Clinical trial NCT06579079: Improving Participation in Universal School Meals (USM)
Official title: A Hybrid Type III Implementation-effectiveness Trial to Improve Implementation and Participation of Universal School Meals (USM)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Food Deprivation
Obesity, Childhood
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: The School District of Philadelphia
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-08-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 11
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: School Meal Participation
timeFrame: Throughout study completion
measure: Qualitative Interviews
timeFrame: 1 year
measure: Implementation Mapping Self-Assessment
timeFrame: 1 year
measure: Implementation Cost Measure
timeFrame: 1 Year
measure: Implementation Outcomes Surveys
timeFrame: 1 Year
Secondary outcomes:
measure: Height
timeFrame: Baseline and 1 year
measure: Food Insecurity
timeFrame: Baseline and 1 year
measure: Dietary Behaviors
timeFrame: Baseline and 1 year
measure: Student Weight
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
References: