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?

This trial aims to determine if an online weight management program for child care staff can enhance the health behaviors of both the staff and the young children they care for. It compares two approaches: one where only center directors use the Go NAPSACC program to improve nutrition and physical activity, and another where both directors and teachers use an enhanced version, Go NAPSACC Enhanced, which includes a weight management program. The goal is to discover if the enhanced program leads to better outcomes in children's diets and activity levels, as well as in teachers' weight and health habits. Centers open for at least a year and serving meals to 2-5-year-olds might be a good fit. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve health outcomes for both children and caregivers.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Go NAPSACC is a well-known program that helps child care providers encourage healthier eating and activity habits in children. Used for over 20 years, it is trusted by many child care centers. Studies have found that Go NAPSACC effectively guides providers in making positive changes without negative effects.

The Go NAPSACC Enhanced program offers all the benefits of the original program and adds a weight management feature for child care providers. This includes self-assessments, personalized goals, and resources to assist with weight management. Although specific safety data for this enhanced version aren't detailed, the long-standing success of the core Go NAPSACC program suggests it is safe and well-tolerated.

In summary, both Go NAPSACC and its Enhanced version aim to improve health habits safely. They focus on creating healthier environments for children and the adults who care for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for managing obesity among child care staff because they offer a structured, supportive approach that is integrated with existing routines. Unlike standard weight management plans that often rely solely on individual effort, Go NAPSACC Enhanced combines goal-setting and self-monitoring with daily tips, weekly reminders, and personalized feedback, all delivered through an online platform. This integration not only focuses on weight goals but also emphasizes diet quality and physical activity, providing a comprehensive health improvement strategy. Additionally, the involvement of health educators and the use of digital tools make the program both interactive and accessible, potentially leading to more sustained behavior changes.

What evidence suggests that this trial's treatments could be effective for improving child care staff obesity and children's health behaviors?

Research has shown that the Go NAPSACC program, one of the study arms, is a promising way to create healthier environments in childcare settings. Studies indicate that it improves nutrition and physical activity in early care programs. In this trial, some centers will receive the Go NAPSACC Enhanced version, which includes a weight management program for staff. This enhanced version aims to improve teachers' weight, diet, and physical activity, potentially leading to better outcomes for both teachers and children. By enhancing the health habits of childcare providers, the program may encourage healthier habits in young children, potentially improving their diet and physical activity levels. ^{1 6 7 8 9}

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 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 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 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 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 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]

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]

Citations

1. snaped.fns.usda.gov snaped.fns.usda.gov/library/intervention/go-napsacc

Go NAPSACC - SNAP-Ed Connection - USDA Go NAPSACC is a direct education and PSE change intervention designed to enhance nutrition and physical activity practices in early care and education programs.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499404606006464

Nutrition and Physical Activity Self-assessment for Child ... Conclusions and Implications. The NAP SACC pilot intervention shows promise as an approach to promote healthy weight environments in preschool settings.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03938103

Evaluation of an Enhanced Delivery Model for Go NAPSACC This study will compare the effectiveness and cost of Basic and Enhanced delivery models for Go NAPSACC on child care centers' use of evidence-based nutrition ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05656807

Evaluation of Child Care Staff Weight Management Program 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6896698/

The impact of basic vs. enhanced Go NAPSACC on child ... This study will examine the cost-effectiveness of two implementation approaches to evaluate whether the added expense of “Enhanced Go NAPSACC” ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10328321/

Protocol for the Go NAPSACC Cares cluster randomized ... Developed over 20 years ago, “Go NAPSACC” is one of the most widely implemented evidence-based childhood obesity prevention initiative [20–24].

7. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-019-0949-4

The impact of basic vs. enhanced Go NAPSACC on child care ... To prevent childhood obesity and promote healthy development, health authorities recommend that child care programs use the evidence-based ...

8. gonapsacc.org gonapsacc.org/

GoNAPSACC Go NAPSACC is an online tool that helps build healthy eating and activity habits in children, guiding providers through 5 steps to make healthy changes.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S149940462200447X

Go NAPSACC On-Demand Trainings for Early Care and ... Twenty-two on-demand nutrition training sessions were developed for Early Care and Education providers and disseminated in 21 states.