Building Blocks for Healthy Preschoolers

University of Maryland Baltimore (UMB)

Status: Terminated

Conditions: Pediatric Obesity

Treatments: Behavioral: CHAMP+; Behavioral: CHAMP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03111264

1R01DK107761-01 (U.S. NIH Grant/Contract)

HP-00065933

Details and patient eligibility

About

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.

Full description

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:

1. 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
2. to examine the sustainability of the interventions
3. 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.

Enrollment: 1,943 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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1,943 participants in 3 patient groups

CHAMP group

Experimental group

Description:

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.

Treatment:

Behavioral: CHAMP

CHAMP+ group

Experimental group

Description:

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.

Treatment:

Behavioral: CHAMP+

Behavioral: CHAMP

Control

No Intervention group

Description:

This group will not receive theCHAMP intervention at the childcare center nor will this group receive the CHAMP+ parenting intervention.