A Hybrid Type III Implementation-effectiveness Trial to Improve Implementation and Participation of Universal School Meals (USM)
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
- 是
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
Gabriella McLoughlin
Assistant Professor
Temple University
