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Active Not RecruitingNCT06579079

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
Phase
N/A
Study type
Interventional
Enrollment
1,000 (estimated)
Sponsor
Temple University · Academic / Other
Sex
All
Age
11 Years – 99 Years
Healthy volunteers
Accepted

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

Interventions

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

Timeline

Start date
2025-02-20
Primary completion
2027-12-01
Completion
2028-01-31
First posted
2024-08-30
Last updated
2025-04-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06579079. Inclusion in this directory is not an endorsement.