Improving Participation in Universal School Meals (USM)

NCT ID: NCT06579079

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2028-01-31

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.

Conditions

Food Deprivation; Obesity, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Implementation Mapping

Intervention Type: OTHER

Implementation mapping is a stakeholder-driven process whereby researchers and practitioners work together to develop an implementation strategy.

Waitlist Control

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

Group Type: ACTIVE_COMPARATOR

Waitlist Comparison - Implementation Mapping

Intervention Type: OTHER

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.

Interventions

Implementation Mapping

Implementation mapping is a stakeholder-driven process whereby researchers and practitioners work together to develop an implementation strategy.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The School District of Philadelphia

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Gabriella McLoughlin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Temple University

Philadelphia, Pennsylvania, United States

Countries

United States

References

McLoughlin GM, Smith A, Dopp AR, Jones R, Martinez O, Kumanyika S, Yucel R, Brownson RC, Fisher JO. Using implementation mapping to optimize the impact of Universal School meals: a type III hybrid implementation-effectiveness study protocol. Implement Sci Commun. 2025 Oct 1;6(1):97. doi: 10.1186/s43058-025-00769-y.

Reference Type: DERIVED

PMID: 41034951 (View on PubMed)

Other Identifiers

#28959

Identifier Type: -

Identifier Source: org_study_id