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临床试验/NCT02746939
NCT02746939撤回不适用

Student Behavior Outcomes in Fitness and Nutrition Integrated Science Education Outreach (InSciEd Out, ISEO)

Mayo Clinic2 个研究点 分布在 1 个国家开始时间: 2016年3月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
Mayo Clinic
试验地点
2
主要终点
Number of participants with completion of ISEO Fitness and Nutrition Curriculum

研究概览

简要总结

The study is designed to examine whether curriculum, designed in partnership with teachers at Moreland Elementary school in West St. Paul and Mayo Clinic InSciEd Out scientists, is able to influence the behavior and health literacy of students. This information will be collected in surveys before and after the students are given the curriculum during the school day.

详细描述

The research will implement a short battery of two survey inventories to measure student outcomes under InSciEd Out Fitness and Nutrition curriculum that is currently administered in 3rd and 4th grade at Lincoln K-8 Choice School. One is a grade-level adapted version of the National Youth Physical Activity and Nutrition Survey (NYPANS) authored by the United States Center for Disease Control (CDC). The other is a grade-level adapted version of the Newest Vital Sign (NVS) health literacy assessment authored by Pfizer and adapted by Dr. Linda Aldoory at the University of Maryland.

These assessments will help inform the health promotion activities of the InSciEd Out partnership within Lincoln K-8 Choice in Rochester, Minnesota (MN) and Moreland Elementary in West St. Paul, MN who originally wrote the curriculum. These assessments will be key to curricular revision and expansion to other schools that partner with InSciEd Out. As such, this study is a single cohort, internally controlled pre-post assessment of an existing behavioral intervention. Pending pilot study success, future follow-up studies are projected to be parallel-group, nonrandomized clinical trials of a treatment school versus a control school with grade levels expansion. This study will inform activities within the InSciEd Out network inside Rochester Public Schools (RPS), where grades Kindergarten through 2nd and 5th through 8th curricula is currently being built. Previously RPS-approved Mayo Clinic Institutional Review Board (IRB) #13-003263 describes the format of InSciEd Out programming in detail, but the general framework of this study operates upon an established partnership between InSciEd Out researchers and Lincoln K-8 Choice/Moreland Elementary administrators, teachers, students, and parents.

IRB#13-003263 describes the format of InSciEd Out programming in detail, but the general framework of this study operates upon an established partnership between InSciEd Out researchers and administration, teachers, and students at Lincoln K-8 Choice Elementary.

研究设计

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

入排标准

年龄范围
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Students attending 3rd and 4th grade classes at Lincoln K-8 Choice Elementary School in Rochester, MN or Moreland Elementary School in West St. Paul, MN who assent to the study

排除标准

  • Students attending 3rd and 4th grade classes at Lincoln K-8 Choice Elementary School in Rochester, MN or Moreland Elementary School in West St. Paul, MN whose parents chose to opt-out of the study or who do not assent to the study

研究组 & 干预措施

Pre-curriculum assessment

No Intervention

Assessments will be administered to 3rd and 4th grade students prior to receiving curriculum training in fitness and nutrition.

Post-curriculum assessment

Experimental

Assessments will be administered to 3rd and 4th grade students (matched from pre-curriculum assessment) after receiving 4-6 week InSciEd Out Fitness and Nutrition Curriculum.

干预措施: InSciEd Out Fitness and Nutrition Curriculum (Behavioral)

结局指标

主要结局

Number of participants with completion of ISEO Fitness and Nutrition Curriculum

时间窗: 9 months

students will undergo 4-6 weeks of ISEO fitness and nutrition curriculum as part of their 3rd or 4th grade coursework. Classroom teachers will decide when to administer the curriculum, but should be completed by January 2017 in our target classrooms.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Pierret

Assistant Professor - Department of Biochemistry and Molecular Biology

Mayo Clinic

研究点 (2)

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