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
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Multi-level preschool obesity control intervention||Not Applicable|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1870 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Addressing Obesity in Early Care and Education Settings|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
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.
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.
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140032
|Contact: Jennie Coleman, MPHfirstname.lastname@example.org|
|Contact: Burton Cowgill, PhDemail@example.com|
|Principal Investigator:||Roshan Bastani, PhD||University of California, Los Angeles|