Trial results for a study addressing Obesity in early care and education settings were posted on ClinicalTrials.gov on 2025-06-12. The intervention demonstrated a statistically significant reduction in child BMI Z-score, with a difference between groups in change of -0.18 (p=0.003) over the study period. The study enrolled 1136 participants.
Background
Childhood obesity is a national epidemic, disproportionately affecting low-income and ethnic minority populations. By preschool, nearly one-third of low-income children are already overweight or obese, which can lead to adverse health outcomes throughout their lives. Current evidence suggests that individual-focused, single-component interventions may not produce long-term, population-level changes in obesity-related outcomes. There is growing support for creating environments, such as schools, where healthy choices are the default option. This study aimed to investigate such an approach in early care and education settings.
Trial design
This completed study, designated as Phase NA, enrolled 1136 participants to address Obesity. The trial investigated an environmental intervention designed to promote healthy choices in early care and education settings. The study compared the intervention group against a control group to assess its impact on child obesity-related outcomes.
Key results
The trial reported the following key measurements:
- Child BMI Z-score: For the Intervention group, mean BMI Z-scores were 0.40 (Standard Deviation 1.07) and 0.31 (Standard Deviation 1.14). For the Control group, mean BMI Z-scores were 0.43 (Standard Deviation 1.13) and 0.48 (Standard Deviation 1.17).
- Percentage of Children Who Eat Fruit Once a Day: The Intervention group reported 82 percent and 86 percent. The Control group reported 76 percent and 82 percent.
- Frequency of Physical Activity: The Intervention group reported mean frequencies of 4.9 days (Standard Deviation 2.1) and 5.2 days (Standard Deviation 2.0). The Control group reported 4.8 days (Standard Deviation 2.1) and 5.4 days (Standard Deviation 2.0).
Key analyses using Mixed Models Analysis revealed:
- A difference between groups in change in BMI Z-score of -0.18, with a 95% Confidence Interval of -0.31 to -0.06 (p=0.003).
- An odds ratio for difference between groups of 1.29, with a 95% Confidence Interval of 0.034 to 4.91 (p=0.7).
- A difference between groups in change in a frequency measure of -0.2, with a 95% Confidence Interval of -0.58 to 0.17 (p=0.3).
- An odds ratio for difference between groups of 1.1, with a 95% Confidence Interval of 0.56 to 2.16 (p=0.8).
- Another odds ratio for difference between groups of 1.1, with a 95% Confidence Interval of 0.56 to 2.16 (p=0.8).
What this means
The results suggest that an environmental intervention in early care and education settings can significantly impact child obesity outcomes. The observed reduction in child BMI Z-score, with a statistically significant difference of -0.18 between the intervention and control groups, indicates a positive effect on this key metric. While there were numerical differences in fruit consumption and physical activity frequency between groups over time, the statistical analyses for these outcomes did not show significant differences (p=0.7 and p=0.3 respectively for the first two odds ratios/frequency change, and p=0.8 for the subsequent odds ratios). This highlights the potential of environmental strategies to address childhood obesity, particularly in early developmental stages.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04140032, titled "Addressing Obesity in Early Care and Education Settings", were posted on 2025-06-12 on clinicaltrials.gov.