Trials / Terminated
TerminatedNCT03111264
Building Blocks for Healthy Preschoolers
Building Blocks for Healthy Preschoolers: Child Care and Family Models
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,943 (actual)
- Sponsor
- University of Maryland, Baltimore · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BEHAVIORAL | 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. |
Timeline
- Start date
- 2016-06-17
- Primary completion
- 2020-03-13
- Completion
- 2020-03-13
- First posted
- 2017-04-12
- Last updated
- 2021-05-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03111264. Inclusion in this directory is not an endorsement.