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Improving Participation in Universal School Meals (USM)

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06579079
Enrollment
1000
Registered
2024-08-30
Start date
2025-02-20
Completion date
2028-01-31
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Deprivation, Obesity, Childhood

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.

Interventions

OTHERImplementation Mapping

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

OTHERWaitlist 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.

Sponsors

The School District of Philadelphia
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
11 Years to 99 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Implementation Outcomes Surveys1 YearImplementation outcomes of perceived acceptability, feasibility, and sustainability of the implementation strategy will be assessed through surveys completed by school stakeholders
School Meal ParticipationThroughout study completionCounts to calculate number of students who participate in breakfast and lunch each day will be generated and totaled for each school.
Qualitative Interviews1 yearFocus group interviews with students, parents, teachers, administration, and food service staff.
Implementation Mapping Self-Assessment1 yearSelf-assessment to document fidelity to implementation mapping procedures.
Implementation Cost Measure1 YearA survey developed through stakeholder interviews to calculate costs of implementation will be completed by schools.

Secondary

MeasureTime frameDescription
Food InsecurityBaseline and 1 yearThe 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.
Dietary BehaviorsBaseline and 1 yearStudents 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.
Student WeightBaseline and 1 yearStudent weight (pounds) is collected by school nurses and other professionals in the school district. These data are a secondary outcome to implementation outcomes.
HeightBaseline and 1 yearStudent height (feet, inches) is collected by school nurses and other professionals in the school district. These data are a secondary outcome to implementation outcomes.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026