Improving Participation in Universal School Meals (USM)

A Hybrid Type III Implementation-effectiveness Trial to Improve Implementation and Participation of Universal School Meals (USM)

The purpose of this study is to assess the impact of an implementation strategy on participation in Universal School Meals (USM).

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity, Childhood; Food Deprivation
• Intervention / Treatment: Other: Implementation Mapping; Other: Waitlist Comparison - Implementation Mapping

Detailed Description

The purpose of this cluster randomized trial is to test the effectiveness of an implementation strategy on implementation and student health outcomes of universal school meals (USM). This will be completed by developing and tailoring of an implementation strategy and testing its effectiveness though a cluster randomized design. Primary implementation outcomes of this trial are acceptability, cost, feasibility, penetration, and sustainability. Secondary student health outcomes are changes in diet quality (district-wide survey for students), food insecurity (USDA 6-item screener), and weight status. Exploratory descriptive models will be run to assess differences between intervention and control schools. To provide evidence for approaches in adolescents at highest risk for poor dietary intake, food security, and obesity risk, racial and ethnic minority adolescents from the School District of Philadelphia will comprise the majority of the sample. The principal investigator has just completed a year-long needs assessment with 8 schools across the district. We will aim to recruit 4 schools to be randomized to 1 of 2 conditions. Recruitment is underway, final recruitment details will be added once randomization is complete. From these schools, we aim to randomize (2 intervention; 2 waitlist comparison) for the development and tailoring of an implementation strategy. At baseline and throughout the 2-year trial period, we aim to collect interview data and surveys, and analyze data on diet quality, food security, and weight status.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122
      • Temple University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• An elementary/middle or high school within the School District of Philadelphia (SDP) that provides free breakfast and lunch to students
• School is willing to be randomized to either a treatment or waitlist comparison condition
• School has a team of teachers, administration, and food service staff who are willing to complete interviews and surveys for data collection
• School has valid data for student Body Mass Index, meal participation, and food insecurity (parent reported).
• Students currently enrolled in a SDP elementary/middle/high school
• Students willing to participate in an interview and complete surveys
• Students have participated in school meals in the last year.

Exclusion Criteria:

• Charter schools and private schools
• Students not enrolled in school full time; students under 11 years of age.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Waitlist Control; Schools in the waitlist control will wait 1 academic year before developing and testing an implementation strategy (1-year pilot)	Other: Waitlist Comparison - Implementation Mapping; Implementation mapping is a stakeholder-driven process whereby researchers and practitioners work together to develop an implementation strategy. Participating schools receiving this treatment will wait one year before developing an implementation strategy for testing.
Experimental: Implementation Strategy - Intervention Condition; Schools in the intervention condition will be assigned to receive coaching and logistical support to develop and tailor an implementation strategy across 1 academic year. This strategy will then be implemented gradually and in the following academic years (2- year pilot).	Other: Implementation Mapping; Implementation mapping is a stakeholder-driven process whereby researchers and practitioners work together to develop an implementation strategy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
School Meal Participation	Counts to calculate number of students who participate in breakfast and lunch each day will be generated and totaled for each school.	Throughout study completion
Qualitative Interviews	Focus group interviews with students, parents, teachers, administration, and food service staff.	1 year
Implementation Mapping Self-Assessment	Self-assessment to document fidelity to implementation mapping procedures.	1 year
Implementation Cost Measure	A survey developed through stakeholder interviews to calculate costs of implementation will be completed by schools.	1 Year
Implementation Outcomes Surveys	Implementation outcomes of perceived acceptability, feasibility, and sustainability of the implementation strategy will be assessed through surveys completed by school stakeholders	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Student height (feet, inches) is collected by school nurses and other professionals in the school district. These data are a secondary outcome to implementation outcomes.	Baseline and 1 year
Food Insecurity	The United States Department of Agriculture (USDA) 6-item food screening questionnaire is administered to parents across the district. These data are a secondary outcome to implementation outcomes.	Baseline and 1 year
Dietary Behaviors	Students complete a survey each year which records their nutrition behaviors such as fruit and vegetable consumption, sugar-sweetened beverages, and other key behaviors. These data are a secondary outcome to implementation outcomes.	Baseline and 1 year
Student Weight	Student weight (pounds) is collected by school nurses and other professionals in the school district. These data are a secondary outcome to implementation outcomes.	Baseline and 1 year

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); The School District of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: #28959

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data elements: 1) Individual linked integrated database containing up to ~1000 records from the School District of Philadelphia from 2024-2027; 2) up to ~100 interview recordings and transcripts conducted with students in middle (6-8) and high (9-12) school grades, teachers, food service staff/personnel, administrators, and other staff; 3) up to ~30-50 survey entries to capture implementation outcomes of acceptability, feasibility, cost, and sustainability.

1) Data are accessible only to the study team through an existing data license agreement between Temple University and the School District of Philadelphia. We do not anticipate the ability to preserve and share these data. 2) Transcripts will be de-identified and any potentially revealing information will be removed prior to sharing. 3) Survey data will be de-identified and any potentially revealing information will be removed prior to sharing.

• IPD Sharing Time Frame: The data will be made available prior to publication of the first manuscript and will be made available open access until 10 years following the end of the trial period.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No