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 Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation (NCT00902694), a randomized na study. The primary outcome is Change in Weight Loss in Kilograms (kg).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00902694 |
| Phase | NA |
| Condition | Overweight and Obesity |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 291 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johns Hopkins University |
| Results posted | Yes |
2. Clinical Question
The trial asks whether a behavioral program combining weight counseling and physical activity, compared with health classes not focused on weight, is associated with a different change in weight among people receiving psychiatric rehabilitation. The registry describes the study as addressing people with serious mental illnesses and lists overweight and obesity as its condition. It does not specify a more detailed primary-outcome population in the registry record.
Population
People with serious mental illnesses in psychiatric rehabilitation, with overweight and obesity listed as the condition. The registry record does not report further eligibility details in the primary-outcome description.
Intervention
The ACHIEVE Intervention: group and individual weight counseling and group physical activity classes for 18 months.
Comparator
Control: group health classes held quarterly, with topics not related to weight.
Primary question
How does mean change in weight from baseline compare between the randomized groups at 6 and 18 months?
The registry record identifies change in weight in kilograms as the primary outcome and describes change from baseline to each follow-up time. It does not give numerical results for either time point. Therefore, the clinical question can be described from the planned comparison, but the posted record does not establish the size or precision of a difference in weight change. It also does not report the direction of any estimated difference.
3. Trial Design
This was a completed, randomized, double-masked, parallel-group trial with enrollment of 291 participants. The registry lists Johns Hopkins University as sponsor. The recorded start was 2008-04 and primary completion was 2012-09. The phase is listed as NA. The registry record does not provide further details about the randomization procedure, concealment, or how masking was implemented.
Participants were assigned to the ACHIEVE Intervention or Control. The intervention included group and individual weight counseling and group physical activity classes for 18 months. The control condition consisted of quarterly group health classes on topics not related to weight. This is an active comparison condition in the sense that the control description includes classes; the registry does not report how much contact participants actually received or whether attendance differed between groups.
The primary outcome was mean change in weight in kilograms from baseline to 6 months and from baseline to 18 months. Secondary outcomes covered exercise testing, waist circumference, blood pressure, lipids, cardiovascular risk, health status, and depression. The registry lists 8 outcome measures and 16 analyses. It does not provide the outcome estimates or analysis details needed to determine how all listed outcomes and time points were handled.
Enrollment and completion status describe the trial record, but do not by themselves establish how many participants contributed data to each analysis. The numbers analyzed at each follow-up, exclusions after randomization, and analysis population are not reported in the registry record. The record also does not describe the trial’s sample-size justification, planned interim analyses, or full statistical plan.
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
| Stage | ACHIEVE Intervention | Control |
|---|---|---|
| STARTED | 144 | 147 |
| COMPLETED | 137 | 142 |
| NOT COMPLETED | 7 | 5 |
Reasons for not completing this period:
| Reason | ACHIEVE Intervention | Control |
|---|---|---|
| Death | 1 | 3 |
| Lost to Follow-up | 1 | 0 |
| Censored per protocol | 3 | 1 |
| Pregnancy | 1 | 1 |
| Incarceration | 1 | 0 |
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.
| Characteristic | Unit | ACHIEVE Intervention | Control | Total |
|---|---|---|---|---|
| Participants analysed | 144 | 147 | 291 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 137 | 145 | 282 |
| Age, Categorical: >=65 years | Participants | 7 | 2 | 9 |
| Age, Continuous | years | 46.6 (SD 11.5) | 44.1 (SD 11.0) | 45.3 (SD 11.3) |
| Sex: Female, Male: Female | Participants | 74 | 72 | 146 |
| Sex: Female, Male: Male | Participants | 70 | 75 | 145 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 5 | 8 | 13 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 139 | 139 | 278 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): Asian | Participants | 3 | 1 | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 52 | 59 | 111 |
| Race (NIH/OMB): White | Participants | 82 | 81 | 163 |
| Race (NIH/OMB): More than one race | Participants | 5 | 5 | 10 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 144 | 147 | 291 |
| primary psychiatric diagnosis: schizophrenia | Participants | 44 | 41 | 85 |
| primary psychiatric diagnosis: schizoaffective disorder | Participants | 41 | 43 | 84 |
| primary psychiatric diagnosis: bipolar disorder | Participants | 28 | 36 | 64 |
| primary psychiatric diagnosis: major depressive disorder | Participants | 18 | 17 | 35 |
| primary psychiatric diagnosis: other | Participants | 13 | 10 | 23 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Weight Loss in Kilograms (kg), measured over 6 and 18 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | kg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in weight, measured in kilograms, from baseline to 6 months and from baseline to 18 months. The registry identifies the summary measure as a mean and the dispersion as a 95% confidence interval. No numerical mean changes, between-group contrasts, or confidence intervals are reported in the registry record.
Weight is a continuous measure: it can take values across a range rather than being limited to categories. Comparing average change allows the trial to describe how the groups’ weight measurements shifted relative to baseline. Considering follow-up at 6 and 18 months also distinguishes the earlier measurement from the later one; the two time points should not be treated as a single estimate.
In general, a confidence interval conveys uncertainty around an estimated quantity. Its width reflects the precision of that estimate under the analysis used. A confidence interval is not a guarantee that the true value lies within its limits, and interpretation depends on the estimand and analysis assumptions. Since the registry record does not report the endpoint estimates or interval limits, their magnitude, direction, and precision cannot be assessed from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the trial’s comparison and the intended primary measure, but does not report numerical primary-outcome results. It identifies mean weight change from baseline at 6 and 18 months, yet supplies no group means, between-group differences, confidence-interval limits, or test results. As a result, the posted record does not support a quantitative interpretation of weight change at either follow-up.
The primary outcome has more than one follow-up time point. The registry indicates that it is not reduced to a single comparison. This matters because a result at 6 months and a result at 18 months would answer related but distinct questions about change over different follow-up periods. Without the estimates and analysis details, it is not possible to determine whether the pattern was consistent across times, whether the investigators designated one time point as more important, or how they addressed multiple comparisons.
The record lists secondary outcomes involving exercise capacity, waist circumference, blood pressure, lipid measures, cardiovascular risk, health status, and depression. These outcomes broaden the scope of measurement, but their inclusion does not establish that results were favorable, unfavorable, or statistically distinguishable between groups. Numerical secondary-outcome results are not reported in the registry record.
The status is completed and the enrollment is 291, but neither fact gives the number of participants included in an outcome analysis. Follow-up data may be incomplete, and the analysis population can differ by outcome and time point. The registry record does not report missing-data counts, participant flow, or the analysis population. These omissions constrain interpretation because the precision and potential biases of an estimate depend partly on who contributed data and how missing measurements were handled.
The record’s sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations are not observed power and do not substitute for trial results. The numerical effect estimates needed to interpret those planning illustrations are not reported in the registry record.
Overall, the record allows a clear description of the randomized comparison and outcome framework, but not an assessment of the observed primary or secondary effects. It cannot establish the size or precision of any difference, nor can it show whether results were consistent across measures. These are limits of what the registry record reports, rather than evidence that the trial found no difference.
9. Statistical Methods Explained
The registry identifies a randomized, double-masked, parallel design. Randomization is intended, in general, to make treatment assignment independent of participants’ characteristics at the point of assignment. This supports a fair comparison of groups, although it does not ensure that every baseline characteristic is balanced in a particular trial. The record does not explain the allocation sequence or concealment procedures, so those implementation details cannot be evaluated.
In a parallel-group design, participants are assigned to one group and followed under that assigned condition. The described comparison is between the ACHIEVE Intervention and Control. Double masking indicates that masking was recorded, but the registry does not say which people were masked or how masking was maintained. Because the intervention includes counseling and physical activity classes while the control has health classes, the practical details of masking are not described in the registry record.
What does a mean change estimate describe?
The primary measure is a mean change in weight, a continuous outcome. A change score compares a follow-up measurement with baseline for each participant; the group mean summarizes those changes. A between-group comparison of mean change would describe the difference between group averages, but no such numerical comparison is reported in the registry record. The record names baseline-to-6-month and baseline-to-18-month changes, so each time point has its own comparison and estimate.
Mean change is not the only possible way to analyze repeated measurements. In general, a model might account for baseline values or the relationship among repeated observations. Different methods can yield different estimates or standard errors, particularly when the data are incomplete or when assumptions differ. The registry record does not report the model, covariate adjustment, or exact contrast used. It is therefore not possible to identify whether the posted endpoint was analyzed as a change score, with an adjusted model, or by another method.
How should a confidence interval be read?
The primary outcome lists a 95% confidence interval as its dispersion measure. In general, a confidence interval is a range calculated from data and an analysis method to express uncertainty about an estimate. A narrower interval indicates greater precision under the method’s assumptions; a wider interval indicates less precision. The interval should be interpreted alongside the estimated effect and the question being tested. No interval endpoints or primary estimates are reported in the registry record, so precision cannot be judged from this information.
A confidence interval is not a measure of the spread of individual participant outcomes. It concerns uncertainty about an estimated quantity. Nor does its stated confidence level alone tell whether the result is clinically important. That interpretation requires the actual estimate, its interval, and a justified threshold for meaningful change; such a threshold is not reported in the registry record.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a statistical model expects. If a model understates variability, standard errors can be too small and intervals can be too narrow. Appropriate methods may need to account for the actual variation or dependence in the data. The primary endpoint is continuous, and the registry does not report a model or diagnose over-dispersion. This general concept should not be read as a claim that over-dispersion occurred in this trial.
What do the planning assumptions mean?
The registry describes sample-size illustrations based on the observed effect, two-sided significance level 0.05, equal allocation, and a normal approximation. The illustrations are framed around detecting a stated fraction of the observed effect. In general, a planning calculation estimates how many participants may be required under specified assumptions to attain a target probability of detecting an effect under a chosen test procedure. It depends on the effect size, variability, significance level, allocation, and other assumptions.
These calculations are planning illustrations, not evidence about the trial’s actual power after completion. They are not observed power. Since the numerical observed effect and corresponding planning values are not reported in the registry record, those illustrations cannot be independently interpreted from the record. The trial’s own sample-size justification is not reported in the registry record, so the illustrations should not be mistaken for the design rationale used by investigators.
Finally, the record lists 8 outcome measures and 16 analyses. In general, multiple outcomes or analyses create multiple opportunities for apparently notable results. How to interpret them depends on prespecification, the hierarchy of outcomes, and any adjustment strategy. Those statistical-plan details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures and 16 analyses. The primary weight outcome is measured at 6 and 18 months, and the record notes that it is not reduced to a single comparison. Several secondary outcomes also cover distinct measures. When multiple outcomes, time points, or analyses are considered, the chance of observing an apparently unusual result across the full set can differ from the chance associated with an individual comparison. In general, a prespecified testing hierarchy or multiplicity adjustment can help clarify how confirmatory conclusions should be drawn.
The registry record does not report whether multiplicity was addressed, which comparisons were designated as primary for inference, or whether particular analyses were exploratory. It is therefore not possible to assess how the number of analyses influenced statistical interpretation. The count of analyses alone does not establish that any particular result is misleading; it identifies a context that requires the analysis plan and results for evaluation.
Missing-data handling and analysis populations are also not reported in the registry record. The record gives total enrollment, but not the number assessed at each follow-up, the number included in each analysis, reasons for missing measurements, or methods used to address missingness. In general, missing data can affect precision and can bias estimates when the probability of missingness is related to participant characteristics or outcomes. The direction and extent of any such effect depend on the data and assumptions.
The record does not state whether analyses followed randomized assignment, were restricted to participants with available measurements, or used another population definition. Without these details, readers cannot determine how the analysis population relates to the randomized groups or whether the approach preserves the benefits of randomization.
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 |
|---|---|---|---|
| ACHIEVE Intervention | 42 | 144 | 29.2% |
| Control | 47 | 147 | 32.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| ACHIEVE Intervention | 2 of 144 |
| Control | 3 of 147 |
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 |
|---|---|
| ACHIEVE Intervention | 0 of 144 |
| Control | 0 of 147 |
Most frequent serious adverse event terms
| Event term | Organ system | ACHIEVE Intervention | Control |
|---|---|---|---|
| psychiatric hospitalization | Psychiatric disorders | 21 of 144 | 30 of 147 |
| medical hospitalizations | General disorders | 26 of 144 | 19 of 147 |
Serious events with the highest arm-level rate: psychiatric hospitalization (20.4%), medical hospitalizations (18.1%).
The registry reports serious adverse-event figures by group. For the ACHIEVE Intervention, 42 participants were recorded as affected among 144 at risk; for Control, 47 were recorded as affected among 147 at risk. Deaths are listed as 2 for the ACHIEVE Intervention and 3 for Control. The record also lists 0 other adverse events in each group, with 144 and 147 at risk, respectively.
The record identifies psychiatric hospitalization at 20.4% and medical hospitalizations at 18.1% among the top serious terms. It does not explain the denominator or the method used to produce these percentages, nor does it assign these terms to a particular group in the listed summary. They should therefore be read as registry-reported terms and percentages, not as group-specific risks.
These figures are counts recorded for the registry’s adverse-event categories, not estimates of a causal effect. The record does not provide event timing, severity detail beyond the serious classification, participant-level overlap, adjudication procedures, or a statistical comparison between groups. A person may potentially contribute to more than one event category, but the record does not clarify how events or affected participants were counted. The figures alone cannot establish whether the groups differed in safety or whether a particular event was caused by an intervention.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of an 18-month behavioral lifestyle program with quarterly health classes unrelated to weight. It names mean weight change from baseline at 6 and 18 months as the primary outcome, with additional measures covering physical, cardiovascular, health-status, and depression outcomes. These details establish what the trial was designed to compare and measure.
The posted record does not include numerical primary-outcome estimates, confidence intervals, or test results. It also does not report numerical secondary-outcome findings. Consequently, it cannot show the direction, magnitude, or precision of any between-group difference. This absence should not be interpreted as evidence of no effect; it means the registry record does not report enough outcome information to make that assessment.
Even when outcome results are available, a statistical estimate and its uncertainty do not, by themselves, settle whether a difference is important to participants or clinically meaningful. Such judgments require context about the measure, relevant thresholds, and the overall evidence. A confidence interval can help show how compatible the data are with different effect magnitudes, but its interpretation depends on the analysis and the quality of the underlying data.
The record also lacks details about missing observations, analysis populations, model specification, and multiplicity. These omissions limit how fully readers can evaluate the reliability and scope of any results. Enrollment, completion status, and a randomized design are important descriptive features, but they cannot replace outcome estimates and analysis details.
The sound conclusion from this record is therefore limited: it documents the trial design, interventions, endpoints, selected secondary measures, and adverse-event counts, while leaving the quantitative treatment comparison unresolved in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable for its combination of a randomized parallel comparison and a continuous primary endpoint measured at more than one follow-up time. The outcome is mean change in weight from baseline at 6 and 18 months. That structure calls for clear reporting of the estimate and uncertainty at each time point, along with an explanation of how the two comparisons relate to the primary analysis.
The control condition is described as group health classes with topics unrelated to weight rather than as no contact. This comparison matters when interpreting what the randomized contrast represents: it contrasts the full ACHIEVE program with the recorded control activities, not simply participation in a program versus no classes. The registry does not report the actual amount of attendance or contact in either group, so implementation cannot be evaluated from these details.
The trial also lists multiple secondary measures and analyses. Such breadth can provide information across several domains, while making prespecification and multiplicity methods important for distinguishing confirmatory findings from exploratory patterns. Those methods are not reported in the registry record. The record also does not report the participant counts contributing data to each outcome, an important part of interpreting precision and missing-data risk.
For statistical readers, the central lesson is that a defined randomized design and named endpoint are not sufficient to interpret an effect. Outcome estimates, confidence intervals, analysis methods, participant flow, and multiplicity decisions are needed to understand what the data support. Because these quantitative results and methods are absent from the registry record, the record supports description of the question and design, but not a conclusion about the estimated weight-change contrast.
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 leaves several trial-specific limitations of interpretation. It gives the primary endpoint and follow-up times but does not report the group-specific mean changes, between-group estimates, confidence-interval limits, or statistical test results. The direction, magnitude, and precision of the primary comparison therefore cannot be assessed.
The record lists 8 outcome measures and 16 analyses, but does not describe the prespecified analysis hierarchy or any adjustment for multiple comparisons. It also does not report which outcomes were available for each participant, how missing observations were handled, or how analysis populations were defined. These gaps prevent evaluation of whether estimates may have been affected by selective availability or analytic choices.
Details needed to assess implementation are limited. The record does not explain the randomization process, allocation concealment, who was masked, adherence to either program, or the actual frequency and duration of participant contact. The program description specifies 18 months of counseling and activity classes, while the control description specifies quarterly health classes; implementation and exposure are not quantified.
The adverse-event summary gives group counts and selected serious-event terms, but does not report event timing, participant overlap across categories, attribution, or comparative analyses. The listed percentages are not accompanied by a stated denominator. They should not be interpreted as group-specific risks without that context.
The registry record does not report the trial’s sample-size justification or interim analyses. Its planning assumptions do not establish the rationale used to design the trial. These are reporting limitations for interpreting the record; they do not imply that the underlying trial lacked procedures or analyses that were simply not recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation — NCT00902694.
- Registry record last updated 2025-07-30; status last verified 2025-07.
- Results first posted 2025-07-30.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
This completed, randomized, double-masked, parallel-group trial enrolled 291 participants and was sponsored by Johns Hopkins University. The recorded study start was 2008-04, and primary completion was 2012-09. The phase is listed as NA, and overweight and obesity are listed as conditions.
The ACHIEVE Intervention consisted of group and individual weight counseling and group physical activity classes for 18 months. Control participants received quarterly group health classes on topics unrelated to weight. The primary outcome was mean change in weight in kilograms from baseline to 6 and 18 months. Secondary measures included exercise testing, waist circumference, blood pressure, lipids, cardiovascular risk, health status, and depression.
Numerical primary and secondary outcome estimates, confidence intervals, analysis populations, missing-data methods, and multiplicity procedures are not reported in the registry record. Serious adverse-event counts are listed by group, along with deaths and selected serious-event terms. The record describes the study question and design, but does not provide the quantitative outcome results required to assess the estimated group differences.