Addressing Obesity in Early Care and Education Settings

NCT04140032 | Completed Results

• 1 other identifier: 19-000570
• Study Type: interventional
• Target: 1,136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

obesity; nutrition; physical activity; preschool; child care centers; policy-system-environment intervention

Outcome Measures

Primary Outcomes (1)

• Child BMI Z-score

  Height and weight of preschool children were measured by trained research staff. These data were used to calculate children's body mass index (BMI) scores. The BMI Z-score is a measure calculated from a child's height and weight that indicates how a child's BMI compares with the BMI of a reference population of U.S. children of the same age and sex. The reference population is based on Center for Disease Control and Prevention (CDC) pediatric growth charts and the BMI Z-score is calculated using a CDC-provided computer program. A Z-score of 0 corresponds to the mean BMI of the reference population. A Z-score of +1 corresponds to a BMI that is one standard deviation above the mean of the reference population, and a Z-score of -1 represents a BMI that is one standard deviation below the mean of the reference population. When used as a measure of obesity risk, a lower Z-score is considered a better outcome.

  Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)

Secondary Outcomes (6)

• Percentage of Children Who Eat Fruit Once a Day

  Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)

• Frequency of Physical Activity

  Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)

• Teacher Nutrition Behaviors

  4 weeks post intervention

• Teacher Physical Activity Behaviors

  4 weeks post intervention

• Nutrition and Physical Activity Policies and Practices at Preschool Site Level

  4 weeks post intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Centers in the group will participate in the A-B-C Healthy Me/Soy Saludable multi- component nutrition and physical activity preschool intervention.

Behavioral: Multi-level preschool obesity control intervention

Control group

NO INTERVENTION

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.

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.

Intervention group

Eligibility Criteria

• Age: 30 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Fielding School of Public Health

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

The impact of COVID-19 led to fewer number of participants analyzed in the intervention and control conditions.

Results Point of Contact

• Title: Dr. Burt Cowgill
• Organization: UCLA Fielding School of Public Health

bcowgill@ucla.edu

310-794-3569

Study Officials

• Roshan Bastani, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 25, 2019
• Study Start: October 1, 2019
• Primary Completion: July 1, 2023
• Study Completion: May 31, 2024
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-06

Locations

US (1)