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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).
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.
Age
11 - 99 years
Sex
ALL
Healthy Volunteers
Yes
Temple University
Philadelphia, Pennsylvania, United States
Start Date
February 20, 2025
Primary Completion Date
December 1, 2027
Completion Date
January 31, 2028
Last Updated
April 24, 2025
1,000
ESTIMATED participants
Implementation Mapping
OTHER
Waitlist Comparison - Implementation Mapping
OTHER
Lead Sponsor
Temple University
Collaborators
NCT06520787
NCT03516968
NCT06520072
Data Source & Attribution
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