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Clinical Trials/NCT06579079
NCT06579079Active, not recruitingNot Applicable

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

Temple University1 site in 1 country1,000 target enrollmentStarted: February 20, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
1,000
Locations
1
Primary Endpoint
School Meal Participation

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
11 Years to 99 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Implementation Strategy - Intervention Condition

Experimental

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).

Intervention: Implementation Mapping (Other)

Waitlist Control

Active Comparator

Schools in the waitlist control will wait 1 academic year before developing and testing an implementation strategy (1-year pilot)

Intervention: Waitlist Comparison - Implementation Mapping (Other)

Outcomes

Primary Outcomes

School Meal Participation

Time Frame: Throughout study completion

Counts to calculate number of students who participate in breakfast and lunch each day will be generated and totaled for each school.

Qualitative Interviews

Time Frame: 1 year

Focus group interviews with students, parents, teachers, administration, and food service staff.

Implementation Mapping Self-Assessment

Time Frame: 1 year

Self-assessment to document fidelity to implementation mapping procedures.

Implementation Cost Measure

Time Frame: 1 Year

A survey developed through stakeholder interviews to calculate costs of implementation will be completed by schools.

Implementation Outcomes Surveys

Time Frame: 1 Year

Implementation outcomes of perceived acceptability, feasibility, and sustainability of the implementation strategy will be assessed through surveys completed by school stakeholders

Secondary Outcomes

  • Height(Baseline and 1 year)
  • Food Insecurity(Baseline and 1 year)
  • Dietary Behaviors(Baseline and 1 year)
  • Student Weight(Baseline and 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gabriella McLoughlin

Assistant Professor

Temple University

Study Sites (1)

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