Evaluation of a Comprehensive School Nutrition Enrichment Intervention (CSNEI) in Rural School Districts

NCT ID: NCT05507866

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 11536 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2026-06-30

Brief Summary

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 partnered with 6 rural Arkansas school districts which to evaluate the effects of an evidence-based population-level intervention designed to improve the nutritional quality of food served in schools.

The primary research question is: "Compared with similar school districts that did not implement the CSNEI, does the CSNEI intervention yield improved obesity prevention outcomes among rural K-12 students?" 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. The evaluation will include ~11,500 students in 6 school districts: ~5,750 from CSNEI school districts and ~5,750 from matched comparison school districts. The study will explore heterogeneity of treatment effects for age and economic standing to understand effects on populations with higher contextual risk for obesity. Baseline data collection will take place prior to implementation (Year 1), and follow-up data will be collected annually thereafter (Years 2-4). The specific aims are: Aim 1.A: Evaluate the effects of a CSNEI on students' relative BMI change over time. Aim 1.B: Evaluate the short-term and long-term effects of a CSNEI on the nutritional quality of food served in school meals. Aim 1.C: Evaluate the short-term and long-term effects of a CSNEI on students' consumption of food served in school meals. Aim 1.D: Evaluate the short-term and long-term effects of a CSNEI on students' skin carotenoid levels, as an indicator of fruit and vegetable intake.

Conditions

Obesity, Childhood; Nutrition, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CSNEI

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 Type: EXPERIMENTAL

CSNEI

Intervention Type: OTHER

CSNEI is a policy intervention designed to address childhood obesity by modifying lunch and breakfast meal/menu items, changing the school cafeteria environments, and making changes to purchasing and procurement practices.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CSNEI

CSNEI is a policy intervention designed to address childhood obesity by modifying lunch and breakfast meal/menu items, changing the school cafeteria environments, and making changes to purchasing and procurement practices.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• N/A

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher R Long, PhD

Role: PRINCIPAL_INVESTIGATOR

UAMS

Locations

University of Arkansas for Medical Sciences Northwest

Springdale, Arkansas, United States

Countries

United States

Other Identifiers

273437

Identifier Type: -

Identifier Source: org_study_id