Weight Management Program for Child Care Staff Obesity

Overseen By Erik Willis, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Non-English speaking families

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

924 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is the Go NAPSACC program safe for humans?

The Go NAPSACC program, which focuses on improving nutrition and physical activity in child care settings, has been successfully implemented in various locations without any reported safety concerns. It is designed to promote healthy habits in children and has been adopted widely, suggesting it is safe for use in these environments. ^{1 2 3 4 5}

How is the Go NAPSACC Enhanced treatment different from other treatments for child care staff obesity?

Go NAPSACC Enhanced is unique because it focuses on improving nutrition and physical activity policies and practices in child care settings, aiming to influence the environment where children and staff interact. Unlike other treatments that might focus solely on individual behavior change, this program targets the broader environment to promote healthy weight behaviors. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Go NAPSACC for weight management in child care staff?

Research shows that the Go NAPSACC program helps improve healthy eating and physical activity practices in child care settings, which can lead to better weight management. Studies have found that similar interventions improve children's body mass index (BMI), suggesting potential benefits for adults in similar environments. ^{1 2 3 4 8}

Who Is on the Research Team?

Erik Willis, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for child care centers that have been operating for at least a year, serve lunch to kids, and are open year-round. It includes directors and teachers of 2-5-year-old classrooms who aren't pregnant or planning pregnancy soon. Children in these classes with English-reading caregivers can join too.

Inclusion Criteria

Been in operation for at least 1 year

Child Care Centers: Be open year-round

I am a teacher for children aged 2-5.

Exclusion Criteria

Child Care Centers: Serve only non-English speaking families

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Child care centers are randomized to either the standard Go NAPSACC or Go NAPSACC Enhanced program. The intervention focuses on improving dietary and physical activity behaviors in children and child care providers.

6 months

Monthly check-ins with center directors

Follow-up

Participants are monitored for changes in diet quality and physical activity behaviors post-intervention.

6 months

Data Collection

Data on dietary intake, physical activity, and environmental scores are collected at baseline, 6 months, and 12 months.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Go NAPSACC
• Go NAPSACC Enhanced

Trial Overview The study tests if an online weight management program (Go NAPSACC Enhanced) for child care providers leads to better diet and activity levels in preschoolers compared to just the Go NAPSACC program which focuses on center-wide health improvements.

How Is the Trial Designed?

Group I: Go NAPSACC Enhanced Experimental Treatment 1 Intervention

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.

Group II: Go NAPSACC Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The NAP SACC intervention, implemented over seven months in 17 child care centers, significantly improved nutrition and physical activity knowledge among 137 child care providers and parents, leading to better center-level policies.

The intervention also resulted in a reduction in children's body mass index (BMI) among 209 children, demonstrating its effectiveness in addressing obesity in preschool-age children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and physical activity randomized control trial in child care centers improves knowledge, policies, and children's body mass index. Alkon, A., Crowley, AA., Neelon, SE., et al.[2023]

The study will evaluate the effectiveness of the Go NAPSACC intervention in promoting healthy eating and physical activity in approximately 485 children aged 3-4 years across 97 child care centers, comparing a basic implementation approach to an enhanced one.

It is hypothesized that the enhanced implementation approach will lead to greater improvements in the adoption and maintenance of evidence-based practices, as well as better outcomes in children's eating and physical activity behaviors, highlighting the importance of tailored support in health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of basic vs. enhanced Go NAPSACC on child care centers' healthy eating and physical activity practices: protocol for a type 3 hybrid effectiveness-implementation cluster-randomized trial. Vaughn, AE., Studts, CR., Powell, BJ., et al.[2023]

The Go NAP SACC intervention significantly improved best practices in physical activity and outdoor play in 201 family child care homes in Nebraska, with 85% of physical activity items and 80% of outdoor play items showing improvement after the program.

While the intervention was effective, further research is necessary to confirm whether these changes led to actual increases in children's physical activity levels and to develop resources tailored to specific geographic areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the Physical Activity and Outdoor Play Environment of Family Child Care Homes in Nebraska Through Go Nutrition and Physical Activity Self-Assessment for Child Care. Dinkel, D., Dev, D., Guo, Y., et al.[2019]

The NAP SACC intervention, aimed at improving diet and physical activity in child-care settings, was implemented with 30 health professionals and 84 child-care centers over a 6-month period, but the overall results showed no significant impact on obesity levels in children.

Exploratory analyses indicated potential benefits in centers that fully engaged with the program, suggesting that the effectiveness of the intervention may depend on the fidelity of implementation and the specific outcome measures used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and physical activity in child care: results from an environmental intervention. Ward, DS., Benjamin, SE., Ammerman, AS., et al.[2015]

The integration of the Healthy Apple Program (HAP) with public health nursing services led to a significant increase in children's exposure to best practices for nutrition and physical activity, with 60% of children in HAP centers participating compared to only 19% in delayed centers.

Children in HAP centers experienced a greater reduction in BMI percentile and z-score, indicating improved body weight management, with mean changes of -2.6 and -0.08 respectively, compared to those in delayed centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy apple program to support child care centers to alter nutrition and physical activity practices and improve child weight: a cluster randomized trial. Stookey, JD., Evans, J., Chan, C., et al.[2020]

The NAP SACC program, aimed at improving nutrition and physical activity in child care centers, has been successfully adopted in Maine, indicating effective implementation of health initiatives.

Improvements were particularly noted in the policies and offerings related to healthier food options in child care settings, benefiting over half of U.S. children aged 3 to 6 years enrolled in such centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notes from the field: the evaluation of Maine Nutrition and Physical Activity Self-Assessment for Child Care (NAPSACC) experience. Martin, SL., Martin, MW., Cook, B., et al.[2016]

The NAP SACC program was implemented at 15 Head Start sites on an American Indian reservation to address the high risk of overweight and obesity among low-income American Indian preschoolers.

This evidence-based intervention aims to improve nutrition and physical activity practices in child care centers, promoting healthier weight development for children aged 2-5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NAP SACC: Implementation of an Obesity Prevention Intervention in an American Indian Head Start Program. Mattingly, JA., Andresen, PA.[2019]

The NAP SACC program is a novel intervention designed to improve nutrition and physical activity in child care settings, developed through extensive research including interviews, focus groups, and literature reviews.

This program has garnered broad interest and shows potential for effective implementation across various child care environments, aiming to promote healthy weight behaviors among young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intervention to promote healthy weight: Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) theory and design. Ammerman, AS., Ward, DS., Benjamin, SE., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Nutrition and physical activity randomized control trial in child care centers improves knowledge, policies, and children's body mass index. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The impact of basic vs. enhanced Go NAPSACC on child care centers' healthy eating and physical activity practices: protocol for a type 3 hybrid effectiveness-implementation cluster-randomized trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Improving the Physical Activity and Outdoor Play Environment of Family Child Care Homes in Nebraska Through Go Nutrition and Physical Activity Self-Assessment for Child Care. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Nutrition and physical activity in child care: results from an environmental intervention. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Healthy apple program to support child care centers to alter nutrition and physical activity practices and improve child weight: a cluster randomized trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Notes from the field: the evaluation of Maine Nutrition and Physical Activity Self-Assessment for Child Care (NAPSACC) experience. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

NAP SACC: Implementation of an Obesity Prevention Intervention in an American Indian Head Start Program. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

An intervention to promote healthy weight: Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) theory and design. [2022]