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临床试验/NCT06579079
NCT06579079进行中(未招募)不适用

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

Temple University2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,000
试验地点
2
主要终点
School Meal Participation

研究概览

简要总结

The purpose of this study is to assess the impact of an implementation strategy on participation in Universal School Meals (USM).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
11 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Charter schools and private schools
  • Students not enrolled in school full time; students under 11 years of age.

结局指标

主要结局

School Meal Participation

时间窗: 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

时间窗: 1 year

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

Implementation Mapping Self-Assessment

时间窗: 1 year

Self-assessment to document fidelity to implementation mapping procedures.

Implementation Cost Measure

时间窗: 1 Year

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

Implementation Outcomes Surveys

时间窗: 1 Year

Implementation outcomes of perceived acceptability, feasibility, and sustainability of the implementation strategy will be assessed through surveys completed by school stakeholders

次要结局

  • Height(Baseline and 1 year)
  • Food Insecurity(Baseline and 1 year)
  • Dietary Behaviors(Baseline and 1 year)
  • Student Weight(Baseline and 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriella McLoughlin

Assistant Professor

Temple University

研究点 (2)

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