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Addressing Obesity in Early Care and Education Settings

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-level preschool obesity control intervention
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring obesity, nutrition, physical activity, preschool, child care centers, policy-system-environment intervention

Eligibility Criteria

30 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA Fielding School of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

Child BMI z-score
Height and weight of preschool children will be measured by trained research staff. This data will be used to calculate children's body mass index (BMI) scores. CDC growth charts and parent's report of child's sex and date of birth will then be used to calculate BMI percentile, weight category and BMI z-score.

Secondary Outcome Measures

Child nutrition behaviors
Dietary intakes of preschool children will be assessed via parent self-report of foods child eats. These data will be used to assess pre-post changes in dietary consumption.
Child physical activity
Physical activity of preschool children will be assessed via parent self-report of child's physical activity in the last seven days. These data will be used to assess changes in child's physical activity.
Teacher nutrition behaviors
Teacher nutrition will be measured via self-report of dietary intake.
Teacher physical activity behaviors
Teacher physical activity will be measured via self-report of physical activity.
Nutrition and physical activity policies and practices at preschool site level
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.

Full Information

First Posted
October 18, 2019
Last Updated
May 8, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04140032
Brief Title
Addressing Obesity in Early Care and Education Settings
Official Title
Addressing Obesity in Early Care and Education Settings
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, nutrition, physical activity, preschool, child care centers, policy-system-environment intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1870 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Centers in the group will participate in the A-B-C Healthy Me/Soy Saludable multi- component nutrition and physical activity preschool intervention.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multi-level preschool obesity control intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child BMI z-score
Description
Height and weight of preschool children will be measured by trained research staff. This data will be used to calculate children's body mass index (BMI) scores. CDC growth charts and parent's report of child's sex and date of birth will then be used to calculate BMI percentile, weight category and BMI z-score.
Time Frame
4 weeks post intervention
Secondary Outcome Measure Information:
Title
Child nutrition behaviors
Description
Dietary intakes of preschool children will be assessed via parent self-report of foods child eats. These data will be used to assess pre-post changes in dietary consumption.
Time Frame
4 weeks post intervention
Title
Child physical activity
Description
Physical activity of preschool children will be assessed via parent self-report of child's physical activity in the last seven days. These data will be used to assess changes in child's physical activity.
Time Frame
4 weeks post intervention
Title
Teacher nutrition behaviors
Description
Teacher nutrition will be measured via self-report of dietary intake.
Time Frame
4 weeks post intervention
Title
Teacher physical activity behaviors
Description
Teacher physical activity will be measured via self-report of physical activity.
Time Frame
4 weeks post intervention
Title
Nutrition and physical activity policies and practices at preschool site level
Description
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.
Time Frame
4 weeks post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burton Cowgill, PHD
Phone
310-794-3569
Email
bcowgill@ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshan Bastani, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Fielding School of Public Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burton Cowgill, PHD
Phone
310-794-3569
Email
bcowgill@ucla.edu

12. IPD Sharing Statement

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Addressing Obesity in Early Care and Education Settings

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