NCT03111264

Building Blocks for Healthy Preschoolers

Terminated NA Last updated 10 May 2021

What this trial tests

NA trial testing CHAMP in Pediatric Obesity in 1,943 participants. Terminated before completion.

Timeline

17 June 2016

Primary endpoint
13 March 2020

13 March 2020

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	prevention
Enrollment	1,943
Start date	17 June 2016
Primary completion	13 March 2020
Estimated completion	13 March 2020
Sites	1 location across United States

Drugs / interventions tested

• CHAMP
• CHAMP+

Conditions studied

• Pediatric Obesity — all drugs for Pediatric Obesity →

Sponsor

University of Maryland, Baltimore

Who can join

18 and older, any sex, with Pediatric Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Caregiver involvement in interventions for improving children's dietary intake and physical activity behaviors.
   Morgan EH, Schoonees A, Sriram U, Faure M, et al · · 2020 · cited 54× · PMID 31902132 · DOI 10.1002/14651858.cd012547.pub2
2. Healthy eating interventions delivered in early childhood education and care settings for improving the diet of children aged six months to six years.
   Yoong SL, Lum M, Wolfenden L, Jackson J, et al · · 2023 · cited 29× · PMID 37306513 · DOI 10.1002/14651858.cd013862.pub2
3. CHAMP: A cluster randomized-control trial to prevent obesity in child care centers.
   Armstrong B, Trude ACB, Johnson C, Castelo RJ, et al · · 2019 · cited 21× · PMID 31525490 · DOI 10.1016/j.cct.2019.105849
4. Healthy eating interventions delivered in early childhood education and care settings for improving the diet of children aged six months to six years.
   Yoong SL, Lum M, Wolfenden L, Jackson J, et al · · 2023 · cited 12× · PMID 37606067 · DOI 10.1002/14651858.cd013862.pub3
5. Motor Competence and Attainment of Global Physical Activity Guidelines among a Statewide Sample of Preschoolers.
   Slaton A, Kowalski AJ, Zemanick A, Pulling Kuhn A, et al · · 2020 · cited 9× · PMID 33217996 · DOI 10.3390/ijerph17228546
6. Interventions to prevent obesity in children aged 2 to 4 years old.
   Phillips SM, Spiga F, Moore TH, Dawson S, et al · · 2025 · cited 3× · PMID 40494564 · DOI 10.1002/14651858.cd015326.pub2
7. Preschoolers BMI: Associations with Patterns of Caregivers' Feeding Practices Using Structural Equation Models.
   Rahmaty Z, Johantgen ME, Storr CL, Wang Y, et al · · 2023 · cited 2× · PMID 35649202 · DOI 10.1089/chi.2022.0026
8. Parent-Reported Feeding Practices Associated With Children's Observed Willingness-to-Try-New-Foods in Childcare.
   Behbehani F, Hurley KM, Black MM. · · 2025 · cited 1× · PMID 39876643 · DOI 10.1111/mcn.13798