Evaluation of Child Care Staff Weight Management Program

NCT05656807 | Recruiting DMC

• 2 other identifiers: 22-0257R01DK128174
• Study Type: interventional
• Target: 924
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Children's Diet Quality at Child Care from Baseline to 6 months

  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.

  Baseline and 6 months post-intervention

• Change in Children's Non-sedentary Time at Child Care from Baseline to 6 months

  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.

  Baseline and 6 months post-intervention

Secondary Outcomes (7)

• Change in Children's Diet Quality at Child Care from 6 to 12 months

  6 months post-intervention and 12 months post-intervention

• Change in Children's Non-sedentary Time at Child Care from 6 to 12 Months

  6 months post-intervention and 12 months post-intervention

• Change in Child Care Providers Diet Quality

  Baseline through 12 months post intervention

• Change in Child Care Providers Physical Activity

  Baseline through 12 months post intervention

• Change in Child Care Providers weight

  Baseline through 12 months post intervention

Study Arms (2)

Go NAPSACC

ACTIVE COMPARATOR

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.

Behavioral: Go NAPSACC

Go NAPSACC Enhanced

EXPERIMENTAL

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.

Behavioral: Go NAPSACC Enhanced

Interventions

Go NAPSACC Enhanced BEHAVIORAL

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.

Also known as: Go NAPSACC Cares

Go NAPSACC Enhanced

Go NAPSACC BEHAVIORAL

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.

Go NAPSACC

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Child Care Centers:
• Serve only non-English speaking families

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Center for Health Promotion and Disease Prevention

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

RECRUITING

Related Publications (1)

• Willis EA, Burney R, Hales D, Ilugbusi LO, Tate DF, Nezami B, Clarke EC, Moore RH, Mathews E, Thompson M, Beckelheimer B, Ward DS. "My wellbeing-their wellbeing "- An eHealth intervention for managing obesity in early care and education: Protocol for the Go NAPSACC Cares cluster randomized control trial. PLoS One. 2023 Jul 7;18(7):e0286912. doi: 10.1371/journal.pone.0286912. eCollection 2023.

  PMID: 37418363 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity; Body Weight

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Erik Willis, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regan V Burney, PhD

CONTACT

336-971-7459; reganb@email.unc.edu

Erik Willis, PhD

CONTACT

704-541-4951; erik.willis@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: January 18, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning at 9 months and continuing for 36 months following publication.
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC-CH.

Locations

US (1)