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 Healthy Homes, Healthy Habits (NCT03433456), a randomized na study. The primary outcome is Weight of Mothers.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03433456 |
| Phase | NA |
| Condition | Obesity, Obesity, Childhood, Obesity; Familial |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 296 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Alabama at Birmingham |
| Results posted | Yes |
2. Clinical Question
Population
Low-income mothers and children reached through ongoing home visitation programs. The registry record reports enrollment of 296, but detailed eligibility criteria and the characteristics of participants at baseline are not reported in the registry record.
Intervention
Home visitation plus the HABITS program. Its module addressed physical activity, fruit and vegetable consumption, sugary beverages, fried foods, and regular self-monitoring and self-weighing, with the aim of reducing obesity risk among mothers or primary caregivers and children.
Comparator
Standard home visitation without the HABITS module. The comparator was the standard home visitation program delivered through the existing service.
Primary question
Did adding HABITS to home visitation affect mothers’ body weight over the planned assessment period? The primary outcome was weight in kilograms, assessed at baseline, 6 months, and 12 months. The registry record does not report the weight results or an estimated difference between groups.
The trial addresses whether a behavior-focused module can be evaluated within an existing home-visitation setting. Its central comparison is not home visitation versus no home visitation: both groups received home visitation, while the additional HABITS module distinguishes the intervention group. This distinction matters when interpreting any eventual contrast, because it concerns the added program in the context of the services both groups received.
The registry record also identifies outcomes related to targeted habit strength and household food and activity environments. Those measures broaden the study’s focus beyond weight, but their numerical findings are not reported in the registry record. Accordingly, the available record supports describing the trial’s question and planned measures, not deciding whether either group changed more or whether a difference was precise.
3. Trial Design
Healthy Homes, Healthy Habits was a randomized, parallel-group trial sponsored by the University of Alabama at Birmingham. The registry record classifies it as single-masked. It does not identify who was masked, how the random sequence was generated, or how assignment was concealed; those details are not reported in the registry record. The phase is recorded as not applicable.
The two behavioral interventions were home visitation plus the HABITS program and standard home visitation. The HABITS module targeted five behaviors: physical activity, more fruit and vegetable consumption, fewer sugary beverages, fewer fried foods, and regular self-monitoring and self-weighing. The comparator received standard home-visitation services without that module. The registry describes delivery in the context of home-visitation services for low-income families.
Enrollment was 296. The record gives a study start date of 2019-12-02, a primary completion date of 2023-02-27, and a completed status. It does not report the number randomized to each arm, the number completing each assessment, or the reasons for withdrawal. Participant flow and adherence to the intervention are not reported in the registry record.
The primary outcome was maternal weight in kilograms, with assessments at baseline, 6 months, and 12 months. The record notes that some participants were unable to complete the 6-month assessment because of the COVID-19 pandemic. The size and characteristics of the group with missing assessments, and how those missing observations were handled, are not reported in the registry record.
These design features define a comparison over time between two active service settings. They do not, by themselves, establish that the groups were comparable after randomization or that the planned outcome analysis was completed. The registry record does not report a statistical analysis plan or numerical results for maternal weight.
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 | Home Visitation + HABITS Program | Standard Home Visitation Program |
|---|---|---|
| STARTED | 158 | 138 |
| Caregivers Started | 79 | 69 |
| Children Started | 79 | 69 |
| Caregivers Completed | 71 | 63 |
| Children Completed | 71 | 63 |
| COMPLETED | 142 | 126 |
| NOT COMPLETED | 16 | 12 |
Reasons for not completing this period:
| Reason | Home Visitation + HABITS Program | Standard Home Visitation Program |
|---|---|---|
| Death | 1 | 1 |
| Lost to Follow-up | 14 | 11 |
| Pt in ICU and unable to complete follow-up visit | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: At 6-month visit, some participants unable to complete assessment due to COVID-19 pandemic.
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 | Home Visitation + HABITS Program | Standard Home Visitation Program | Total |
|---|---|---|---|---|
| Participants analysed | 158 | 138 | 296 | |
| Age, Categorical: Caregivers – <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Caregivers – Between 18 and 65 years | Participants | 79 | 68 | 147 |
| Age, Categorical: Caregivers – >=65 years | Participants | 0 | 1 | 1 |
| Age, Categorical: Children – <=18 years | Participants | 79 | 69 | 148 |
| Age, Categorical: Children – Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Children – >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous: Caregivers | Years | 31.52 (SD 6.83) | 32.52 (SD 9.66) | 31.98 (SD 8.26) |
| Age, Continuous: Children | Years | 2.71 (SD 1.24) | 2.59 (SD 1.22) | 2.66 (SD 1.22) |
| Sex: Female, Male: Caregivers – Female | Participants | 78 | 69 | 147 |
| Sex: Female, Male: Caregivers – Male | Participants | 1 | 0 | 1 |
| Sex: Female, Male: Children – Female | Participants | 40 | 34 | 74 |
| Sex: Female, Male: Children – Male | Participants | 39 | 35 | 74 |
| Ethnicity (NIH/OMB): Caregivers – Hispanic or Latino | Participants | 6 | 3 | 9 |
| Ethnicity (NIH/OMB): Caregivers – Not Hispanic or Latino | Participants | 73 | 66 | 139 |
| Ethnicity (NIH/OMB): Caregivers – Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Children – Hispanic or Latino | Participants | 6 | 2 | 8 |
| Ethnicity (NIH/OMB): Children – Not Hispanic or Latino | Participants | 73 | 67 | 140 |
| Ethnicity (NIH/OMB): Children – Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Caregivers – Black or African American | Participants | 60 | 53 | 113 |
| Race (NIH/OMB): Caregivers – White | Participants | 15 | 11 | 26 |
| Race (NIH/OMB): Caregivers – More than one race | Participants | 1 | 4 | 5 |
| Race (NIH/OMB): Caregivers – Unknown or Not Reported | Participants | 3 | 1 | 4 |
| Race (NIH/OMB): Children – American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Children – Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Children – Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Children – Black or African American | Participants | 61 | 55 | 116 |
| Race (NIH/OMB): Children – White | Participants | 14 | 8 | 22 |
| Race (NIH/OMB): Children – More than one race | Participants | 2 | 6 | 8 |
| Race (NIH/OMB): Children – Unknown or Not Reported | Participants | 2 | 0 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Weight of Mothers, measured over Baseline, 6 months, 12 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Kilograms |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is mothers’ body weight, measured in kilograms at baseline, 6 months, and 12 months. Weight is a continuous measure: it can take a range of values rather than placing participants into a limited set of categories. The registry record specifies that the measure is to be summarized as a mean with a standard deviation. It describes body weight at baseline and follow-up assessments.
Weight is relevant to the trial’s stated objective of evaluating an intervention intended to address obesity risk and weight gain among mothers and children. A continuous measure can represent changes across the range of observed weights, rather than only whether participants cross a chosen threshold. The mean describes the central level of weight in a group, while the standard deviation describes how spread out individual measurements are around that mean. These are descriptive summaries; neither alone establishes a difference attributable to the intervention.
Repeated assessment allows weight to be considered at baseline and follow-up, but interpretation depends on the analysis used to compare groups and account for measurements over time. The registry record does not report the observed group means, standard deviations, change estimates, confidence intervals, or statistical tests. It therefore does not establish the direction, size, or precision of any weight difference.
The record specifically notes that some participants could not complete the 6-month assessment because of the COVID-19 pandemic. Missing outcome data can affect the interpretation of a repeated-measure comparison, particularly if the available measurements do not represent all enrolled participants. The extent of missingness and the method used to address it are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison and a primary outcome, but it does not report the primary outcome results. No arm-specific mean weights, standard deviations, changes from baseline, between-group estimates, confidence intervals, or p-values are reported in the registry record. As a result, the statistical evidence for a difference in maternal weight cannot be assessed from this record.
The intended comparison concerns adding the HABITS module to standard home visitation, not replacing home visitation with a different service. The intervention included several behavior targets, so a potential difference in weight would reflect the program as delivered in that setting. The record does not provide adherence information or results for the behaviors, and it does not report whether the module changed the targeted habits.
Three assessment occasions are named for the primary outcome: baseline, 6 months, and 12 months. The record notes that some people could not complete the 6-month assessment because of the COVID-19 pandemic. Without the number of missing assessments, the distribution of missingness across groups, and the analysis approach, it is not possible to judge how much this issue affects interpretation. A missing observation is not evidence of either improvement or worsening.
The registry lists secondary outcomes concerning habit strength and household availability of food and activity-promoting items. It does not provide their outcome values or statistical comparisons. Although the record lists 9 outcome measures, it records 0 analyses. The absence of reported analyses means that the planned outcomes cannot be treated as completed statistical tests based on this record.
Statistical precision is also unknown. A confidence interval, when reported, conveys the range of effect estimates compatible with the data and analysis under the stated method. No such interval for maternal weight is reported in the registry record. Without an estimate and its uncertainty, a reader cannot distinguish a potentially small, precisely estimated difference from a larger but uncertain one. A p-value alone, if it were available, would not describe the magnitude or practical meaning of an effect; no p-value is reported.
The safety entries record serious events and deaths in the intervention and comparator groups, but they do not establish whether any event was caused by the program. The entries should be read as counts within the listed groups, not as a causal comparison. Detailed event descriptions, timing, relatedness assessments, and inferential comparisons are not reported in the registry record.
Overall, the record describes a relevant randomized design and its main outcome, but the posted information does not support a conclusion about the magnitude, direction, or precision of the primary outcome result. The appropriate interpretation is that the trial question is clear while the numerical evidence needed to answer it is not reported in the registry record.
9. Statistical Methods Explained
The primary outcome is continuous, and the registry specifies a mean and standard deviation as its summary form. In general, a mean represents the average of measured values in a group. A standard deviation describes how dispersed those values are around the average. The mean and standard deviation can help characterize each group, but a comparison of group averages requires an estimate of the contrast and an assessment of its uncertainty. Those results are not reported in the registry record.
Because maternal weight was assessed at baseline, 6 months, and 12 months, a complete analysis could address both group differences and change over time. General statistical approaches for repeated measurements can account for the fact that measurements from the same participant are related. The specific model, covariates, comparison time point, and handling of repeated observations are not reported in the registry record. It would not be justified to assume which method was used.
Randomization is intended to create groups that are comparable, on average, with respect to measured and unmeasured baseline factors. In general, this supports interpreting a between-group contrast as an effect of assignment, provided the trial is analyzed appropriately and follow-up and outcome measurement are handled adequately. Randomization alone does not answer how missing data, nonadherence, or departures from the assigned intervention were handled. Those analysis details are not reported in the registry record.
Confidence intervals are a general way to express statistical uncertainty around an estimate. A narrower interval indicates greater precision under the chosen method; a wider interval indicates less precision. A confidence interval does not guarantee that the true effect lies within its limits, and its interpretation depends on the model and assumptions used. No confidence interval for the primary endpoint is reported in the registry record, so precision cannot be evaluated.
Similarly, a p-value is a measure tied to a specified statistical test and its assumptions. It is not a measure of effect size, clinical importance, or the probability that a hypothesis is true. The registry record does not report a p-value or identify the test used for the primary outcome. No statement about statistical significance can be made from the outcome information recorded.
Over-dispersion is a general issue for count outcomes: it occurs when the variability in counts exceeds what a simple model assumes. Models that account for over-dispersion can produce more appropriate uncertainty estimates in such settings. The primary endpoint in this trial is continuous body weight, not a count outcome, so over-dispersion is not the central issue for the primary analysis. The registry record does not describe the statistical model for secondary outcomes, and no model-specific issue can be assessed from the posted information.
The registry’s planning assumptions describe a separate sample-size illustration based on the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. The illustrations are described as participants per arm for non-time-to-event outcomes and as total events for time-to-event outcomes; this trial’s primary weight outcome is continuous. Such illustrations are planning aids, not observed power and not evidence that the trial detected an effect. The effect estimates and illustrated sample sizes are not reported in the registry record, so the adequacy of the trial’s enrollment for the primary comparison cannot be evaluated from the record.
The registry lists enrollment of 296, but enrollment alone does not show how many participants contributed to each endpoint or analysis. In general, precision depends on the amount and variability of outcome information available, as well as the analysis design. The number randomized per arm, the number assessed at each follow-up, and the outcome variability are not reported in the registry record. No new estimate of precision can therefore be calculated from the posted details.
Multiplicity refers generally to the increased chance of at least one false-positive finding when many outcomes or comparisons are tested. The record names secondary outcomes for habit strength and household food and activity environments, and lists 9 outcome measures. It records 0 analyses. Whether particular hypotheses were prioritized, whether comparisons were adjusted for multiplicity, or whether a hierarchy of tests was specified is not reported in the registry record. The existence of several measures does not establish that any one comparison was statistically significant.
Missing-data methods are also important. The record notes incomplete 6-month assessments related to the COVID-19 pandemic, but does not report how many were missing, whether missingness differed by arm, or how incomplete records were treated. In general, complete-case analysis, imputation, and likelihood-based approaches rely on different assumptions. No particular method or assumption should be attributed to this trial without a registry report.
Finally, analysis populations determine which participants are included in a comparison. An intention-to-treat analysis generally compares participants according to their randomized assignment, while other analysis populations may apply different inclusion rules. The population used for the primary endpoint, the handling of participants who did not receive the intervention as planned, and any per-protocol analysis are not reported in the registry record. This information is needed to interpret the estimand and the scope of any result.
10. Multiplicity, Missing Data and Analysis Populations
The registry record identifies 9 outcome measures and names secondary outcomes involving targeted habit strength and the household availability of different food and activity-promoting items. It records 0 analyses. The outcome descriptions do not include numerical results or statistical comparisons. It is therefore not possible to determine which outcomes were analyzed, whether multiple comparisons were made, or whether a multiplicity adjustment was used.
Multiplicity is a general concern when a study tests multiple outcomes, time points, or contrasts. Each additional test can contribute to the chance of at least one apparently notable result arising by chance. Prespecifying a primary outcome and a testing hierarchy, or adjusting for multiple tests, can help address this concern. Whether the trial used any of these approaches is not reported in the registry record. The primary outcome is identified as mothers’ weight, but the record does not specify a primary time point or a statistical testing hierarchy.
The record notes that some participants were unable to complete the 6-month assessment because of the COVID-19 pandemic. It does not report the number of missing assessments, the number affected in each group, reasons beyond the stated context, or how missing measurements were handled. The analysis population and the assumptions used for missing data are not reported in the registry record.
These omissions limit both the assessment of bias and the interpretation of uncertainty. Missingness can affect an estimate if the observed participants differ systematically from those without measurements. General methods for missing data rely on assumptions that should be described and examined where possible. No method or sensitivity analysis can be attributed to this trial from the registry record. The same applies to inclusion rules, deviations from assigned treatment, and analysis populations: they are not reported.
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 |
|---|---|---|---|
| Home Visitation + HABITS Program: Caregivers | 0 | 79 | 0.0% |
| Home Visitation + HABITS Program: Children | 1 | 79 | 1.3% |
| Standard Home Visitation Program: Caregivers | 1 | 69 | 1.4% |
| Standard Home Visitation Program: Children | 0 | 69 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Home Visitation + HABITS Program: Caregivers | 0 of 79 |
| Home Visitation + HABITS Program: Children | 1 of 79 |
| Standard Home Visitation Program: Caregivers | 1 of 69 |
| Standard Home Visitation Program: Children | 0 of 69 |
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 |
|---|---|
| Home Visitation + HABITS Program: Caregivers | 0 of 79 |
| Home Visitation + HABITS Program: Children | 0 of 79 |
| Standard Home Visitation Program: Caregivers | 0 of 69 |
| Standard Home Visitation Program: Children | 0 of 69 |
Most frequent serious adverse event terms
| Event term | Organ system | Home Visitation + HABITS Program: Caregivers | Home Visitation + HABITS Program: Children | Standard Home Visitation Program: Caregivers | Standard Home Visitation Program: Children |
|---|---|---|---|---|---|
| Hospitalization | Infections and infestations | 0 of 79 | 1 of 79 | 1 of 69 | 0 of 69 |
Serious events with the highest arm-level rate: hospitalization (1.4%).
The registry lists serious adverse events separately for caregivers and children in each intervention group. In the home-visitation-plus-HABITS group, 0 of 79 caregivers and 1 of 79 children are listed as affected by a serious event. In the standard home-visitation group, 1 of 69 caregivers and 0 of 69 children are listed as affected by a serious event. These are the counts recorded for the named groups; they are not, by themselves, evidence that the intervention caused or prevented an event.
The death entries list 1 death among children in the home-visitation-plus-HABITS group and 1 among caregivers in the standard home-visitation group. The other two group entries list 0 deaths. The registry entries do not provide enough detail to determine the circumstances, timing, or relationship of these deaths to the intervention. The record lists hospitalization as a serious-event term at 1.4%.
For other adverse events, the registry lists 0 affected in each of the four caregiver and child group entries. Interpretation should account for the populations and categories listed: caregivers and children are reported separately, and these entries should not be treated as a single group-level risk comparison. Detailed event narratives, attribution, duration, and statistical comparisons are not reported in the registry record. Small event counts in a registry listing also provide limited information about the range of possible risks.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group trial evaluated home visitation with the HABITS module against standard home visitation. Its primary endpoint was maternal weight in kilograms, assessed at baseline, 6 months, and 12 months. It also identifies secondary measures related to habits and household environments. These details describe the research question and the outcomes the trial set out to assess.
The record does not report the numerical results for maternal weight or the named secondary outcomes. It does not report a treatment contrast, uncertainty interval, p-value, or analysis result. Consequently, it cannot show whether weight changed, whether changes differed between groups, or how precisely any such difference was estimated. The absence of reported results is not evidence that the groups had equal outcomes, nor is it evidence that one group had better outcomes.
The trial evaluated a program added to standard home visitation. Any conclusion about its effect would need to be based on the randomized comparison, the outcome data, and the analysis methods. The record does not report enough information about missing follow-up, adherence, analysis populations, or statistical methods to evaluate those elements. The note about COVID-19-related inability to complete some 6-month assessments is especially relevant to interpretation of follow-up measurements, but its extent and handling are not described.
Safety entries list serious events and deaths, but the counts do not establish causation or permit a full comparison of risk. Event details and assessments of relatedness are not reported in the registry record. The entries should therefore be understood as descriptive registry counts, not as a definitive safety conclusion.
In general, a trial result is most informative when it reports the size of the between-group estimate, its precision, and the population and methods used to obtain it. Those elements are unavailable for the primary endpoint in this record. The appropriate conclusion is limited: the registry documents the study design and outcomes, while the posted information does not permit an assessment of the intervention’s effect on maternal weight.
13. Why This Trial Matters Statistically
This trial is statistically notable for evaluating a behavioral module within an existing service setting. The contrast is between home visitation plus HABITS and standard home visitation, rather than between a service and no service. That design focuses the question on the added program, while making clear that the comparison takes place in the context of ongoing home-visitation services.
The primary measure is continuous maternal weight, collected at baseline and follow-up. Repeated measurements can support analysis of both differences between groups and patterns over time, but they also require clear reporting of the time points and analysis approach. The record identifies baseline, 6-month, and 12-month assessments and notes that some 6-month assessments were missed because of the COVID-19 pandemic. Without results and missing-data methods, readers cannot assess whether the longitudinal design yielded a precise comparison.
The intervention targets several behaviors, and the record also lists outcomes for habits and household environments. This breadth can help describe potential pathways by which a behavioral program might be evaluated. It also raises general questions about how multiple outcomes and time points are prioritized and interpreted. The record does not report a multiplicity strategy or statistical analyses, so those questions remain open.
The registry’s planning assumptions also underscore a distinction that matters in clinical research: a sample-size illustration is not the same as evidence from an observed comparison. The record reports enrollment of 296, but does not report primary outcome estimates or the number contributing data at each assessment. Enrollment alone cannot establish the precision of the weight comparison.
These statistical considerations are relevant beyond this trial. Clear reporting of estimates, uncertainty, missing-data handling, and analysis populations is necessary for readers to distinguish an inconclusive record from evidence of little or no difference. In this case, the record describes the trial question and design but does not report the analyses needed to answer its primary question.
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 trial is that the registry record does not report numerical results for the primary endpoint. Without group summaries, a between-group estimate, or a measure of uncertainty, neither the direction nor the magnitude of any weight difference can be assessed. The record also lists 0 analyses, so no primary statistical comparison is documented.
Follow-up completeness is uncertain. The record notes that some participants could not complete the 6-month assessment because of the COVID-19 pandemic, but it does not report how many participants were affected, whether missingness differed between groups, or how missing measurements were handled. No results for the 12-month assessment are reported either.
Important design and analysis details are not reported in the registry record, including the allocation procedure, who was masked, the number randomized to each group, the analysis population, adherence, and the statistical model. The registry identifies the trial as randomized and single-masked, but does not provide these additional details. It also does not report participant characteristics that would help describe the enrolled population.
The record names secondary outcomes and lists 9 outcome measures, but gives no outcome results or analysis plan. It does not report whether analyses accounted for multiple outcomes or time points. The available safety information is also limited to group-level counts and a serious-event term, without detailed narratives or causal assessments.
These limitations concern what can be learned from the registry record; they do not establish that the trial did not collect or analyze the information. For this record, however, the missing outcome and analysis details prevent a quantitative assessment of the primary question and constrain interpretation of safety and follow-up.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Healthy Homes, Healthy Habits — NCT03433456.
- Registry record last updated 2024-10-29; status last verified 2024-10.
- Results first posted 2024-04-24.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
Healthy Homes, Healthy Habits (NCT03433456) was a completed, randomized, parallel-group trial sponsored by the University of Alabama at Birmingham. The registry identifies it as single-masked and lists enrollment of 296. The study began on 2019-12-02, with primary completion on 2023-02-27.
The comparison was home visitation plus the HABITS behavioral module versus standard home visitation. The primary outcome was mothers’ weight in kilograms at baseline, 6 months, and 12 months. Some participants were unable to complete the 6-month assessment because of the COVID-19 pandemic.
The record does not report numerical primary or secondary outcome results, statistical comparisons, missing-data methods, or analysis populations. Serious-event and death counts are listed separately for caregivers and children. These entries are descriptive and do not establish causation.