N/A
N=1,136
Addressing Obesity in Early Care and Education Settings
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04140032 ↗Enrolled (actual)
1,136
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Child BMI Z-score — 0.40; 0.43; 0.31; 0.48 Z-score — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multi-level preschool obesity control intervention (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child BMI Z-score |
0.40; 0.43; 0.31; 0.48 | 0.003 sig |
| SECONDARY Percentage of Children Who Eat Fruit Once a Day |
82; 76; 86; 82 | 0.7 |
| SECONDARY Frequency of Physical Activity |
4.9; 4.8; 5.2; 5.4 | 0.3 |
| SECONDARY Teacher Nutrition Behaviors |
— | — |
| SECONDARY Teacher Physical Activity Behaviors |
— | — |
| SECONDARY Nutrition and Physical Activity Policies and Practices at Preschool Site Level |
— | — |
| SECONDARY Percentage of Children Who Eat Vegetables Once a Day |
61; 61; 69; 69 | 0.8 |
Summary
Childhood obesity is a national epidemic that disproportionately burdens low income and ethnic minority populations. By preschool, nearly one-third of low income children are already overweight or obese, setting the stage for adverse health outcomes over their life course. Evidence is mounting that individual-focused, single-component interventions fail to produce long-term population-level changes in obesity-related outcomes. Evidence increasingly supports creating entire environments (e.g., schools) in which the healthy choice is the default option.
The investigators will conduct a pragmatic cluster randomized trial to evaluate the effectiveness of a multilevel (organization, teacher, parent, child) intervention to support healthy eating and physical activity in preschools. The study is being conducted in partnership with Child Care Resource Center (CCRC), a non-profit organization dedicated to ensuring that all children receive high quality preschool experiences. The investigators will randomly assign 60 preschool sites (stratified by size), located in underserved areas of Los Angeles, to the intervention or a usual practice control conditions.
The investigators will evaluate the effectiveness of the intervention on child BMI z-scores (primary outcome) and parent-reported child nutrition and physical activity (secondary outcomes). The investigators will systematically examine the implementation process to understand factors that may facilitate or hinder intervention uptake and success. The findings from this work will be critical for informing future dissemination efforts.
Eligibility Criteria
Inclusion Criteria
Preschool Sites:
- Must be in CCRC network of preschools
- Have 20 or more preschool aged children (2.5-5 years old) in attendance at site
- Children must eat at least one meal on-site per school day
- Must have at least one preschool classroom
Providers (Teachers and Preschool Site Directors):
- Teachers must teach a preschool class at participating preschool
- Be able to provide informed consent
Parents and Children:
- Child must be 2.5-5 years old and enrolled in the participating preschool
- Child primary caregiver must have at least one child 2.5-5 years old that is enrolled in the preschool
- Child primary care giver must be able to read and write in English or Spanish
Exclusion Criteria
Preschool Sites:
- Have less than 20 preschool aged children (2.5-5 years old) enrolled.
- Do not have a preschool classroom
- Are not in the CCRC network
- Preschools that are based in a family-home or serve special needs children exclusively
- Children do not eat at least one meal on-site per school day
Providers (Teachers and Preschool Site Directors):
-Teachers not currently teaching a preschool class
Parents and Children:
- Child primary care giver unable to read or write in English or Spanish
- Primary care giver who does not have a child currently enrolled in a preschool class
Data sourced from ClinicalTrials.gov (NCT04140032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.