A Hybrid Type III Implementation-effectiveness Trial to Improve Implementation and Participation of Universal School Meals (USM)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Temple University
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- School Meal Participation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 11 Years to 99 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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).
Intervention: Implementation Mapping (Other)
Waitlist Control
Schools in the waitlist control will wait 1 academic year before developing and testing an implementation strategy (1-year pilot)
Intervention: Waitlist Comparison - Implementation Mapping (Other)
Outcomes
Primary Outcomes
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.
Qualitative Interviews
Time Frame: 1 year
Focus group interviews with students, parents, teachers, administration, and food service staff.
Implementation Mapping Self-Assessment
Time Frame: 1 year
Self-assessment to document fidelity to implementation mapping procedures.
Implementation Cost Measure
Time Frame: 1 Year
A survey developed through stakeholder interviews to calculate costs of implementation will be completed by schools.
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
- Height(Baseline and 1 year)
- Food Insecurity(Baseline and 1 year)
- Dietary Behaviors(Baseline and 1 year)
- Student Weight(Baseline and 1 year)
Investigators
Gabriella McLoughlin
Assistant Professor
Temple University
