An interventional study of Implementation Mapping and Waitlist Comparison - Implementation Mapping in Food Deprivation and Obesity, Childhood, sponsored by Temple University. Active, not recruiting at 1 site in United States. Open to participants aged 11 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Temple University · Not applicable, Interventional, and Prevention
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.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Other: Implementation Mapping
Schools in the waitlist control will wait 1 academic year before developing and testing an implementation strategy (1-year pilot)
Other: Waitlist Comparison - Implementation Mapping
Implementation mapping is a stakeholder-driven process whereby researchers and practitioners work together to develop an implementation strategy.
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.
School Meal Participation
Counts to calculate number of students who participate in breakfast and lunch each day will be generated and totaled for each school.
Time frame: Throughout study completion
Qualitative Interviews
Focus group interviews with students, parents, teachers, administration, and food service staff.
Time frame: 1 year
Implementation Mapping Self-Assessment
Self-assessment to document fidelity to implementation mapping procedures.
Time frame: 1 year
Implementation Cost Measure
A survey developed through stakeholder interviews to calculate costs of implementation will be completed by schools.
Time frame: 1 Year
Implementation Outcomes Surveys
Implementation outcomes of perceived acceptability, feasibility, and sustainability of the implementation strategy will be assessed through surveys completed by school stakeholders
Time frame: 1 Year
Height
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.
Time frame: Baseline and 1 year
Food Insecurity
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.
Time frame: Baseline and 1 year
Dietary Behaviors
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.
Time frame: Baseline and 1 year
Student Weight
Student weight (pounds) is collected by school nurses and other professionals in the school district. These data are a secondary outcome to implementation outcomes.
Time frame: Baseline and 1 year
Plan to share: Yes — Data elements: 1) Individual linked integrated database containing up to \~1000 records from the School District of Philadelphia from 2024-2027; 2) up to \~100 interview recordings and transcripts conducted with students in middle (6-8) and high (9-12) school grades, teachers, food service staff/personnel, administrators, and other staff; 3) up to \~30-50 survey entries to capture implementation outcomes of acceptability, feasibility, cost, and sustainability. 1) Data are accessible only to the study team through an existing data license agreement between Temple University and the School District of Philadelphia. We do not anticipate the ability to preserve and share these data. 2) Transcripts will be de-identified and any potentially revealing information will be removed prior to sharing. 3) Survey data will be de-identified and any potentially revealing information will be removed prior to sharing.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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