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OpenTrials
Completed

NCT Number: NCT05507866

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

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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences Northwest

Springdale, Arkansas, 72762, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

CSNEI

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.

Primary outcomes

  1. Change in student body mass index (BMI) z-score

    Time frame: Baseline; 3 years post-intervention; 5 years post-intervention

    Student BMI data will be provided by the Arkansas School BMI Database. Changes in BMI z-score will be assessed from baseline to each follow-up time point.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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