Building Blocks for Healthy Preschoolers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1943 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-17

Study Completion Date

2020-03-13

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.

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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:

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.

Conditions

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Pediatric Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

One third of recruited childcare centers (control) will not receive any intervention (CHAMP nor CHAMP+). The remaining two-thirds of the recruited centers will receive the CHAMP intervention, of those, one third will also receive the CHAMP+ parenting intervention.

Study Groups

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CHAMP group

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.

Group Type EXPERIMENTAL

CHAMP

Intervention Type BEHAVIORAL

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.

CHAMP+ group

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.

Group Type EXPERIMENTAL

CHAMP

Intervention Type BEHAVIORAL

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.

CHAMP+

Intervention Type BEHAVIORAL

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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CHAMP

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.

Intervention Type BEHAVIORAL

CHAMP+

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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes