Building Blocks for Healthy Preschoolers

Pediatric Obesity Clinical Trial

Official title:

Building Blocks for Healthy Preschoolers: Child Care and Family Models

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03111264
• Other study ID #: HP-00065933
• Secondary ID: 1R01DK107761-01
• Status: Terminated
• Phase: N/A
• Start date: June 17, 2016
• Est. completion date: March 13, 2020

Study information

• Verified date: May 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1943
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland Growth and Nutrition Division	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of Physical Activity for preschoolers and childcare center staff	Moderate to Vigorous Physical Activity (MVPA) based on anthropometrics	Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
Secondary	Change in Gross Motor Skills	Measured by Test of Gross Motor Development-2	Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Secondary	Change in Preschoolers to try new foods	Measured by Food Neophobia Scale (Caregiver report)	Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Secondary	Change in Preschoolers to try new foods	Measured by Fruit & Vegetable Knowledge & Preference Test	Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Secondary	Change in Preschoolers to try new foods	Measured by Food Tasting Assessment	Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up