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Clinical Trials/NCT03111264
NCT03111264
Terminated
Not Applicable

Building Blocks for Healthy Preschoolers: Child Care and Family Models

University of Maryland, Baltimore1 site in 1 country1,943 target enrollmentJune 17, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Obesity
Sponsor
University of Maryland, Baltimore
Enrollment
1943
Locations
1
Primary Endpoint
Change of BMI Z-score for preschoolers
Status
Terminated
Last Updated
4 years ago

Overview

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: 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.

Registry
clinicaltrials.gov
Start Date
June 17, 2016
End Date
March 13, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maureen Black

Professor

University of Maryland, Baltimore

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

Outcomes

Primary Outcomes

Change of BMI Z-score for preschoolers

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

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

Secondary Outcomes

  • 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 Preschoolers to try new foods(Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up)
  • Change in Gross Motor Skills(Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up)

Study Sites (1)

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