search
Back to results

Building Blocks for Healthy Preschoolers

Primary Purpose

Pediatric Obesity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHAMP
CHAMP+
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Obesity focused on measuring Overweight, Obesity, Prevention, Children, Childcare, Physical Activity, Nutrition, Wellness, Environment, Intervention, Feeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Maryland Growth and Nutrition Division

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

CHAMP group

CHAMP+ group

Control

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Change of BMI Z-score for preschoolers
Measured weight and height for the preschoolers, calculated as age and gender-specific BMI Z-score

Secondary Outcome Measures

Change of Physical Activity for preschoolers and childcare center staff
Moderate to Vigorous Physical Activity (MVPA) based on anthropometrics
Change in Gross Motor Skills
Measured by Test of Gross Motor Development-2
Change in Preschoolers to try new foods
Measured by Food Neophobia Scale (Caregiver report)
Change in Preschoolers to try new foods
Measured by Fruit & Vegetable Knowledge & Preference Test
Change in Preschoolers to try new foods
Measured by Food Tasting Assessment

Full Information

First Posted
March 27, 2017
Last Updated
May 5, 2021
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT03111264
Brief Title
Building Blocks for Healthy Preschoolers
Official Title
Building Blocks for Healthy Preschoolers: Child Care and Family Models
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Covid-19 Closures & Lockdown
Study Start Date
June 17, 2016 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Overweight, Obesity, Prevention, Children, Childcare, Physical Activity, Nutrition, Wellness, Environment, Intervention, Feeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
1943 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHAMP group
Arm Type
Experimental
Arm 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.
Arm Title
CHAMP+ group
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will not receive theCHAMP intervention at the childcare center nor will this group receive the CHAMP+ parenting intervention.
Intervention Type
Behavioral
Intervention Name(s)
CHAMP
Intervention Description
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
Intervention Name(s)
CHAMP+
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of BMI Z-score for preschoolers
Description
Measured weight and height for the preschoolers, calculated as age and gender-specific BMI Z-score
Time Frame
Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
Secondary Outcome Measure Information:
Title
Change of Physical Activity for preschoolers and childcare center staff
Description
Moderate to Vigorous Physical Activity (MVPA) based on anthropometrics
Time Frame
Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
Title
Change in Gross Motor Skills
Description
Measured by Test of Gross Motor Development-2
Time Frame
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Title
Change in Preschoolers to try new foods
Description
Measured by Food Neophobia Scale (Caregiver report)
Time Frame
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Title
Change in Preschoolers to try new foods
Description
Measured by Fruit & Vegetable Knowledge & Preference Test
Time Frame
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Title
Change in Preschoolers to try new foods
Description
Measured by Food Tasting Assessment
Time Frame
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen M Black, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Growth and Nutrition Division
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35649202
Citation
Rahmaty Z, Johantgen ME, Storr CL, Wang Y, Black MM. Preschoolers BMI: Associations with Patterns of Caregivers' Feeding Practices Using Structural Equation Models. Child Obes. 2023 Apr;19(3):169-178. doi: 10.1089/chi.2022.0026. Epub 2022 Jun 1.
Results Reference
derived
PubMed Identifier
31525490
Citation
Armstrong B, Trude ACB, Johnson C, Castelo RJ, Zemanick A, Haber-Sage S, Arbaiza R, Black MM. CHAMP: A cluster randomized-control trial to prevent obesity in child care centers. Contemp Clin Trials. 2019 Nov;86:105849. doi: 10.1016/j.cct.2019.105849. Epub 2019 Sep 13.
Results Reference
derived

Learn more about this trial

Building Blocks for Healthy Preschoolers

We'll reach out to this number within 24 hrs