Addressing Obesity in Early Care and Education Settings

Not Applicable

Completed

Conditions: Obesity

Registration Number: NCT04140032

Lead Sponsor: University of California, Los Angeles

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.

Detailed Description: This study involves a 2-group design with stratified cluster randomization at the level of the preschool. The investigators will recruit 60 preschools from LA County's most vulnerable communities, stratified by size (large, small). The investigators will randomly select pairs of schools from each stratum and randomly assign one member of each pair to the intervention or control conditions. Given the 10-month instructional year (Sept. 1-June 30), preschools will be recruited in three cohorts over three instructional years (\~20 schools per cohort). To control for time trends in outcomes, the randomization protocol will be implemented independently within each cohort. Baseline data collection, conducted in the first six weeks of the school year, will include surveys (site directors, teachers, parents), anthropometric measures (children), preschool policy reviews and direct observation in preschools including child-level eating behavior and physical activity.

The multilevel intervention will be initiated immediately following baseline data collection and will consist of 1) establishment of organizational policies to support healthy nutrition and physical activity, 2) integration of nutrition and physical activity content into curricula 3) supports for teachers and staff to model healthy behavior, and 4) engagement of parents as partners in implementing healthy policies in preschool and at home. Implementation measures will be collected throughout the project period. Follow-up data collection, in the last four-six weeks of the school year, will mirror baseline data collection.

Study Hypotheses:

1. Children at intervention schools will gain less weight relative to height gains compared to children at control schools, resulting in lower mean BMI z-scores at follow-up (effectiveness). Outcomes will be assessed in the overall sample and among the subset of children who are overweight or obese at baseline.

2. Intervention preschools will have greater implementation of healthy nutrition and physical activity policies and practices at follow-up compared to control preschools.

The primary effectiveness outcome will be child age-and sex-adjusted BMI z-score. The investigators will obtain baseline data on 1,630 children, 815 per condition, 60 preschool site directors and approximately 135 teachers. Estimating 80% child retention at follow-up, the investigators anticipate having follow-up data on 1,304 children, 652 per study arm. Data will also be collected from the parents of participating children at baseline and follow-up.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1136

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Child BMI Z-score	Measured pre-intervention at the beginning of the school year and post-intervention at the end of the school year (approximately 10 months later)	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.

Secondary Outcome Measures

Name	Time	Method
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)	Parents completed surveys regarding children's physical activity and nutrition. For frequency of fruit consumption, the following question was asked: How often does your child eat... fruit? Include fresh, frozen, or canned fruit. DO NOT include juices. The response is dichotomized as at least once a day versus less than once a day.
Teacher Nutrition Behaviors	4 weeks post intervention	Teacher nutrition will be measured via self-report of dietary intake.
Teacher Physical Activity Behaviors	4 weeks post intervention	Teacher physical activity will be measured via self-report of physical activity.
Nutrition and Physical Activity Policies and Practices at Preschool Site Level	4 weeks post intervention	Nutrition and physical activity policies of the preschool will be assessed via in-person all day observations of one preschool classroom per site. Trained research staff will conduct these observations during an on-site visit to the center. Additionally, preschool site directors will complete a nutrition and physical activity policy and practice survey to assess center nutrition and physical activity policies.
Percentage of Children Who Eat Vegetables 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)	Parents completed surveys regarding children's physical activity and nutrition. For frequency of vegetable consumption, the following question was asked: How often does your child eat... vegetables? DO NOT count potatoes, or beans. The response is dichotomized as at least once a day versus less than once a day.
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)	Parents completed surveys regarding children's physical activity and nutrition. For frequency of physical activity, the following question was asked: During the past 7 days, on how many days was your child physically active for a total of at least 60 minutes per day?

Trial Locations

Locations (1): UCLA Fielding School of Public Health
🇺🇸
Los Angeles, California, United States
UCLA Fielding School of Public Health
🇺🇸Los Angeles, California, United States