Building Blocks for Healthy Preschoolers

Study Overview
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Brief Summary
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Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families. Childcare centers provide an excellent opportunity to build healthy dietary and physical activity lifestyle habits and avoid the rapid weight gain that leads to health disparities. Building on a statewide survey among childcare centers and a pilot evaluation of an environmental intervention, this 3-cell randomized trial evaluates the impact of a staff-led wellness intervention and a staff-led and family-focused intervention, against a control condition.

Detailed Description
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The intervention trial will be conducted in 48-55 childcare centers throughout Maryland, enrolling 864 children age 30-54 months from childcare centers serving low-income families. The aims are: to examine the impact of the wellness intervention individually and combined with the family intervention versus control on BMI z-score, food preferences and knowledge, and physical activity among children to examine the sustainability of the interventions to examine whether changes in outcomes measures for children's BMI z-score, gross motor skills, food preferences and knowledge, and physical activity are mediated by changes in the childcare staff wellness-related attitudes and behaviors and/or parent wellness-related attitudes and behaviors (exploratory). Findings from the trial will inform programs and policies in childcare centers to prevent obesity and reduce disparities, and will be disseminated locally, regionally, and nationally through conferences, information briefs, social media, and peer-reviewed journal articles. The overall objective is to promote statewide strategies that reduce pediatric obesity and the long-term health disparities.

Official Title
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Building Blocks for Healthy Preschoolers: Child Care and Family Models

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Behavioral: CHAMP
* Behavioral: CHAMP+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preschooler 30-54 months Caregiver and childcare staff must be at least 18 years old Childcare center staff members willing to participate Licensed childcare centers serving low-income communities Children attending participating childcare centers (at least 3 days per week) Exclusion Criteria: Caregivers and staff who do not speak or read English Childcare staff and preschoolers with health problems that would interfere with participation in physical activities

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The investigators will examine the impact of the teacher-led CHAMP intervention individually and combined with a CHAMP+ parenting intervention versus control on child BMI z-score, food tasting, food preferences and knowledge, gross motor skills, and physical activity.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHAMP group<br>Childcare centers randomly assigned the CHAMP group will receive an intervention that promotes physical activity in the classroom by developing gross motor skills through movement and enhances the nutritional environment in the centers by exposing preschoolers to new foods. | Behavioral: CHAMP<br>* The CHAMP only group intervention is based on Food Friends & Mighty Moves, a nutritional program designed to introduce new foods over the course of 12 weeks to preschoolers to create positive eating experiences. In conjunction with the nutritional program, the intervention also consists of an 18 week physical activity program designed to develop gross motor skills.<br>|
| Experimental: CHAMP+ group<br>These childcare centers, also randomly assigned, will have the same intervention as the CHAMP group in addition to a parenting intervention that promotes wellness and healthy behaviors within families. | Behavioral: CHAMP<br>* The CHAMP only group intervention is based on Food Friends & Mighty Moves, a nutritional program designed to introduce new foods over the course of 12 weeks to preschoolers to create positive eating experiences. In conjunction with the nutritional program, the intervention also consists of an 18 week physical activity program designed to develop gross motor skills.<br>Behavioral: CHAMP+<br>* The CHAMP+ component is comprised of a curriculum of parenting, wellness, physical activity, and feeding in the home environment. The CHAMP+ intervention will span over the course of the CHAMP intervention.<br>|
| No Intervention: Control<br>This group will not receive theCHAMP intervention at the childcare center nor will this group receive the CHAMP+ parenting intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of BMI Z-score for preschoolers | Measured weight and height for the preschoolers, calculated as age and gender-specific BMI Z-score | Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Physical Activity for preschoolers and childcare center staff | Moderate to Vigorous Physical Activity (MVPA) based on anthropometrics | Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up | 
| Change in Gross Motor Skills | Measured by Test of Gross Motor Development-2 | Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up | 
| Change in Preschoolers to try new foods | Measured by Food Neophobia Scale (Caregiver report) | Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up | 
| Change in Preschoolers to try new foods | Measured by Fruit & Vegetable Knowledge & Preference Test | Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up | 
| Change in Preschoolers to try new foods | Measured by Food Tasting Assessment | Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Overweight, Obesity, Prevention, Children, Childcare, Physical Activity, Wellness, Environment, Intervention, Feeding