NCT04140032Completed
Addressing Obesity in Early Care and Education Settings
Source: ClinicalTrials.gov · Last updated 12 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1136 (actual)
- First submitted
- 18 Oct 2019
- Start date
- 1 Oct 2019
- Primary completion date
- 1 Jul 2023
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Obesity
- NCT number
- NCT04140032
What you commit to
- Study type: Interventional
- Participants enrolled: 1136
- From 1 Oct 2019 to the primary completion date, 1 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Have less than 20 preschool aged children (2.5-5 years old) enrolled.
Other
- Preschool Sites:
- 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
Who the study is looking for
- 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
Age in the registry: 30 months to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA Fielding School of Public Health Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.