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 Intervention for the Prevention of Obesity in Preschool (NCT01539070), a randomized na study. The primary outcome is Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01539070 |
| Phase | NA |
| Condition | Childhood Obesity |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 306 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Coordinación de Investigación en Salud, Mexico |
| Results posted | Yes |
2. Clinical Question
Population
The study aimed to address obesity prevention among preschool children described as aged 2 to 4 years 11 months with risk of overweight or with overweight. For the primary outcome analysis, the registry record describes an intent-to-treat population of children aged 24 to 59 months with BMI z scores from 0 to 3, whose parents signed consent. These descriptions identify the intended age range and the population specified for analysis; they should not be treated as interchangeable eligibility definitions without further protocol information.
Intervention
The intervention was eating and physical-activity counseling. The intervention description says participants received a 6 week curriculum focused on obesity awareness and prevention. A trained nutritionist led workshops on diet, healthy growth and physical activity, while a health educator led workshops on healthy habits and routines in childhood. The available description does not fully explain every component or how consistently the curriculum was delivered.
Comparator
The comparator was usual care. The registry record describes care under an existing clinical practice guide within IMSS: a physician could refer an obese child to a nutritionist, provide general dietary advice, or, if considered necessary, send the child for blood lipid and glucose analyses. The description is truncated, so further details about usual care are not reported in the registry record.
Primary question
The primary outcome concerned change from baseline to 3 months in children’s consumption of foods, reported by parents and grouped into dietary categories. The statistical question is whether the recorded dietary measures changed differently by randomized assignment. The registry record does not report the outcome values or an estimated between-group effect, so the direction, size and precision of any difference cannot be assessed from the results described.
3. Trial Design
The registry record describes a randomized, parallel-group study with no masking. Its title is Intervention for the Prevention of Obesity in Preschool, and its official title describes the design and feasibility of a clinical-based intervention to prevent obesity in preschool children. The recorded enrollment is 306. The phase is listed as not applicable. The status is completed, with a start date of 2012-03 and primary completion date of 2013-04. The sponsor is Coordinación de Investigación en Salud, Mexico.
Participants were assigned to eating and physical-activity counseling or usual care. The intervention is described as a 6 week curriculum focused on obesity awareness and prevention, involving nutritionist-led workshops on diet, healthy growth and physical activity and health-educator-led workshops on healthy habits and routines. The available intervention description ends before all details are complete. Usual care was described in relation to the existing IMSS clinical practice guide. It could include physician dietary advice, referral to a nutritionist, or laboratory analyses when considered necessary. The recorded comparator description is also truncated.
The primary outcome was assessed from baseline to 3 months. Parents were asked about the average number of servings of specified foods consumed in a week or month. The registry record identifies an intent-to-treat analysis using multiple imputation for missing data and describes the analysis population as children aged 24 to 59 months with BMI z scores from 0 to 3 whose parents signed consent. The study’s broader aim refers to children aged 2 to 4 years 11 months with risk of overweight or overweight. The record does not explain the relationship between that aim and the narrower description of the primary analysis population.
The registry record lists a secondary outcome concerning the number of families completing 3 month follow-up in each group. It records 4 outcome measures and 12 analyses, but does not give the outcome results or detail the complete analysis plan. The rationale for the enrollment target, allocation procedures beyond randomization, masking procedures beyond the no-masking designation, and other protocol details are not reported in the registry record. Completion status alone does not establish that all planned measurements were collected or that the results were fully reported.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Of the 3095 (Ix n=2111; UC n=984) children initially screened, 1406 (Ix n=984; UC n=422) were eligible to participate and 306 (Ix n=168; UC n=138) agreed to participate. Of these 306, 189 (Ix n=93; UC n=96 control) participated in both the 3 and 6 month follow-up.
Overall Study
| Stage | Eating and Physical Activity Counseling | Usual Care |
|---|---|---|
| STARTED | 168 | 138 |
| COMPLETED | 109 | 99 |
| NOT COMPLETED | 59 | 39 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-treat analyses with multiple imputation to account for missing data. Were included in the analysis of children between 0 and 3 BMI z score, age between 24 and 59 months and parents signed letter of consent to participate in the 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.
| Characteristic | Unit | Eating and Physical Activity Counseling | Usual Care | Total |
|---|---|---|---|---|
| Participants analysed | 168 | 138 | 306 | |
| Age, Categorical: <=18 years | Participants | 168 | 138 | 306 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 3.34 (SD 0.84) | 3.42 (SD 0.82) | 3.38 (SD 0.83) |
| Sex: Female, Male: Female | Participants | 81 | 64 | 145 |
| Sex: Female, Male: Male | Participants | 87 | 74 | 161 |
| Region of Enrollment: Mexico | participants | 168 | 138 | 306 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment, measured over 0, 3 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Error |
| Unit | servings/week |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns change in children’s consumption of foods from baseline to 3 months, by randomized assignment. The measure is described as a mean, with servings per week as its unit and standard error as its stated measure of dispersion. Parents reported the average number of servings the child consumed in a week or month. The foods were grouped into categories including sweet snacks, fast food, savory snacks, fruit, vegetables, sugar-sweetened beverages and added sugar in beverages.
Dietary consumption is relevant to this study because the intervention was intended to change feeding practices and physical-activity patterns through counseling to mothers. Measuring reported food consumption can therefore describe one behavioral outcome related to that aim. It is not, by itself, a direct measure of obesity status, growth, or a clinical diagnosis. The registry record does not describe the primary endpoint as a single overall dietary score, and the listed outcome covers multiple food categories and time points rather than one reduced comparison.
The distinction between the stated unit and the reporting question matters for interpretation: the outcome unit is servings per week, while parents were asked about consumption in a week or month. The registry record does not explain how month-based reports were handled, how food reports were validated, or how serving size was standardized. It also does not report category-specific means, changes, uncertainty estimates, or between-group comparisons. As a result, the endpoint’s intended measurement can be described, but the observed dietary pattern and the precision of any estimated change cannot be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of eating and physical-activity counseling with usual care and specifies a dietary outcome measured from baseline to 3 months. It does not report the primary outcome values or a statistical estimate comparing the randomized groups. Consequently, there is no basis in the registry record for describing whether consumption increased or decreased in either group, whether the groups differed, or how large or precise any difference was.
The endpoint is not a single dietary quantity. It covers grouped food measures, and the record states that the primary outcome has several categories or time points that were not reduced to one comparison. A result for one category would not automatically represent all the others. For example, a change in one reported food group would not establish a corresponding change in another category. Without category-level results and an analysis plan explaining how the outcomes relate, the overall dietary finding cannot be summarized as a single direction of effect.
The outcome description reports means and standard errors. In general, a mean describes the average on the measured scale, while a standard error describes the precision of an estimated mean. Neither conveys the range of individual responses by itself. A confidence interval, if reported, would show a range of effects compatible with the data under the chosen statistical method. No primary-outcome estimates or confidence intervals are reported in the registry record, so neither the magnitude nor precision of the intervention contrast can be judged.
The registry record says that the primary analysis used an intent-to-treat approach and multiple imputation for missing data. These are relevant features, but their labels alone do not establish how the analysis was implemented. The record does not report the imputation model, the extent or pattern of missing primary outcome data, or sensitivity analyses. Those details affect how robustly the analysis addresses missing measurements.
The registry record also lists a secondary outcome concerning families completing 3 month follow-up, but does not report its result. Serious adverse event figures list zero affected participants in each group; deaths are not reported. These safety entries are limited to what the record contains and do not fill the gap in efficacy reporting. Overall, the available record supports a description of the trial question and planned or recorded methods, not a conclusion about the dietary effect of counseling.
9. Statistical Methods Explained
Statistical interpretation depends on distinguishing the trial design, the measured outcome, and the numerical result. The design identifies how groups were formed; the endpoint defines what was measured; the analysis estimates how the observed data relate to the research question. In this case, the record describes randomized assignment to counseling or usual care, and a primary outcome concerning parent-reported food consumption at baseline and 3 months. The outcome results needed to connect these elements are not reported in the registry record.
What does randomization contribute?
In general, randomization assigns participants to study groups by chance. Its purpose is to reduce systematic differences between groups at assignment, including differences that may not have been measured. It does not guarantee that groups will be identical, nor does it correct problems that arise after assignment, such as incomplete follow-up or differences in how outcomes are measured. A parallel-group design means each randomized participant is assigned to a group and the groups are compared over the study period. The registry record identifies randomization and a parallel model but does not report the sequence-generation method, allocation concealment procedure, or other implementation details.
The no-masking designation means the record does not identify masking. In general, masking can reduce the influence of expectations on care, reporting, or outcome assessment. Its relevance varies by outcome and by who is masked. Parent-reported dietary consumption may be affected by recall or reporting, and counseling participants know the content they receive. The registry record does not describe which people, if any, were unaware of assignment, or procedures used to limit measurement or reporting bias.
How should a mean and standard error be read?
In general, a mean is an average of measured values. The primary outcome is described as a mean of food consumption, expressed in servings per week. A mean can provide a compact description, but it does not show the full distribution of individual observations. The standard error describes the estimated precision of a mean, rather than the spread of individual measurements. A standard deviation, by contrast, describes variation among observations. The record specifies standard error as the dispersion measure but does not report the numerical means or standard errors for the primary outcome.
For a randomized comparison, a useful effect estimate would ordinarily state how the groups differ on the outcome, with an uncertainty interval. A confidence interval represents a range of values that are reasonably compatible with the observed data and the statistical model, under its assumptions. A narrow interval indicates greater precision than a wide interval, though interpretation also depends on the endpoint and context. The registry record reports no primary outcome effect estimate or confidence interval. It is therefore not possible to assess either the estimated contrast or its uncertainty.
Why do food categories matter?
The endpoint covers grouped measures of sweet snacks, fast food, savory snacks, fruit, vegetables, sugar-sweetened beverages and added sugar in beverages. These are distinct dietary measures, rather than repeated readings of one identical quantity. In general, each category may have a different distribution, reporting pattern and interpretation. Changes need not move in the same direction across categories. A summary across several outcomes requires a prespecified approach, such as defining one primary measure or explaining how multiple measures will be interpreted together. The registry record does not report such a summary rule, and the primary outcome is not reduced to one comparison.
The stated unit is servings per week, while parents were asked about average consumption in a week or month. In general, differences in recall period can affect comparability if reports are not collected or converted consistently. The record does not describe the handling of month-based reports, validation of parental reporting, or serving-size definitions. These gaps limit assessment of measurement reliability, even apart from the absence of outcome results.
What does multiple imputation do?
The record states that multiple imputation was used to account for missing data in the intent-to-treat analysis. In general, multiple imputation uses observed information to create several plausible completed datasets, analyzes each dataset, and combines the estimates to reflect uncertainty due to missing values. It can help avoid discarding every participant with an incomplete outcome, but it relies on assumptions about the relationship between missingness and observed information. It does not recover an unobserved value with certainty.
Important details include how much data were missing, which variables informed imputation, whether the imputation model matched the analysis, and whether conclusions changed under alternative assumptions. The registry record does not report those details. The label multiple imputation should therefore be read as a stated method, not as proof that missing data could not bias the estimated effect.
What do planning calculations represent?
In general, a sample-size calculation estimates the amount of information needed to detect a specified effect under stated assumptions. A planning illustration is not the same as observed power, and it does not establish what effect the trial actually found. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation, and a normal approximation; the target effect is expressed as a fraction of the observed effect. The registry record does not report the trial’s own sample-size justification. Without a reported primary effect estimate, the planning illustration cannot establish the clinical importance, reliability, or replicability of the trial result.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome includes several food categories and time points, and the registry record indicates that these were not reduced to one comparison. The record also lists 4 outcome measures and 12 analyses. When an analysis considers several outcomes or comparisons, the chance of obtaining at least one apparently notable result can rise if each is interpreted independently. In general, statistical methods can address multiplicity through prespecified primary outcomes, adjusted testing procedures, or a clear hierarchy of questions. The registry record does not report a multiplicity strategy or specify how the 12 analyses relate to the primary question.
This does not establish that any result is false or that the analysis was inappropriate. It means that results across multiple measures would need to be interpreted with attention to which comparisons were planned, which were exploratory, and whether uncertainty was adjusted or otherwise accounted for. The record does not report the primary outcome estimates or the analysis details needed to make that assessment.
The primary analysis is described as intent-to-treat with multiple imputation for missing data. In general, intent-to-treat analysis seeks to retain participants according to randomized assignment, preserving the comparison created by randomization. The registry record describes the analysis population as children aged 24 to 59 months with BMI z scores from 0 to 3 and parental consent. It does not explain how this population description relates to all randomized participants or report exclusions from the analysis.
Multiple imputation can use available data to address missing outcomes, but its validity depends on assumptions and model choices. The amount and pattern of missingness, variables included in imputation, and sensitivity analyses are not reported in the registry record. The secondary outcome concerning families completing 3 month follow-up is listed, but its result is not reported. Without follow-up results and missing-data details, the completeness of outcome measurement and the robustness of the analysis cannot be assessed.
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 |
|---|---|---|---|
| Eating and Physical Activity Counseling | 0 | 168 | 0.0% |
| Usual Care | 0 | 138 | 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 |
|---|---|
| Eating and Physical Activity Counseling | 0 of 168 |
| Usual Care | 0 of 138 |
The registry record lists serious adverse event figures for the eating and physical-activity counseling group and the usual-care group. The number at risk for serious events is recorded as 168 in the counseling group and 138 in usual care; the number affected is recorded as 0 in each group. These entries describe the posted serious-event counts and should be read as such, rather than as a complete account of every possible harm or unwanted event.
The deaths field is not populated for either group. A missing entry is not equivalent to a reported count of zero; deaths are therefore not reported in the registry record. The record also does not provide serious-event terms, and it does not describe the event definitions, collection procedures, observation period, or how adverse events were assessed. The absence of listed serious-event terms does not establish that all other types of events were assessed or absent.
In general, safety interpretation depends on what was monitored, how consistently information was collected, and how long participants were followed. The recorded figures can be stated, but they do not by themselves establish the completeness of safety surveillance or allow a broad comparison of all potential adverse outcomes. They should be kept separate from the primary dietary endpoint, for which outcome results are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
This trial record describes a randomized comparison of a counseling curriculum with usual care, aimed at preventing obesity among preschool children with risk of overweight or overweight. Its primary outcome concerns parent-reported consumption across food categories, measured from baseline to 3 months. The record also identifies an intent-to-treat analysis using multiple imputation for missing data. These details make the research question and some aspects of the analytic approach understandable.
What the record does not establish is the result of the primary comparison. There are no reported category-level consumption values, changes, between-group estimates, or uncertainty intervals. Without those statistics, the direction and magnitude of any observed dietary changes are unknown from the registry record. It is not possible to say whether the intervention group differed from usual care, how precise such a difference might have been, or whether any difference was consistent across dietary categories.
Even if dietary results were available, a change in reported food consumption would not by itself demonstrate a change in body weight, growth, or obesity status. The listed primary endpoint is dietary consumption, not a direct measure of those outcomes. The study aim describes prevention, but the aim is not evidence that the intended outcome occurred. Likewise, the completed status and the recorded enrollment do not substitute for results.
In general, a non-significant test, if one were reported, would not prove that groups were identical; its interpretation would depend on the estimated effect and uncertainty. Conversely, an apparently large estimate would need to be assessed for precision, measurement quality, multiplicity and missing-data assumptions. No such primary comparison is reported in the registry record. The sound reading is therefore limited: the record identifies the trial design, target population, counseling approach and dietary question, while leaving the central effectiveness estimate unavailable. The serious adverse-event entries are also limited and do not constitute a complete safety assessment.
13. Why This Trial Matters Statistically
This study is statistically relevant because it illustrates the difference between a clearly stated research question and a result that can be evaluated. Randomized allocation can support a comparative interpretation, but conclusions still require outcome estimates, uncertainty and adequate reporting of follow-up. The registry record identifies a randomized, parallel-group design and a defined dietary measurement period, yet does not report the primary outcome comparison. Design information alone cannot show the size or precision of an effect.
The endpoint also raises a common measurement issue in behavioral research: the primary question spans several related but distinct outcomes. Parent-reported servings across food categories may be informative about reported dietary patterns, but categories can behave differently and may have different reporting properties. A single broad claim about diet would require a defensible summary strategy or careful category-by-category interpretation. The record does not report a strategy that turns these measures into one overall result.
Missing-data handling is another important statistical feature. Intent-to-treat analysis and multiple imputation are stated, but the reasons for missingness, extent of incomplete follow-up, imputation model and sensitivity analyses are not reported. These are not minor technical details: they help readers judge whether estimates remain credible under plausible departures from assumptions.
Finally, the listed counts for serious adverse events need to be interpreted within the limits of the safety information recorded. A zero affected count in the listed fields is not equivalent to comprehensive evidence that no harms occurred. Together, the absent primary estimates, multiple outcome dimensions and limited reporting of missingness and safety show why transparent reporting is essential to statistical interpretation, particularly for behavioral interventions where both measurement and follow-up matter.
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 central limitation of the registry record for interpreting this trial is that it does not report the primary outcome results. No means, changes, group contrasts, uncertainty intervals or statistical tests are available for the dietary endpoint. The intervention effect therefore cannot be estimated or characterized from the recorded information.
The endpoint relies on parent reports of average food consumption over a week or month, while the stated unit is servings per week. The record does not explain how recall periods were harmonized, how serving sizes were defined, or whether the reports were validated. Self-reported dietary measures can be affected by recall and reporting, but the degree of any such issue in this study is not reported in the registry record.
The outcome covers several food categories and time points, and the record lists 12 analyses. It does not report the full statistical plan, the role of each analysis, or a multiplicity approach. This leaves uncertainty about how the primary question was distinguished from other comparisons and how multiple findings were intended to be interpreted.
Although intent-to-treat analysis and multiple imputation are stated, the missing-data proportion and pattern, imputation specification, and sensitivity analyses are not reported. The record also does not explain the relation between the broader target description of children aged 2 to 4 years 11 months with risk of overweight or overweight and the primary analysis population described as children aged 24 to 59 months with BMI z scores from 0 to 3 and parental consent.
Finally, the intervention and usual-care descriptions are incomplete, and details about allocation implementation, outcome assessment and safety monitoring are not reported in the registry record. These limitations constrain reproducibility and assessment of bias, beyond the absence of outcome estimates.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Intervention for the Prevention of Obesity in Preschool — NCT01539070.
- Registry record last updated 2014-04-22; status last verified 2014-03.
- Results first posted 2014-04-22.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed randomized, parallel-group study with no masking, sponsored by Coordinación de Investigación en Salud, Mexico. Enrollment is recorded as 306. The study compared eating and physical-activity counseling with usual care. The counseling curriculum lasted 6 weeks and included workshops on diet, healthy growth, physical activity, healthy habits and routines.
The primary outcome concerned change from baseline to 3 months in parent-reported consumption across food categories, with servings per week as the stated unit. The primary analysis is described as intent-to-treat with multiple imputation, among children aged 24 to 59 months with BMI z scores from 0 to 3 whose parents consented. The record lists a secondary follow-up completion outcome, 4 outcome measures and 12 analyses.
Primary outcome estimates are not reported in the registry record. Serious adverse event figures list 0 affected participants in each group; deaths are not reported. Details of the statistical plan, missing-data implementation, sample-size justification and complete intervention and comparator descriptions are also not reported in the registry record.