NCT05656807 · UNC Lineberger Comprehensive Cancer Center
Evaluation of Child Care Staff Weight Management Program
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Go NAPSACC Enhanced
Centers will receive the Go NAPSACC program as well as an online weight management intervention that focuses on personal weight management strategies. Participants will have access to materials that will support their adoption of evidence-based strategies for their weight management or loss goal. Behavior change strategies used are meant to increase intervention adherence and improve weight loss.
BEHAVIORAL
Go NAPSACC
Go NAPSACC is an online evidence-based behavioral intervention that supports centers as they adopt center-wide healthy weight practices. It anticipates producing change in the child care environment through fostering best practices in center provisions, practices, policies, and professional development around child nutrition and physical activity and in turn foster healthier habits in the children in their care.
Primary outcome measures
Change in Children's Diet Quality at Child Care from Baseline to 6 months
Time frame: Baseline and 6 months post-intervention
Dietary intake of food consumed by 2-5-year-old children will be assessed via the Diet Observation in Child Care (DOCC) by a trained and certified data collector in the 2-5-year old classroom. Dietary intake data will be used to calculate Healthy Eating Index 2015 (HEI2015) scores to produce an estimate of children's diet quality. Scores range from 0-100, where scores closer to 100 indicate higher diet quality.
Change in Children's Non-sedentary Time at Child Care from Baseline to 6 months
Time frame: Baseline and 6 months post-intervention
Physical activity of children 2-5-years old will be assessed by a GT3X+ accelerometer. Children are fitted on the first day of data collection and wear the accelerometer on their non-dominant wrist for 24 hours per day over 7 consecutive days. Cut-points developed for preschool-aged children will be applied to children's accelerometer data to calculate minutes spent in different levels of physical activity (total non-sedentary, sedentary, light, moderate, and vigorous). Non-sedentary time (light, moderate, and vigorous combined) is the primary outcome for this study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chapel Hill, North Carolina
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations