- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arkansas
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Springdale, Arkansas, United States, 72762
- University of Arkansas for Medical Sciences Northwest
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Student currently enrolled at one of the 6 rural public school districts
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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No Intervention: Control
Schools randomized to the control arm will follow their existing nutritional practices.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in student body mass index (BMI) z-score
Time Frame: Baseline; 3 years post-intervention; 5 years post-intervention
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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.
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Baseline; 3 years post-intervention; 5 years post-intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher R Long, PhD, UAMS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 273437
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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