Building Blocks for Healthy Preschoolers

NCT03111264 | Terminated DMC

• 2 other identifiers: HP-000659331R01DK107761-01
• Study Type: interventional
• Target: 1,943
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

Overweight; Obesity; Prevention; Children; Childcare; Physical Activity; Nutrition; Wellness; Environment; Intervention; Feeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of Physical Activity for preschoolers and childcare center staff

  Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up

• Change in Gross Motor Skills

  Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

• Change in Preschoolers to try new foods

  Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

• Change in Preschoolers to try new foods

  Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

• Change in Preschoolers to try new foods

  Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

Study Arms (3)

CHAMP group

EXPERIMENTAL

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

CHAMP+ group

EXPERIMENTAL

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; Behavioral: CHAMP+

Control

NO INTERVENTION

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

Interventions

CHAMP+ 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.

CHAMP+ group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Maryland Growth and Nutrition Division

Baltimore, Maryland, 21201, United States

Location

Related Publications (3)

• Kowalski AJ, Armstrong B, Trude ACB, Arbaiza R, Czinn A, Bellows LL, Johnson SL, Wang Y, Hager ER, Black MM. Creating healthy habits for Maryland preschoolers (CHAMP): a cluster-randomized controlled trial among childcare centers. Int J Behav Nutr Phys Act. 2025 Dec 10;22(1):156. doi: 10.1186/s12966-025-01824-6.

  PMID: 41372951 DERIVED

• 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.

  PMID: 35649202 DERIVED

• 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.

  PMID: 31525490 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Overweight; Obesity; Motor Activity

Interventions

Mov10l1 protein, mouse

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Maureen M Black, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 12, 2017
• Study Start: June 17, 2016
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)