Recruiting

Go NAPSACC vs. Go NAPSACC Enhanced

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT05656807

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

Go NAPSACC Enhanced

Go NAPSACC

Study Details

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.

Conditions

Obesity

Study ID

NCT05656807

Start date

Jan 18, 2023

Status verified date

Mar, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

924 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Go NAPSACC

Centers randomized to Go NAPSACC will receive the traditional Go NAPSACC program. This will include the center director leading the Go NAPSACC effort with support from a Go NAPSACC Implementation advisor. The advisor will orient each center to Go NAPSACC and its online tools and check in monthly with directors as they work through 2 cycles of Go NAPSACC over 6 months. Centers will take self-assessments on nutrition and physical activity, choose 6 goals (3 from each), create action plans, and take action to achieve their chosen goals.

experimental: Go NAPSACC Enhanced

Centers randomized to Go NAPSACC Enhanced will receive the traditional Go NAPSACC program as described in the Active Comparator arm. Additionally, child care providers will simultaneously receive a weight management program, Go NAPSACC Cares over 6 months. The health educator will orient providers with the website and its tools and resources. Providers will take a self-assessment and choose a goal of weight maintenance or weight loss. They will go through 18 lessons with accompanying resources. Within the website they will self-monitor their weight, physical activity, and red foods (diet quality). Providers will receive daily tips, weekly reminders via text message or email, and tailored weekly feedback based on their weight management goals and progress.

Interventions

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.

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 measure

  • Change in Children's Diet Quality at Child Care from Baseline to 6 months [ Time Frame: Baseline and 6 months post-intervention ]
  • Change in Children's Non-sedentary Time at Child Care from Baseline to 6 months [ Time Frame: Baseline and 6 months post-intervention ]

Central Contacts and Locations

Central contacts

Locations

UNC Center for Health Promotion and Disease Prevention

Recruiting

Chapel Hill, North Carolina, United States, 27599-7426

Contacts

Principal Investigator:

Erik Willis, PhD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • child care centers
  • child care provider health
  • nutrition
  • physical activity
  • body weight
  • behavior change

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-03-23.