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Addressing Obesity in Early Care and Education Settings

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ClinicalTrials.gov Identifier: NCT04140032
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Roshan Bastani, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE October 18, 2019
First Posted Date  ICMJE October 25, 2019
Last Update Posted Date October 29, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
Child BMI z-score [ Time Frame: 4 weeks post intervention ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • Child nutrition behaviors [ Time Frame: 4 weeks post intervention ]
    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 [ Time Frame: 4 weeks post intervention ]
    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 [ Time Frame: 4 weeks post intervention ]
    Teacher nutrition will be measured via self-report of dietary intake.
  • Teacher physical activity behaviors [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Addressing Obesity in Early Care and Education Settings
Official Title  ICMJE Addressing Obesity in Early Care and Education Settings
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: Multi-level preschool obesity control intervention
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 Arms  ICMJE
  • 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.
    Intervention: Behavioral: Multi-level preschool obesity control 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2019)
1870
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jennie Coleman, MPH 310-206-8954 jencol@ucla.edu
Contact: Burton Cowgill, PhD 310-794-3569 bcowgill@ucla.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04140032
Other Study ID Numbers  ICMJE 19-000570
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roshan Bastani, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roshan Bastani, PhD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP