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 Study of the Validity of Using the MEQ to Measure Mindful Eating in Pregnant Women (NCT01734655), a registered phase not stated study. The primary outcome is Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01734655 |
| Phase | Phase not stated |
| Condition | Pregnancy |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pennington Biomedical Research Center |
| Results posted | Yes |
2. Clinical Question
The study addresses whether the Mindful Eating Questionnaire (MEQ) is understandable and suitable for use with pregnant women, and whether responses are consistent when the questionnaire is repeated. The registry describes qualitative assessment of the questionnaire’s content and comprehension, alongside a test-retest reliability outcome. It also planned to collect other questionnaire data for convergent and discriminant validity.
Population
Pregnant women were the population of interest. The study enrolled 40 participants. The project description says participants were intended to be similar in age, ethnicity, education, and marital status to women targeted for recruitment in the parent study; further eligibility details are not reported in the registry record.
Intervention
There was no treatment intervention described. Participants completed the MEQ, the Eating Inventory Questionnaire, the Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS), and then responded to the MEQ items and response choices. The study also included a focus group and cognitive interviews.
Comparator
No like-for-like control group or randomized comparison is described. The registry identifies an All Participants group, and allocation is not stated. The repeated MEQ assessment at screening and a study visit is used to assess consistency over time, rather than to compare treatments.
Primary question
What test-retest reliability coefficient was observed for the MEQ between screening and the study visit, and how precisely was it estimated? The visits were separated by a minimum of 24 hours and a maximum of 5 months. The coefficient and its uncertainty are not reported in the registry record.
3. Trial Design
This is a completed questionnaire evaluation study in pregnant women, registered as NCT01734655. Its title concerns the validity of using the MEQ to measure mindful eating in pregnant women; the official title describes a qualitative evaluation of the questionnaire. The registry lists Pregnancy as the condition, Pennington Biomedical Research Center as the sponsor, and an enrollment of 40.
The project description emphasizes content validity and qualitative evaluation. It describes a focus group with 10 participants followed by 30 individual cognitive interviews. Interview comments were to be analyzed systematically for each of the 28 MEQ questions. The interviewer was to use findings from initial interviews to inform subsequent interviews. The assessment was intended to address comprehension, retrieval, judgment, and response, and to report strengths, weaknesses, relevance, comprehensiveness, and interpretations for each item.
Participants were asked to complete the MEQ and three other questionnaires: the Eating Inventory Questionnaire, MAAS, and NEWS. The registry also describes sequential responses to the MEQ items and response choices. The primary outcome is test-retest reliability, assessed using the MEQ at screening and at a study visit. The timeframe permits a minimum of 24 hours and a maximum of 5 months between visits.
The study started in 2012-11, had primary completion in 2014-12, and is listed as completed. Allocation is not stated, and the registry does not describe a randomized treatment comparison. Additional protocol details, including the exact timing of all interviews and the full recruitment procedures, 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.
Overall Study
| Stage | Participants |
|---|---|
| STARTED | 40 |
| COMPLETED | 40 |
| NOT COMPLETED | 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.
Population: All participants were pregnant women between the ages of 18-40 with a self-reported pre-pregnancy BMI between 25 and 40. All women had a singleton pregnancy and were otherwise healthy.
| Characteristic | Unit | All Participants |
|---|---|---|
| Participants analysed | 40 | |
| Age, Continuous | years | 30 (SD 4) |
| Sex: Female, Male: Female | Participants | 40 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 40 |
| Pre-pregnancy BMI | kg/m2 | 30.0 (SD 4.1) |
| Pre-pregnancy Body Weight | kg | 83.5 (SD 17.6) |
| Gestational Age | weeks | 19.9 (SD 8.3) |
| Current BMI | kg/m2 | 31.8 (SD 4.7) |
| Current Body Weight | kg | 86.5 (SD 14.9) |
6. Primary Endpoint
The registry lists the primary outcome as Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ), measured over SV and V1; minimum of 24 hours between visits, maximum of 5 months between visits.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | test-retest coefficent |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the test-retest reliability of the MEQ, expressed as a coefficient. Participants completed the questionnaire at screening and again at a study visit. The interval between visits was a minimum of 24 hours and a maximum of 5 months. The registry describes this repeated measurement as an effort to establish whether MEQ responses are reliable over time.
General statistical explanation: Test-retest reliability concerns the consistency of measurements when the same instrument is administered to the same people on separate occasions. A reliability coefficient summarizes some aspect of that consistency. Its meaning depends on the particular coefficient and analysis method: some approaches emphasize agreement in scores, while others emphasize whether participants retain their relative ordering.
The coefficient type, its observed value, and any confidence interval are not reported in the registry record. The record therefore does not establish how strong the estimated repeatability was or how precisely it was measured. The interval between administrations also matters to interpretation: a shorter interval may limit real change between measurements, while a longer interval may allow genuine changes in the underlying characteristic. The registry gives the possible interval but does not report each participant’s actual interval or describe how interval variation was handled.
Reliability is distinct from validity. A measure can produce consistent responses without necessarily capturing the intended concept. The study description accordingly includes qualitative evaluation of item meaning and questionnaire content, as well as plans to examine convergent and discriminant validity using other questionnaires.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes the study’s purpose and planned assessments, but it does not report the primary test-retest coefficient. Consequently, the posted record does not permit an assessment of the magnitude of MEQ repeatability in this sample. It also does not report a confidence interval or other measure of uncertainty for that coefficient. Without those results, neither the strength nor the precision of the primary reliability estimate can be characterized.
The project’s qualitative component was designed to investigate whether pregnant women understood and interpreted MEQ items as intended. The description identifies comprehension, retrieval, judgment, and response as areas for cognitive evaluation. It also states that comments would be analyzed for each of the 28 questions and used to describe item strengths, weaknesses, relevance, comprehensiveness, and interpretations. These are stated aims; the registry record does not report the resulting interview findings.
The study also planned to collect the Eating Inventory Questionnaire, MAAS, and NEWS for traditional validation parameters, including convergent and discriminant validity. The registry record does not report those validity results or specify which questionnaire relationships were expected. It lists six outcome measures and three analyses, but their complete definitions and results are not reported in the registry record.
General statistical explanation: A reliability coefficient should be interpreted in light of how it was calculated, the scale of the scores, the intended use of the instrument, and the population in which it was assessed. An estimate without an uncertainty interval can be difficult to distinguish from a less precise estimate. The assessment interval is also relevant because responses may differ due to measurement instability, changes in participants’ circumstances, or both. The registry reports a broad allowable interval from a minimum of 24 hours to a maximum of 5 months, but does not describe the observed intervals or any adjustment for them.
The study is not a randomized comparison of treatments. Its design and registry outcomes concern questionnaire assessment, not effects of a clinical intervention. The All Participants group and the absence of a stated allocation do not support a treatment-versus-control interpretation. The registry lists 40 enrolled participants, but it does not report how many contributed usable data to the primary analysis. Thus, even the analysis population for the reliability estimate cannot be identified from the record.
Overall, the registry supports a description of what the study intended to evaluate, but not a conclusion about the measured reliability or validity results. The completed status indicates that the study is listed as completed; it does not substitute for numerical outcome findings.
9. Statistical Methods Explained
General statistical explanation: Measurement studies ask whether an instrument captures a construct in a useful and reproducible way. Reliability concerns consistency; validity concerns whether the measure is appropriate for its intended interpretation. These concepts are related but not interchangeable. A consistent score is not, by itself, evidence that the questionnaire measures the intended aspect of mindful eating.
What does test-retest reliability assess?
Test-retest reliability compares measurements from repeated administrations of the same instrument. In this study, the MEQ was given at screening and at a study visit. The primary outcome is described as a test-retest coefficient. Depending on the statistical method, such a coefficient may reflect agreement between repeated scores or the consistency of participants’ relative positions. The registry record does not identify the coefficient used, the score construction, or the statistical model. These omissions prevent a more specific interpretation of the endpoint.
Repeatability also depends on the interval between assessments and on whether the underlying construct is expected to remain stable over that interval. The registry allows a minimum of 24 hours and a maximum of 5 months between visits. A short interval can make recall of earlier answers relevant, while a longer interval can allow genuine changes in the measured characteristic. These are general considerations, not reported findings about participants in this study. The record does not state how actual visit intervals were distributed or whether they were considered analytically.
How do the interviews contribute?
The qualitative work addresses how participants understand and answer questionnaire items. The planned focus group and individual cognitive interviews were intended to elicit comments about MEQ questions and response options. The project description specifies comprehension, retrieval, judgment, and response as areas of interest. In general, comprehension concerns how a person understands a question; retrieval concerns how relevant information is recalled; judgment concerns how that information is evaluated; and response concerns how the person maps the judgment to an available answer.
The description says interview comments would be summarized and analyzed systematically for each of the 28 MEQ questions, with insights from earlier interviews informing later interviews. This iterative approach can help identify unclear wording, missing concepts, or response options that do not fit participants’ interpretations. The record does not report the analytic framework in greater detail, how interviewers were trained, how disagreements were handled, or the resulting themes. The planned qualitative assessment therefore should not be mistaken for reported evidence that particular items were clear or problematic.
What do convergent and discriminant validity mean?
General statistical explanation: Convergent validity asks whether a measure relates to other measures in ways consistent with the intended construct. Discriminant validity asks whether it remains distinguishable from measures of different constructs. Participants were asked to complete the Eating Inventory Questionnaire, MAAS, and NEWS in addition to the MEQ, and the project description says these data would support traditional validation parameters. The registry does not report the hypothesized relationships, analytic procedures, estimated associations, or findings. No direction or magnitude of association can therefore be inferred.
How should precision and planning be understood?
General statistical explanation: A confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. It helps distinguish an estimate that is comparatively precise from one compatible with a broad range of values. The registry does not report a confidence interval for the reliability coefficient, so its precision cannot be assessed from the record.
The stated sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Those assumptions do not describe the study’s own design, which is not a randomized comparison. No sample-size justification for this questionnaire study is reported in the registry record. Planning illustrations are hypothetical design calculations, not observed power, and they cannot replace reporting the actual estimate, its uncertainty, and the number of participants included in the analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures and three analyses, but it does not report their complete definitions or analysis results. The primary outcome is test-retest reliability of the MEQ. The project also describes qualitative assessment of each of the 28 MEQ questions and planned convergent and discriminant validity work using other questionnaires. These multiple aims create several possible opportunities for analysis, but the registry record does not state whether multiplicity was addressed or whether any outcome was designated as secondary beyond the listed primary outcome.
General statistical explanation: When many outcomes, questionnaire items, or statistical comparisons are examined, the chance of finding an apparently notable result by chance can increase. An analysis plan may address this through prespecified primary outcomes, adjustment methods, or a clearly exploratory interpretation. Which approach is appropriate depends on the questions and methods. The registry record does not report a multiplicity strategy, a prespecified hierarchy among the other outcomes, or whether item-level findings were intended to be confirmatory or descriptive.
Missing-data procedures are not reported in the registry record. The record does not say how incomplete questionnaires, missed visits, or unavailable interview responses were handled. It also does not state whether the reliability analysis required complete responses at both administrations or how partially completed items were scored.
The analysis population is not described. Although enrollment is listed as 40, the number contributing data to the primary reliability analysis and to the interview assessments is not reported in the registry record. The registry does not explain exclusions, withdrawals, or how participants were selected for each component. Interim analyses and a broader statistical analysis plan are also not reported in the registry record. These omissions limit assessment of whether the reported analyses, if available elsewhere, would reflect the intended analysis strategy.
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 |
|---|---|---|---|
| All Participants | 0 | 40 | 0.0% |
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 |
|---|---|
| All Participants | 2 of 40 |
Most frequent non-serious adverse event terms
| Event term | Organ system | All Participants |
|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | 1 of 40 |
| Vaginal Spotting | Pregnancy, puerperium and perinatal conditions | 1 of 40 |
The registry reports serious adverse events for the All Participants group as 0 affected among 40 at risk. It reports other adverse events as 2 affected among 40 at risk. These figures describe event reporting in the registry; they do not establish that an event was caused by study participation. The record does not provide the event terms, and no top serious-event terms are listed.
The death count is not reported in the registry record. The event observation period, definitions used for serious and other adverse events, and methods for collecting events are also not reported in the registry record. The figures should therefore be read as the reported counts for this study, not as a complete account of every possible event or as a comparative safety estimate.
This study does not describe a randomized treatment comparison. The All Participants group is not a treatment arm compared with a control arm, and the adverse-event figures cannot establish differences between treatments. The registry record also does not provide detail about severity or timing for the other adverse events. These limitations matter when interpreting event counts, particularly in a study focused on questionnaire evaluation rather than a treatment effect.
12. What the Result Does, and Does Not, Mean
The record describes a completed project intended to evaluate the MEQ for use in pregnant women. Its aims combine qualitative assessment of questionnaire content with a test-retest reliability assessment and planned comparisons with other questionnaires. The registry provides useful information about the questions the project set out to study, including item comprehension and response processes.
It does not, however, report the primary reliability coefficient or its uncertainty. It also does not report the qualitative findings, the convergent or discriminant validity results, or the detailed outcomes for the listed analyses. The record therefore cannot establish whether the MEQ showed strong or weak repeatability in this sample, whether participants interpreted particular items as intended, or how MEQ scores related to the other questionnaires.
General statistical explanation: Reliability and validity evidence is specific to the instrument, the population, the administration conditions, and the intended interpretation. Findings from a questionnaire assessment in pregnant women would not automatically establish measurement performance in every other population or setting. Nor does a reliability result alone establish that an instrument measures the intended construct.
The study should not be interpreted as a test of a clinical treatment. It has no stated allocation and no like-for-like control comparison; the registry describes questionnaire completion, a focus group, and cognitive interviews. The adverse-event counts likewise do not compare treatments or establish causation. The posted results cannot support a treatment-effect conclusion.
In short, the registry establishes the study’s stated purpose, design elements, and endpoint definition, but not the numerical measurement findings needed to judge the results. The completed status is not itself evidence that the instrument met its aims. A fuller interpretation would require the primary coefficient, its precision, analysis-population details, and the reported qualitative and validity findings.
13. Why This Trial Matters Statistically
This study matters statistically because evaluating a questionnaire requires more than calculating a score. Researchers need evidence that participants understand the items, can retrieve and assess relevant information, and can choose responses that represent their judgments. The planned focus group and cognitive interviews address these measurement processes directly, while the repeated MEQ assessment addresses consistency over time.
The project also illustrates why reliability and validity should be considered together. Test-retest reliability concerns repeatability, whereas content evaluation and planned convergent and discriminant validity work concern whether the instrument’s content and relationships with other measures support its intended use. Neither type of evidence substitutes for the other. A questionnaire may be repeatable yet still require scrutiny of item meaning and relevance.
The registry’s description is particularly relevant to interpretation because the study was designed around pregnant women and the project aimed to evaluate item appropriateness in that population. The qualitative approach can surface misunderstandings that aggregate scores alone may not reveal. At the same time, the registry does not report the resulting interview themes or the primary reliability estimate, so the methodological aims cannot be treated as demonstrated findings.
More broadly, the record shows the importance of complete outcome reporting in measurement studies. A named endpoint is not enough to assess performance: readers also need the estimate, its uncertainty, the analysis population, and sufficient information about scoring and analysis. Without those details, the study’s statistical contribution remains difficult to evaluate from the registry record.
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 main limitation for interpreting the registry record is that the primary test-retest coefficient is not reported. Its confidence interval, calculation method, scoring details, and analysis population are also not reported in the registry record. As a result, the central quantitative endpoint cannot be evaluated for magnitude or precision.
The record describes the qualitative plan but does not report its findings. It does not provide interview themes, item-level conclusions, or results concerning comprehension, retrieval, judgment, and response. Similarly, it describes plans for convergent and discriminant validity but does not report the analyses or results. Six outcome measures and three analyses are listed, but their full definitions and findings are not available in the registry record.
Some design details are also absent. Allocation is not stated, and the registry does not describe a randomized comparison. The allowable interval between MEQ administrations spans a minimum of 24 hours to a maximum of 5 months, but the actual intervals and their analytic handling are not reported. The record does not report missing-data procedures, participant flow, reasons for nonparticipation or withdrawal, or the number contributing to each analysis.
The study description concerns pregnant women, and the project aimed to recruit participants similar in age, ethnicity, education, and marital status to women targeted for the parent study. Further population details and recruitment procedures are not reported in the registry record. Generalization beyond the studied population therefore cannot be assessed from this information. Finally, the registry’s completed status does not resolve these reporting gaps or establish that the stated measurement aims were achieved.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of the Validity of Using the MEQ to Measure Mindful Eating in Pregnant Women — NCT01734655.
- Registry record last updated 2017-07-25; status last verified 2017-06.
- Results first posted 2016-03-03.
- 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
NCT01734655 is a completed study sponsored by Pennington Biomedical Research Center. The registry lists Pregnancy as the condition and enrollment of 40. The study started in 2012-11, with primary completion in 2014-12.
The project aimed to evaluate the MEQ for pregnant women through a focus group, individual cognitive interviews, and other questionnaire assessments. The primary outcome is the MEQ test-retest reliability coefficient, based on administration at screening and a study visit separated by a minimum of 24 hours and a maximum of 5 months.
The primary coefficient, its precision, and the qualitative and validity findings are not reported in the registry record. Allocation is not stated, and no randomized treatment comparison is described. The record lists serious adverse events as 0 affected among 40 at risk and other adverse events as 2 affected among 40 at risk; deaths are not reported in the registry record.