Enhancing Fitness in Older Pre-diabetic Veterans: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Enhancing Fitness in Older Pre-diabetic Veterans (NCT00594399), a randomized phase 2, phase 3 study. The primary outcome is Fasting Insulin.

2. Clinical Question

The registry describes a trial of physical activity counseling for older adults who were overweight and had impaired fasting glucose. The brief summary sets out a question about the effect of a one-year counseling intervention on glucose metabolism and secondary outcomes, compared with usual care. The primary measure posted for statistical interpretation, however, is fasting insulin at baseline.

The registry’s brief summary proposes a three-year randomized trial and describes a one-year intervention. The actual posted primary endpoint is recorded at baseline, and the registry record does not report a later fasting-insulin result in the material available for this comparison. This distinction matters: a baseline comparison cannot establish the effect of an intervention delivered later.

3. Trial Design

The registry record describes a randomized, parallel-group clinical trial with no masking. It lists the phases as Phase 2 and Phase 3 and reports enrollment of 302. The brief summary describes a planned three-year randomized trial, with a one-year physical activity counseling intervention compared with usual care. The trial is marked completed. Its recorded start is 2008-10 and its primary completion is 2011-03.

Participants in the counseling arm were assigned a behavioral program. The arm description lists a baseline in-person counseling session, telephone calls, a physician endorsement of physical activity during a primary care visit, monthly automated calls from the primary care provider encouraging activity, and quarterly mailed material. The description is truncated, so any further components are not reported in the registry record. The comparator arm received usual care from primary, women’s, or geriatric clinics.

The record describes older adults ages 60 and over who were overweight, with body mass index 25-40 and impaired fasting glucose of 100 - 125. The conditions listed in the record also include impaired glucose tolerance, obesity, and diabetes. Details on recruitment sites, how randomization was generated or concealed, eligibility exclusions, and the population analyzed for each result are not reported in the registry record.

The primary measure posted for interpretation is fasting insulin at baseline. The registry also lists physical activity and endurance as secondary outcomes, with baseline values posted for physical activity in minutes per week. These baseline measurements provide a description of the groups at entry; they are not follow-up comparisons of the response to counseling. Results at later time points, adherence to the intervention, and the primary outcome analysis specified for the trial’s intervention question are not reported in 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.

Initial 3 Month Counseling

Reasons for not completing this period:

Rerandomization Arm 1 Only

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: The average age of the sample was 67 year with a range of 60 to 89. Participant were in a normal usual walking speed for their ages but were at the 10th percentile in norms for six-minute walk distance indicating poor aerobic capacity for their age.

6. Primary Endpoint

The registry lists the primary outcome as Fasting Insulin, measured over Baseline.

Fasting insulin is a continuous laboratory measure reported in uIU/ml. The registry identifies the primary measure as a mean with standard deviation and places its measurement at baseline. It describes analysis at a VA central laboratory by technicians not affiliated with the study. Participants were instructed to fast from food and drink other than water and medications after midnight; study personnel verified fasting before the blood draw, and a reminder call was placed the night before the appointment.

Fasting insulin is used as a measure related to glucose metabolism. In a trial focused on impaired fasting glucose, a laboratory measure of insulin can help describe metabolic status. That general role does not change what this particular posted result can establish: a baseline mean comparison describes the groups before the counseling intervention could have produced a response. It is not a measurement of change over time or a comparison of follow-up results.

The posted results report mean fasting insulin of 10.26 uIU/ml in the counseling arm and 10.39 uIU/ml in the usual-care arm, with standard deviations of 6.09 and 8.58. These values and their comparison characterize baseline levels and variability. They do not, on their own, show whether the intervention altered insulin, whether glucose metabolism changed, or whether any later difference occurred. Follow-up timing and primary endpoint results for the intervention question are not reported in the registry record.

7. Results Posted in the Registry

• Arm 2: mean 10.39 versus 10.26 on control; difference 0.13 (95% CI -1.63 to 1.89), standardized effect d = 0.02; z-test p = 0.885.

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.

Physical Activity, Endurance

• 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:
  • Arm 2: mean 115.29 versus 73.39 on control; difference 41.90 (95% CI 4.91 to 78.89), standardized effect d = 0.28; z-test p = 0.026.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Arm 2 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry lists Physical Activity, Endurance as a secondary outcome and provides a baseline comparison in minutes per week. Its posted values describe the groups before the intervention period. The registry also lists the outcome title repeatedly, but does not provide a set of distinct, fully reported follow-up comparisons across those entries. Later secondary results and the timing of any such results are not reported in the registry record.

The secondary baseline comparison differs in pattern from the primary fasting-insulin comparison: the observed activity mean is higher in the usual-care arm, and its unadjusted interval does not include zero. This is still a cross-sectional baseline contrast, not a change caused by counseling. It cannot explain what happened during follow-up, and it does not answer the trial’s stated intervention question. Baseline differences can arise by chance even in a randomized study.

Secondary outcomes are useful for describing other domains of interest, but they generally carry less confirmatory weight than a clearly prespecified primary endpoint analyzed at the relevant follow-up. Testing multiple outcomes can increase the chance of a nominally small p-value. The registry record does not report a multiplicity procedure, a hierarchy for interpreting endpoints, or a complete statistical analysis plan. Accordingly, an unadjusted secondary result should be treated as descriptive or exploratory rather than as decisive evidence.

The posted secondary information does not establish whether activity changed, whether endurance changed, or whether any secondary measure supports a treatment effect. No conclusions about secondary intervention outcomes can be drawn from baseline measurements alone. Interpreting the secondary findings alongside the primary result means keeping the timing and endpoint role clear: both are baseline comparisons, and neither is a follow-up estimate of counseling’s effect.

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

• Physical Activity, Endurance
• Physical Activity, Endurance
• Physical Activity, Endurance

9. Statistical Interpretation

10. Statistical Methods Explained

The posted arm summaries give a mean and standard deviation for a continuous outcome in each group. A mean describes the arithmetic average of observed values. A standard deviation describes how dispersed those observations are around the mean. The primary measure is fasting insulin at baseline, reported in uIU/ml. The secondary measure with numerical results is physical activity in minutes per week, also at baseline.

What does the mean difference compare?

The unadjusted mean difference compares the two arm means by subtracting one from the other. For the primary result, the comparison is recorded as usual care minus counseling: the arm means are 10.26 and 10.39 uIU/ml, and the resulting difference is 0.13 uIU/ml. A value of zero would correspond to equal sample means. A positive or negative value indicates which arm has the larger observed mean according to the stated subtraction order.

This is a simple, unadjusted comparison of posted summary statistics. It does not account for covariates or use an adjusted model. The registry record does not report the trial’s detailed analysis plan, whether the investigators used an adjusted analysis elsewhere, or the population definition for each analysis. The recalculated comparison is not a substitute for an analysis specified by the trial investigators.

How should standard deviations be read?

Standard deviations describe variability in individual measurements, not uncertainty in the mean difference. Fasting insulin has standard deviations of 6.09 in the counseling arm and 8.58 in the usual-care arm. The secondary baseline activity measure has standard deviations of 119.8 and 183.7 minutes per week. These values indicate that observations vary within each group. When continuous outcomes have substantial variation, an estimated difference can be imprecise even when the group means themselves are available.

In general, a standard error describes the sampling uncertainty of an estimate, while a confidence interval combines an estimate with its uncertainty to give a range of values compatible with the data under the method used. The posted comparison includes a confidence interval for the mean difference. That interval is more informative about precision than the point estimate alone, but it depends on the method and assumptions used to construct it.

What does the p-value say?

The unadjusted p-value for the primary comparison is 0.885. In general, a p-value measures how compatible the observed data are with a specified null hypothesis, under the assumptions of the statistical test. It is not the probability that the null hypothesis is true, nor does it quantify the probability that the groups are identical. The result is a baseline comparison, so its p-value should not be interpreted as a test of counseling’s effect.

The posted secondary baseline comparison has an unadjusted p-value of 0.026. Because it is secondary, unadjusted, and measured at baseline, this value should not be treated as a confirmatory result about the intervention. When several outcomes or comparisons are examined, the chance of observing a small p-value by chance can increase. Whether the trial planned adjustment or a hierarchy among endpoints is not reported in the registry record.

Why do the timing and analysis population matter?

Randomization is intended to create groups that are comparable on average at assignment, but chance differences in baseline measurements can remain. A baseline comparison can describe the observed groups; it cannot show an effect of an intervention delivered after baseline. The primary fasting-insulin value and the secondary activity result are both recorded at baseline. The registry record does not report corresponding follow-up values for these measures in the posted results.

Analysis populations can also affect interpretation. For example, an analysis might include everyone assigned to a group or only participants with an available measurement. Which population was used for these posted comparisons, how missing observations were handled, and whether any participants were excluded are not reported in the registry record. It is therefore not possible to assess those choices from these summaries alone.

General statistical guidance is that continuous outcomes can be analyzed using methods that account for their distribution and study design. The posted summaries permit a simple unadjusted comparison, but the detailed model, distributional diagnostics, transformations, covariate adjustments, and any robust or nonparametric methods are not reported in the registry record. No assumption about those methods should be inferred from the arm summaries alone.

The primary comparison has no stated discrepancy between the posted recalculation and a sponsor analysis. The registry record does not give a detailed sponsor analysis for this baseline contrast. The posted estimate and interval should therefore be understood as the unadjusted summary-statistic comparison, not as a complete account of every analysis that may have been undertaken.

11. Confidence Intervals and Precision

The primary mean difference is 0.13 uIU/ml, with a 95% confidence interval from -1.633 to 1.893. A confidence interval gives a range of effect values reasonably compatible with the observed data under the method used. It communicates uncertainty around the estimate; it is not a range containing a known true value with certainty, nor does it assign a probability to each value in the interval.

For the primary baseline comparison, the interval includes zero and extends to negative and positive differences. Thus the estimate is not precise enough to rule out a baseline contrast in either direction. The interval’s breadth should be considered alongside the point estimate rather than treating the point estimate as an exact difference. The comparison is unadjusted, and the registry record does not report a model-based adjustment or further analysis details.

Precision is different from clinical importance. The confidence interval describes uncertainty about a group mean contrast; it does not establish what difference would matter clinically. A threshold for meaningful change is not reported in the registry record. Also, because fasting insulin was recorded at baseline, this interval is not uncertainty around a treatment effect or a change following counseling.

The secondary baseline activity comparison has its own confidence interval, but it too describes a baseline group contrast, not an intervention response. In general, the precision of an estimate depends on the amount of information and the variability of the outcome. The standard deviations indicate substantial spread in these continuous measures, and the interval is essential for understanding how much uncertainty remains around each estimate.

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 sample-size figures are planning illustrations based on the observed effect, not the trial’s original design calculation. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set at the stated fraction of the observed effect. The registry record does not report the trial’s original sample-size assumptions or justification.

The figures are participants per arm, not total participants and not total events. The 80% power column gives the illustrative number of participants per arm under the stated assumptions for an 80% chance of detecting the selected effect if that effect were the true one. The 90% power column expresses the same planning idea using a higher target probability of detection. These are design calculations, not a statement about what the completed trial achieved.

The planning rows consider the full observed effect and smaller fractions of it. Smaller effects are harder to distinguish from random variation, so the illustration requires more participants per arm as the target effect becomes smaller. The listed counts can be very large when the observed contrast is small, as is the case for the primary baseline comparison. Such figures should be read as sensitivity illustrations, not as recommended enrollment targets: the observed baseline difference may not be a relevant target for a later intervention effect.

This is not observed power. It is a prospective calculation using an effect estimate from the posted summary and stated planning assumptions. It does not report the probability that the trial’s actual analysis detected an effect, and it cannot replace interpretation of the estimate and confidence interval. The registry record does not state that these assumptions were used to design the trial.

13. How the Sample Size Is Derived

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

Formula

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

Worked calculation for this trial

1. Observed difference Δ = 0.130; pooled standard deviation σ = 7.199.
2. n = 2 × (1.96 + 0.842)² × 7.199² / 0.130² = 48,134.7, rounded up to 48,135 participants per arm for 80% power.

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

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.130000000000001                      # observed difference in means
sigma <- 7.19869300637275                     # 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(594399)
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 = 48,135 (80% power), 64,439 (90% power)
 75% of observed effect: n per arm = 85,573 (80% power), 114,558 (90% power)
 50% of observed effect: n per arm = 192,539 (80% power), 257,755 (90% power)
power.t.test: 48135.7 
Simulated power at n = 48,135 per arm: 0.800 (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 assesses several outcomes, time points, or comparisons. In general, the more statistical tests considered, the greater the chance that at least one will appear unusual by chance, even if there is no underlying effect. Procedures such as a prespecified outcome hierarchy or adjustment of significance thresholds can address aspects of this issue. The registry record does not report whether any such procedure was planned or used.

The record identifies fasting insulin as the primary outcome and lists physical activity and endurance as secondary outcomes. It reports three secondary outcome entries with the same title, but the posted secondary analysis information is limited. The number and structure of planned tests, any distinctions among time points, and whether all intended analyses are reported are not reported in the registry record. The unadjusted secondary p-value should therefore be interpreted with caution and not as a standalone confirmatory finding.

Missing-data handling is also important. If measurements are unavailable for some participants, the analysis may depend on how missingness is defined and handled. The registry record does not report the number of missing endpoint measurements, reasons for missingness, imputation procedures, or sensitivity analyses. The posted arm summaries do not establish whether all randomized participants contributed to the endpoint analysis.

The analysis population is not described in enough detail to determine whether the comparisons followed an intention-to-treat approach, included only participants with available measurements, or used another population definition. The trial’s detailed analysis plan, interim analyses, and rules for selecting analyses are not reported in the registry record. These omissions limit assessment of the full analysis process, but they do not alter the basic timing point: the posted primary comparison is at baseline rather than after the intervention.

15. Safety Results

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

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: while blowing leaves in his yard, his feet got tangled & he fell (0.8%), when the ra checked cprs for the patient's next schedule stated date of death (0.8%), one-third of patients left lung was removed. he was diagnosed with lung ca. (0.8%), via ct scan at regular visit to pulmonologist, discovered blood clot in lung. out of breath. (0.8%), shortness of breath - diagnosed with a heart attack. (0.8%).

The registry reports serious adverse event figures for both arms. The physical activity counseling arm lists 26 affected among 180 at risk, and the usual-care arm lists 11 affected among 122 at risk. These are raw posted counts with their listed at-risk denominators; they should not be converted into a comparative safety conclusion without additional information on event definitions, collection, follow-up time, and statistical analysis.

Other adverse events are listed for 158 among 180 at risk in the counseling arm and 50 among 122 at risk in the usual-care arm. The registry also lists several serious event terms, each marked 0.8%. The terms include a fall, a record of death, lung cancer, a pulmonary blood clot, a heart attack, and hospitalization for bronchitis and shortness of breath. The list is not enough to establish whether these terms represent separate participants, how events were adjudicated, or how they relate to the group-level affected counts.

Death counts are not reported in the registry record. The record does not provide enough detail to assess exposure duration, event severity beyond the serious classification, causality, or differences in ascertainment between arms. These figures describe what the registry lists; they do not by themselves establish that an event was caused by the intervention or provide a complete safety comparison.

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

The posted primary result says that the two randomized groups had similar observed mean fasting-insulin values at baseline, with substantial uncertainty around their estimated difference. The confidence interval includes differences in either direction, and the unadjusted p-value does not indicate a clear baseline contrast. This is a limited description of the groups at study entry.

It does not show whether physical activity counseling changed fasting insulin, glucose metabolism, activity, or endurance. The primary measure is recorded at baseline, and the posted secondary physical-activity measure is also at baseline. The registry record does not report follow-up results for these measures in the posted analyses. A trial designed to evaluate an intervention can only answer that question through an appropriate comparison of outcomes after exposure, often with attention to baseline values and the analysis plan.

The baseline comparison also does not prove that the groups were identical in every respect. Randomization can support comparable groups on average, but individual baseline measurements can differ by chance. A nonsignificant p-value is not a test of equivalence, and no equivalence margin is reported in the registry record. The confidence interval is the more direct guide to the range of baseline differences compatible with the data.

The registry’s study description and posted result should therefore be kept distinct. The description concerns a proposed evaluation of counseling over time; the statistics discussed for the primary endpoint are a baseline snapshot. Without post-intervention results, no conclusion about the intervention’s benefit, lack of benefit, or clinical effectiveness follows from this result. No medical advice can be drawn from these group summaries.

The same distinction applies to the secondary baseline activity result. It may describe an entry difference between the groups, but it cannot show that counseling produced that difference. Interpretation of intervention effects would require the relevant follow-up estimates, their uncertainty, the analysis population, and an understanding of the study’s prespecified analysis choices. Those details are not reported in the registry record.

17. Why This Trial Matters Statistically

This trial illustrates why the timing of an endpoint is as important as its label. Fasting insulin is identified as the primary measure, and it is a biologically relevant continuous marker for a study concerned with impaired fasting glucose. But the posted time point is baseline. The statistics therefore describe entry values rather than a response to the intervention. A reader who overlooks timing could mistake a baseline comparison for an efficacy analysis.

It also shows why estimates and intervals should be read together. The mean difference alone is small in the units reported, but the confidence interval extends across negative and positive values. Reporting both makes clear that the data do not pin down the baseline contrast precisely. A p-value alone would not convey that range or distinguish precision from clinical importance.

The design description and result record serve different purposes. The registry describes randomization, a behavioral counseling program, and usual care, while the posted statistics provide baseline group summaries. Interpreting a trial requires connecting the design’s question to the timing and analysis of the outcomes actually reported. When those do not align, the limitation is not repaired by the trial’s randomized design.

Finally, the planning illustration demonstrates that sample-size calculations depend on the effect selected for detection. A small observed contrast can produce very large illustrative enrollment requirements, but that does not tell us how the trial was designed or what effect it was intended to detect. The original design assumptions are not reported in the registry record. Keeping planning calculations separate from observed results prevents the figures from being mistaken for evidence of trial power or intervention success.

18. Limitations

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

The most important limitation for interpreting the primary result is that the posted fasting-insulin measurement is at baseline. The registry record does not provide a later primary outcome result or a change-from-baseline comparison in the posted results. This prevents the posted statistics from answering the intervention question described in the brief summary.

The result is an unadjusted comparison of group means from summary statistics. The registry record does not report the trial’s detailed analysis model, covariate adjustment, distributional checks, analysis population, or handling of missing endpoint data. It also does not report whether the baseline comparison was part of the trial’s prespecified analysis plan.

The intervention description is incomplete in the registry record: it ends during the description of quarterly mailed material. Further program details, adherence, uptake, and fidelity are not reported. The comparator is described as usual care, but the record does not detail care received during follow-up or whether it differed across clinics.

The record reports enrollment of 302, while its brief summary describes a proposed trial with n=300. These are presented as distinct registry statements; further explanation of the difference is not reported in the registry record. The original sample-size rationale, recruitment flow, attrition, and reasons for missing data are also not reported.

Secondary outcome information is limited, with baseline activity results and no posted follow-up comparison. The registry does not report a multiplicity plan, complete statistical analysis plan, interim-analysis details, or a full account of outcome reporting. Safety summaries list affected counts and event terms, but event timing, causality assessment, and detailed ascertainment are not reported. These gaps constrain interpretation of both intervention outcomes and safety.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Enhancing Fitness in Older Pre-diabetic Veterans — NCT00594399.
• Registry record last updated 2015-04-27; status last verified 2014-08.
• Results first posted 2015-01-09.
• 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 registry record describes NCT00594399, Enhancing Fitness in Older Pre-diabetic Veterans, as a completed randomized, parallel-group study without masking. It lists Phase 2 and Phase 3, enrollment of 302, a start in 2008-10, and primary completion in 2011-03. The brief summary describes a three-year trial of a one-year physical activity counseling intervention compared with usual care.

The primary result posted for interpretation is baseline fasting insulin. The unadjusted mean difference is 0.13 uIU/ml, with a 95% confidence interval from -1.633 to 1.893 and p = 0.885. Because the measure is at baseline, this result describes the groups at entry and is not an estimate of intervention effect. The registry record does not report the later primary outcome result in the posted analyses.

The record also lists baseline physical activity and endurance as a secondary outcome and provides a numerical baseline comparison. Follow-up secondary findings, the detailed statistical plan, missing-data methods, and the original sample-size justification are not reported in the registry record.