School Nutrition Program for Childhood Obesity

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

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

Compensation: Varies

Number of Visits: Unknown

11536 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Obesity is a significant cause of cancer and cardiovascular disease incidence and mortality, and diabetes incidence among rural communities. Arkansas has the sixth-highest proportion of rural population (\~41%),and has the third-highest obesity prevalence (37.4%) in the nation. Arkansas has the third-highest prevalence of obesity for high school students (22.1%) and the fifth-highest prevalence for children ages 10-17 (20.2%). In Arkansas, children in rural areas have very high rates of both food insecurity (26%) and free and reduced lunch eligibility (72.9%). In the study's 6 participating school districts, free and reduced lunch eligibility ranges from 51.4% to 79.3%. School meals are an important opportunity to influence students' nutritional intake and long-term food preferences, which can reduce obesity. A multidisciplinary team has partnered with 6 rural Arkansas school districts which have agreed to participate in a study to evaluate the effects of an evidence-based population-level policy intervention designed to improve the nutritional quality of food served in schools. The study team will conduct a matched-pairs cluster-randomized trial with pre-test and repeated post-tests in 6 rural Arkansas school districts, 3 implementing CSNEI, and 3 matched comparison school districts following their existing nutritional practices. Baseline data collection will take place prior to implementation (Year 1), and follow-up data will be collected annually thereafter (Years 2-5). The study will compare individual-level change in relative body mass index (adjusted for age and sex) and district-level changes in the nutritional quality of food served, amount of food consumed per diner, and fruit and vegetable intake in school districts implementing the intervention compared to matched comparison districts.

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 School Nutrition Program for Childhood Obesity safe for children?

The research on school nutrition programs, including changes in food policies and practices, generally focuses on improving children's diets and reducing obesity. While specific safety data isn't detailed, these programs aim to promote healthier eating habits, which are typically safe and beneficial for children. ^{1 2 3 4 5}

How does the CSNEI treatment for childhood obesity differ from other treatments?

The CSNEI treatment is unique because it involves a comprehensive school nutrition program that includes parental, school, and home-based components to promote healthy eating habits and reduce obesity in children. Unlike other treatments that may focus solely on diet or exercise, this approach integrates community involvement and educational elements to create a supportive environment for long-term lifestyle changes. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment CSNEI for childhood obesity?

Research shows that school-based programs combining nutrition education, behavior modification, and physical activity can lead to significant weight loss in children. For example, one study found that 95% of children in such a program lost weight, compared to only 21% in a control group, suggesting that similar comprehensive approaches can be effective in reducing childhood obesity. ^{9 11 12 13 14}

Who Is on the Research Team?

Christopher R Long, PhD

Principal Investigator

UAMS

Are You a Good Fit for This Trial?

This trial is for students currently enrolled in one of the six rural public school districts in Arkansas. It aims to address high rates of childhood obesity and poor nutrition, particularly where food insecurity and reliance on free or reduced lunch programs are prevalent.

Inclusion Criteria

Student currently enrolled at one of the 6 rural public school districts

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Baseline data collection will take place prior to implementation

Year 1

Intervention Implementation

Implementation of the CSNEI intervention in selected school districts

3 years

Follow-up

Follow-up data will be collected annually to assess changes in BMI and nutritional quality

Years 2-5

What Are the Treatments Tested in This Trial?

Interventions

• CSNEI

Trial Overview The CSNEI program is being tested to see if it can improve the nutritional quality of food served in schools. The study will compare changes in student body mass index and dietary habits between schools implementing CSNEI and those that do not over a five-year period.

How Is the Trial Designed?

Group I: CSNEI Experimental Treatment 1 Intervention

Schools randomized to receive the CSNEI intervention arm will receive help in addressing childhood obesity by modifying meal/menu items, changing school cafeteria environments, and making changes to purchasing and procurement practices.

Group II: Control Active Control 1 Intervention

Schools randomized to the control arm will follow their existing nutritional practices.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Published Research Related to This Trial

Project Healthy Schools (PHS) has demonstrated significant improvements in health metrics and lifestyle behaviors among middle school students in Michigan, indicating its effectiveness in addressing childhood obesity.

The program's success is linked to collaborative efforts among stakeholders and changes in the school environment, suggesting that such comprehensive approaches can be replicated to combat childhood obesity in other settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Top 10 Lessons Learned from Project Healthy Schools. Rogers, R., Krallman, R., Jackson, EA., et al.[2019]

In a 10-week school-based program involving 63 obese children aged 5 to 12, 95% of participants lost weight, achieving an average weight loss of 4.4 kg and a 15.4% decrease in their percentage overweight.

The program was significantly more effective than no intervention, as only 21% of a control group of obese children lost weight, highlighting the importance of comprehensive behavior modification and support in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based behavior modification, nutrition education, and physical activity program for obese children. Brownell, KD., Kaye, FS.[2018]

The Expanded Food and Nutrition Education Program (EFNEP) was successfully integrated into five medical clinics, with physicians generating 686 referrals and 106 parents participating in the 8-week pediatric obesity prevention intervention.

Parents reported significant improvements in their children's behaviors related to sleep, screen time, physical activity, and nutrition, indicating that the intervention was both feasible and beneficial for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Colocating a Nutrition Education Program into a Medical Clinic Setting to Facilitate Pediatric Obesity Prevention. Shilts, MK., Diaz Rios, LK., Panarella, KH., et al.[2021]

A three-year school-based intervention in a low-income district serving 5,000 children led to a significant decrease in mean BMI percentile from 70.4 to 65.7%, indicating effective weight management among students.

The intervention also resulted in a significant reduction in the number of students categorized as overweight or obese, suggesting that changes in physical activity and nutrition can positively impact childhood obesity rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-Based Obesity Intervention Associated with Three Year Decrease in Student Weight Status in a Low-Income School District. Cadzow, RB., Chambers, MK., Sandell, AM.[2018]

Citations

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

Top 10 Lessons Learned from Project Healthy Schools. [2019]

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

A school-based behavior modification, nutrition education, and physical activity program for obese children. [2018]

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

Making an IMPACT: effect of a school-based pilot intervention. [2015]

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

Feasibility of Colocating a Nutrition Education Program into a Medical Clinic Setting to Facilitate Pediatric Obesity Prevention. [2021]

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

Reducing obesity and related chronic disease risk in children and youth: a synthesis of evidence with 'best practice' recommendations. [2022]

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

Childhood obesity and schools: evidence from the national survey of children's health. [2022]

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

Effects of changes in lunch-time competitive foods, nutrition practices, and nutrition policies on low-income middle-school children's diets. [2013]

8. Croatia pubmed.ncbi.nlm.nih.gov

Addressing childhood overweight through schools. [2009]

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

Comparative risk assessment of school food environment policies and childhood diets, childhood obesity, and future cardiometabolic mortality in the United States. [2021]

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

Improving school breakfasts: effects of the CATCH Eat Smart Program on the nutrient content of school breakfasts. [2015]

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

Improving healthy dietary behaviors, nutrition knowledge, and self-efficacy among underserved school children with parent and community involvement. [2016]

12. Netherlands pubmed.ncbi.nlm.nih.gov

School-Based Obesity Intervention Associated with Three Year Decrease in Student Weight Status in a Low-Income School District. [2018]

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

Exposure to a comprehensive school intervention increases vegetable consumption. [2022]

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

Evaluation of the healthy schools program: Part I. Interim progress. [2022]