Clinical trial NCT03111264: Building Blocks for Healthy Preschoolers
Official title: Building Blocks for Healthy Preschoolers: Child Care and Family Models
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Overweight
Obesity
Prevention
Children
Childcare
Physical Activity
Nutrition
Wellness
Environment
Intervention
Feeding
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-04-12
Enrollment: 1943
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change of BMI Z-score for preschoolers
timeFrame: Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
Secondary outcomes:
measure: Change of Physical Activity for preschoolers and childcare center staff
timeFrame: Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
measure: Change in Gross Motor Skills
timeFrame: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
measure: Change in Preschoolers to try new foods
timeFrame: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
measure: Change in Preschoolers to try new foods
timeFrame: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
measure: Change in Preschoolers to try new foods
timeFrame: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Growth and Nutrition Division
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Maureen M Black, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.