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Active, Not Recruiting

NCT Number: NCT06579079

Improving Participation in 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

11 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple University

Philadelphia, Pennsylvania, 19122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implementation Mapping

Other

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

Waitlist Comparison - Implementation Mapping

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.

Primary outcomes

  1. 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.

  2. Qualitative Interviews

    Time frame: 1 year

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

  3. Implementation Mapping Self-Assessment

    Time frame: 1 year

    Self-assessment to document fidelity to implementation mapping procedures.

  4. Implementation Cost Measure

    Time frame: 1 Year

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

  5. 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

  1. Height

    Time frame: Baseline and 1 year

    Student height (feet, inches) is collected by school nurses and other professionals in the school district. These data are a secondary outcome to implementation outcomes.

  2. Food Insecurity

    Time frame: Baseline and 1 year

    The 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.

  3. Dietary Behaviors

    Time frame: Baseline and 1 year

    Students 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.

  4. Student Weight

    Time frame: Baseline and 1 year

    Student weight (pounds) is collected by school nurses and other professionals in the school district. These data are a secondary outcome to implementation outcomes.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • The School District of Philadelphia

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 30, 2024
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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