Recruiting

Resilience & Physical Activity

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06919952

Conditions

Resilience

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Resilience

Physical Activity

Study Details

Brief summary:

The goal of this 15-month cluster clinical trial is to compare a resilience and stress management program to a physical activity program for early childhood education (ECE) staff on change in well-being. It will also look to see if changes in well-being continue over time.

The study sample will include 80 child care centers. Including 80 ECE center directors and approximately 560 ECE center staff.

Some ECE centers will receive only the remotely delivered Resilience program. This program works with ECE staff and helps them recognize and strengthen their resilience assets and resources. Other ECE centers will receive only the remotely delivered Physical Activity program that will focus on staff physical activity habits and strength training.

There will be 3 months of active program participation and 12 months of a maintenance period where participants will only have access to program materials.

Conditions

Resilience

Study ID

NCT06919952

Start date

Aug 11, 2025

Status verified date

Sep, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Child Care Centers

  • Licensed with no plans to close in the next 2 years
  • Been in operation for at least 1 year
  • Has at least 4 employees

ECE Staff

  • Must be at least 18 years old
  • Be able to read and speak English
  • Must have access to an online resource (e.g., smartphone, tablet, computer)
  • Must be willing to receive text messages

Exclusion Criteria:

  • None

Study Design

Enrollment

640 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Resilience

Centers randomized to Resilience will receive the Stress Management And Resilience Training program. Participating staff will be led through the program by a behavioral health counselor for 3 months. This counselor will orient participants to the Resilience program and the 4 modules. The counselor will also provide 4 coaching calls with directors (at the start of each module). Additionally, the counselor will provide a webinar every 3 weeks (at the end of each module) to all participants. Participants will have access to video lessons and resources. They will receive weekly reminders and encouragement through text messages.

active comparator: Physical Activity

Centers randomized to the control arm will receive a physical activity program. Participating staff will be led through the program by a behavioral health counselor for 3 months. This counselor will orient participants to the physical activity program and the 4 modules. The counselor will also provide 4 coaching calls with directors (at the start of each module). Additionally, the counselor will provide a webinar every 3 weeks (at the end of each module) to all participants. Participants will have access to video lessons and resources. They will receive weekly reminders and encouragement through text messages.

Interventions

Resilience

The Resilience program focuses on drawing on resilience assets and resources, both internal and external. Participants will have access to materials (e.g., lessons, videos, webinars, coaching calls) supporting the adoption of strategies for improving well-being. Behavior change strategies used are meant to increase intervention adherence and improve well-being and resilience.

Physical Activity

The Physical Activity program focuses on supporting physical activity health habits. Participants will have access to materials (e.g., lessons, videos, webinars, coaching calls) supporting the adoption of strategies of evidence-based strategies for physical activity goals. Behavior change strategies used are meant to help establish, improve or maintain healthy physical activity habits.

Primary outcome measure

  • Change in Resilience from Baseline to 3 months [ Time Frame: Baseline and 3 months ]

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:

Derek Hales, PhD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • child care provider well-being
  • child care centers
  • early childhood education
  • physical activity
  • resilience
  • 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 University of North Carolina, Chapel Hill on 2026-09-08.