Temple University
Philadelphia, Pennsylvania, 19122, United States
NCT Number: NCT06579079
The purpose of this study is to assess the impact of an implementation strategy on participation in Universal School Meals (USM).
This study is active but is not currently recruiting participants.
11 year–99 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19122, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 1 year
Focus group interviews with students, parents, teachers, administration, and food service staff.
Time frame: 1 year
Self-assessment to document fidelity to implementation mapping procedures.
Time frame: 1 Year
A survey developed through stakeholder interviews to calculate costs of implementation will be completed by schools.
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
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.
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.
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.
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.
Temple University
Other
A Hybrid Type III Implementation-effectiveness Trial to Improve Implementation and Participation of Universal School Meals (USM)
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.
Published trials that share one or more normalized conditions with this study.
NCT07042243
Behavior, Behavior, Animal
Gainesville, Florida, United States
View Trial DetailsNCT04832243
Food Deprivation, Water Deprivation
Mbarara, Uganda
View Trial DetailsNCT05472441
Diabetes Mellitus, Diabetes Mellitus, Type 2
Columbus, Ohio, United States
View Trial DetailsNCT04933305
Bariatric Surgery, Behavior
Zurich, Switzerland
View Trial Details