary approach, not the resulting mean, interquartile range, or participant-level distribution. Thus, the endpoint identifies what the study intended to assess, but the posted record does not quantify the observed result or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a study of physical health in midlife and its relationships with individual characteristics, adversity, and relationships over time. It does not describe random assignment. The study is classified as kind other, and allocation is not stated. The arm names, Cross-Sectional and Longitudinal, describe different study groupings rather than establishing a randomized intervention and control structure. The record itself cautions that the arms are not a like-for-like control comparison.

What does a mean and interquartile range describe?

The primary outcome is titled Hormonal Levels, with MEAN as the stated parameter and Inter-Quartile Range as the dispersion measure. In general, the mean is the arithmetic average of observed values. The interquartile range describes the spread between the lower and upper quartiles, capturing the central part of a distribution. These summaries provide complementary information: the mean indicates an average level, while the interquartile range indicates how dispersed central observations are. Neither summary alone shows the full shape of a distribution, and the mean may be influenced by extreme observations.

The stated unit is ng/ml and the timeframe is 2.5 years. The description also lists insulin and glucose, adipokines, myokines, triglycerides, HDL cholesterol, and proinflammatory markers as relevant measures. The record does not say which of these is the specific primary hormonal variable, how repeated observations were handled, or whether the same measure was collected at each point in time. Those measurement and modeling details are not reported in the registry record.

Why does the study structure matter?

In general, cross-sectional information describes measurements or characteristics at a point or period, while longitudinal information concerns observation over time. Longitudinal data can help describe change and temporal patterns, but that does not by itself establish causation. Interpretation depends on how participants were selected, what was measured, when it was measured, and how factors that differ between participants were addressed. The registry describes group backgrounds but does not report enough detail to determine how those issues were handled analytically.

A comparison of groups is most interpretable when the groups are sufficiently comparable for the question being asked and the analysis accounts for relevant design features. Here, allocation is not stated and the registry explicitly rejects treating the arms as a like-for-like control comparison. Therefore, methods used for randomized treatment comparisons should not be presumed. The analysis model, adjustment variables, and approach to repeated measurements are not reported in the registry record.

How should uncertainty be read?

In general, an estimate is more informative when accompanied by a measure of uncertainty. A confidence interval describes a range of values compatible with the data and model, and its width helps indicate precision. A narrow interval generally indicates greater precision than a wide interval, while neither guarantees that the model or study design is free of bias. The registry record reports no primary-outcome estimate, confidence interval, or p-value, so the precision and statistical evidence of any result cannot be evaluated.

General statistical interpretation also distinguishes statistical evidence from clinical or practical importance. A small p-value, if reported, would not by itself show that an effect is large or meaningful; an estimate and its uncertainty would still be needed. Conversely, an imprecise estimate might be compatible with a range of effects. No result is posted from which to make either assessment for this study.

What do planning illustrations mean?

The record describes a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. For time-to-event tables, the stated convention is a total number of events using Schoenfeld; for other illustrations, it is participants per arm. These are planning assumptions, not observed study outcomes.

In general, sample-size calculations depend on assumptions about the effect to detect, variability or event rate, significance threshold, allocation, and analysis method. Changing an assumption changes the planning result. A calculation based on an observed effect is especially sensitive to the estimate used and should not be interpreted as the study’s original design justification unless that purpose is documented. The original sample-size justification and its assumptions are not reported in the registry record. Planning numbers are not observed power, and they do not show whether an analysis detected an effect.

The record reports six outcome measures and two named secondary outcomes, but it does not provide an analysis plan specifying models, contrasts, covariate adjustment, or uncertainty calculations. Nor does it report methods for missing observations or an analysis population definition. Without those details and the outcome estimates, readers cannot reproduce or fully evaluate an inferential analysis from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures and names Body Mass Index (BMI) and Health Risk Factors as secondary outcomes. It does not report how many hypotheses were planned, which outcomes were treated as confirmatory, or whether any adjustment for multiple testing was planned. A multiplicity strategy is not reported in the registry record.

In general, testing many outcomes or contrasts can increase the chance of finding at least one apparently notable result by chance. Possible approaches include prioritizing a primary outcome, using an adjustment procedure, or treating secondary findings as exploratory. Which approach is appropriate depends on the study question and analysis plan. Because the record does not specify a plan, no multiplicity correction or confirmatory status should be assumed.

Missing-data methods are also not reported in the registry record. The record does not give outcome-specific numbers observed, numbers missing, reasons for missingness, or methods used to address incomplete observations. In general, missingness can affect both precision and the validity of an estimate, particularly if data availability is related to participant characteristics or outcomes. Enrollment of 210 does not establish the analysis denominator for any particular measure.

Analysis populations are not defined in the registry record. It is not stated whether analyses included all enrolled participants, participants with available measurements, or another defined subset. The record identifies zero analyses, so there are no posted analysis results from which to infer the population actually used. These gaps limit assessment of selection, attrition, and the extent to which any reported estimate would represent the enrolled group.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event record lists the Cross-Sectional group with 151 participants at risk. It records zero serious adverse events, zero other adverse events, and zero deaths for that group. No top serious adverse-event terms are listed. These are the posted safety counts for the group and should be read as registry entries, not as proof that no events occurred outside the record’s reporting scope.

The study is described as observational in purpose, with no treatment assignment stated. The safety figures therefore do not provide a randomized comparison of harms between an intervention and a control group. The record does not describe the event-collection procedures, observation duration for safety reporting, definitions used for adverse events, or whether the listed at-risk group covers every enrolled participant. It also does not provide separate safety counts for the Longitudinal group.

In general, zero recorded events do not establish that the underlying event risk is zero. Interpretation depends on how many people were observed, for how long, what counted as an event, and how completely events were captured. The 151 listed at risk is a registry count for the Cross-Sectional group; the overall enrollment is 210, and the registry does not explain the difference in the populations represented. These safety data are therefore limited descriptions of what was recorded, not comparative evidence about treatment safety.

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

The record documents a completed study focused on physical health in midlife, including factors related to cardiovascular disease and type 2 diabetes. It identifies Hormonal Levels as the primary outcome, describes a timeframe of 2.5 years, and names several biological measures and secondary outcomes. It also records enrollment of 210 and describes Cross-Sectional and Longitudinal groups. These details define the study’s scope, but do not establish a finding about any biological measure or health condition.

No outcome estimates or analyses are reported in the registry record. As a result, the posted information does not show whether hormonal levels were higher or lower in a particular group, how much they varied, or how precisely any association was estimated. It does not report evidence that adversity or relationships caused a change in physical health. Nor does it report prevalence estimates for established cardiovascular disease or diabetes, despite these being part of the stated study objective.

The two arm labels should not be treated as treatment and control. The registry says allocation is not stated and cautions that the arms are not a like-for-like control comparison. Thus, even if group differences were available, the design information would require careful consideration before attributing those differences to a cause. No such results are posted for evaluation.

In general, a study’s stated aims and measured outcomes are distinct from its findings. The registry description indicates what investigators intended to examine; it does not substitute for estimates, uncertainty measures, or a transparent account of analysis. Likewise, a planning illustration is not evidence that an effect was observed, and it is not observed power. The record’s zero analyses means there is no reported inferential result to interpret.

The appropriate conclusion from the registry record is limited: it describes a completed investigation of midlife physical health and relevant psychosocial and biological factors, but does not report the results needed to judge the size, direction, precision, or statistical support of associations. This absence of results should not be converted into a positive or negative finding.

13. Why This Trial Matters Statistically

This study is statistically notable for the distinction between a broad research objective and a reported estimand. The description aims to examine physical health, risk factors, life stresses, relationships, and psychosocial outcomes over time. The primary outcome is titled Hormonal Levels, while the accompanying description covers multiple biological measures and broader objectives related to cardiovascular disease and type 2 diabetes. The record does not clarify how these aims map to specific analyses.

That distinction matters because a broad set of outcomes can generate many possible comparisons. Clear identification of primary and secondary questions, analysis populations, and multiplicity procedures helps readers understand which findings are confirmatory and which are exploratory. The registry lists six outcome measures and names two secondary outcomes, but does not report the analysis plan or multiplicity approach. It records zero analyses, so the available record does not permit evaluation of inferential results.

The study also illustrates why group labels are not sufficient to establish a comparison design. Cross-Sectional and Longitudinal groups may have different histories and recruitment pathways, and the record explicitly says they are not a like-for-like control comparison. In general, statistical adjustment cannot automatically remove bias from unmeasured or poorly described differences. Understanding group formation is essential before interpreting an association causally.

Finally, sample-size planning and analysis results answer different questions. The registry describes a planning illustration based on an observed effect and specified assumptions, but reports no study-specific design justification or outcome analysis. A planning calculation cannot establish that an effect exists, and a completed study’s enrollment does not by itself indicate the precision of its estimates. The missing estimates and uncertainty measures are central to interpreting the study statistically.

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.

Several limitations follow directly from the registry record. Although the study is marked completed and enrollment is 210, no outcome estimates or analyses are posted. The record therefore does not permit evaluation of the primary outcome’s observed level, variability, or association with the study’s exposures and participant characteristics. It also does not report confidence intervals, p-values, or other measures of inferential uncertainty.

The primary outcome description is broad. It names Hormonal Levels and gives a unit, summary parameter, dispersion measure, and timeframe, while the explanatory text lists several biological measures and multiple physical-health objectives. The exact mapping between these items and the primary outcome is not reported in the registry record. This makes it difficult to identify precisely which result would answer the primary question.

The registry describes cross-sectional and longitudinal groups, but the longitudinal-arm description is incomplete. Allocation is not stated, and the record cautions that the arms are not a like-for-like control comparison. Details on recruitment, eligibility, measurement timing, follow-up, repeated-measure handling, and covariate adjustment are not reported. Without those details, the potential for differences in group composition and measurement cannot be assessed.

The record also does not report outcome-specific denominators, missing-data procedures, analysis-population definitions, a multiplicity plan, or the original sample-size justification. Although safety counts are listed for the Cross-Sectional group, the safety reporting period and event-collection methods are not described, and separate counts for the Longitudinal group are not reported. These limitations concern what can be assessed from the registry record; they do not establish that the study itself lacked procedures that are simply not documented there.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Physical Health in Midlife: Influences of Adversity and Relationships Over Time — NCT01853332.
• Registry record last updated 2017-07-24; status last verified 2017-04.
• Results first posted 2017-07-24.
• 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.

18. Record Summary

NCT01853332 is a completed study titled Physical Health in Midlife: Influences of Adversity and Relationships Over Time, sponsored by Beth Israel Deaconess Medical Center. The recorded start is 2009-01, primary completion is 2014-05, and enrollment is 210. The registry classifies the study as kind other and names Cross-Sectional and Longitudinal groups; allocation is not stated, and the groups are not described as a like-for-like control comparison.

The primary outcome is Hormonal Levels, with a stated unit of ng/ml, parameter MEAN, Inter-Quartile Range for dispersion, and timeframe of 2.5 years. The study description also names measures related to cardiovascular disease and type 2 diabetes. Body Mass Index (BMI) and Health Risk Factors are listed as secondary outcomes. The registry reports zero analyses and does not include outcome estimates, an analysis plan, or a study-specific sample-size justification. The posted record therefore describes the study and its intended measures but does not provide results for statistical interpretation.