NCT05656807 Evaluation of Child Care Staff Weight Management Program
| NCT ID | NCT05656807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 924 participants |
| Start Date | 2023-01-18 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 924 participants in total. It began in 2023-01-18 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this 12-month cluster clinical trial is to evaluate if improving child care providers' health behaviors using an online provider weight management program elicits meaningful change in dietary and physical activity behaviors in 2-5-year-old preschool children in their care and the child care environment. The study sample will include 84 child care centers. Including: 84 center directors, 168 2-5-year-old classroom teachers, 672 2-5-year old children. Some centers will do only the online Nutrition and Physical Activity Self-Assessment for Child Care (Go NAPSACC) program. This program works with child care center directors to make changes to their center around child nutrition and physical activity to foster healthier habits for the children enrolled in their care. Other centers will do Go NAPSACC Enhanced. This will include center directors doing Go NAPSACC and 2-5 year old teachers doing an online weight management program with support. Researchers will compare centers in Go NAPSACC with centers in Go NAPSACC Enhanced to see if there are greater improvements in children's diet quality and physical activity, as well as the nutrition and physical activity environment of centers in the Go NAPSACC Enhanced group. Additionally, they will see if there are greater improvements in teachers' weight, diet quality, and physical activity in centers using Go NAPSACC Enhanced.
Eligibility Criteria
Inclusion Criteria: Child Care Centers: * Be open year-round * Licensed with no plans to close in the next 2 years * Been in operation for at least 1 year * Have at least two classrooms serving children 2-5 years-old * Serve at least lunch to the 2-5-year old children * Have no history of Go NAPSACC participation in the past 6 months * Two 2-5-year-old classroom providers and 4 parents from each classroom must provide consent to participate in the study Child Care Providers (Directors and Teachers): * Ability to provide informed consent. * Age 18 years or older. * Teacher only: Be a teacher in a 2-5-year-old classroom. * Teacher only: Not pregnant, nor planning to become pregnant in the next year Children: * Be in a classroom with a participating child care teacher. * Be 2-5 years old. * The consenting primary caregiver must be able to read English Exclusion Criteria: Child Care Centers: * Serve only non-English speaking families
Contact & Investigator
Erik Willis, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT05656807 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05656807 currently recruiting?
Yes, NCT05656807 is actively recruiting participants. Contact the research team at reganb@email.unc.edu for enrollment information.
Where is the NCT05656807 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT05656807 clinical trial?
NCT05656807 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Erik Willis, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 924 participants.
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