Addressing Obesity in Early Care and Education Settings
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.
Conditions:
🦠 Obesity
🗓️ Study Start (Actual) 1 October 2019
🗓️ Primary Completion (Estimated) 30 June 2023
✅ Study Completion (Estimated) 31 May 2024
👥 Enrollment (Estimated) 1870
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 30 Months to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 October 2019
  • First Submitted that Met QC Criteria 23 October 2019
  • First Posted 25 October 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 May 2023
  • Last Update Posted 9 May 2023
  • Last Verified May 2023