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

Sponsor
University of Arkansas (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05507866
Collaborator
(none)
11,536
1
2
52.6
219.3

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: CSNEI
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
11536 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Matched-pairs cluster-randomized trialMatched-pairs cluster-randomized trial
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of a Comprehensive School Nutrition Enrichment Intervention (CSNEI) in Rural School Districts
Actual Study Start Date :
Jan 12, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: 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.

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Student currently enrolled at one of the 6 rural public school districts
Exclusion Criteria:
  • N/A

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Arkansas for Medical Sciences Northwest Springdale Arkansas United States 72762

Sponsors and Collaborators

  • University of Arkansas

Investigators

  • Principal Investigator: Christopher R Long, PhD, UAMS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT05507866
Other Study ID Numbers:
  • 273437
First Posted:
Aug 19, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022