Addressing Obesity in Early Care and Education Settings

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT04140032
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Months - N/A
Healthy Volunteers
Accepted

Interventions

  • Multi-level preschool obesity control intervention — BEHAVIORAL
    The multi-level intervention is a preschool-based program that integrates healthy nutrition and physical activity policies and practices into preschool operations via the Sesame Street Healthy Habits for Life curriculum. In addition to the curriculum, the intervention includes coaching sessions to enhance teacher lesson planning to routinely include nutrition and physical activity; as well as assist preschool site directors with implementing policy changes and parent engagement sessions.

Study Details

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.

Key Dates

Start date
Oct 1, 2019
Status verified
Jun 2025
Primary completion
Jul 1, 2023
Completion
May 31, 2024

Study Design

Enrollment
1,136 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Intervention group
    Centers in the group will participate in the A-B-C Healthy Me/Soy Saludable multi- component nutrition and physical activity preschool intervention.
  • No Intervention: Control group
    Preschools in the group will continue with "usual care" practices. Control group preschools will receive intervention materials and accompanying instructions after follow-up measures are collected for each cohort.

Primary Outcome Measure

Child BMI Z-score [ Time Frame: Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA Fielding School of Public HealthLos AngelesCalifornia90095-

Find similar trials in Los Angeles, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
UCLA Fielding School of Public Health· Los Angeles, CA

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