Evaluation of a Comprehensive School Nutrition Enrichment Intervention (CSNEI) in Rural School Districts
Primary Purpose
Obesity, Childhood, Nutrition, Healthy
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CSNEI
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Childhood
Eligibility Criteria
Inclusion Criteria:
- Student currently enrolled at one of the 6 rural public school districts
Exclusion Criteria:
- N/A
Sites / Locations
- University of Arkansas for Medical Sciences Northwest
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CSNEI
Control
Arm Description
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.
Schools randomized to the control arm will follow their existing nutritional practices.
Outcomes
Primary Outcome Measures
Change in student body mass index (BMI) z-score
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05507866
Brief Title
Evaluation of a Comprehensive School Nutrition Enrichment Intervention (CSNEI) in Rural School Districts
Official Title
Evaluation of a Comprehensive School Nutrition Enrichment Intervention (CSNEI) in Rural School Districts
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Nutrition, Healthy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Matched-pairs cluster-randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11536 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CSNEI
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Schools randomized to the control arm will follow their existing nutritional practices.
Intervention Type
Other
Intervention Name(s)
CSNEI
Intervention Description
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 Outcome Measure Information:
Title
Change in student body mass index (BMI) z-score
Description
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.
Time Frame
Baseline; 3 years post-intervention; 5 years post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Student currently enrolled at one of the 6 rural public school districts
Exclusion Criteria:
- N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R Long, PhD
Organizational Affiliation
UAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences Northwest
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a Comprehensive School Nutrition Enrichment Intervention (CSNEI) in Rural School Districts
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