Skip to content

Building Blocks for Healthy Preschoolers

Building Blocks for Healthy Preschoolers: Child Care and Family Models

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03111264
Enrollment
1943
Registered
2017-04-12
Start date
2016-06-17
Completion date
2020-03-13
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

Keywords

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

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.

Interventions

BEHAVIORALCHAMP

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.

BEHAVIORALCHAMP+

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of BMI Z-score for preschoolersBaseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-upMeasured weight and height for the preschoolers, calculated as age and gender-specific BMI Z-score

Secondary

MeasureTime frameDescription
Change of Physical Activity for preschoolers and childcare center staffBaseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-upModerate to Vigorous Physical Activity (MVPA) based on anthropometrics
Change in Gross Motor SkillsBaseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-upMeasured by Test of Gross Motor Development-2
Change in Preschoolers to try new foodsBaseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-upMeasured by Food Neophobia Scale (Caregiver report)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026